FlexFactory Users Manual 29164188AA

FlexFactory™ Automation
User Manual
Table of Contents
Table of Contents
1 Introduction .......................................................................................................... 6
1.1 About this manual ................................................................................................................................ 7
1.2 Important user information ............................................................................................................. 8
1.3 Associated documentation .............................................................................................................. 10
1.4 Abbreviations .......................................................................................................................................... 12
2 System overview .................................................................................................. 14

2.1 FlexFactory description ..................................................................................................................... 15
2.2 FlexFactory components .................................................................................................................. 16
2.3 FlexFactory overview .......................................................................................................................... 17
3 FlexFactory description ...................................................................................... 18

3.1 Automation and process control ................................................................................................... 19
3.1.1 M-Station OIT ................................................................................................................................... 20
3.1.2 Historian ............................................................................................................................................. 22
3.2 Production equipment ........................................................................................................................ 23
3.2.1 XDR Bioreactor ................................................................................................................................ 24
3.2.2 ReadyToProcess WAVE 25 .......................................................................................................... 26
3.3 Purification equipment ....................................................................................................................... 28
3.3.1 ÄKTA ready ........................................................................................................................................ 29
3.3.2 ÄKTAprocess ..................................................................................................................................... 31
3.3.3 BioProcess NFF Pump System ................................................................................................. 33
3.3.4 UniFlux ................................................................................................................................................ 35
3.4 Supporting equipment ....................................................................................................................... 37
3.4.1 XDUO Mixer ...................................................................................................................................... 38
3.4.2 AxiChrom Master ........................................................................................................................... 40
3.4.3 Temperature control unit (TCU) ................................................................................................ 42
3.4.4 Remote pump .................................................................................................................................. 43
3.4.5 Scale .................................................................................................................................................... 44
3.5 User interface ......................................................................................................................................... 45
3.5.1 Software overview ........................................................................................................................ 46
3.5.2 Wonderware .................................................................................................................................... 47
3.5.3 UNICORN ........................................................................................................................................... 49
4 Wonderware user interface: description ......................................................... 51

4.1 Security levels ......................................................................................................................................... 52
4.2 User interface overview ..................................................................................................................... 58
4.2.1 User interface overview .............................................................................................................. 59
4.2.2 Elements on the overview screen ........................................................................................... 62
4.3 General overview screens ................................................................................................................ 66
4.3.1 PID Faceplates ............................................................................................................................... 67
4.3.2 Alarm Config ................................................................................................................................... 69
4.3.3 Batch Overview ............................................................................................................................. 70
4.3.4 Default PID Setpoint ................................................................................................................... 76
4.4 Flex Info functions ................................................................................................................................ 77
4.4.1 Trending ............................................................................................................................................ 78
2 FlexFactory Automation User Manual 29164188 AA

Table of Contents
4.4.2 Alarm Summary ............................................................................................................................ 80

4.4.3 Alarm History ................................................................................................................................. 84
4.4.4 Platform Status ............................................................................................................................. 87
4.5 General dialog boxes .......................................................................................................................... 88
4.5.1 PID faceplate dialog box ............................................................................................................. 89
4.5.2 Alarm configuration dialog box ............................................................................................... 94
4.5.3 Batch Overview dialog boxes ................................................................................................. 97
5 Wonderware user interface: instruments ....................................................... 101

5.1 XDR Bioreactor ....................................................................................................................................... 102
5.1.1 XDR Bioreactor .............................................................................................................................. 103
5.1.2 Control ............................................................................................................................................... 108
5.2 XDUO Mixer ............................................................................................................................................. 111
5.3 BioProcess NFF Pump System ........................................................................................................ 115
5.4 Remote pumps and scales ............................................................................................................... 119
5.4.1 Remote Pumps ............................................................................................................................... 120
5.4.2 Remote Scales ................................................................................................................................ 121
5.5 ÄKTA ready ............................................................................................................................................... 123
5.6 ÄKTAprocess ............................................................................................................................................ 126
5.7 ReadyToProcess WAVE 25 ................................................................................................................ 130
5.8 UniFlux ....................................................................................................................................................... 134
6 Operate XDR Bioreactor ..................................................................................... 137

6.1 Safety precautions ............................................................................................................................... 138
6.2 XDR Bioreactor interlocks ................................................................................................................. 139
6.3 Start up the system ............................................................................................................................. 142
6.4 Configure control loops ..................................................................................................................... 147
6.4.1 Map a control loop directly to an output device ............................................................... 148
6.4.2 Map a control loop with lookup tables ................................................................................. 156
6.4.3 Map a control loop with split range deadband ................................................................ 168
6.4.4 Map a control loop with split range dead zone ................................................................ 177
6.4.5 Unmap a directly mapped control loop ............................................................................... 188
6.4.6 Unmap a control loop mapped with lookup tables ........................................................ 192
6.4.7 Unmap a control loop mapped with split range deadband ........................................ 198
6.4.8 Unmap a control loop mapped with split range dead zone ....................................... 203
6.5 Manage the disposable bag contents ........................................................................................ 210
6.5.1 Calibrate the pump ....................................................................................................................... 211
6.5.2 Manage pump flow ....................................................................................................................... 215
6.5.3 Manage gas flow ............................................................................................................................ 221
6.5.4 Fill the disposable bag with media ......................................................................................... 232
6.5.5 Use the agitator .............................................................................................................................. 234
6.5.6 Access the control functions ..................................................................................................... 240
6.5.7 Take a sample ................................................................................................................................. 244
6.5.8 Standardize pH probe .................................................................................................................. 248
6.5.9 Calibrate the DO probe with O2 ............................................................................................... 250
6.6 Finish a process run ............................................................................................................................. 255
6.7 Shut down the software .................................................................................................................... 261
FlexFactory Automation User Manual 29164188 AA 3

Table of Contents
7 Operate XDUO Mixer ........................................................................................... 263

7.2 XDUO Mixer interlocks ........................................................................................................................ 265
7.3 Start up the system ............................................................................................................................. 267
7.4 Manage the disposable bag contents ........................................................................................ 272
7.4.1 Manage pump flow ....................................................................................................................... 273
7.4.2 Monitor mixer weight ................................................................................................................... 275
7.4.3 Use the agitator .............................................................................................................................. 277
7.4.4 Control the pH ................................................................................................................................. 284
7.4.5 Access the control functions ..................................................................................................... 288
7.5 Add liquid contents .............................................................................................................................. 292
7.6 Add solid contents ................................................................................................................................ 299
7.7 Complete a run ...................................................................................................................................... 303
7.7.1 Collect the product ........................................................................................................................ 304
7.7.2 Remove the disposable bag ...................................................................................................... 305
7.7.3 Shut down the system ................................................................................................................. 312
8 Operate BioProcess NFF Pump System ............................................................ 314

8.2 Process control mode ......................................................................................................................... 316
8.3 Set BioProcess NFF Pump System interlocks .......................................................................... 317
8.4 Configure the software ...................................................................................................................... 320
8.5 Calibrate flow sensor .......................................................................................................................... 325
8.6 Adjust zero ............................................................................................................................................... 332
8.7 Configure control loops ..................................................................................................................... 335
8.7.1 Control functions ............................................................................................................................ 336
8.7.2 Map to flow control ....................................................................................................................... 337
8.7.3 Map to pressure control .............................................................................................................. 341
8.7.4 Map to flow and pressure control ........................................................................................... 345
8.7.5 Disable the control loop mapping .......................................................................................... 349
8.8 Operate BioProcess NFF Pump System manually ................................................................. 351
8.8.1 Start, stop and prime the pump .............................................................................................. 352
8.8.2 Collect and view flow information .......................................................................................... 361
9 Operate remote devices ..................................................................................... 365

9.1 Operate remote pumps ..................................................................................................................... 366
9.2 Operate scales ....................................................................................................................................... 370
10 View UniFlux, ÄKTA and WAVE instruments .................................................... 372
11 Batch Control function ........................................................................................ 374

11.1 Batch Control function description ............................................................................................. 375
11.1.1 Batch Control overview ............................................................................................................. 376
11.1.2 Batch schedule creation ............................................................................................................. 379
11.2 Prepare the instrument ...................................................................................................................... 381
11.2.1 Prepare XDR Bioreactor .............................................................................................................. 382
11.2.2 Prepare XDUO Mixer ..................................................................................................................... 389
11.2.3 Prepare BioProcess NFF Pump System ................................................................................ 392

Table of Contents
11.3 Create and start a batch for XDR Bioreactor and XDUO Mixer ....................................... 393
11.4 Create a batch for BioProcess NFF Pump System ................................................................ 404
11.5 Modify a batch ....................................................................................................................................... 415
11.6 Manage batch stops ........................................................................................................................... 424
11.6.1 Manage an alarmed batch ........................................................................................................ 425
11.6.2 Hold, abort or restart a batch ................................................................................................... 428
11.6.3 Batch Timer .................................................................................................................................... 431
11.7 Finish a batch ......................................................................................................................................... 433
12 Wonderware general functions ........................................................................ 437

12.1 Enable/Disable function ................................................................................................................... 438
12.2 Alarms and alarming .......................................................................................................................... 441
12.2.1 Description of alarms ................................................................................................................... 442
12.2.2 Set, view and acknowledge alarms ....................................................................................... 445
12.2.3 Use event and alarm logs ........................................................................................................... 450
12.3 Control loop configuration ............................................................................................................... 452
12.3.1 Control loops .................................................................................................................................... 453
12.3.2 Control loop mapping description .......................................................................................... 455
12.3.3 Control loop mapping illustrations ......................................................................................... 458
12.3.4 Intermediate control elements ................................................................................................. 464
12.3.5 Examples of XDR Bioreactor control loop setup .............................................................. 466
12.4 Trending application ........................................................................................................................... 469
12.5 Dream Report ......................................................................................................................................... 475
12.5.1 Dream Report description .......................................................................................................... 476
12.5.2 Create a report template ............................................................................................................ 477
12.5.3 Create and view a report ............................................................................................................ 503
13 Administration ...................................................................................................... 506

13.1 Manage Wonderware software ..................................................................................................... 507
13.1.1 Add and remove users in Wonderware ............................................................................... 508
13.1.2 Wonderware passwords ............................................................................................................ 516
13.2 Manage UNICORN software ............................................................................................................ 518
13.2.1 Add and remove users in UNICORN ....................................................................................... 519
13.2.2 UNICORN passwords .................................................................................................................... 522
13.2.3 UNICORN database management ......................................................................................... 524
13.3 Manage Dream Report application .............................................................................................. 531
13.3.1 Dream Report user authentication ........................................................................................ 532
13.3.2 Manage project access ................................................................................................................ 536
13.4 Software security .................................................................................................................................. 541
Index ....................................................................................................................... 543

1 Introduction
1 Introduction
About this chapter

This chapter contains important user information about FlexFactory.
In this chapter
Section See page
1.1 About this manual 7
1.2 Important user information 8
1.3 Associated documentation 10
1.4 Abbreviations 12

1 Introduction
1.1 About this manual
1.1 About this manual
Purpose of this manual

The User Manual provides the users (operator, Supervisor, and Engineer) with general
information of FlexFactory, its main additional components, and its operating software.
The User Manual provides instructions how to manage the operating units of FlexFactory
via the central control system in a safe way.
Scope of this manual

This manual covers the FlexFactory operating units and software packages
(Wonderware™ and UNICORN™) needed to operate FlexFactory.
Detailed information about each operating unit and UNICORN is available in separate
manuals.
Typographical conventions
Hardware items on the instrument, controls on the computer or keyboard are shown in
the text in the bold regular typeface (for example, Power).
Software items are shown in the text in the bold italic typeface (for example, Batch
Timer).
Menu paths are shown in a bold italic typeface with a separating colon between each
level. For example, File:Open refers to the Open command on the File menu.
Text that the user must either type exactly as shown in the manual, or that the software
displays as a response (not a regular part of the graphic user interface), is shown by a
monospaced typeface (for example, Recipe Information).

1 Introduction
1.2 Important user information
Read this before operating

FlexFactory
All users must read the entire User Manual before operating or maintaining the
product.
Always keep the User Manual at hand when operating the product.
Do not operate the product in any other way than described in the user documentation.
If you do, you may be exposed to hazards that can lead to personal injury and you may
cause damage to the equipment.
Intended use of FlexFactory

Xcellerex™ FlexFactory is a flexible and configurable biomanufacturing platform providing
a complete production train from cell culture to drug substance formulation.
FlexFactory is not a medical device and should not be used for diagnostic purposes in
any clinical or in vitro procedures.
FlexFactory is operated using software packages (Wonderware and UNICORN).
Prerequisites
In order to operate FlexFactory in a safe way and according to its intended use, the fol-
lowing prerequisites must be fulfilled:
• You should be acquainted with the use of general biomanufacturing equipment and
with handling of biological materials.
• The system must be installed by a GE representative.
• A working knowledge of how to use Wonderware software is required.
• Supervisors and Engineers must be familiar with basic operations in Microsoft®
Windows® operating system.

1 Introduction
Safety notices
This user documentation contains safety notices (WARNING, CAUTION, and NOTICE)
concerning the safe use of the product. See definitions below.
WARNING
WARNING indicates a hazardous situation which, if not avoided,
could result in death or serious injury. It is important not to proceed
until all stated conditions are met and clearly understood.
CAUTION
CAUTION indicates a hazardous situation which, if not avoided,
could result in minor or moderate injury. It is important not to pro-
ceed until all stated conditions are met and clearly understood.
NOTICE
NOTICE indicates instructions that must be followed to avoid
damage to the product or other equipment.
Notes and tips

Note: A note is used to indicate information that is important for trouble-free and
optimal use of the product.
Tip: A tip contains useful information that can improve or optimize your procedures.

1 Introduction
1.3 Associated documentation
Introduction
This section describes the user documentation that is delivered with FlexFactory.
System-specific documentation
In addition to the User Manual, the documentation package supplied with FlexFactory
also includes product documentation binders, containing drawings, specifications, and
quality documents.
User documentation
The table below describes the user documentation for FlexFactory, which is available
as printed books, in electronic form (PDF file), or from the Help menu in UNICORN.
Document Main contents
FlexFactory User Manual Instructions on how to operate FlexFactory, and the

operating units included in FlexFactory, in a safe way.
Detailed description of Wonderware functions rele-
vant for FlexFactory. Instructions on administration
of FlexFactory.
XDR Bioreactor Operating Instructions on how to install, operate and maintain

Instructions XDR in a safe way.
XDUO Mixer Operating In- Instructions on how to install, operate and maintain
structions XDUO in a safe way.
ReadyToProcess WAVE™ 25 Instructions needed to install, operate and maintain

Operating Instructions ReadyToProcess WAVE 25 in a safe way. Includes
basic UNICORN system control functions.
ReadyToProcess WAVE 25 Detailed system descriptions and instructions on how

System Handbook to run, maintain and troubleshoot ReadyToProcess
WAVE 25. Includes UNICORN system control functions,
method creation and handling, together with evalua-
tion and presentation of data.
ÄKTAprocess™ Operating Instructions on how to install, operate and maintain

Instructions ÄKTAprocess in a safe way.

1 Introduction
Document Main contents
ÄKTA™ ready Operating In- Instructions on how to install, operate and maintain
structions ÄKTA ready in a safe way.
UniFlux™ System Operating Instructions on how to install, operate and maintain

Instructions UniFlux in a safe way.
BioProcess™ NFF Pump Sys- Instructions on how to install, operate and maintain
temOperating Instructions BioProcess NFF Pump System in a safe way.
AxiChrom™ 300-1000 Instructions on how to install, operate and maintain

columns Operating Instruc- AxiChrom 300-1000 columns in a safe way, including
tions instructions for AxiChrom Master.
UNICORN manual package • The manuals contain detailed instructions on how

to administer UNICORN, work with methods, per-
form runs and evaluate results.
• The Online help contains dialog descriptions for
UNICORN. The Online help is accessed from the
Help menu.
Wonderware user documen- The manuals contain descriptions of components of

tation package 1 the software, and provide detailed instructions on
how to use the software.
1 The documentation is located in the Server Rack, on the Historian (HST-1) server.

1 Introduction
1.4 Abbreviations
1.4 Abbreviations
The following terms and abbreviations are used in FlexFactory Automation User Manual:
Term/Abbreviation Definition
CIP Cleaning-in-place
Cleaning of the system using chemicals, heat, and water
without disassembling the system.
CV controlled variable
The output from the PID controller, or a manually set value
that controls the process variable.
CVHL controlled variable high limit
CVLL controlled variable low limit
DB deadband
1 An interval of a signal where no action occurs (the

system is dead).
2 Type of split range (an intermediate control element of
Wonderware) that sends the signal directly to an output
device.
DZ dead zone
Type of split range (an intermediate control element of
Wonderware) that sends the signal to an output device
through a lookup table (an intermediate control element).
DO dissolved oxygen
HMI user interface (human machine interface)
I/O Cabinet Input/Output Cabinet
MFC Mass Flow Controller
NFF normal flow filtration
OIT operator interface terminal
PID proportional integral derivative

A PID controller calculates an error value as the difference
between a measured process variable (PV) and a designat-
ed setpoint (SP). The PID controller attempts to minimize
the error by adjusting the process control inputs (adjusting
CV).

1 Introduction
1.4 Abbreviations
Term/Abbreviation Definition
PLC programmable logic controller
PV process variable
The actual measurement of the parameter.
SAT Site Acceptance Test
SCADA supervisory control and data acquisition
SLPM standard liters per minute
SP setpoint
The process target value that an automatic control system,
for example PID controller, attempts to reach by adjusting
the process control inputs.
SPHL setpoint high limit
SPLL setpoint low limit
TCU temperature control unit
UPS uninterruptible power supply

A UPS can postpone power failure, which allows time for
a controlled shut-down of the relevant system and prevents
data loss.

2 System overview
2 System overview
About this chapter

This chapter provides a general description of FlexFactory and an overview of the
FlexFactory setup.
In this chapter
Section See page
2.1 FlexFactory description 15
2.2 FlexFactory components 16
2.3 FlexFactory overview 17

2 System overview
2.1 FlexFactory description
2.1 FlexFactory description
Definition of FlexFactory
FlexFactory is a biomanufacturing system for production of bulk drug substance. The
production is started from a seed-sized cell culture and can produce a bulk drug formu-
lation. FlexFactory consists of various operating units, which are connected to each
other via disposable tubing sets to build a complete production train. The operating units
have been designed to use primarily disposable components. Additionally, it is possible
to connect any type of external equipment to FlexFactory via PROFIBUS™, or via OPC
over Ethernet.
FlexFactory is designed to utilize single-use technology.
The FlexFactory operating units are integrated into a centralized automation system.
Local control is available for some operating units.

2 System overview
2.2 FlexFactory components
2.2 FlexFactory components
Process equipment
The process equipment is primarily based on the use of disposable components. The
equipment comprises three groups of instruments:
Instrument group and examples Purpose
Upstream process instruments: WAVE Production of the raw material of the in-
Bioreactors, XDR Bioreactors. tended product.
Downstream process instruments: ÄKTA Purification of the raw material.

chromatography systems.
Supporting instruments: mixers, buffer Intermediate process steps, preparation

hold tanks, remote pumps and other de- of solutions, packing of columns, storage.
vices.
Connecting equipment
Standard single-use tubing sets and connectors are used to link the operating units.
Standard commercially available filters and probes are used, depending on the process
needs. The connectivity sets are customized to fit the production process.
Automation platform
All major operating units are integrated and incorporated into a centralized supervisory
control and data acquisition (SCADA) system. The automation platform uses Wonderware
as a main software platform, providing a common and seamless user interface for the
operators. The automation platform is delivered as pre-defined automation hardware
and software system.

2.3
Clarification
Chromatography
Scale-up
Seed Filtration
FlexFactory Automation User Manual 29164188 AA

FlexFactory overview
Product
Concentration,
sterile filtration Chromatography
Virus filtration
Filtration,
buffer change
Chromatography
17
2.3 FlexFactory overview
2 System overview
3 FlexFactory description
About this chapter

This chapter provides a short description of each FlexFactory operating unit. A short
description of the software is also provided.
In this chapter
Section See page
3.1 Automation and process control 19
3.2 Production equipment 23
3.3 Purification equipment 28
3.4 Supporting equipment 37
3.5 User interface 45

3.1 Automation and process control
Introduction
This section provides general information about the hardware that is used for process
control.
In this section
Section See page
3.1.1 M-Station OIT 20
3.1.2 Historian 22

3.1.1 M-Station OIT
3.1.1 M-Station OIT
Description
The M-Station OIT is a mobile unit for monitoring and control of the processes. The M-
Station OIT includes the following components:
• Computer system
• Touchscreen
• Washable keyboard
• Mouse
• Uninterruptible power supply (UPS)
The M-Station OIT is used to control processes of FlexFactory operating units, for example
bioreactors, mixers, and remote devices.
The operator interface is based on Wonderware software running on Microsoft Windows
operating system.

3.1.1 M-Station OIT
Illustration of the M-Station OIT

3.1.2 Historian
3.1.2 Historian
Description
Historian (HST-1) is a server computer that is located in the Server Rack.
The complete process database is stored on the Historian server. The database contains
both the input data and the data generated by FlexFactory during the production process.
The historical process data can be displayed as curves using the Trending application,
or as data tables using the Dream Report™ application.
The complete data set consists of the following main databases:
• Wonderware database
• UNICORN database
A secondary UNICORN database is also created on Historian during the production
process for immediate use in Wonderware functions, for example in Trending application.
See UNICORN database, on page 50 for more information about the UNICORN database.
The Historian server also stores UNICORN licence database.

3.2 Production equipment
Introduction
This section provides general information about the equipment in FlexFactory used for
manufacturing of the bulk substance.
In this section
Section See page
3.2.1 XDR Bioreactor 24
3.2.2 ReadyToProcess WAVE 25 26

3.2.1 XDR Bioreactor
Introduction
XDR Bioreactor is a stirred-tank bioreactor intended for cell cultivation and microbial
fermentation processes used in researching, developing, or manufacturing biologics or
drugs.
The bioreactor is a modular system. The system consists of the following parts:
• XDR vessel
• Electrical cabinet
• Gas supply cabinet
• Temperature control unit (TCU)
Operating principle
The cell cultivation process is performed in a disposable bag, which is installed inside
the XDR vessel. Media and cells are added into the disposable bag. The growth environ-
ment in the disposable bag is monitored and controlled by the FlexFactory control system.
The liquids are introduced into the bag through sterile integral fittings. Mixing of the
disposable bag contents is performed by a motor which is magnetically coupled to an
impeller inside the bag. The agitator assembly is welded into the bottom of the disposable
bag.
The system is managed using Wonderware software.

Illustration of XDR Bioreactor

3.2.2 ReadyToProcess WAVE 25
Introduction
ReadyToProcess WAVE 25 is a bioreactor intended to be used as laboratory and manu-
facturing equipment for cell cultivation.
The bioreactor is a modular system. The system consists of the following parts:
• Rocker
• Control unit (ReadyToProcess™ CBCU)
• Pump (ReadyToProcess Pump 25)
Operating principle
Cell cultivation is performed inside a disposable cellbag, which is installed on the rocker
and filled with gas, culture medium and cells. Gas transfer and mixing of cell culture is
accomplished by wave-induced agitation, performed by the rocker unit.
The rocker is the main unit of the system. Through the rocker the weight of the cellbag
is measured, the temperature of the cellbag and the rocking motion are controlled.
The system can work in single mode (cell culture in one cellbag) or in dual mode (cell
culture in two cellbags simultaneously). In dual mode, two cellbags are placed on the
same rocker and the culture conditions are controlled independently in each cellbag.
The system is managed using UNICORN software.

Illustration of ReadyToProcess
WAVE 25
3
2
1 4
Part Function
1 Screen
2 Rocker with a tray and a cellbag
3 Pump
4 Control unit

3.3 Purification equipment
Introduction
This section provides general information about the equipment in FlexFactory used for
purification of the bulk substance.
In this section
Section See page
3.3.1 ÄKTA ready 29
3.3.2 ÄKTAprocess 31
3.3.3 BioProcess NFF Pump System 33
3.3.4 UniFlux 35

3.3.1 ÄKTA ready
3.3.1 ÄKTA ready
Introduction
ÄKTA ready is an isocratic, low pressure, automated liquid chromatography system using
ÄKTA ready flow kits (low flow or high flow) and ReadyToProcess columns up to 20 liter
size. ÄKTA ready is designed for process scale-up and small scale production. In small-
scale production, the system can be used to produce purified material for clinical testing
programs, or for small-scale production of diagnostic or therapeutic products.
The system is designed to work with liquid chromatography techniques, for example ion
exchange, affinity chromatography, and hydrophobic interaction.
Description
ÄKTA ready comprises equipment for monitoring the system contents: fluid pressure
and velocity, pH, temperature, conductivity, and absorbance. The system is also designed
for continuous monitoring of air bubbles in the chromatography fluid.
ÄKTA ready can be equipped with an extra gradient pump in parallel to the existing
pump, allowing the user to perform chromatography runs with gradient elution.
ÄKTA ready uses disposable flow kits that include all the necessary tubing from inlet to
outlet, including flow cells, air trap, column connection tubing, and pump tubing. The
flow kits are ordered separately.

3.3.1 ÄKTA ready
Illustration of ÄKTA ready

3.3.2 ÄKTAprocess
3.3.2 ÄKTAprocess
Introduction
ÄKTAprocess is a low-pressure automated liquid chromatography system intended for
precision transportation of fluids to and from chromatography columns of different sizes.
The system is intended for large-scale pharmaceutical manufacturing.
ÄKTAprocess can be individually configured according to the specific process require-
ments.
Description
The basic system options are the following:
• Skid. The rigid stainless skid structure supports and protects all installed components
and the electrical cabinet. At the same time the skid allows easy access to the
components.
• Electrical cabinet for all electrical and pneumatic equipment.
• Fully automated control system.
• Inlets, outlets, and connections supporting one column.
• A single drain outlet that collects all drains, making sure that no back pressure is
applied on any parts of the processing system.
• A set of meters and sensors that provide data to the control system.
• A system pump, supporting isocratic operation.
• An air trap to de-gas buffers. The air trap also contains two sensors for automatic
liquid level control.
• Inlet and outlet valves: air trap valves, sample pump connection valves, column valve
sets.
ÄKTAprocess can be configured according to a range of options, including a second
column, extra pumps, gradient feedback control, outlets, monitors, and others.

3.3.2 ÄKTAprocess
Illustration of ÄKTAprocess

3.3.3 BioProcess NFF Pump System
Introduction
In normal flow filtration (NFF), the fluid flow moves perpendicularly to the membrane
and purified liquid passes through the membrane. Membrane filters primarily retain
matter due to size differences between the molecules and the pores in the membrane.
Description
BioProcess NFF Pump System is intended for transportation of fluids from a production
bioreactor to a normal flow filtration train in applications such as harvest clarification
and virus filtration. The system is intended for large-scale pharmaceutical manufacturing.
The system is designed to be easy to move.
The basic system options are the following:
• Supporting frame. The rigid stainless steel structure supports the pump, the process
components and the electrical cabinet. At the same time the frame allows easy access
to the components.
• Electrical cabinet for all electrical and pneumatic equipment.
• Pump. The pump can be centrifugal or diaphragm-type. The pump head (centrifugal
pump) and the chamber (diaphragm pump) are gamma-sterilizable single-use items.
• A single-use flow sensor connected into the flow path.
• Single-use pressure sensors (up to 6) to be set up according to the designated con-
figuration.
Operating principle
BioProcess NFF Pump System performs flow rate and pressure measurement in the flow
path.

Illustration of BioProcess NFF

Pump System
The following illustration shows an example of BioProcess NFF Pump System (with di-
aphragm pump).

3.3.4 UniFlux
3.3.4 UniFlux
Introduction
In cross-flow filtration, the fluid flow moves across the filter membrane (tangentially) at
positive pressure relative to the permeate side. A proportion of the material which is
smaller than the membrane pore size passes through the membrane as permeate or
filtrate; everything else is retained on the feed side of the membrane as retentate.
The tangential motion of the bulk of the fluid across the membrane causes trapped
particles on the filter surface to be rubbed off. This means that a cross-flow filter can
operate continuously at relatively high solids loads without blocking the filter surface.
Description
The UniFlux series is a standard line of filtration systems. UniFlux combines cross-flow
membranes and high performance hardware in a single system. The systems are con-
figured to operate with two types of filtration hardware:
• Hollow fiber cartridges for microfiltration applications, such as cell harvesting.
• Cassettes for ultrafiltration applications, such as protein concentration and diafiltra-
tion in downstream unit operations.
UniFlux has been developed to maximize productivity in cross flow filtration.
Operating principle
UniFlux performs pH and conductivity measurement on the permeate side, and flow
rate measurement on both sides of the membrane. Standard options for the system in-
clude UV sensor on the permeate side for detection of protein leakage, permeate flow
control, transfer pump and other.
UniFlux cross-flow filtration systems are fully automated for clarification, concentration
and diafiltration applications in pilot to production scale.

3.3.4 UniFlux
Illustration of UniFlux

3.4 Supporting equipment
Introduction
This section provides general information about the additional equipment in FlexFactory,
used in production of the bulk substance.
In this section
Section See page
3.4.1 XDUO Mixer 38
3.4.2 AxiChrom Master 40
3.4.3 Temperature control unit (TCU) 42
3.4.4 Remote pump 43
3.4.5 Scale 44

3.4.1 XDUO Mixer
3.4.1 XDUO Mixer
Description
XDUO Mixer is a mixing system for commercial and clinical production of biopharmaceu-
ticals, vaccines, and other biologics. XDUO Mixer is configurable to meet a broad range
of mixing requirements.
XDUO Mixer consists of the following subsystems:
• Mixer vessel
• Temperature control unit (TCU) (optional)
The mixer vessel can be non-jacketed or jacketed. The jacketed vessel allows temperature
control and regulation, using an external temperature control unit.
The control of the mixing process can be performed locally or remotely through the
FlexFactory control system.
Operating principle
The mixing process is performed in a disposable bag, which is designed to minimize the
risk of cross-contamination.
The disposable bag assembly is a pre-sterilized single-use bag, designed for liquid-solid
or liquid-liquid dissolution processes. The disposable bag assembly is available in two
variants:
• Basic bag assembly
• Plus bag assembly
Both bag assemblies have entry points for addition of solid and liquid components.
Mixing of the disposable bag contents is performed by a motor which is magnetically
coupled to an impeller inside the bag. The agitator assembly is welded into the bottom
of the disposable bag.
In addition, the Plus bag assembly contains two more liquid addition lines, two probe
ports, and a thermowell.

3.4.1 XDUO Mixer
Illustration of XDUO Mixer

3.4.2 AxiChrom Master
Introduction
AxiChrom Master is used in connection with the AxiChrom family of process columns.
The AxiChrom columns have been designed for low pressure chromatographic separation
of biomolecules such as proteins, peptides and oligonucleotides in GMP-regulated pro-
duction environments.
Description
AxiChrom Master is a self-contained operator console for work procedures such as col-
umn packing, unpacking, assembling, disassembing, and maintenance. The user interface
is a touchscreen panel. The operator has control over the workflow, and can manage
the process manually to control the adapter movement and open or close the media
valve. The AxiChrom Master procedures are accomplished using interactive guides
(wizards).
One AxiChrom Master unit can be used to control several columns, one at a time.

Illustration of AxiChrom Master

3.4.3 Temperature control unit (TCU)
3.4.3 Temperature control unit (TCU)
Description
Temperature control of the processes is provided by separate temperature control units
(TCUs). The TCU provides heating only or heating and cooling, depending on the TCU
model selected and purchased. The TCU is connected to the relevant operating unit and
can be managed through Wonderware software.
See the manufacturer's manual for more information about TCU.
Illustration of TCU
The following illustration shows an example of a temperature control unit.

3.4.4 Remote pump
3.4.4 Remote pump
Description
Remote pumps can be used in intermediate steps to transport the cell culture, the buffers,
or the cell culture media between different operating units. The pumps are connected
to the PROFIBUS network and can be controlled through Wonderware software. Up to
20 remote pumps can be connected to FlexFactory Automation.
Illustration of a remote pump

The following image shows an example of a remote pump.
Part Description
1 Display and keypad
2 Pump head
3 Pump head cover

3.4.5 Scale
3.4.5 Scale
Description
A scale is used to measure the weight of a disposable bag with its contents during a
temporary storage between the process steps. The scale is a Mettler-Toledo™ precision
single cell load weighing platform. The scale is connected to to the PROFIBUS network
and can be controlled through Wonderware software.
Up to 10 scales can be connected to FlexFactory Automation.
Illustration of a scale
The following image shows an example of a scale.

3.5 User interface
3.5 User interface
Introduction
This section provides general information about the software used to manage FlexFactory.
In this section
Section See page
3.5.1 Software overview 46
3.5.2 Wonderware 47
3.5.3 UNICORN 49

3.5 User interface
3.5.1 Software overview
3.5.1 Software overview
Description
Two software packages, Wonderware and UNICORN, are used to manage different
components of FlexFactory.
Wonderware is used to manage the following instruments:
• XDR Bioreactor
• XDUO Mixer
• BioProcess NFF Pump System
• Remote pump
• Scale
UNICORN is used to manage the following instruments:
• ReadyToProcess WAVE 25
• ÄKTAprocess
• ÄKTA ready
• UniFlux
• AxiChrom Master
A short description of each software is given below.

3.5 User interface
3.5.2 Wonderware
3.5.2 Wonderware
Description
Wonderware software runs under Microsoft Windows operating system. The user interacts
with the instrument via a touchscreen or a mouse, and a keyboard.
Wonderware software provides continuous control and monitoring of the process. All
process parameters can be accessed for viewing or modification through Wonderware
screens.
The automated process control is achieved by connecting the input signal from a
transmitter unit to a final control element. This process of setting up the connections
between units is called control loop mapping.
For detailed information on Wonderware screens, screen elements, and control loop
mapping see Chapter 4 Wonderware user interface: description, on page 51 and Chap-
ter 12 Wonderware general functions, on page 437.

3.5 User interface
3.5.2 Wonderware
Overview illustration
The main overview screen for each instrument shows a detailed graphic display of the
selected instrument and allows the user to monitor and control the process.
The illustration below shows the XDR Bioreactor screen as an example of a main screen.

3.5 User interface
3.5.3 UNICORN
3.5.3 UNICORN
Description
UNICORN is a complete software package for control, supervision, and evaluation of
processes. UNICORN consists of four modules: Administration, Evaluation, Method
Editor and System Control. The main functions of the modules are described in the table
below.
Module Main functions
Administration Perform user and system setup, system log and

database administration.
Evaluation Open results, evaluate runs and create reports.
Method Editor Create and edit methods.
System Control Start, view and control a manual or a method run.
In System Control module, it is possible to choose the Process Picture or the Chro-
matogram view. The Process Picture view is interactive: it allows manual interactions
with the system and provides feedback on run parameters. The Chromatogram view
shows a graphical presentation of data throughout the run. It is also possible to manu-
ally interact with an ongoing run using Manual instructions.
A comprehensive help utility is included in the UNICORN software.
More detailed information about UNICORN is available in separate manuals.

3.5 User interface
3.5.3 UNICORN
Overview illustration
The illustration below shows the System Control module for ÄKTAprocess, as an example
of a UNICORN screen.
UNICORN database
The UNICORN database contains the complete process data collected from
ReadyToProcess WAVE 25, ÄKTAprocess, ÄKTA ready, and UniFlux. The complete UNICORN
database is stored on the Historian server (HST-1) in the Server Rack.
A set of UNICORN data is also made available for use in Wonderware functions. A sec-
ondary database is created for this purpose on the Historian server. For example, when
the user creates graphs based on UNICORN data in Trending application, the secondary
database is used.
The parameter sampling frequency for the secondary database is lower, therefore the
secondary database contains fewer data points. The user should keep in mind that the
complete set of data for ReadyToProcess WAVE 25, ÄKTAprocess, ÄKTA ready, and
UniFlux is only available via UNICORN.

4 Wonderware user interface: description
4 Wonderware user interface:

description
About this chapter

This chapter provides general information about the Wonderware user interface. It de-
scribes software security levels, gives a general overview of the interface and a detailed
overview of dialog boxes.
Specific information about each instrument user interface is given in Chapter 5
Wonderware user interface: instruments, on page 101.
In this chapter
Section See page
4.1 Security levels 52
4.2 User interface overview 58
4.3 General overview screens 66
4.4 Flex Info functions 77
4.5 General dialog boxes 88

4.1 Security levels
4.1 Security levels
Introduction
This section contains important information regarding Wonderware software modes
and security levels.
Overview
The Wonderware software has two security modes:
• View only
• Operation
All users can access the view only mode.
The operation mode has four security levels. The access rights for each level are described
in the following table.
Security level Access
Operator All common functions for each operating unit.
Supervisor Software configuration parameters for each operating unit.
Engineer Functionality defining parameters for each operating unit.
Developer GE access only (configuration for each operating unit).
Each higher level has access to all lower level functions, plus access to the functions
defined for their own level.
Note: The roles of Operator, Supervisor, and Engineer are appointed by the customer.
View only mode

All users can access the view only mode by logging out. This mode enables you to navi-
gate and view the status of the conditions and the alarms. The list below shows which
functions in the software are accessible in view only mode.
• Access and view the screens from the header toolbar
• Open trends
• Open and view PID faceplate dialog boxes
• Start the viewer software

4.1 Security levels
See Chapter 4 Wonderware user interface: description, on page 51 and Chapter 12

Wonderware general functions, on page 437 for the description of these functions.
Operation mode
The operation mode allows you to modify functions of the operating units. The following
table shows access levels for individual system functions. See Section 4.2 User interface
overview, on page 58 and Section 4.5 General dialog boxes, on page 88 for description
of system functions that are shown in the table below.
See Security levels for Batch Control function, on page 56 for security levels defined for
Batch Control function.
Note: All functions listed below may not be relevant for each instrument.
Note: The security level clearance ( / ) applies to all entries in respective columns.

4.1 Security levels
System functions Security level
Operator Supervisor Engineer
• Acknowledge alarms
• Adjust process setpoints (SP)
• Adjust controlled variables (CV)
• Calibrate BioProcess NFF Pump System flow

sensor
• Change agitator direction
• Change PID control loop modes (Remote/Local

and Auto/Manual)
• Configure BioProcess NFF Pump System
• Control exhaust filter heater valve
• Define default PID setpoints
• Enable and disable the operating units
• Filter alarms
• Operate totalizers:
- MFC
- NFF flow sensor
- Pumps
• Tare:
- Bag pressure
- Vessel weight
• View and configure trends

4.1 Security levels
• Adjust alarm settings
• Adjust main PID control loop tuning parame-

ters (P, I, D, DB)
• Calibrate the pumps
• Configure pressure critical interlocks

(BioProcess NFF Pump System)
• Control MFC valves (change gas flow paths)
• Enable and disable agitator
• Enable and disable alarms
• Map and unmap PID control loops
• Select filtration BioProcess NFF Pump System

configuration (Stage Selection)
• Shut down the WindowViewer™ software 1
• Switch between probe channels (A/B)
• Adjust range defining parameters (CVHL, CVLL,

SPHL, SPLL) for:
- Agitator
- Auxiliary inputs
- Dissolved oxygen
- Exhaust filter temperature
- MFC
- pH
- Pumps
- Vessel temperature
• Change pump direction
1 Shutting down the WindowViewer software does not change any setpoints or current control values of the
system.

4.1 Security levels
Security levels for Batch Control

function
The following table shows the access levels for specific actions in Batch Control.
Batch Client application
• Abort batch, phase, and operating unit
• Access batch schedule
• Acknowledge (Ack.) phases
• Allocate equipment
• Adjust allocated queue
• Answer questions
• Edit phase parameters
• Hold batch, phase, and operating unit
• Edit Batch Schedule list
• Release equipment
• Restart batch, phase, and operating unit
• Select equipment
• Start batch and phase
• Use batch and phase action buttons
• View documentation
• View documentation and acknowledge
• Write comments
• Change batch mode
• Edit phase parameters
• Force transition
• Operate phases manually
• Save recipe

4.1 Security levels
Other Batch Control applications
Logger Editor
Materials Editor
Model Editor
Phase Logic
Recipe Editor
Tag Linker
Train Editor

4.2 User interface overview
Introduction
This section provides general information about the Wonderware software user interface.
In this section
Section See page
4.2.1 User interface overview 59
4.2.2 Elements on the overview screen 62

4.2.1 User interface overview
Introduction
When you log in to Wonderware software, the main overview screen is shown. From
this screen you have the access to all FlexFactory components.
Navigation
Tap the touchscreen or use the mouse to select buttons and objects.
Illustration of the overview

screen
The following illustration shows the XDR Bioreactor screen as an example of the main
screen. A similar overview screen is accessible for each operating unit in FlexFactory.
4
5

Part Name Description
1 Header toolbar Provides access to all screens in Wonderware soft-

ware.
2 Main pane Contains graphic objects that display process data

and give the user access to process control parame-
ters.
3 Active batches Displays summary information on all Batch Control

pane 1 processes that are currently active.
4 Alarm summary Presents the current alarms with a date and time
pane stamp.
5 Footer toolbar Displays the current user and the computer identifi-
cation, allows shutdown of Wonderware application,
changing user password, and changing the user.
1 Active batches pane is visible for logged in users only.
Overview of the screens

The user can access all software screens from the header toolbar.
All screens listed below may not be relevant for each instrument.
Screen Description
Overview screen for each Provides a detailed graphic display of the system layout. Graphic objects
operating unit: give the user the access to process control parameters.
• XDR Bioreactor
• XDUO Mixer
• NFF System
• Pumps, scales
• ÄKTA ready
• ÄKTAprocess
• RTP WAVE
• UniFlux
Control Displays input and output devices and intermediate control elements.
Allows the user to configure the interaction of units that are part of the
instrument control system.

Screen Description
PID Faceplates 1 Displays an overview of all individual PID control loop faceplates. Each
faceplate provides access to a PID control loop and allows the user to
adjust PID control loop tuning parameters.
Alarm Config1 Displays an overview of alarm configuration dialog boxes for all available
process variables. Each dialog box allows the user to activate the alarms
and define the limits for deviation of a variable from a setpoint.
Batch Overview Displays an overview of currently specified automatic processes

(batches). Allows the operator to start a defined process run. Allows the
qualified users to set up new automatic processes.
Trending 2 Opens an independent Wonderware application. The Trending screen

displays historical and real-time data as graphs. Trending application
records all process parameters while the computer is on and is connect-
ed to the electrical cabinet.
Alarm Summary2 Displays all currently active alarms and shows detailed information
about each alarm. The user can select and acknowledge individual
alarms.
Alarm History2 Displays all alarms and events that are associated with the current
process, both active alarms and acknowledged alarms. All information
contained on this screen is saved in the database.
Platform Status2 Displays the software version of the automation control system.
1 This screen may be displayed in two or more pages.

2 These screens are accessible from Flex Info button on the toolbar.

4.2.2 Elements on the overview screen
Header toolbar
The header toolbar is located at the top of the screen and is available from all application
interfaces. All screens are accessible from this toolbar.
The header toolbar consists of two menu rows. The top row is static and shows all
component groups included in FlexFactory. The bottom row is dynamic and shows the
accessible menu options for the selected component group.
When you click a button on the top menu row, a drop-down menu allows you to select
an available instrument in this group. The bottom menu row then shows all accessible
menu options for this instrument.
The following illustration shows the header toolbar.
Footer toolbar
The footer toolbar is located at the bottom of the screen and is available from all appli-
cation interfaces. It allows logging in, changing the password and shutting down the
software. It also shows which user is currently logged in.
The following illustration shows the footer toolbar.
1 2 3 4 5 6
Part Function
1 Interactive buttons
2 Security symbol
3 User identification text box
4 Close button (displayed for the user with Supervisor or Engineer access)
5 Computer identification
6 Date and time field

Alarm summary pane

The alarm summary pane is shown at the bottom of the instrument overview screen
and presents the current alarms with a date and time stamp. Full scale display of this
pane is available via header toolbar Flex Info:Alarm Summary option.
The following illustration shows the alarm summary pane.
For description of table contents see Alarm Summary and Alarm History tables, on
page 81.
Active batches pane

The active batches pane is shown above the alarm summary pane on the instrument
overview screen. The active batches pane presents an overview of all currently active
Batch Control processes.
Active batches pane is visible for logged in users only and is not shown when the user
is logged out.
The following illustration shows the active batches pane.
See Active batches pane description, on page 74 for more detailed description of the
contents of the pane.
See Chapter 11 Batch Control function, on page 374 for explanation of Batch Control
function description and details.

Panels on the overview screen

Two types of panels are present on the instrument overview screen: display panels and
active panels.
Name and illustration (example) Description
Display panel Display panels are read-only objects and do not

allow modification of the displayed values.
Clicking the display panel opens the Calibration
Offset dialog box.
Active panel Active panels let the user access and modify
the state of the process.
Clicking the active panel opens a dialog box and
allows the user to control the process.
PID loop overview panels are examples of active
panels.
Active panel, interlocked An active panel is marked with an orange frame,

when the PID loop has been stopped by an in-
terlock.
More information about active panels is given in the following sections.
PID loop overview panels

PID loop overview panels are active panels that are connected to a PID control loop. PID
loop overview panels are shown on the instrument overview screen. Clicking a PID loop
overview panel opens the relevant PID faceplate. The following illustration is an example
of a PID loop overview panel.
3
4

1 PID loop name The tag name of the control loop
2 Process Variable (PV) The actual measurement of the parameter
3 Setpoint (SP) The target value of the parameter
4 Unit The unit of measurement of the parameter
See Section 4.5.1 PID faceplate dialog box, on page 89 for description of PID faceplate.

4.3 General overview screens
Introduction
This section provides information about the Wonderware screens that are generally
used to manage different operating units. For information about specific screens for
each operating unit, see Chapter 5 Wonderware user interface: instruments, on page 101.
In this section
Section See page
4.3.1 PID Faceplates 67
4.3.2 Alarm Config 69
4.3.3 Batch Overview 70
4.3.4 Default PID Setpoint 76

4.3.1 PID Faceplates
PID Faceplates screen

description
PID Faceplates screen is available for XDR Bioreactor, XDUO Mixer, BioProcess NFF Pump
System, and remote pumps. PID Faceplates screen (Page 1 and Page 2, if relevant) is
accessed from the header toolbar. This screen displays all PID control loops associated
with the instrument and allows users to access PID control loop parameters. If there are
no PID control loops to display, the screen shows a message that it was intentionally left
blank.
The contents of Page 1 and Page 2 are displayed as follows:
PID Faceplates Page 1 PID Faceplates Page 2
• Dissolved oxygen (DO) • Mass flow controllers (MFC)
• pH • Pumps
• Vessel temperature
• Agitator
• Exhaust filter heater 1
• Exhaust filter heater 2
• Auxiliary Input 1
• Auxiliary Input 2
For information about PID control, see Section 4.5.1 PID faceplate dialog box, on page 89
and Section 12.3 Control loop configuration, on page 452.

Illustration of PID Faceplates

screen
The following illustration shows an example of PID Faceplates Page 1.
For more detailed description of PID faceplates see Section 4.5.1 PID faceplate dialog
box, on page 89.

4.3.2 Alarm Config
4.3.2 Alarm Config
Alarm Config screen description

Alarm Config screens (Page 1 and Page 2, if relevant) are accessed from the header
toolbar. These screens display each available process variable and allow the user to
configure alarm setpoints.
The following illustration shows an example of Alarm Config Page 1.
A red text box shows that this parameter is currently in alarmed state.
For more details about alarm configuration for each variable, see Section 4.5.2 Alarm
configuration dialog box, on page 94.

4.3.3 Batch Overview
Batch Overview screen

description
Batch Overview screen is available for XDR Bioreactor, XDUO Mixer and BioProcess NFF
Pump System. Batch Overview screen is accessed from the header toolbar. The screen
displays a list of currently active batches (automatic processes) and allows the qualified
users to set up new automatic processes using all available FlexFactory components,
combining the pre-defined phases in Wonderware.

Illustration of Batch Overview

screen
The following illustration shows the Batch Overview screen.
1 2 3 4 5 6
21 8
20 9
19 10
18 11
17 12
13
16 15 14
Part Description
1 Active batches pane

Click the batch row to select the batch. See Active batches pane description,
on page 74 for more information.
2 Text boxes
The boxes show information on the selected batch.

Part Description
3 Questions list
The list displays all currently unanswered questions of the selected batch.
Click the question to select it.
4 Screen identification banner
5 Buttons for answering the questions

Click a button to answer the selected question on the Questions list.
6 Messages list
The list displays all messages related to the selected batch, including the
messages for all batch phases. The messages are displayed when they
are issued during the batch run.
7 BatchSchedule button
Click the button to open the BatchSchedule dialog box.
8 Batch action buttons

Click a button to change the state of a selected batch. Confirm with your
password. The following actions are available:
• Start
• Hold
• Restart
• Abort
See Section 11.6 Manage batch stops, on page 424 for more information.
9 Select Equipment button

Click the button to open the BatchEquipSelect dialog box.
10 Phase action buttons

Click a button to change the state of a selected phase. Confirm with your
password. The following actions are available:
• Start
• Hold
• Restart
• Abort

Part Description
11 Ack. (Acknowledge, Acknowledge) button

Click the button to change the state of a selected phase from Wait to Run.
Confirm with your password.
See Start a semi-automatic batch, on page 400 for more information.
12 SFC button
Click the button to open the BatchSFC screen. See BatchSFC screen de-
scription, on page 97 for more information.
13 Phase Parameters list
14 Change Parameter button and text box for parameter value input
15 Comment button, text input box, and comment target list (Batch or Phase)
16 Alarm summary pane
17 Error messages list

The list displays all errors that occur during the current batch run.
18 Phase messages list

The list displays all messages related to the selected phase and prompts
for operator action. The messages are displayed when they are issued
during the batch run.
19 Phase list
Click the phase row to select a phase.
20 Batch mode list

Select the mode in the list to change the mode of the selected batch.
Confirm with your password. The following modes are available:
• Automatic
• Semi-Auto
• Manual
21 Batch status display

The text box displays the current status of the selected batch.

Active batches pane description

The active batches pane is shown at the top of the Batch Overview screen. This pane
is also shown on the overview screen for each instrument that can be controlled by
Batch Control function: XDR Bioreactor, XDUO Mixer, and BioProcess NFF Pump System.
The active batches pane is displayed above the alarm summary pane on the instrument
overview screen. Active batches pane is visible for logged in users only and is not shown
when the user is logged out.
The active batches pane presents an overview of all currently active Batch Control
processes.
Illustration of the active batches

pane
The following illustration shows the active batches pane.
Element Description
Campaign User-defined identifier for a specific process run. 1
Lot User-defined identifier for a specific process run.1
Batch User-defined identifier for a specific process run.1
Recipe A template for a production process for a FlexFactory operating

unit.
Size Parameter currently not applicable. 2
Train A specified FlexFactory operating unit that performs the process.
Mode The batch mode controls how a batch is started.

Element Description
Status Current status of the process:
• Aborted
• Done
• Held
• Open
• Ready
• Run
Action Double asterisks (**) are shown, if a batch waits for operator ac-
tion.
1 Campaign, Lot and Batch are combined to create a unique identification tag for each process.
At least one of these identifies must be unique for each process to specify the process.
2 The Size parameter is not active in the current software. The value is set automatically by the
recipe without operator intervention.

4.3.4 Default PID Setpoint
4.3.4 Default PID Setpoint
Default PID Setpoint

The Default PID Setpoint screen can be accessed by clicking PID Default Setpoints on
XDR Bioreactor or XDUO Mixer screen. The illustration below shows an example of the
Default PID Setpoints screen.
The default PID setpoints are used to define the setpoints that do not change during a
process run. The setpoints typed into the text boxes of the Default PID Setpoint screen
are applied at process start and are not changed by the control system during the run.
The setpoints can be changed by the operator during the run.
For XDR Bioreactor and XDUO Mixer, when a PID control loop is in Auto/Remote mode
and is not mapped to a device, the value in the Default PID Setpoint screen is used as
the active setpoint.
Note: The setpoints for BioProcess NFF Pump System are set in the Configuration
Screen dialog box.

4.4 Flex Info functions
Introduction
This section gives information about Wonderware functions which are accessible by
clicking Flex Info on the top row of the header toolbar.
In this section
Section See page
4.4.1 Trending 78
4.4.2 Alarm Summary 80
4.4.3 Alarm History 84
4.4.4 Platform Status 87

4.4.1 Trending
4.4.1 Trending
Trending application
The Trending application is an independent Wonderware program. It is accessed from
the header toolbar by selecting the Flex Info:Trending option.
This selection opens a screen that displays data from any function that is monitored
and controlled by the instrument control system. The Trending application allows the
user to display historical and real-time data in graph format. All process parameters are
recorded to create a historical trend display. The data is shown by Wonderware Historian
Client Trending application.
See Wonderware manufacturer's manual for more information about the Trending ap-
plication. The application help is available in Start:All programs:Wonderware:Books:His-
torian Client User Guide, if installed at recommended location.

4.4.1 Trending
Illustration of the Trending

screen
The following illustration shows an example of the Trending screen.
1 2
Part Name Function
1 Tag picker pane Selects the variable to be shown in the trend chart.
2 Trend chart Displays the trend for the selected parameter over the
selected time period.
3 Pens pane Displays a list of tags selected for viewing and allows
selection and editing of tag properties.

4.4.2 Alarm Summary
4.4.2 Alarm Summary
Alarm Summary screen

description
The Alarm Summary screen is the overview screen for all active alarms of the whole
FlexFactory system. This screen displays all currently active alarms with a date and time
stamp and alarm status. When an alarm has been acknowledged by the user and the
parameter value is not in alarmed state anymore, the alarm disappears from the Alarm
Summary screen. It remains available on the Alarm History screen.
The Alarm Summary screen is accessed from the header toolbar by selecting the Flex
Info:Alarm Summary option.
Illustration of the
Alarm Summary screen
The following illustration shows an example of the Alarm Summary screen.

4.4.2 Alarm Summary
Part Function
1 Alarm display pane
2 Buttons to acknowledge and view the alarms
The buttons at the bottom of the screen have the following functions:
Button Description
ACK ALL Allows the user to acknowledge all currently active alarms.
ACK SEL Allows the user to acknowledge an individual alarm or a selected

group of alarms.
FILTER Allows the user to view a selection of alarms.
Note:
See Filter function description, on page 83 for more information.
For description of other elements on the Alarm Summary screen see Alarm Summary
and Alarm History tables, on page 81.
Alarm Summary and

Alarm History tables
The following illustration shows an example of table contents that is presented on both
Alarm Summary and Alarm History screens.
The following elements are shown in the table:
Element Description
TimeLCT Time when the state of the alarm changed.
Name Tag name or data point of the component that is in alarmed state.
Comment Specification of the alarm.
Value Value that triggered the alarm.

4.4.2 Alarm Summary
Element Description
Limit/OldValue Limit value that was passed to trigger the alarm.
State Current state of the alarm.

See further down for more information.
See Alarm colors, on page 444 for more information about alarm
display colors.
Typ Codes for alarm condition.

For detailed explanation, see Alarm type codes, on page 442.
Group The logical location the alarm originated from (for example: system
platform, a bioreactor, or any other system).
Operator User name of the operator.
Prior Characterizes the severity of the alarm.

For detailed explanation, see Alarm priority codes, on page 443.
Alarm states
The following alarm states can be shown in Alarm Summary and Alarm History tables:
Alarm state Description
UNACK The parameter is in alarmed state and has not been acknowl-
edged by the user.
UNACK_ALM The parameter is in alarmed state. The user has disabled the
alarm when it was in alarmed state, without acknowledging it
first.
Note:
This state is visible only on the Alarm History screen.
UNACK_RTN The parameter was in alarmed state at some time point but has
now returned to normal state. It has not been acknowledged by
the user.
ACK The parameter is in alarmed state and has been acknowledged

by the user.

4.4.2 Alarm Summary
Filter function description

Alarms and events from all FlexFactory components are visible in Alarm Summary and
Alarm History tables. The filter function allows the user to select only a relevant group
of alarms and events for viewing. For example, the user can select one FlexFactory
component to view only the alarms and events for this system.

4.4.3 Alarm History
4.4.3 Alarm History
Alarm History screen description

Alarm History screen is the overview screen for all alarms of the whole FlexFactory
system. This screen displays all alarms and events associated with the process, both the
active alarms and the acknowledged alarms that are not in active state anymore.
The information contained on the Alarm History screen is saved in the database for
storage and retrieval. This functionality permits auditing of the entire FlexFactory system.
End-to-end audits of each step can be done on any operating unit in FlexFactory.
The Alarm History screen is accessed from the header toolbar by selecting the Flex In-
fo:Alarm History option.
Illustration of the Alarm History

screen
The following illustration shows an example of the Alarm History screen.
For description of the elements in the table see Alarm Summary and Alarm History tables,
on page 81.

4.4.3 Alarm History
The functions of footer toolbar buttons are described below.
Alarm History footer toolbar

The following illustration shows Alarm History footer toolbar.
Element Description
ALARMS Displays only alarms and hides events.
EVENTS Displays only events and hides alarms.
Note:
Events are the actions which a user performs through Wonderware
software. See Alarm History events, on page 86 for more informa-
tion.
BOTH Displays both alarms and events.
Note:
Both alarms and events are displayed by default.
FILTER Allows the user to view a selection of alarms or events.
Note:
See Filter function description, on page 83 for more information.
Text field Shows the start and end time of the displayed group of alarms
and events.
Start Time Allows the user to define start time for displayed alarms and
events.
End Time Allows the user to define end time for displayed alarms and events.
Apply Applies the modifications in start and end time.
Requery Allows the user to refresh the list of alarms and events.

4.4.3 Alarm History
Alarm History events

Events are the actions which a user performs through Wonderware software. The follow-
ing user actions are recorded as events in Alarm History table:
• Alarm setpoint change
• Control mode change
• Controlled variable change
• Mapping change
• PID parameter change
• Reactor state change
• Sequence change
• Setpoint change

4.4.4 Platform Status
4.4.4 Platform Status
Platform Status screen

description
The Platform Status screen is for information purposes only. This screen displays the
PLC and HMI version numbers. The Platform Status screen is accessed from the header
toolbar by selecting the Flex Info:Platform Status option.
Illustration of the Platform

Status screen
The following illustration shows an example of the Platform Status screen.

4.5 General dialog boxes
Introduction
This section gives information about dialog boxes that are generally used in Wonderware
software.
In this section
Section See page
4.5.1 PID faceplate dialog box 89
4.5.2 Alarm configuration dialog box 94
4.5.3 Batch Overview dialog boxes 97

4.5.1 PID faceplate dialog box
PID faceplate dialog box

Proportional-integral-derivative (PID) control is used to control XDR Bioreactor, XDUO
Mixer and BioProcess NFF Pump System. PID control is applied to all modules as well as
most processes. Each PID faceplate contains the tuning parameters for an individual
PID control loop. Process PID settings can be adjusted by a user with appropriate access
rights.
PID faceplate dialog boxes can be accessed from the following screens, by clicking a
relevant PID control loop overview panel:
• XDR Bioreactor, XDUO Mixer, NFF System, Remote Pumps creens
• Control screen
• PID Faceplates screens (Page 1 and Page 2)
See PID loop overview panels, on page 64 for the description of the panels.

Illustration of PID faceplate

dialog box
The illustration below shows an example of a PID faceplate dialog box.
1
12
11
2 10
3
9
6 7
Object Description
1 PID faceplate tag name and description.
2 Interlock icon
3 Process variable (PV) display bar.
4 Setpoint (SP) slider.
5 Range defining parameters.
Note:
See PID control loop range defining parameters, on page 93 for the descrip-
tion of range defining parameters.
6 STORE button. Press the button to save the PID control parameters as the
default tuning parameters.

Object Description
7 RESET button. Press the button to revert to the default tuning parameter
values.
8 Text boxes for values of PID tuning parameters:
• Proportional (P)
• Integral (I)
• Derivative (D)
• Deadband (DB)
9 PID control mode status indicator and changing buttons:
• Auto/Manual mode
• Remote/Local mode
Note:
See further down for the description of PID control modes.
10 Controlled variable (CV), text box for input and output.
11 Setpoint (SP), text box for input and output of the process target value.
12 Process variable (PV), the measured value of the process.
Note: Operator-introduced changes to tuning parameters take effect immediately.
PID control loop modes

The following table describes PID loop control modes.
PID control modes Description
Auto The loop is controlled by the computer control system to

setpoint (SP), displayed in white on the PID faceplate.
Note:
In Auto mode the user cannot change the controlled variable
(CV).

PID control modes Description
Manual The loop is controlled by controlled variable (CV) value (in

%) defined by the user. The CV value is displayed in cyan.
Note:
The user can change the setpoint (SP), but the change has
no effect on the output (CV) until the loop is set to Auto
mode.
Remote The computer control system has control of the loop set-
point (SP).
Local The operator has control of the loop setpoint (SP) in Auto
mode or the loop controlled variable (CV) in Manual mode
via M-Station OIT.
When the instrument is in Auto/Local mode, the user can
change SP values by typing a new value into the SP text
box.
When the instrument is in Manual/Local mode, the user
can change CV values by typing a new value into the CV
text box.
Cascade The loop is controlled by an output device of another PID

loop, that provides the setpoint (SP) for the loop that is in
Cascade mode.
Note:
The status mode indicator field on PID faceplate is highlight-
ed in turquoise when the loop is in Cascade mode. The PID
loop name on the instrument main overview screen is also
highlighted in turquoise.
Batch This situation may occur when a controller is mapped to

a split range object. When the controlled variable (CV) of
the master PID loop is within the configured deadband
(DB), the controlled variable is forced to the configured split
range percentage.
Note:
This situation is typical to pH control through split range.

PID control loop range defining

parameters
Range defining parameters are as follows:
Parameter Function
Setpoint high limit The control system cannot increase the setpoint above the
(SPHL) SPHL. The operator cannot type a setpoint value higher
than SPHL into the SP text box.
Setpoint low limit (SPLL) The control system cannot decrease the setpoint below
the SPLL. The operator cannot type a setpoint value lower
than SPLL into the SP text box.
Controlled variable The control system cannot increase the controlled variable
high limit (CVHL) (output) above the CVHL. The operator cannot type a value
higher than CVHL into the CV text box.
Controlled variable low The control system cannot decrease the controlled variable
limit (CVLL) (output) below the CVLL. The operator cannot type a value
lower than CVLL into the CV text box.
The units for CVHL, CVLL, SPHL and SPLL always match the units and ranges of the CV
and SP, respectively.
Note: In some cases the limits (CVHL, CVLL, SPHL and SPLL) are applied to the system
at the factory. This information can be found in Factory Acceptance Test doc-
umentation.

4.5.2 Alarm configuration dialog box
Alarm status
The following symbols and colors are used to describe the status of the alarms:
Object Description
The alarm is enabled.
The alarm is disabled.
A white text box shows that the parameter is active and not in
alarmed state.
A gray text box shows the value of a disabled alarm.
A red text box shows that the parameter is currently in alarmed

state.
Alarm configuration dialog box

The alarm configuration dialog boxes are found on the Alarm Config screen.
The illustration below shows the details of alarm configuration for a single controlled
variable.

1 2
7
8
Part Function
1 Icon to enable or disable all alarms for the controlled variable.
2 Icon to enable or disable an individual alarm (enabled and disabled states).
3 Parameter tag name and description.
4 Parameter input range.
5 Current value of the alarmed parameter.

Part Function
6 Range limits for the set alarm:
• LoLo, critical low limit
• Lo, warning low limit
• Hi, warning high limit
• HiHi, critical high limit
• Time DB (time deadband), the length of time a value must be outside

the value deadband to issue an alarm.
• Value DB (value deadband), a range around the set alarm value where
no alarm is issued.
Note:
Setting the deadband values avoids the alarms coming on and off ("chatter-
ing") when close to the limit.
7 Parameter deviation from the setpoint:
• Dev Target, deviation target - current setpoint of the PID control loop.
• Dev Target Minor, the allowed deviation limit from a parameter setpoint
before a warning alarm is issued.
• Dev Target Major, the allowed deviation limit from a parameter setpoint
before a critical alarm is issued.
• Dev DB, deviation deadband - a range around the setpoint where no
alarm is issued.
• Settling Period, the length of time a setpoint change is allowed to take
without issuing an alarm.
Tip:
By defining the Settling Period you can prevent the deviation alarm
being issued when you make a sudden change to a setpoint.
8 Parameter in alarmed state.
See Configure alarms, on page 446 for instructions on how to configure alarms.

4.5.3 Batch Overview dialog boxes
BatchSFC screen description

The BatchSFC screen is accessed from the Batch Overview screen by clicking the SFC
button. The BatchSFC screen displays the Sequential Function Chart of the selected
batch. The BatchSFC screen shows how the recipe is built and how it is progressing.
When the batch is running, the BatchSFC screen displays info about the current status
of the process.
Illustration of BatchSFC screen

The following illustration shows the BatchSFC screen.
1 2
3 4 5
Part Function
1 Force Transition button.

Click the button to force the process to continue to the next phase. You
must have Supervisor or Engineer access rights to perform this operation.
2 Recipe area toggle buttons.

Click the button to display or hide a recipe pane.

Part Function
3 Unit Procedures pane.

Displays an overview of current FlexFactory process.
4 Operations pane.
Displays an overview of a process of a selected operating unit in a current
FlexFactory process.
5 Phases pane.
Displays all phases of the selected batch process.
• Gray: inactive
• Green: active
• Magenta: loss of communication with control system
• Red: Interlocked, Held, or waiting for operator action
• Yellow: completed
Equipment selection dialog box

The BatchEquipSelect dialog box can be accessed from the Batch Overview screen by
clicking the Select Equipment button. The BatchEquipSelect dialog box is used to select
the operating unit for a batch run, or to change the pre-selected operating unit in a
batch recipe.
The illustration below shows the BatchEquipSelect dialog box.

The selected equipment is applied to the batch by clicking Allocate.
Batch Timer dialog box

The Batch Timer dialog box can be accessed from the instrument overivew screen by
clicking the Batch Timer button. The Batch Timer function is available for XDR Bioreactor,
XDUO Mixer, and BioProcess NFF Pump System.
The illustration below shows the Batch Timer dialog box.

1 3
Part Function
1 START button
2 Batch Timer status field. The following statuses are possible:
• RUNNING
• STOPPED
3 STOP button
4 Elapsed time counter
5 RESET button
6 Alarm setpoint display

5 Wonderware user interface: instruments
5 Wonderware user interface: instru-

ments
About this chapter

This chapter describes Wonderware user interface for each operating unit that is shown
in Wonderware.
In this chapter
Section See page
5.1 XDR Bioreactor 102
5.2 XDUO Mixer 111
5.3 BioProcess NFF Pump System 115
5.4 Remote pumps and scales 119
5.5 ÄKTA ready 123
5.6 ÄKTAprocess 126
5.7 ReadyToProcess WAVE 25 130
5.8 UniFlux 134

5.1 XDR Bioreactor
5.1 XDR Bioreactor
Introduction
This section gives information about specific features of Wonderware user interface for
XDR Bioreactor.
In this section
Section See page
5.1.1 XDR Bioreactor 103
5.1.2 Control 108

5.1 XDR Bioreactor
XDR Bioreactor screen

description
XDR Bioreactor screen is the main overview screen for each bioreactor. This screen
provides a detailed graphical display of the bioreactor system layout and allows the
user to monitor and control the cell cultivation process. Each XDR Bioreactor screen
can be accessed from the header toolbar by clicking XDR Bioreactor and selecting the
relevant bioreactor from the drop-down menu.

5.1 XDR Bioreactor
Illustration of the XDR Bioreactor

screen
The following illustration shows the XDR Bioreactor screen.
2 3 4 5 6 7 8 9
10
22
21
20
19
18 11
17
16 15 14 13 12
Part Description
1 Enable/Disable button
Click the button to disable or enable the operating unit.
2 Pump totalizer panels

Click a panel to open the corresponding pump totalizer dialog box.
3 Pump panels
Click a panel to open the corresponding pump PID faceplate dialog box.

5.1 XDR Bioreactor
Part Description
4 Pump icons
Click an icon to open the corresponding Pump Flow Calibration dialog
box.
5 Exhaust filter heater icons and valve icon

The green filter icon indicates that the exhaust filter valve is open.
Click the valve icon to open the ExhaustFilterHeaterValve dialog box.
6 Vessel weight display
7 Instrument identification banner
8 Solenoid valve icons

Click an icon to open the corresponding valve selection dialog box.
9 MFC icons
Click an icon to open the corresponding MFC totalizer dialog box.
Note:
See Gas flow path colors, on page 107 for more information about solenoid
valves and MFC icons.
10 MFC panels
Click a panel to open the corresponding MFC PID faceplate dialog box.
11 Main PID loops panels and Select buttons

Click a panel to open the corresponding PID faceplate dialog box.
Click Select to switch between duplicate probes. 1
13 Agitator icon
Click the icon to open the Agitator Enable dialog box.
Note:
See Section 6.5.5 Use the agitator, on page 234 for more information about
agitator icon.
14 Agitator panel
Click the panel to open the agitator PID faceplate dialog box.
15 Exhaust filter heater temperature panels and Select buttons

Click Select to select one exhaust filter heater.

5.1 XDR Bioreactor
Part Description

See Chapter 11 Batch Control function, on page 374 for more info about
the Batch Control function.
17 PID Default Setpoints access button

Click the button to access Default PID Setpoint screen. See Section 4.3.4
Default PID Setpoint, on page 76 for more information.
18 Batch Timer access button

Click the button to access the Batch Timer dialog box.
19 Vessel temperature panel and Select button

Click the panel to open the vessel temperature PID faceplate dialog box.
Click Select to switch between duplicate temperature probes.1
20 CO2 panel
21 Vessel weight panel and Tare button

Click Tare to open the vessel weight tare dialog box.
22 Bag pressure panel and Tare button

Click Tare to open the bag pressure tare dialog box.
1 Optional. Depending on your system configuration, this function might not be present.

5.1 XDR Bioreactor
Gas flow path colors

The MFCs are displayed as gray cylinders with a line through the center, representing
the flow path.
The following colors are used to show the state of the gas flow:
Illustration Color Description
Solenoid valve green. Valve selected. Gas flow active.
Solenoid valve center block green. Valve selected. No gas flow.
Solenoid valve gray. Valve not selected. No gas flow.
MFC gas flow path green. Gas flow active.
MFC gas flow path gray. No gas flow.

5.1 XDR Bioreactor
5.1.2 Control
5.1.2 Control
Control screen description

The Control screen is accessed from the header toolbar. The Control screen allows the
users to map PID control loops (that is, to configure the interaction of units that are part
of the bioreactor control system). The users must have Supervisor or Engineer access
rights to do the mapping.
The following elements can be shown on the Control screen:
Type Examples
Input devices (transmitters) Auxiliary inputs

Dissolved oxygen (DO) sensor
pH sensor
Vessel weight sensor
Output devices Mass flow controllers

Pumps
Agitator
Intermediate control elements Lookup tables

Split ranges
Mapping buttons The buttons enable or disable connections between

the devices and intermediate control elements.
Mapping a PID control loop establishes a connection between a transmitter (input device)
and a control element (output device), optionally through an intermediate control element.
See Section 12.3 Control loop configuration, on page 452 for description of the principles
and the elements of control loop mapping.
See Section 6.4 Configure control loops, on page 147 for instructions of control loop
mapping.

5.1 XDR Bioreactor
5.1.2 Control
Illustration of the Control screen

without mapped devices
The following illustration shows the general layout of the Control screen without any
mapped devices.
1 2 3
Part Description
1 Input (transmitter) device panels (main PID loops panels)
2 Mapping (enable and disable) buttons
3 Output device panels

5.1 XDR Bioreactor
5.1.2 Control
Illustration of the Control screen

with mapped devices
The following illustration shows a Control screen mapped for pH control using split range
dead zone option, and for DO control using lookup tables.
1 2 3 4
Part Description
1 Input (transmitter) device panels (main PID loops panels) and activation
buttons
2 Split range selection panel and activation button
3 Lookup table panels and activation buttons
4 Lookup table assignment panels and activation buttons
5 Output device panels

5.2 XDUO Mixer
5.2 XDUO Mixer
Introduction
XDUO Mixer.
XDUO Mixer screen description

XDUO Mixer screen is the main overview screen for each mixer. This screen provides a
detailed graphical display of the mixer system layout and allows the user to monitor and
control the mixing process. Each XDUO Mixer screen can be accessed from the header
toolbar by clicking XDUO Mixer and selecting the relevant mixer from the drop-down
menu.

5.2 XDUO Mixer
Illustration of the XDUO Mixer

screen
The following illustration shows the XDUO Mixer screen.
2 3 4 5 6
16
15
14
13
7
12
11
10 9 8
Part Description
2 Pump panels 1
3 Pump icons1
Click an icon to open the corresponding Pump Direction dialog box.

5.2 XDUO Mixer
Part Description
4 Instrument mode description banner:
• FlexFactory Mode
• Stand-Alone Mode
5 Mixer weight display
7 Main PID loops panel and Select button1

Click the panel to open the corresponding PID faceplate dialog box.
Click Select to switch between duplicate probes.

9 Agitator icon
Click the icon to open the Agitator Enable dialog box.
Note:
See Section 7.4.3 Use the agitator, on page 277 for more information about
agitator icon.
11 PID Default Setpoints access button

Click the button to access Default PID Setpoint screen. See Section 4.3.4
Default PID Setpoint, on page 76 for more information.

13 Agitator panel
Click the panel to open the agitator PID faceplate dialog box.
14 Vessel weight panel and Tare button1

Click Tare to open the vessel weight tare dialog box.
15 Conductivity panel

5.2 XDUO Mixer
Part Description
16 Vessel temperature panel and Select button1

Click the panel to open the vessel temperature PID faceplate dialog box.
Click Select to switch between duplicate temperature probes.
1 Optional. Depending on purchased configuration, these functions might not be present.

5.3 BioProcess NFF Pump System
Introduction
BioProcess NFF Pump System.
NFF System screen description

NFF System screen is the main overview screen for each BioProcess NFF Pump System.
This screen provides a detailed graphical display of the pump system layout and allows
the user to monitor and control the filtration process. The NFF System screen displays
icons for all filter units that are currently installed at the selected BioProcess NFF Pump
System, and shows the flow path configuration (sequential flow path or parallel filtration)
for this system.
Each NFF System screen can be accessed from the header toolbar by clicking NFF
System and selecting the relevant pump system from the drop-down menu.

Illustration of the NFF System

screen
The following illustration shows an example of the NFF System screen. The detailed
layout of your screen depends on your system configuration.
1 2 3 4
16
5
15
6
14 7
13
12
8
11
10 1 9
Part Description
1 Filter pre-pressure panels
Note:
Each panel shows pressure in the flow path before the filter that is located
to the right of the panel. The pre-pressure is shown for each filter in your
system.

Part Description
2 Delta pressure panels
Note:
Each panel shows the difference in pressure before and after the filter that
is located to the left of the panel. The delta pressure is not shown for the
last filter in the flow path.
4 Filter icon (membrane filter)
5 Pump control buttons

Click Enable to start the pump.
Click Disable to stop the pump.
6 Pump status display (Enabled or Disabled)
7 Main PID loops panels and control mode notification

Note:
A control mode notification is always shown. The process control mode is
not active until the user activates the control loop mapping.
8 Configuration Screen access button

Click the button to access Configuration Screen dialog box.


12 Pump flow panel

Click the panel to open the Flow Meter - Feedback Screen.
13 Pump icon
14 Pump panel
Click the panel to open the pump PID faceplate dialog box.
15 Filter icon (depth filter)

Part Description

5.4 Remote pumps and scales
Introduction
remote devices: remote pumps and scales.
In this section
Section See page
5.4.1 Remote Pumps 120
5.4.2 Remote Scales 121

5.4.1 Remote Pumps
5.4.1 Remote Pumps
Remote Pumps screen

description
Remote Pumps screen is the overview screen for remote (external) pumps. This screen
displays pump PID faceplates for each remote pump and allows the user to monitor and
control the pump. Page 1 displays PID faceplates for remote pumps 1–10 and page 2
for pumps 11–20.
Remote Pumps screens can be accessed from the header toolbar by clicking Pumps,
scales and selecting RemotePumpP1 or RemotePumpP2 from the drop-down menu.
Illustration of Remote Pumps

screen
The following illustration shows an example of the Remote Pumps screen, page 1. The
number of displayed faceplates depends on your system configuration.

5.4.2 Remote Scales
5.4.2 Remote Scales
Remote Scales screen description

Remote Scales screen is the overview screen for all external scales connected to
FlexFactory. This screen provides a weight faceplate dialog box for each scale, where
the user can monitor and tare the scale.
The Remote Scales screen can be accessed from the header toolbar by clicking Pumps,
scales and selecting Remote Scales from the drop-down menu.
Illustration of Remote Scales

screen
The following illustration shows the Remote Scales screen. The number of displayed di-
alog boxes depends on your system configuration.

5.4.2 Remote Scales
Illustration of Remote Scales

dialog box
The following illustration shows a remote scale dialog box.
Part Description
1 Tag name and description
2 Scale name (assigned by the user)
3 Parameter name and unit
4 Weight display fields:
Gross Total weight of the object (Net + Tare)
Net Added weight after taring
Tare Initial weight at which the scale was tared
5 TARE button

5.5 ÄKTA ready
5.5 ÄKTA ready
Introduction
ÄKTA ready.
ÄKTA ready screen description

ÄKTA ready screen is the overview screen for ÄKTA ready system. This screen provides
a detailed graphical display of the flow path layout and allows the user to monitor the
chromatography process. Each ÄKTA ready screen can be accessed from the header
toolbar by clicking ÄKTA ready and selecting the relevant instrument from the drop-
down menu.
ÄKTA ready is managed through UNICORN, using the built-in computer. It is also possible
to access ÄKTA ready via M-Station OIT, see Access UNICORN software, on page 372 for
more information.

5.5 ÄKTA ready
Illustration of the ÄKTA ready

screen
The following illustration shows the ÄKTA ready screen.
1 2 3 4 5 6
7 8 9
Part Description
1 Pump 1 icon, with inlets
2 Process parameter panels
Note:
See further down for more detailed explanation.
3 Air trap icon, with valves

5.5 ÄKTA ready
Part Description
5 Run status banner
6 Outlet valves
7 Pump 2 icon, with inlet
9 Column icon, with valves
The process parameter panels show the following system information:
Tagname Description and measurement unit
Cond101 Conductivity (mS/cm)
DP1_2 Differential pressure (bar)

The delta pressure is calculated between P111 and P112.
Flow141 Flow rate (LPH), post-column
P111 Pre-column pressure (bar)

The pressure is measured after the pump.
P112 Post-column pressure (bar)

The pressure is measured after the column, before the sensors.
P113 Post-column pressure (bar)

The safety pressure is measured before the outlets (after tempera-
ture sensor, conductivity cell, and UV cell)
pH121 pH (pH units)
UV131 UV (mAU)

5.6 ÄKTAprocess
5.6 ÄKTAprocess
Introduction
ÄKTAprocess.
ÄKTAprocess screen description

ÄKTAprocess screen is the overview screen for ÄKTAprocess system. This screen provides
a detailed graphical display of the flow path layout and allows the user to monitor the
chromatography process. Each ÄKTAprocess screen can be accessed from the header
toolbar by clicking ÄKTAprocess and selecting the relevant instrument from the drop-
down menu.
ÄKTAprocess is managed through UNICORN, using the built-in computer. It is also possible
to access ÄKTAprocess via M-Station OIT, see Access UNICORN software, on page 372 for
more information.

5.6 ÄKTAprocess
Illustration of the ÄKTAprocess

screen
The following illustration shows the ÄKTAprocess screen.
1 2 3 4 5 6
7 8 9 10 11 12 13
Part Description
1 System pump A icon, with inlets
Open
Closed
2 Air trap icon, with valves

5.6 ÄKTAprocess
Part Description
3 Run status banner
4 Filter inlet icon, with valves
6 Outlet valves 1
7 System pump B icon, with inlets
8 Intelligent Packing / CIP valves 2
9 Process parameters panels
Note:
See the following illustration for details.
11 Sample pump icon, with inlets (optional)
12 Column 1 icon, with valves
13 Column 2 icon, with valves
1 The number of outlet valves depends on purchased configuration.

2 Optional. Depending on purchased configuration, this function might not be present.
The following illustration shows the detailed view of the process parameters panels.
1 2 3
4 5 6 7

5.6 ÄKTAprocess
Part Description
1 Conductivity and temperature panel (pre-column)
2 Conductivity and temperature panel (post-column)
3 Pre-column pressure panel
4 System flow rate panel (pump A + pump B)
5 Pump flow rate panel (pump A)
6 UV panel
7 pH panel

5.7 ReadyToProcess WAVE 25
Introduction
ReadyToProcess WAVE 25.
RTP WAVE screen description

RTP WAVE screen is the overview screen for ReadyToProcess WAVE 25. This screen
provides a detailed graphical display of the system layout and allows the user to monitor
the cell cultivation process. Each RTP WAVE screen can be accessed from the header
toolbar by clicking RTP WAVE and selecting the relevant instrument from the drop-down
menu.
ReadyToProcess WAVE 25 is managed through UNICORN, using the system-specific
computer. It is also possible to access ÄKTAprocess via M-Station OIT, see Access UNICORN
software, on page 372 for more information.

Illustration of the RTP WAVE

screen
The following illustration shows the RTP WAVE screen.
1 2 3 4 5 6 7
9
14
13
12
11
10
Part Description
1 Pump state and role information
Note:
See the following illustration for details.
2 Pump flow panels (the accumulated flow volume, L)
4 Run status banner
5 Bag temperature panel
6 Bag weight panel

Part Description
7 Process functions displays:
• CO2 mix (On/Off)
• Heating (On/Off)
• O2 mix (On/Off)
• Rocking (On/Off)
• Sampling (Normal/Sampling)
8 Media exchange status (On/Off) and media control mode display:
• Media addition
• Perfusion
9 Gas flow status (On/Off) and gas type display:
• Compressed air
• N2
11 pH panel
12 pH control information:
• pH Ctrl: pH control status On/Off
• pH Read: pH reading status On/Off
• pHCntrlScheme: currently selected pH control scheme. The following

values are possible: CO2, Acid/Base, CO2/Base.
Note:
pHCntrlScheme is functional only when pH Ctrl status is On.
13 DO (dissolved oxygen) control information:
• DO Ctrl: DO control status On/Off
• DO Read: DO reading status On/Off
• DOCntrlScheme: selected DO control scheme. The following values

are possible: O2, Rocking Speed, O2 and Rocking Speed.
14 DO panel

The following illustration shows the detailed view of the pump information section of
the RTP WAVE screen.
Part Description
1 Pump number and state: Running/Not Running
2 Role assigned to the pump:
• Acid
• Base
• Feed1 to Feed4
• Harvest

5.8 UniFlux
5.8 UniFlux
Introduction
UniFlux.
UniFlux screen description

UniFlux screen is the overview screen for UniFlux. This screen provides a detailed
graphical display of the pump system layout and allows the user to monitor the filtration
process. Each UniFlux screen can be accessed from the header toolbar by clicking UniFlux
and selecting the relevant instrument from the drop-down menu.
UniFlux is managed through UNICORN, using the built-in computer. It is also possible to
access ÄKTAprocess via M-Station OIT, see Access UNICORN software, on page 372 for
more information.

5.8 UniFlux
Illustration of the UniFlux screen

The following illustration shows the UniFlux screen.
5 6 7
4
3
8
2
Part Description
1 Feed pump icon
2 Quadruple inlet valve 1–4 icons
3 Feed tank icon
4 Feed transfer pump icon
6 Run status banner
7 Filter icon (depth filter)
8 Transfer and permeate pump icon

5.8 UniFlux
Part Description
The process parameter panels show the following system information:
Tagname Description and measurement unit
AIT131 Permeate UV (AU)
AT121 Permeate pH (pH units)
CIT101 Permeate conductivity (mS/cm)
Conc_Fac Concentration factor
DeltaP Differential pressure (bar)
DF_X_Fct Diafiltration factor (DV)
Flux Water flux (the rate at which water permeates the membrane)
(L/h/m2)
FT141 Feed flow meter (L/min)
FT142 Permeate flow meter (L/min)
FT142Vtot Permeate totalizer (L)
M241 Feed tank impeller speed (%)
PCV341_Pct Retentate pressure control (%)
PT111 Feed pump outlet pressure meter (bar)
PT112 Feed pump inlet pressure meter (bar)
PT113 Retentate pressure meter (bar)
PT114 Permeate pressure meter (bar)
TE161 Retentate temperature ( °C)
TMP Transmembrane pressure (bar)
WIT176 Feed tank weight (kg)
VolRetent Retentate volume (L)

6 Operate XDR Bioreactor
About this chapter

This chapter provides required information to operate XDR Bioreactor from Wonderware
software.
All users must read the entire XDR Bioreactor Operating Instructions before operating
or maintaining the product.
Enable the system

Make sure the XDR Bioreactor is enabled before starting to work with the system. See
Section 12.1 Enable/Disable function, on page 438.
In this chapter
Section See page
6.1 Safety precautions 138
6.2 XDR Bioreactor interlocks 139
6.3 Start up the system 142
6.4 Configure control loops 147
6.5 Manage the disposable bag contents 210
6.6 Finish a process run 255
6.7 Shut down the software 261

6.1 Safety precautions
CAUTION
Tuning PID control loops. Make sure that personnel tuning PID
control loops are qualified to perform this task. Incorrectly tuned
PID loops could cause injury to personnel and damage the instru-
ment.
CAUTION
Pinch hazard. Do not operate the pumps without the covers in
place.
CAUTION
Secure pump tubing. Make sure that the pump tubing is secure
and in good condition before using the pump. Do not block or kink
the tubing downstream of the pump.
CAUTION
Changing split range setup. Only qualified personnel should
change the split range percentage. Incorrectly set up split range
could cause injury to personnel and damage the instrument.

6.2 XDR Bioreactor interlocks
Description
If... Then...
the XDR vessel weight is less than the interlocks stop the agitator, DO control,
agitator interlock limit pH control, and vessel temperature con-
trol.
the XDR vessel weight is less than the low interlocks stop DO control, pH control,
weight interlock limit and vessel temperature control. The
mass flow controllers and pumps that
are not assigned to DO or pH control
continue to work.
the XDR vessel weight is more than the interlocks stop mass flow controllers and
over-volume interlock limit pumps.
bag pressure exceeds 48 millibar interlocks stop mass flow controllers and
(0.7 psi g) pumps. 1
the agitator is shut off manually interlocks stop DO control, pH control,

and vessel temperature control.
1 If the interlocked PID control loop is in the Auto mode, the control starts automatically 30 sec-
onds after the interlock condition is corrected.
The weight interlock limits depend on the XDR vessel size. See the following section for
detailed information.

Interlock limits
The following table shows the interlock limits for different sizes of XDR Bioreactor.
Interlock type
XDR vessel size Over-volume Low weight Agitator
50 L 55 kg 22 kg 2 kg
200 L 220 kg 38 kg 9 kg
500 L 525 kg 85 kg 12 kg
1000 L 1050 kg 175 kg 33 kg
2000 L 2100 kg 348 kg 63 kg
50–2000 L, delay time 30 s 15 s 30 s
If the interlocked PID control loop is in the Auto mode, the control starts automatically
when the interlock condition is corrected and the delay time has passed.

Illustration of the interlocks

The panels for stopped PID control loops are marked with orange frames on the XDR
Bioreactor screen. The interlock alarms are shown in the alarm summary pane. The il-
lustration below shows the XDR Bioreactor screen for an interlocked XDR Bioreactor.
An interlock icon is shown on the PID faceplates of the stopped PID control loops.

6.3 Start up the system
Introduction
This section provides the information how to start and log in to the software.
Log in
Follow the instructions below to log in to the Wonderware software.
Step Action
1 Open the Wonderware:
•
click the WindowViewer™ icon on the desktop or on the taskbar
or
• select Start:WindowViewer.
Result: The Wonderware start view opens.

Step Action
2 Click XDR Bioreactor on the header toolbar. Select the relevant bioreactor
from the drop-down menu, if available.
Result: The XDR Bioreactor screen opens.
3 Click Login on the footer toolbar.
Result: The Login to ArchestrA 1 dialog opens.
4 Type the user name in the User Name text box.
5 Type your password in the Password text box.
Note:
The Domain text box is filled automatically.

Step Action
6 Click OK.
Result:
• The Login button text changes to Logout.
• The security symbol turns green.
• The user name is shown in the text field on the screen footer.
• The Close button is displayed for the user with Supervisor or Engineer
access.
1 ArchestrA™ is a registered trademark of Schneider Electric.

Log out
Click Logout on the screen footer to log out of the Wonderware software.
Result: The user is logged out. The security symbol turns red and the user name is shown
as None. The Wonderware start view opens.
Auto log off
If you have been inac- Then...

tive for ...
more than 25 minutes an AutoLogOffWarning message is displayed on the

screen.


tive for ...
more than 30 minutes the user is automatically logged out. An AutoLoggedOff

message is displayed on the screen indicating that the
user has been logged out. The security symbol on the
screen footer turns red and the user name is shown as
None.
After being logged out, the user must log in again, selecting the applicable operating
unit on the header toolbar.

6.4 Configure control loops
Introduction
This section provides the instructions on how to map and unmap XDR Bioreactor control
loops, and how to change the mapping.
For general information about planning the process control see Section 12.3 Control loop
configuration, on page 452.
In this section
Section See page
6.4.1 Map a control loop directly to an output device 148
6.4.2 Map a control loop with lookup tables 156
6.4.3 Map a control loop with split range deadband 168
6.4.4 Map a control loop with split range dead zone 177
6.4.5 Unmap a directly mapped control loop 188
6.4.6 Unmap a control loop mapped with lookup tables 192
6.4.7 Unmap a control loop mapped with split range deadband 198
6.4.8 Unmap a control loop mapped with split range dead zone 203

6.4.1 Map a control loop directly to an output device
Introduction
Any primary control loop can be directly mapped to any secondary control loop to control
the functioning of an output device. In the following example, the DO control loop is
mapped to MFC1 (air MFC).
Map a control loop to a device

Follow the instructions below to connect the DO PID control loop to the the output device.
Step Action
1 Click Control on the header toolbar.
Result: The Control screen is displayed. The illustration below shows an un-
mapped Control screen.

Step Action
2 Click the dark green I button on the right of the DO control loop panel to
select the primary control loop.
Result: A confirmation dialog box opens.
3 Click YES in the dialog box.
Result: A drop-down menu is displayed on the Control screen, below the

buttons.

Step Action
4 Click DirectMap on the drop-down list.
5 Click Assign MFC1 on the right side of the screen to select the output device.
Result: A dialog box opens, showing the available devices for mapping.

Step Action
Select Dissolved Oxygen from the list of devices. Click OK to close the dialog
box.
Note:
The OK button is shown when you have selected the device on the list.
Result: DO->MFC1 panel and the corresponding activation buttons are shown
in the middle of the Control screen, lined up with the primary control loop.

Step Action
Note:
The name of the panel depends on the PID control loops you are currently
mapping.
Continue the mapping as described in the following section.
Activate mapping
Set the PID control loops to Auto mode and activate the mapping. Follow the instructions
below.
Step Action
1 Click PID Faceplates on the header toolbar to open the PID Faceplates
screen.

Step Action
2 Find the Dissolved Oxygen PID faceplate (the primary control loop you are
currently mapping) on the screen.
1 On the PID faceplate, click A and L (1) to set the the DO control loop in
Auto/Local mode.
2 Type an appropriate setpoint value into the SP text box (2).
3 Find the MFC1 PID faceplate (the secondary control loop you are currently
mapping) on the screen.
On the PID faceplate, click A and R to set the the MFC1 control loop in Au-
to/Remote mode.
4 Click Control on the header toolbar to open the Control screen.

Step Action
5 On the Control screen, click the dark green I button on the left of the
DO->MFC1 panel.
6 Click YES in the confirmation dialog box.

Result: The button turns bright green, indicating that the direct mapping is
active.

Description of completed direct

mapping
After completing the direct mapping procedure, the primary control loop (the DO control
loop) is connected to the secondary control loop (MFC1 control loop). The mapping is
activated. The functionality of MFC1 is controlled by the CV of the DO PID control loop.
The MFC1 PID faceplate shows that the control loop is in Cascade mode. The PID loop
name on the MFC1 panel on the XDR Bioreactor overview screen is highlighted in
turquoise.
The following illustration shows the Control screen with completed DO direct mapping.

6.4.2 Map a control loop with lookup tables
Introduction
DO control loop is a typical primary control loop that is mapped using lookup tables. Up
to three lookup tables can be mapped to a primary control loop. See Lookup table de-
scription, on page 464 for more information.
In the following example, this loop is controlled by two lookup tables:
• Air MFC
• Oxygen MFC

Map the control loop to lookup

tables
Follow the instructions below to connect the DO PID control loop to lookup tables.
Step Action

Step Action
2 Click the dark green I button on the right of the DO control loop panel to

buttons.

Step Action
4 Click LookupTable on the drop-down menu.
Result: The lookup table panels (DOC126->LU4, DOC126->LU5, DOC126-

>LU6) and the corresponding activation buttons are displayed in the middle
of the Control screen, lined up with the primary control loop. Up to 3 lookup
tables can be mapped to the primary control loop.

Step Action
5 Click Assign MFC1 on the right side of the screen to select the output device
and connect the output device to a lookup table.
6 Select a lookup table from the list. Click OK to close the dialog box.
Note:

Step Action
Result: The lookup table assignment panel LU4->MFC1 and the corresponding
activation button are displayed on the right of the lookup table panel.
Note:
mapping.
7 Connect the second output device to the second lookup table, as described
in steps 5–6 above.
Note:
Only the available lookup tables are shown in the dialog box.
Result: The second lookup table assignment panel LU5->MFC2 and the cor-
responding activation button are displayed.
8 Connect the third output device to the third lookup table, if necessary for
your production process.

Activate mapping
Activate the mapping, configure the lookup tables and set the PID control loops to Auto
mode. Follow the instructions below.
Step Action
screen.
2 Find the MFC1 and the MFC2 PID faceplates. Click M and L to set both MFC
control loops in Manual/Local mode.
4 Enable the MFC1: click the dark green I button on the left of the LU4-
>MFC1 (1) and click YES in the confirmation dialog box.

Step Action
5 Enable the MFC2: click the dark green I button on the left of the LU5-
>MFC2 (2) and click YES in the confirmation dialog box.
Result: Both dark green buttons turn bright green, indicating that the mass
flow controllers are enabled.
6 Enable the first lookup table (LU4): click the dark green I button on the
left of the DOC126->LU4 (1) and click YES in the confirmation dialog box.
Result: The MFC1 PID control loop is controlling the gas flow through MFC1.
7 Enable the second lookup table (LU5): click the dark green I button on
the left of the DOC126->LU5 (2) and click YES in the confirmation dialog box.
Result: The MFC2 PID control loop is controlling the gas flow through MFC2.

Step Action
8 Click the lookup table panel DOC126->LU4 to open the lookup table dialog
box.
9 Type the designated values in the table, as necessary for your production
process. Click Close Popup to close the dialog box.
Result: The gas flow through the MFC1 is regulated according to the values
in the Lookup Table 4.

Step Action
10 Click the lookup table panel DOC126->LU5 to open the second lookup table
dialog box. Fill in the values as necessary and close the dialog box, as de-
scribed in step 9.
Result: The gas flow through the MFC2 is regulated according to the values
in the Lookup Table 5.
screen.
12 Find the MFC1 and the MFC2 PID faceplates. Click A and R to set both MFC
control loops in Auto/Remote mode.

Step Action
13 Find the DO (Dissolved Oxygen) PID faceplate. Click A and L to set the DO
control loop in Auto/Local mode.

Description of the completed

mapping with lookup tables
After completing the mapping via two lookup tables, the primary control loop (the DO
control loop) is connected to two secondary control loops (MFC1 and MFC2, that is, air
MFC and oxygen MFC). The functionalities of MFC1 and MFC2 are controlled by the CV
of the DO PID control loop in a non-linear manner, according to the values defined in
the lookup tables. The MFC1 and MFC2 PID faceplates show that the control loops are
in Cascade mode. The PID loop names on the MFC panels on the XDR Bioreactor overview
screen are highlighted in turquoise.
The following illustration shows the Control screen with completed DO mapping using
lookup tables.

6.4.3 Map a control loop with split range deadband
Introduction
The pH control loop is a typical primary control loop that is mapped using a split range.
The split range mapping can be set up as deadband or dead zone option. See Split range
description, on page 464 for more information.
The following mapping example describes the mapping procedure using split range
deadband (DB) option.
The pH can be controlled by pumps or by an MFC:
• CO2 MFC or acid pump for the low pH range control,
• Base pump for the high pH range control.
Map the control loop

The instructions describe how to map the acid pump (pump 2) to the split range. If you
want to control the low pH range with CO2, assign the CO2 MFC to the split range (instead
of the pump 2) in step 7.
Follow the instructions below to map the pH PID control loop to a split range with
deadband.

Step Action
2 Click the dark green I button on the right of the pH control loop panel to

Step Action

buttons.
4 Click SplitRange DB on the drop-down menu.
Result: The split range 1 selection panel PHC125->Split Rng1 and the corre-
sponding activation button are displayed in the middle of the Control screen,
lined up with the primary control loop.

Step Action
5 Click Assign Pump1 on the right side of the screen to select an output device
and connect the output device to the split range.
6 Select Split Range Upper 1 from the list to connect the base pump (pump
1) to split range. Click OK to close the dialog box.
Note:

Step Action
Result: The split range panel SR1Up->PMP1 and the corresponding activation
button are displayed on the right side of the screen.
Note:
mapping.
7 Connect the second output device (click Assign Pump2 to connect the acid
pump, or Assign MFC to connect the CO2 MFC) to split range, as described
in step 6 above.
Note:
Only the available split range choices are shown in the dialog box.
Result: The second split range panel SR1Low->PMP2 is displayed.

Activate mapping
Set the PID control loops to Auto mode and activate the mapping. Follow the instructions
below.
Step Action
screen.
2 Find the Pump1 and the Pump2 PID faceplates. Click A and R to set both
pump control loops in Auto/Remote mode.
SR1Up->PMP1 panel (1) and click YES in the confirmation dialog box.

Step Action
4 Click the dark green I button on the left of the SR1Low->PMP2 panel (2)
and click YES in the confirmation dialog box.
Result: The buttons turn bright green, indicating that the pump connections
to split range are enabled.
5 On the PID Faceplates screen, find the pH PID faceplate. Click A and L to set
the pH control loop in Auto/Local mode.

Step Action
PHC125->Split Rng1 panel.

Result: The button turns bright green, indicating that the split range mapping
is active.


mapping
After completing the mapping of split range low and high ranges, the primary control
loop (the pH control loop) is connected to two secondary control loops (base pump and
acid pump, or base pump and CO2 MFC). The functionality of the pumps (or the MFC) is
controlled by the CV of the pH PID control loop in such way that only one device can run
at any time. This setup avoids the conflict of raising and lowering the pH simultaneously.
Both pump PID faceplates show that the control loops are in Cascade mode. The PID
loop names on the pump panels on the XDR Bioreactor overview screen are highlighted
in turquoise.
The following illustration shows the Control screen with completed pH mapping using
split range deadband.

6.4.4 Map a control loop with split range dead zone
Introduction
The pH control loop is a typical primary control loop that is mapped using a split range.
The split range mapping can be set up as deadband or dead zone option. See Split range
description, on page 464 for more information.
The following mapping example describes the mapping procedure using split range
dead zone (DZ) option, where lookup tables mediate the output from the primary control
loop to the secondary control loop.
The pH can be controlled by pumps or by an MFC:
• CO2 MFC or acid pump for the low pH range control,
• Base pump for the high pH range control.
Map the control loop

The instructions describe how to map the acid pump (pump 2) to the split range. If you
want to control the low pH range with CO2, assign the CO2 MFC to the split range (instead
of the pump 2) in step 7.
Follow the instructions below to map the pH PID control loop to a split range with
dead zone.

Step Action
2 Click the dark green I button on the right of the pH control loop panel to

Step Action
4 Click SplitRange DZ on the drop-down menu.
Result: The split range 1 selection panel PHC125->Split Rng1 and the corre-
sponding activation button are displayed on the Control screen. The lookup
table panels (SR1 Up->LU1, SR1 Low->LU2) and the corresponding activation
buttons are displayed on the right of the split range 1 selection panel. The
panels and the buttons are lined up with the primary control loop.

Step Action
5 Click Assign Pump1 on the right side of the screen to select an output device
and connect the output device to a lookup table.
6 Select Lookup Table 1 from the list to connect the base pump (pump 1) to
the lookup table. Click OK to close the dialog box.
Note:

Step Action
Result: The lookup table assignment panel Lu1->PMP1 and the corresponding
activation button are displayed on the right side of the screen.
Note:
mapping.
7 Connect the second output device (click Assign Pump2 to connect the acid
pump, or Assign MFC to connect the CO2 MFC) to the second lookup table,
as described in steps 5–6 above.
Note:
Only the available lookup tables are shown in the dialog box.
Result: The second lookup table assignment panel Lu2->PMP2 and the cor-
responding activation button are displayed.

Activate mapping
Activate the mapping, configure the lookup tables and set the PID control loops to Auto
mode. Follow the instructions below.
Step Action
screen.
2 Find the Pump1 and the Pump2 PID faceplates. Click M and L to set both
pump control loops in Manual/Local mode.
4 Enable the pump connection: click the dark green I button on the left of
the Lu1->PMP1 panel (1) and click YES in the confirmation dialog box.
1

Step Action
5 Click the dark green I button on the left of the Lu2->PMP2 panel (2) and
click YES in the confirmation dialog box.
Result: Both dark green buttons turn bright green, indicating that the pump
connections to lookup tables are enabled.
6 Enable the first lookup table (LU1): click the dark green I button on the
left of the SR1 Up->LU1 (1) and click YES in the confirmation dialog box.
7 Enable the second lookup table (LU2): click the dark green I button on
the left of the SR1 Low->LU2 (2) and click YES in the confirmation dialog box.
Result: Both dark green buttons turn bright green, indicating that the lookup
tables are enabled.

Step Action
8 Click the dark green I button on the left of the PHC125->Split Rng1 panel.

Result: The button turns bright green, indicating that the split range dead zone
mapping is active.
10 Click the lookup table panel SR1 Up->LU1 to open the lookup table dialog
box.

Step Action
11 Type the designated values in the table, as necessary for your production
process. Click Close Popup to close the dialog box.
12 Click the lookup table panel SR1 Low->LU2 to open the lookup table 2 dialog
box. Fill in the values as necessary and close the dialog box, as described in
step 11 above.
Result: The values in the lookup tables regulate the split range high and low
ranges.
screen.

Step Action
14 Find the Pump1 and the Pump2 PID faceplates. Click A and R to set both
pump control loops in Auto/Remote mode.
15 Find the pH PID faceplate. Click A and L to set the pH control loop in Auto/Lo-
cal mode.


mapping
After completing the mapping of split range low and high ranges, and configuring the
two lookup tables, the primary control loop (the pH control loop) is connected to two
secondary control loops (base pump and acid pump, or base pump and CO2 MFC). The
functionality of the pumps (or the MFC) is controlled by the CV of the pH PID control loop
in such way that only one device can run at any time. This setup avoids the conflict of
raising and lowering the pH simultaneously. The connection is mediated via lookup tables
in a non-linear manner, according to the values defined in the lookup tables.
Both pump PID faceplates show that the control loops are in Cascade mode. The PID
loop names on the pump panels on the XDR Bioreactor overview screen are highlighted
in turquoise.
The following illustration shows the Control screen with completed pH mapping using
split range dead zone.

6.4.5 Unmap a directly mapped control loop
Disable the direct mapping

Follow the instructions below to disconnect the DO PID control loop from the the output
device.
Step Action
Result: The Control screen is displayed. The illustration below shows a Control
screen with DO direct mapping.

Step Action
2 Click the dark red O button on the left of the DO->MFC1 panel.
Result: The button turns bright red, indicating that the mapped device (MFC1)
is disconnected.
4 Click the DO->MFC1 panel to open the device selection dialog box.

Step Action
5 Click RESET. Close the dialog box by clicking the close button .
Result: The DO->MFC1 panel and the corresponding activation buttons are
removed from the screen.
6 Click the dark red O button on the right of the DO control loop panel.

Result: The button turns bright red. The drop-down menu is removed from
the screen.

Step Action
The direct mapping of the PID control loop to the output device is disabled.

6.4.6 Unmap a control loop mapped with lookup tables
Disconnect the mapping with

lookup tables
Follow the instructions below to disconnect the DO PID control loop mapping.
Step Action
screen, with DO mapped to two MFCs using lookup tables.

Step Action
2 Disable the MFC1: click the dark red O button on the left of the LU4-
>MFC1 panel (1).
4 Click the dark red O button on the left of the LU5->MFC2 panel (2) and
Result: Both dark red buttons turn bright red, indicating that the mass flow
controllers are disabled.

Step Action
5 Click the lookup table assignment panel LU4->MFC1 to open the lookup table
selection dialog box.
Result: The LU4->MFC1 panel and the corresponding activation button are

Step Action
7 Click the lookup table assignment panel LU5->MFC2 to open the lookup table
selection dialog box.
Result: The LU5->MFC2 panel and the corresponding activation button are
Continue the unmapping as described in the following section.
Unmap the control loop

Follow the instructions below to unmap the DO PID control loop from the lookup tables.
Step Action
1 Click the dark red O button on the left of the lookup table 1 panel DOC126-
>LU4 (1).

Step Action

Result: The button turns bright red, indicating that the lookup table 1 is dis-
connected.
3 Click the dark red O button on the left of the lookup table 2 panel DOC126-
>LU5 (2) and click YES in the confirmation dialog box.
Result: The button turns bright red, indicating that the lookup table 2 is dis-
connected.
4 Click the dark red O button on the right of the DO control loop panel.

Result: The button turns bright red. The lookup table panels and the corre-
sponding activation buttons are removed from the screen. The drop-down
menu is removed from the screen.

Step Action
The PID control loop mapping with lookup tables is disabled.

6.4.7 Unmap a control loop mapped with split range deadband
Disable the split range deadband

mapping
Follow the instructions below to disconnect the pH mapping of split range with deadband.
Step Action
screen with devices, mapped using split range deadband.

Step Action
2 Click the dark red O button on the left of the SR1Up->PMP1 panel (1).
4 Click the dark red O button on the left of the SR1Low->PMP2 panel (2)
and click YES in the confirmation dialog box.
Result: Both dark red buttons turn bright red, indicating that the pump con-
nections to split range are disabled.

Step Action
5 Click the device assignment panel SR1Up->PMP1 to open the device selection
dialog box.
Result: The SR1Up->PMP1 panel and the corresponding activation button

are removed from the screen.

Step Action
7 Click the device assignment panel SR1Low->PMP2 to open the device selec-
tion dialog box.
Result: The SR1Low->PMP2 panel and the corresponding activation button
are removed from the screen.

Follow the instructions below to unmap the pH PID control loop from a split range with
deadband.
Step Action
1 Click the dark red O button on the left of the split range 1 selection panel
PHC125->Split Rng1.

Step Action

Result: The button turns bright red, indicating that the split range mapping
is disconnected.
3 Click the dark red O button on the right of the pH control loop panel.

Result: The button turns bright red. The split range 1 selection panel PHC125-
>Split Rng1 and the activation button are removed from the screen. The
drop-down menu is removed from the screen.
The split range deadband mapping is disabled.

6.4.8 Unmap a control loop mapped with split range dead zone
Disconnect the split range

dead zone mapping
Follow the instructions below to disconnect the pH mapping of split range with dead zone.
Step Action
screen with devices mapped using split range dead zone.

Step Action
2 Click the dark red O button on the left of the PHC125->Split Rng1 panel.
Result: The button turns bright red, indicating that the split range dead zone
mapping is disconnected.
4 Disable lookup table 1: click the dark red O button on the left of the SR1
Up->LU1 (1) and click YES in the confirmation dialog box.

Step Action
5 Disconnect lookup table 2: click the dark red O button on the left of the
SR1 Low->LU2 (2) and click YES in the confirmation dialog box.
Result: Both dark red buttons turn bright red, indicating that the lookup tables
are disabled.
6 Click the dark red O button on the left of the Lu1->PMP1 panel (1) and
7 Click the dark red O button on the left of the Lu2->PMP2 panel (2) and
Result: Both dark red buttons turn bright red, indicating that the pump con-
nections to lookup tables are disabled. The following illustration shows the
Control screen when all split range dead zone mapping connections are
disabled.


Follow the instructions below to unmap the pH PID control loop from a split range with
dead zone.
Step Action
1 Click the lookup table assignment panel Lu1->PMP1 to open the device se-
lection dialog box.
Result: The Lu1->PMP1 panel and the corresponding activation button are

Step Action
3 Click the lookup table assignment panel Lu2->PMP2 to open the device se-
lection dialog box.
4 Click Lookup Table 1 in the dialog box. Click RESET and close the dialog box.
Result: The Lu2->PMP2 panel and the corresponding activation button are

Step Action
5 Click the dark red O button on the right of the pH control loop panel.
Result: The button turns bright red. The split range 1 selection panel PHC125-
>Split Rng1, the lookup table panels (SR1 Up->LU1, SR1 Low->LU2), and the
activation buttons are removed from the screen. The drop-down menu is

Step Action
The split range dead zone mapping is disabled.

6.5 Manage the disposable bag contents
Introduction
This section provides information about how to fill the XDR Bioreactor disposable bag
with culture media and how to control liquid and gas flow.
In this section
Section See page
6.5.1 Calibrate the pump 211
6.5.2 Manage pump flow 215
6.5.3 Manage gas flow 221
6.5.4 Fill the disposable bag with media 232
6.5.5 Use the agitator 234
6.5.6 Access the control functions 240
6.5.7 Take a sample 244
6.5.8 Standardize pH probe 248
6.5.9 Calibrate the DO probe with O2 250

6.5.1 Calibrate the pump
When to calibrate
The pumps are calibrated by the user. The pump must be calibrated each time a different
tubing size is used in a particular pump. Pump calibration should be performed routinely
to ensure operational accuracy over time. Contact your GE representative for help and
suggestions.
Note: Remote (external) pumps are calibrated using the procedure defined by the
manufacturer. See the manufacturer's documentation for more information.
Preparation
The pump calibration procedure determines the flow factor for the pump. The flow factor
is used for calculation of the flow rate and the totalized flow.
The following equipment is needed for pump calibration:
• a water reservoir (minimum 2 L)
• tubing (identical to the tubing used during process)
• a collection container (volume minimum 2 L).
Note: The collection container must enable the quantification of collected water.
The container could be a graduated vessel or a tared container placed on
a scale. Consider the accuracy required for your particular operation.
To prepare for pump calibration follow the steps described below.
CAUTION
place.
Step Action
1 Place the water reservoir onto the same height as the process liquid.
2 Install the tubing into the pump. See XDR Bioreactor Operating Instructions
for instructions.
3 Put the inlet of the tubing into the water reservoir.
4 Put the outlet of the tubing into the collection container.

Step Action
5 Prime the pump:
A Click the relevant pump panel on the XDR Bioreactor screen to

open the pump PID faceplate.
nnn
B On the pump PID faceplate, click M and L to set the pump in

Manual/Local mode.
C Type the appropriate pump speed value into the CV text box.
D Run the pump until the tubing is filled with water.

Step Action
6 Discard the priming water.
Calibration
To start the pump calibration follow the instructions below.
CAUTION
place.
Note: Pump calibration is performed in rpm per volume of transferred liquid. When
the pump is run in calibration mode, pump speed is displayed in rpm on PID
faceplate.
Step Action
1 Empty and tare the collection container, if needed.
2 Click the relevant pump icon on the XDR Bioreactor screen.
Result: The Pump Flow Calibration dialog box opens.

Step Action
3 Click Reset.
Result: The volume and the elapsed time values are set to zero.
4 Click Start.
Result: The pump starts to operate. The Elapsed Time counter starts. The
volume shown in pump totalizer panel increases.
5 Run the pump for at least 5 minutes.
Tip:
The longer the pump runs, the more accurate the calibration.
6 Click Stop in the Pump Flow Calibration dialog box.
7 Determine the volume of the collected liquid.
8 Type the volume of the collected liquid into the Volume (Liters) text box.
Result: A new flow factor is calculated and shown in the New Flow Factor
text box.
9 Click Accept.
Result: The new flow factor is shown in the Current Flow Factor text box
and is used for the pump flow.

6.5.2 Manage pump flow
Start the pump

To start the pump without pH control follow the instructions below.
Step Action
1 Verify that all clamps are open on the tubing that connects the disposable
bag with the liquid reservoir.
2 Verify that the clamps on the exhaust gas tubing are open, to avoid over-
pressure.
3 Click the relevant pump panel on the XDR Bioreactor screen to open the
pump PID faceplate.

Step Action
4 On the pump PID faceplate, click M and L to set the pump in Manual/Local
mode.
5 Type the applicable pump speed value into the CV text box on the pump PID
faceplate.
Result: The pump starts.

Stop the pump

Follow the instructions below to stop the pump.
Step Action
1 Click the relevant pump panel on the XDR Bioreactor screen to open the
pump PID faceplate.
2 On the pump PID faceplate, type 0 into the CV text box.
Result: The pump stops.

Change pump flow direction
NOTICE
Do not change pump flow direction when the pump totalizer is
running.
The same pump can be used to fill the XDR vessel and to harvest the contents. Change
the pump flow direction if you want to switch from filling the XDR vessel to draining the
vessel.
Follow the instructions below to change the pump flow direction.
Step Action
1 Click the relevant pump icon on the XDR Bioreactor screen to open the
Pump Flow Calibration dialog box.

Step Action
At the bottom of the dialog box, click the button showing the designated
flow direction.
Result: The flow direction changes. The pump icon on the XDR Bioreactor
screen shows the current flow direction.

Measure the liquid flow

Follow the instructions below to measure the pump flow volume.
Step Action
1 Click the relevant pump totalizer panel on the XDR Bioreactor screen to
open the pump Totalizer dialog box.
2 Click RESET, then click START to start the pump totalizer.
Result: The measurement of the pumped liquid volume starts. The STOPPED
text is replaced by the blue TOTALIZING text. The recorded volume is contin-
uously updated in the mL text box.
3 Click STOP to stop the pump totalizer when the process is completed.
4 Click RESET to reset the pump totalizer.

6.5.3 Manage gas flow
Start the gas flow

Follow the instructions below to start the gas flow and define the volume that passes
through the mass flow controller.
Step Action
1 Click the applicable MFC control loop panel on the XDR Bioreactor screen
to open the MFC PID faceplate.

Step Action
2 On the MFC PID faceplate, type the applicable setpoint value into the SP text
box (1).
3 Click A and L (2) to put the MFC into Auto/Local mode.
Result: The solenoid valve icon turns green to indicate active gas flow.
Measure the gas flow

Follow the instructions below to measure the gas volume that passes through the mass
flow controller.
Note: The MFC totalizer can be started when the MFC is running or stopped.

Step Action
1 Click the applicable MFC icon on the XDR Bioreactor screen.
Result: The MFC Totalizer dialog box opens.
2 Click RESET, then click START to start the MFC totalizer.

Result: The measurement of the pumped gas volume starts. The STOPPED
uously updated in the sL text box.
3 Click STOP to stop the MFC totalizer when the process is completed.
4 Click RESET to reset the MFC totalizer.

Change gas flow path

A bank of solenoid valves, or alternatively the gas manifold inside the gas supply cabinet,
allows the user to change the flow path of a specific gas and redirect the gas to the in-
tended destination.
If you want to send one gas (for example, pure oxygen) through one set of sparge discs
and a different gas through another set, follow the instructions below.
Step Action
1 Click the applicable solenoid valve icon on the XDR Bioreactor screen.
Result: The valve selection dialog box opens.
2 Click the applicable option button to select the designated destination

(Headspace, Sparge 1 or Sparge 2).
3 Click ENABLE SELECTED to enable the gas flow, or click DISABLE ALL to
close all valves.

Step Action
4 Close the dialog box by clicking the close button .
Operate exhaust filter valve

manually
Exhaust filter valve can be operated manually or automatically.
For manual operation, do the following:
Step Action
1 On the XDR Bioreactor screen, click the exhaust filter valve icon to open the
dialog box.
2 In the dialog box, click OPEN to open the valve manually.
Result: The valve opens. The valve status is shown as Manual in the dialog
box. The valve icon on the XDR Bioreactor screen turns green.

Step Action
3 To close the valve manually, click CLOSE in the dialog box.

Result: The valve closes. The valve icon on the XDR Bioreactor screen turns
gray.
Operate exhaust filter valve

automatically
Exhaust filter valve can be operated manually or automatically.
For automatic operation, do the following:
Step Action
1 On the XDR Bioreactor screen, click the exhaust filter valve icon to open the
dialog box.
2 In the dialog box, click RET AUTO to set the valve control to Auto mode.
Result: The valve status is shown as Auto.
3 Click the text box in the bottom right corner and type the appropriate pres-
sure limit value (psi) into the box.
Result: The exhaust filter valve is closed when the disposable bag pressure
is below the specified value (0.700 psi in the example above). The valve is
open when the bag pressure is above the specified value.
The valve icon on the XDR Bioreactor screen is green when the valve is
open.

Step Action
4 Click OPEN or CLOSE to set the valve into Manual mode.
Tare bag pressure

Follow the instructions below to tare the disposable bag pressure.
Step Action
1 Click TARE above the bag pressure panel on the XDR Bioreactor screen.
Result: A dialog box opens.
2 Confirm by clicking YES in the dialog box.
3 Make sure that that the bag pressure is shown as 0 bar (0.0 psi).

Fill the bag with air
CAUTION
Quality of gases. The gases supplied to the system should be clean,
filtered, and pharmaceutical quality. Failure to use pharmaceutical
quality filtered gases could result in malfunction of flow control
valves and gas supply solenoids.
Fill the disposable bag with air before filling the bag with liquid. This allows the user to
gently adjust the bag position and fit the bag inside the XDR vessel.
During the bag filling procedure, make sure that bag pressure data are shown as de-
scribed in the instructions below. If the bag pressure readings are not as expected, the
bag pressure sensor may have failed.
Follow the instructions below to adjust the disposable bag and fill the bag with air.
Step Action
1 Verify that all tubing clamps are closed, except on the following lines:
• The line for filling the disposable bag with air
• The sparge line
2 Make sure that the bag pressure is shown as 0 bar (0.0 psi).

Step Action
3 In the software, configure one MFC to use process air through the headspace
line. Follow the instructions below.
A. Click the MFC1 panel to open the MFC1 PID faceplate.
B. Click A and L (2) to put the MFC into Auto/Local mode.
C. Type a setpoint that is 25% of full scale into the SP text box (1).
Note:
Full scale is based on the flow rate of the installed MFC.

Step Action
4 When the flow is established, increase the SP value to increase the air flow
rate if necessary.
NOTICE
Check for folds and wrinkles while filling the bag with
air.
5 Make sure that proper alignment of the bag is maintained while the bag is
filled with air:
• Correct orientation of sample, pH, DO and temperature probe connectors

in the probe window at the front of the XDR vessel.
• Impeller baseplate remains correctly engaged to the magnetic drive
head.
6 Fill the disposable bag until either the bag pressure is approximately 7 millibar
(0.1 psi), or until the bag shape fits the vessel shape and the bag is still soft
to the touch.
NOTICE
Do not overfill the bag.

Step Action
7 On the MFC1 PID faceplate, type 0 into the SP text box (0 SLPM).
Result: The gas supply to the disposable bag is turned off.
8 Check and arrange the disposable bag inside the XDR vessel as necessary,
to remove folds and wrinkles.

6.5.4 Fill the disposable bag with media
Tare XDR vessel weight

Follow the instructions below to tare the XDR vessel weight.
Step Action
1 Click TARE above the vessel weight panel on the XDR Bioreactor screen.
3 If the password is required, type your password.

Prepare for filling
NOTICE
Make sure that the disposable bag has been filled with air prior to
filling the bag with media. Failure to first inflate the bag might result
in incorrect fit and cause bag fracture during filling.
See Fill the bag with air, on page 228 for instructions about how to fill the bag with air.
Tip: It is recommended to use the largest pump connected to the system for fill
and harvest operations.
Step Action
1 Make sure that the leveling feet are set down and that the full weight load
is removed from the casters before filling the XDR vessel.
2 Install the tubing for filling the disposable bag through the appropriate pump
head on the pump cabinet front panel. See XDR Bioreactor Operating Instruc-
tions for instructions.
3 Make sure that the pump has been calibrated using the correct tubing size.
See Section 6.5.1 Calibrate the pump, on page 211 for instructions.
4 Weld or connect the media reservoir to the tubing.
5 Verify that all clamps are open on the tubing that connects the disposable
bag with the media reservoir.
6 Verify that the XDR vessel is tared. See Tare XDR vessel weight, on page 232
for instructions.
Fill the bag with culture media

A recipe must be run to fill the disposable bag with the culture media. Example recipes
are provided with the FlexFactory Automation. The end user is responsible for developing
the appropriate recipes for their processes.
See Chapter 11 Batch Control function, on page 374 for more information about recipes.

6.5.5 Use the agitator
Start the agitator motor

Follow the instructions below to start and control the agitator motor.
Step Action
1 Click the agitator icon on the XDR Bioreactor screen.
Result: The Agitator Enable dialog box opens.
In the Agitator Enable dialog box, do the following:
• Click ENABLE to enable the agitator.
• Click the “up” arrow for pumping up (clockwise direction) or the “down”
arrow for pumping down (counterclockwise direction).
Result: The DISABLED text is replaced with blue ENABLED text. The agitator
direction arrow on the XDR Bioreactor screen points to the selected direction.

Step Action
4 Click the agitator panel on the XDR Bioreactor screen to open the Agitator
PID faceplate.
• If the bioreactor is in Auto mode, type an applicable setpoint value into

the SP text box.
• If the bioreactor is in Manual mode, type an applicable value into the
CV text box.
Result: The agitator starts. The agitator icon turns green.

Step Action
6 Monitor the system to make sure that agitation control is working as expect-
ed.
The agitator must not be operated in solutions with viscosity above 5 cP. Using the agi-
tator in viscous solutions may lead to decoupling of the impeller baseplate from the
magnetic drive head. The impeller assembly may shift from its stable position, damage
the disposable bag and the process.
Correct impeller baseplate

position
If the impeller baseplate is not correctly installed, the agitation system is not properly
magnetically coupled and does not function correctly. If the agitator emits a loud clicking
noise during operation, the impeller baseplate is decoupled from the magnetic drive
head.
Follow the instructions below to correct the problem.
Step Action
1 Stop the agitator motor as described in Stop the agitator motor, on page 237.
2 Disengage the agitator motor. See XDR Bioreactor Operating Instructions for
instructions how to handle the agitator motor and the impeller baseplate.
3 Arrange the impeller baseplate correctly.
4 Engage the agitator motor.
5 Start the agitation as described in Start the agitator motor, on page 234.

Stop the agitator motor

Follow the instructions below to stop the agitator motor.
Step Action
1 Click the agitator panel on the XDR Bioreactor screen to open the Agitator
PID faceplate.
Result: The Agitator faceplate is displayed.
• If the bioreactor is in Auto mode, type 0 into the SP text box.
• If the bioreactor is in Manual mode, type 0 into the CV text box.

Step Action
Click DISABLE to stop the agitator.

Result: The agitation stops. The blue ENABLED text is replaced with DISABLED
text. The agitator icon turns gray.

Change agitator direction

Follow the instructions below to change agitator direction.
Step Action
Click the “up” arrow for pumping up (clockwise direction) or the “down” arrow
for pumping down (counterclockwise direction).
Result: The agitation direction is set.

6.5.6 Access the control functions
Access PID control loop faceplate

To access a PID control loop faceplate select the relevant PID control loop display:
• on the XDR Bioreactor screen
or
• on the Control screen
or
• on the PID Faceplates screen.
See Section 5.1 XDR Bioreactor, on page 102 and Section 4.3.1 PID Faceplates, on page 67
for detailed description of these screens.
Select probe
Duplicate probes can be available for dissolved oxygen (DO), pH, exhaust filter heater
temperature, or XDR vessel temperature. If duplicate probes of the same type are installed
on the system, the user can switch between the alternative probes.
Follow the instructions below to select an alternative probe.

Step Action
1 Click Select above the relevant process variable panel on the XDR Bioreactor
screen.
Result: The transmitter selection dialog box opens.
The currently selected probe is highlighted. Click Switch to select the alter-
native probe.
3 Confirm by clicking YES.

Step Action
Temperature control
Follow the instructions below to set the temperature control of the XDR vessel.
Step Action
1 Verify that the agitator is running.
2 Click the vessel temperature panel on the XDR Bioreactor screen to open
the Vessel Temperature PID faceplate.

Step Action
3 Click A (1) to set the temperature in Auto mode.
4 Type the designated temperature setpoint in the SP text box (2).
5 On the front panel of temperature control unit, switch on the unit.
6 Monitor the system to make sure that temperature control is working as

expected.
DO control
Dissolved oxygen level can be controlled by changing the agitation speed. See Start the
agitator motor, on page 234 for instructions how to start the agitator motor and to set
the agitation speed.

6.5.7 Take a sample
6.5.7 Take a sample
Take a sample of the disposable

bag contents
Follow the instructions below to take a sample of the bag contents during the cell culture
process.
Step Action
1 Find the sample tubing in the probe window.
2 Disinfect the end of the sample tubing with 70% ethanol.

6.5.7 Take a sample
Step Action
3 Remove the cap from the end of the sample tubing.
4 Disinfect the connector with 70% ethanol.

6.5.7 Take a sample
Step Action
5 Connect an aseptic disposable syringe to the connector.
6 Open the clamp on the sample tubing (1).
7 Rinse the sample tubing by pulling approximately 5 mL of the cell culture

into the syringe (2).
8 Disconnect the syringe. Discard the liquid and the syringe.

6.5.7 Take a sample
Step Action
9 Disinfect the connector with 70% ethanol.
10 Connect a new aseptic disposable syringe to the connector.
11 Pull the necessary amount of the cell culture into the syringe.
12 Close the clamp on the sample tubing.
13 Disconnect the syringe and transfer the sample into a suitable receptacle.
14 Disinfect the connector on the sample tubing and replace the cap.

6.5.8 Standardize pH probe
Preparation
For the greatest possible accuracy a standardization procedure must be performed. You
need to standardize the pH probe using a sample of your current cell culture. Perform
this procedure when the probes have been installed in the disposable bag and the bag
has been filled with the cell culture media.
See XDR Bioreactor Operating Instructions for instructions about probe installation, and
Section 6.5.4 Fill the disposable bag with media, on page 232 for instructions about filling
the disposable bag.
Make sure that the following has been completed before pH probe standardization:
• The disposable bag has been filled with media.
• The media has equilibrated to the process temperature.
• The temperature probe has been calibrated. See XDR Bioreactor Operating Instructions
for calibration instructions.
Standardize the probe (offset at

reference pH)
Follow the instructions below to perform the pH probe standardization.
Step Action
1 Take a sterile sample of the disposable bag contents as described in Sec-

tion 6.5.7 Take a sample, on page 244.
2 Measure the pH of your sample using an external calibrated pH meter.
3 Perform the standardization as follows, using the pH/DO transmitter display

on the electrical cabinet:

Step Action
4 Press MENU (1).
Result: A menu is displayed on the transmitter screen.
5 Use the navigation keys to make selections in the menu:
1 Select Calibrate and press ENTER (2).
2 Select Sensor 1 and press ENTER.
3 Select pH and press ENTER.
4 Select Standardize and press ENTER.
5 Enter the externally measured pH value of your sample and press ENTER.
6 Press EXIT (3) repeatedly until you reach to the main screen.

6.5.9 Calibrate the DO probe with O2
Preparation
Note: If the bioreactor is used in a GMP regulated environment, the DO probe is a
GMP critical component.
Note: For operational safety, a password can be set for DO calibration. See the
manufacturer's manual for instructions how to enable the password protection.
Make sure that the following has been completed before DO probe calibration:
• The disposable bag has been filled with media.
• The media has equilibrated to the process temperature.
• The temperature probe has been calibrated. See XDR Bioreactor Operating Instructions
for instructions.
• The DO probe has been energized / polarized for a minimum of two hours from the
time the cable was connected (polarographic sensors only).
Perform the following calibration procedures on DO probe in the order shown below:
1 Temperature calibration.
2 Calibration at 0% saturation level.
3 Calibration at 100% saturation level.
These procedures are described further down in this section.
WARNING
Fire and explosion hazard. Follow the instructions below to avoid
a fire or explosion when using oxygen:
• Monitor oxygen flow rates displayed on the user interface.
• Check for leaks, poor connections, or damages to the equip-
ment prior to use.
• Use proper ventilation when operating the bioreactor using
oxygen.
• Do NOT expel oxygen into an enclosed space.

Calibrate the DO probe

temperature
Before doing the oxygen calibration, calibrate the DO probe temperature as described
in the instructions below.
Step Action
1 Verify that the agitator is running at full operational speed.
2 Do the following using pH/DO transmitter display on the electrical cabinet:
3 Press MENU (1).
Result: A menu is displayed on the transmitter screen.

Step Action
4 Use the navigation keys to make selections in the menu:
1 Select Calibrate and press Enter (2).
2 Select Sensor 2 and press Enter.
3 Select Temperature and press Enter.
4 Find out the current media temperature. It is displayed on the vessel

temperature panel on the XDR Bioreactor screen.
5 Type the current media temperature into the text box in the DO transmit-
ter display on the electrical cabinet. Press Enter.
6 Press Exit (3) repeatedly until you reach to the main screen.

Calibrate the DO probe at 0% O2

saturation level
Step Action
1 Turn off gas inlets for the gases that contain oxygen.
2 Direct N2 into the XDR vessel through the sparge tubing at maximum flow.
Tip:
For fastest mass transfer rates and best equilibrium time, use the smaller size
sparge disc.
3 Open the trend for the DO value (see Section 12.4 Trending application, on
page 469) and monitor the DO reading. Wait until the DO value stabilizes at
minimum level.
1 Press MENU.
2 Using the navigation keys, select Calibrate and press ENTER.
4 Select Oxygen and press ENTER.
5 Select Zero Cal and press ENTER.

Result: WAIT is displayed.
6 Wait until Sensor Zero done is displayed.
7 Press EXIT repeatedly until you reach to the main screen.
Calibrate the DO probe at 100%

O2 saturation level
Step Action
1 Turn off all non-air gas inlets.
2 Direct air into the XDR vessel through the sparge tubing at the flow rate
equal to 100% controlled variable (CV).
3 Open the trend for the DO value (see Section 12.4 Trending application, on
page 469) and monitor the DO reading. Wait until the DO value stabilizes at
maximum level.

Step Action
1 Press MENU.
2 Using the navigation keys, select Calibrate and press ENTER.
4 Select Oxygen and press ENTER.
5 Select Air Cal and press ENTER.
6 Select Start Calibration and press ENTER.
7 Type the current atmospheric pressure into the text box, press ENTER.
Result: WAIT is displayed.
8 When the calibration is successfully completed, the screen returns to
the calibration sub-menu.
9 Press EXIT repeatedly until you reach to the main screen.

6.6 Finish a process run
End the run

Follow the instructions below to end the currently active run.
Step Action
1 Click Batch on the header toolbar.
Result: The Batch Overview screen opens.
2 Click the relevant process in the Active Batches field (1).
3
2
3 Verify that Do you want to end this recipe? (2) is displayed in the Questions
field in the Batch Control pane. Click Yes (3).

Step Action
4 Verify that Are any Phases running still? (4) is displayed in the Questions
field in the Batch Control pane. Click No (5).
4 5
Result: The process stops. The status of the stopped process in the Active
Batches field is displayed as Done (6).
5 Put all MFC PID control loops to the safe state following the instructions be-
low.
A. Click XDR Bioreactor on the header toolbar. Select the relevant bioreactor
Result: The XDR Bioreactor screen opens.

Step Action
B. Click the relevant MFC panel to open the MFC PID faceplate.
C. Click A and L to put the MFC into Auto/Local mode.

Step Action
D. Type 0 into the SP text box (0 SLPM).
E. Repeat steps B–D for all active MFCs.
Result: All mass flow controllers stop.
6 Put all pump PID control loops to the safe state following the instructions
below.
A. Click the relevant pump panel on the XDR Bioreactor screen to open the
pump PID faceplate.

Step Action
B. Type 0 into the CV text box.
C. Repeat steps A–B for all active pumps.
Result: All pumps stop.
7 Put the agitator PID control loop to the safe state following the instructions
below.
A. Click the agitator panel on the XDR Bioreactor screen to open the agitator
PID faceplate.

Step Action
B. Click M and L (1) to put the agitator into Manual/Local mode.
C. Type 0 in the CV text box (2).
Result: The agitator stops.
8 Visually verify that the agitator, all pumps, and all MFCs have stopped.
Disconnect the bag

For instructions on how handle the disposable bag and harvest the product, refer to XDR
Bioreactor Operating Instructions.

6.7 Shut down the software
Shut down bioreactor software
NOTICE
Always shut down the software using the instructions below. Failure
to shut down the computer in a proper way might result in software
corruption and hardware failure.
NOTICE
Only the Supervisor or the Engineer can exit the software.
Before shutting down the software, make sure that the system is in a safe state and that
all mechanical systems are switched off.
Follow the instructions below to shut down the software.
Step Action
1 Click XDR Bioreactor on the header toolbar. Select the relevant bioreactor
2 Click Close on the footer toolbar.
Result: The Wonderware application closes and the Windows desktop be-
comes visible.
3 Log off from Windows:
• Press the Windows key on the keyboard

or
• Click Start on Windows taskbar.
Select Shut down:Log off from the pop-up menu.
4 Log in as Engineer.

Step Action
5 Click Start on Windows taskbar.
6 Select Shut down from the pop-up menu. Follow the prompts to shut down
the computer.

7 Operate XDUO Mixer
About this chapter

This chapter provides required information to operate XDUO Mixer from Wonderware
software.
All users must read the entire XDUO Mixer Operating Instructions before operating
or maintaining the product.
Enable the system

Make sure the XDUO Mixer is enabled before starting to work with the system. See Sec-
tion 12.1 Enable/Disable function, on page 438.
In this chapter
Section See page
7.2 XDUO Mixer interlocks 265
7.3 Start up the system 267
7.4 Manage the disposable bag contents 272
7.5 Add liquid contents 292
7.6 Add solid contents 299
7.7 Complete a run 303

WARNING
Acids and bases. Acids and bases are dangerous if not handled
correctly. Properly tune PID control loops to avoid unwanted release
of acids or bases.
CAUTION
Tuning PID control loops. Make sure that personnel tuning PID
control loops are qualified to perform this task. Incorrectly tuned
PID loops could cause injury to personnel and damage the instru-
ment.
CAUTION
place.
CAUTION
Secure pump tubing. Make sure that the pump tubing is secure
and in good condition before using the pump. Do not block or kink
the tubing downstream of the pump.

7.2 XDUO Mixer interlocks
Description
The interlocks work in the same way both in the local mode and in FlexFactory mode.
If... Then...
the vessel weight is less than the low interlocks stop the agitator, pH control,
weight interlock limit 1 and vessel temperature control.
the vessel weight is more than the over- interlocks stop the pumps.
volume interlock limit
the agitator is shut off while temperature interlocks stop pH control and vessel
or pH control is running 2 temperature control.
1 XDUO Mixer agitator interlock and low weight interlock limits are equal.
2 The temperature and pH setpoints are stored. When the agitator is turned back on, these values
are held until the control loops are restarted.
The weight interlock limits depend on the mixer vessel size. See the following section for
detailed information.
Interlock limits
The following table shows the interlock limits for different sizes of XDUO Mixer.
Interlock type
Mixer vessel size Over-volume Low weight and agitator
100 L 110 kg 28 kg
200 L 220 kg 44 kg
500 L 550 kg 76 kg
1000 L 1010 kg 119 kg
100–1000 L, delay time 30 s 30 s
If the interlocked PID control loop is in the Auto mode, the control starts automatically
when the interlock condition is corrected and the delay time has passed.

Illustration of the interlocks

The panels for stopped PID control loops are marked with orange frames on the XDUO
Mixer screen. The interlock alarms are shown in the alarm summary pane.
The illustration below shows the XDUO Mixer screen for an interlocked XDUO Mixer.
An interlock icon is shown on the PID faceplates of the stopped PID control loops.

Introduction
This section provides the information how to start and log in to the software.
Log in
Follow the instructions below to log in to the Wonderware software.
Step Action
1 Open Wonderware:
•
click the WindowViewer icon on the desktop or on the taskbar
or
• select Start:WindowViewer.
Result: The Wonderware start view opens.

Step Action
2 Click XDUO Mixer on the header toolbar. Select the relevant mixer from the
drop-down menu, if available.
Result: The XDUO Mixer screen opens.
3 Click Login on the footer toolbar.
Result: The login dialog box opens.
4 Type the user name in the User Name text box.
5 Type your password in the Password text box.
Note:
The Domain text box is filled automatically.

Step Action
6 Click OK.
Result:
• The Login button text changes to Logout.
• The security symbol turns green.
• The user name is shown in the text field on the screen footer.
• The Close button is displayed for the user with Supervisor or Engineer
access.

Log out
Click Logout on the screen footer to log out of the Wonderware software.
Result: The user is logged out. The security symbol turns red and the user name is shown
as None. The Wonderware start view opens.
Auto log off

tive for ...
more than 25 minutes an AutoLogOffWarning message is displayed on the

screen.


tive for ...
more than 30 minutes the user is automatically logged out. An AutoLoggedOff

message is displayed on the screen indicating that the
user has been logged out. The security symbol on the
screen footer turns red and the user name is shown as
None.
After being logged out, the user must log in again, selecting the applicable operating
unit on the header toolbar.

Introduction
This section describes how to manage the XDUO Mixer disposable bag contents from
the Wonderware software.
In this section
Section See page
7.4.1 Manage pump flow 273
7.4.2 Monitor mixer weight 275
7.4.3 Use the agitator 277
7.4.4 Control the pH 284
7.4.5 Access the control functions 288

Start and stop the pump

XDUO Mixer pumps are designed to be used for adjustment of the pH of the disposable
bag contents. See Section 7.4.4 Control the pH, on page 284 for instructions on how to
set up the pH control.
The XDUO Mixer pumps cannot be used independently of the pH control.
Change pump flow direction

Follow the instructions below to change the pump flow direction.
Step Action
1 Click the relevant pump icon on the XDUO Mixer screen to open the Pump
Direction dialog box.
Click the button showing the designated flow direction.

Step Action
Result: The flow direction changes. The pump icon on the XDUO Mixer screen
shows the current flow direction.

7.4.2 Monitor mixer weight
Tare mixer weight

Follow the instructions below to tare mixer weight.
Step Action
1 Click TARE above the vessel weight panel on the XDUO Mixer screen.

Monitor mixer weight

Mixer vessel weight is displayed on the vessel weight panel on the XDUO Mixer screen.
Follow the instructions below to verify that monitoring of mixer weight is working cor-
rectly.
Step Action
1 Tare the mixer weight. See Tare mixer weight, on page 275 for instructions.
2 Use water or weights to increase the mixer weight:
• Add a known quantity of water into the disposable bag installed inside
the mixer,
or
• Place a known quantity of weights onto the mixer.
3 Verify that the weight displayed on the mixer weight panel corresponds to
the added weight.
Result: Mixer weight monitoring functionality is verified.
Note:
If the weight reading is not correct, contact your GE representative for assis-
tance.

Start the agitator motor

Follow the instructions below to start and control the agitator motor.
Step Action
1 Click the agitator icon on the XDUO Mixer screen.
direction arrow on the XDUO Mixer screen points to the selected direction.

Step Action
3 Click the agitator panel on the XDUO Mixer screen to open the Agitator PID
faceplate.
Result: The Agitator PID faceplate is displayed.
• If the mixer is in Auto mode, type an applicable setpoint value into the
SP text box.
• If the mixer is in Manual mode, type an applicable value into the CV text
box.
5 Monitor the system to make sure that agitation control is working as expect-
ed.

The agitator must not be operated in solutions with viscosity above 5 cP. Using the agi-
tator in viscous solutions may lead to decoupling of the impeller baseplate from the
magnetic drive head. The impeller assembly may shift from its stable position, damage
the disposable bag and the process.
Correct impeller baseplate

position
If the impeller baseplate is not correctly installed, the agitator system is not properly
magnetically coupled and does not function correctly. If the agitator emits a loud clicking
noise during operation, the impeller baseplate is decoupled from the magnetic drive
head.
Follow the instructions below to correct the problem.
Step Action
1 Stop the agitator motor as described in Stop the agitator motor, on page 281.
2 Disengage the impeller and arrange the impeller correctly, as shown below.
CAUTION
Magnetic components. Use caution when handling
magnetic components. There is a strong magnetic at-
traction between the impeller and the motor drive
coupling.

Step Action
See XDUO Mixer Operating Instructions for more information.
3 Start the agitator motor as described in Start the agitator motor, on page 277.

Stop the agitator motor

Follow the instructions below to stop the agitator motor.
Step Action
1 Click the agitator panel on the XDUO Mixer screen to open the Agitator PID
faceplate.
Result: The Agitator faceplate is displayed.
• If the mixer is in Auto mode, type 0 into the SP text box.
• If the mixer is in Manual mode, type 0 into the CV text box.

Step Action
Click DISABLE to stop the agitator.

Result: The agitation stops. The blue ENABLED text is replaced with DISABLED
5 Close the dialog box.

Change agitator direction

Follow the instructions below to change agitator direction.
Step Action
Click the “up” arrow for pumping up (clockwise direction) or the “down” arrow
for pumping down (counterclockwise direction).
Result: The agitation direction is set.
3 Close the dialog box.

7.4.4 Control the pH
Set the pH control

Follow the instructions below to set the pH to control the pump flow rate.
Step Action
1 Click the agitator icon on the XDUO Mixer screen to open the Agitator Enable
dialog box.

Step Action
4 Click the agitator panel to open the agitator PID faceplate.
5 On the agitator PID faceplate, click A and L (1) to set the agitator in Auto/Lo-
cal mode.
6 Type an applicable value into the SP text box (2) and close the PID faceplate.

Step Action
7 Click the pH panel to open the pH PID faceplate.
8 On the pH PID faceplate, click A and L (1) to set the pH control in Auto/Local
mode.
9 Type an applicable value into the SP text box (2).

Result: The automatic pH control of the disposable bag contents is active.
• If the current pH in the disposable bag is lower than the setpoint value,
the base pump starts.
• If the current pH in the disposable bag is higher than the setpoint value,
the acid pump starts.

Stop the pH control

Follow the instructions below to stop the pH control of the pump flow rate.
Step Action
1 Click the pH panel to open the pH PID faceplate.
2 On the pH PID faceplate, click M and L (1) to set the pH control in Manual/Lo-
cal mode.
3 Type 50 into the CV text box (2).

Result: The pumps stop. When the pH controlled variable (CV) is set at 50%,
pH control is not active.

Access PID control loop faceplate

To access a PID control loop faceplate select the relevant PID controller display:
• on the XDUO Mixer screen
or
• on the PID Faceplates screen.
See Section 5.2 XDUO Mixer, on page 111 and Section 4.3.1 PID Faceplates, on page 67
for detailed description of these screens.
Select probe
Duplicate probes can be available for pH and XDUO vessel temperature. If duplicate
probes of the same type are installed on the system, the user can switch between the
alternative probes.
Follow the instructions below to select an alternative probe.
Step Action
1 Click Select above the relevant process variable panel on the XDUO Mixer
screen.
Result: The transmitter selection dialog box opens.

Step Action
The currently selected probe is highlighted. Click Switch to select the alter-
native probe.
3 Confirm by clicking YES.

Control the temperature

Temperature control function is optional for XDUO Mixer.
Follow the instructions below to set the temperature control of the mixer vessel.
Step Action
1 Click the agitator icon on the XDUO Mixer screen to open the Agitator Enable
dialog box.

Step Action
4 Click the vessel temperature panel on the XDUO Mixer screen to open the
vessel temperature faceplate.
5 Click A (1) to set the temperature in Auto mode.
6 Type the designated temperature setpoint in the SP text box (2).
7 On the front panel of temperature control unit, switch on the unit.
8 Monitor the system to make sure that temperature control is working as

expected.

7.5 Add liquid contents
Prepare the mixer

Fluids can be added through the addition lines. The illustration below shows the possible
liquid entry points.
Before adding the liquids, make the following preparations:
Step Action
1 Verify that the liquid addition lines are not kinked and are free from obstruc-
tions.
2 Verify that the liquid addition lines do not impede the adjustment of the
disposable bag inside the mixer.

Step Action
3 Verify that the clamp on the drain line is fully engaged.

Step Action
4 500 L and 1000 L mixers have a side access door. Remove the door, if not
already removed.
Follow the instructions below to remove the door:
A Grip the door handle.
B Turn the door counterclockwise.
C Remove the door.
5 Connect the liquid source to the addition lines of the bag assembly.
6 If your mixer has a weight monitoring option, tare the mixer weight. See Tare
mixer weight, on page 275 for instructions.

Add liquids into the disposable

bag
CAUTION
Check floor safety. Before filling the disposable bag with liquid,
verify that the total system weight is below the established floor
loading safety limits of the facility.
NOTICE
Help the disposable bag into position during the filling procedure,
as folds in the disposable bag might interfere with the mixing pro-
cess. This also makes sure that the maximum capacity of the dis-
posable bag is used.
To add liquids into the disposable bag, follow the instructions below.
Step Action
1 Start filling the disposable bag through the liquid addition line.
2 Stop the flow when the liquid level has reached 3 to 5 cm and the bag begins
to fill the mixer vessel.
3 Verify that the following conditions are met:
• No folds in the bag assembly.
• Minimal wrinkles in the bag assembly.
Tip:
Examine for wrinkles at the bag bottom.
4 Adjust the bag assembly inside the mixer vessel as follows:
• Pull the bottom and top corners of the bag assembly to correct positions.
• If your mixer has a side access opening, reach through the opening to
adjust the bottom corners of the bag assembly.

Step Action
5 Re-install the side access door on 500 L and 1000 L mixers as follows:
A Using the handle, lift the door and match it with the side access
opening.
B Turn the door clockwise to secure it.
C Release the handle.
NOTICE
The side access door must be in place before the liquid
level rises above the lowest edge of the door opening.

Finish the addition of liquids

To finish the addition of liquids follow the instructions below.
Step Action
1 Continue filling the disposable bag with liquid. During the addition of liquid,
gently adjust the bag position so that the bag shape fits the mixer vessel
shape. Make sure that the bag corners fit into the mixer vessel corners.
2 If the probes have been installed, make sure that the probes stay in place
in the probe port during the filling.
3 If your mixer has a weight monitoring option, monitor the weight of the
added liquid. When the weight approaches the desired level, decrease the
liquid addition speed. See Monitor mixer weight, on page 276 for weight
monitoring instructions.
4 Stop filling the bag when the designated liquid weight is reached.

Step Action
5 Install one mixer vessel lid section and pull the lines through the rectangular
opening at the lid corner.
6 Secure the powder addition port in the center opening of the lid with the Tri-
Clamp™ (1). Install the other lid section (2).
Tip:
The lid helps to protect the top of the bag and to hold the powder addition
port in place.
7 If needed, clamp the fill lines and disconnect the liquid source.

7.6 Add solid contents
Consider before addition

Follow the general guidelines for the addition of solid material:
• Add solid material only while the agitation is switched on. This prevents the aggrega-
tion near the agitator.
• Use fine grained material. Large crystals or granular material dissolves slowly and
can damage the disposable bag material.
• Add solid material near the end of the liquid addition process, if possible.
• Add solid material slowly to avoid supersaturated solutions in the mixer.
Add solid material into

disposable bag
Any addition port with 3″ connection or a powder bag with gasket can be used for addition
of solid material. Follow the instructions below to add solid contents into the disposable
bag.
CAUTION
Heavy object. The container with solid ingredients is heavy. Use
caution when filling the disposable bag from the top of the mixer,
to avoid personal injury.

Step Action
1 Slide one mixer vessel lid section slightly outwards (1), to facilitate the access
to the Tri-Clamp.
2 Disconnect the Tri-Clamp from the disposable bag powder addition port (2).
3 Remove the protective cap from the powder addition port.

Step Action
4 Make sure that the O-ring stays in place on the powder addition port.
5 Place the hopper onto the powder addition port (1) and secure it with the
Tri-Clamp (2).

Step Action
6 Slide the mixer vessel lid back, so that the Tri-Clamp is resting on the lid.
7 Verify that the agitator motor is running.
8 Add the solids to the bag contents through the hopper.
9 When the addition is complete, remove the hopper.
Tip:
Slide the vessel lid outwards for easier access to the powder addition port.
10 Replace the protective cap to the powder addition port.
11 Replace the Tri-Clamp.
12 Slide the lid back into place around the base of the Tri-Clamp.

7.7 Complete a run
7.7 Complete a run
Introduction
This section provides information how to complete a run and shut down XDUO Mixer.
In this section
Section See page
7.7.1 Collect the product 304
7.7.2 Remove the disposable bag 305
7.7.3 Shut down the system 312

7.7 Complete a run
7.7.1 Collect the product
7.7.1 Collect the product
Drain the product from the

disposable bag
Follow the instructions below to drain the contents of the disposable bag. Consider also
your local requirements for product and waste handling.
Step Action
1 Insert the drain line into a suitable receptacle.
2 For ease and speed, it is recommended to drain the product by gravity.
Tip:
Install the drain line in a pump, if gravity draining is not desired.
3 Remove the mixer vessel lid.
4 Open the clamp on the drain line.
5 Monitor the draining process to make sure that it proceeds as expected.
6 During the draining procedure, gently adjust the disposable bag position,
so that the bag edges move towards the drain opening at the bottom of the
mixer vessel.
Tip:
You can loosen a clamp on a liquid addition line to reduce the vacuum in the
disposable bag and facilitate the draining.
7 Allow all contents to drain from the disposable bag.

7.7 Complete a run
7.7.2 Remove the disposable bag
Disconnect the disposable bag

Follow the instructions below to disconnect the probes and lines from the disposable
bag after finished mixing procedure.
Step Action
1 Make sure the disposable bag is empty.
2 Stop the agitator motor following the instructions below:
A. Click the agitator panel on the XDUO Mixer screen to open the Agitator
PID faceplate.
Result: The Agitator PID faceplate is displayed.

7.7 Complete a run
Step Action
B.
• If the mixer is in Auto mode, type 0 into the SP text box.
• If the mixer is in Manual mode, type 0 into the CV text box.
C. Click the agitator icon on the XDUO Mixer screen.
Result: The Agitator Control dialog box opens.

7.7 Complete a run
Step Action
D. Click DISABLE to stop the agitator.

Result: The agitation stops. The blue ENABLED text is replaced with STOPPED
3 Remove the mixer vessel lid.

7.7 Complete a run
Step Action
4 Disconnect the probe cables as appropriate:
• pH probes
• conductivity probes
5 Remove the temperature probe from the disposable bag. Clean the probe
according to facility procedures. Store the probe in a clean place according
to manufacturer's instruction.

7.7 Complete a run
Step Action
6 Remove the pH and conductivity probes from the disposable bag. Clean the
probes according to facility procedures. Autoclave and store the probes in
a clean place according to manufacturer's instructions.
7 Clamp all probe connector ends.
8 Disconnect all lines.
9 Make sure that the disconnect switch on variable frequency drive is in O

position.
Remove the disposable bag
CAUTION
Magnetic components. Use caution when handling magnetic
components. There is a strong magnetic attraction between the
impeller and the motor drive coupling.
Follow the instructions below to remove the disposable bag from the XDUO Mixer.

7.7 Complete a run
Step Action
1 Remove the side access doors as follows:
A Hold the door handle tightly.
B Turn the door counterclockwise.
C Remove the door.
2 Disconnect the agitator drive head: pull the bag assembly impeller base off
the magnetic drive head in the agitator opening.
3 Lift the disposable bag out of the mixer vessel.

7.7 Complete a run
Disposal of the bag

Follow the instructions below to dispose of the used disposable bag assembly.
Step Action
1 If the site policy requires decontamination of the bag prior to disposal, rinse
the walls of the empty bag with a decontamination solution, then drain.
2 Dispose of the bag assembly according to national and local environmental

regulations.

7.7 Complete a run
7.7.3 Shut down the system
Shut down the XDUO Mixer
NOTICE
Only the Engineer shall turn off the instrument.
To turn off the mixer do the following:

• Disconnect the power cord
or
• Switch off the power supply circuit breaker.
Note: The circuit breaker is provided by the user. The location of the circuit breaker
varies.
Exit Wonderware software
NOTICE
Always shut down the software using the instructions below. Failure
to shut down the computer in a proper way might result in software
corruption and hardware failure.
NOTICE
Only the Supervisor or the Engineer can exit the software.
Before shutting down the software, make sure that the system is in a safe state and that
all mechanical systems are switched off.

7.7 Complete a run
Follow the instructions below to exit the software.
Step Action
1 Click XDUO Mixer on the header toolbar. Select the relevant mixer from the
drop-down menu, if available.
Result: The XDUO Mixer screen opens.
2 Click Close on the footer toolbar.
Result: The Wonderware application closes and the Windows desktop be-
comes visible.
3 Log off from Windows:
• Press the Windows key on the keyboard

or
• Click Start on Windows taskbar.
Select Shut down:Log off from the pop-up menu.
5 Click Start on Windows taskbar.
6 Select Shut down from the pop-up menu. Follow the prompts to shut down
the computer.

8 Operate BioProcess NFF Pump System
8 Operate BioProcess NFF Pump

System
About this chapter

This chapter provides information to operate BioProcess NFF Pump System.
All users must read the entire BioProcess NFF Pump System Operating Instructions
before operating or maintaining the product.
Enable the system

Make sure the BioProcess NFF Pump System is enabled before starting to work with the
system. See Section 12.1 Enable/Disable function, on page 438.
In this chapter
Section See page
8.2 Process control mode 316
8.3 Set BioProcess NFF Pump System interlocks 317
8.4 Configure the software 320
8.5 Calibrate flow sensor 325
8.6 Adjust zero 332
8.7 Configure control loops 335
8.8 Operate BioProcess NFF Pump System manually 351

WARNING
Operating limits. Never exceed the operating limits stated in the
user documentation and on the system label. Operation of the
product outside these limits can damage equipment and cause
personal injury or death.
WARNING
Electrical cabinet doors. During operation, all electrical cabinet
doors must always be closed and locked.
WARNING
Test flow path for leakage. For continued protection against injury
risks due to fluid jets, burst pipes or potentially explosive atmo-
sphere, the user must test the flow path for leakage at maximum
operating pressure.
• Always perform a leakage test after assembly or maintenance.
• Always perform a leakage test before operation.

8.2 Process control mode
8.2 Process control mode
Control mode notification

A control mode notification is always shown on the NFF System screen, in the Main PID
Loops pane:
• Constant Flow Selected
• Constant Pressure Selected
• Constant Flow + Pressure Selected
The notification shows the most recently used control mode. This information is stored
when the instrument is switched off, and is replaced only when a new control loop
mapping is done.
The process control mode is not active until the user maps the PID control loops and
activates the control loop mapping. See Section 8.7 Configure control loops, on page 335
for control loop mapping instructions.

8.3 Set BioProcess NFF Pump System interlocks
Interlocks
Refer to BioProcess NFF Pump System Operating Instructions for detailed information
about the interlocks.
Define interlock parameters

The interlocks are set by the user with Supervisor or Engineer access. The interlocks stay
active when BioProcess NFF Pump System is turned off. The interlock values are lost
when power to the PLC is switched off, and must be redefined when the PLC is switched
on again.
Follow the instructions below to define the interlock values.
Step Action
1 Click NFF System on the header toolbar. Select the relevant system from
the drop-down menu, if available.
Result: The NFF System screen opens.

Step Action
2 Click Configuration Screen.
Result: The Configuration Screen dialog box opens.

Step Action
3 In the Pressure Critical Interlocks pane, type the applicable interlock values
into the text boxes.
• Pressure Low SP: pressure low limit (psi)
• Flow Hi SP: high limit for pump flow rate (mL/min)
• Alarm Wait time: the length of time a value must be outside the limit to
activate the interlock (seconds)
Note:
Bubble detection interlock is activated when air is detected for longer than 5
seconds.
4 Click the close button to close the Configuration Screen dialog box.

8.4 Configure the software
Configure Wonderware software

Wonderware software must be configured according to your BioProcess NFF Pump
System hardware setup. Follow the instructions below to define the system configuration.
Step Action
1 Click Configuration Screen on the NFF System screen.

Step Action
2 Click the appropriate button in the Stage Selection pane to select the filtration
configuration for your system.
Result: The configuration is set. The selected configuration button is high-

lighted.
Note:
Refer to BioProcess NFF Pump System Operating Instructions for more infor-
mation on filtration configuration.

Step Action
3 For parallel filtration (2-stage or 3-stage) configuration, the pressure control

must be defined by one of the parallel filtration lines (1 or 2).

Step Action
Click the applicable button to select the Master PT:
• For line 1, click PIT111
• For line 2, click PIT114
Result: The pressure sensor that controls system pressure is set. The selected
Master PT button is highlighted.

Step Action
4 Click Config. & Calib..
Result: The Levitronix Flow Meter - Configuration & Calibration 1 dialog

box opens.
5 Click Normal Mode to set the instrument in normal operational mode.
Result: The Normal Mode Active button is highlighted.
6 Click the close button to close Levitronix Flow Meter - Configuration

& Calibration and Configuration Screen.
1 Levitronix® is a registered trademark of Levitronix.

8.5 Calibrate flow sensor
Introduction
BioProcess NFF Pump System includes a disposable (single-use) flow sensor that is located
in the flow path after the pump.
The flow sensor is provided with 6 calibration parameters, which are shown on the flow
sensor tag. To calibrate the flow sensor, the calibration parameters must be supplied to
Wonderware software.
The calibration can be done manually or automatically, depending on the built-in software
of your flow sensor. See the following sections for instructions.
Identify the automatic sensor

Some types of the flow sensors used with BioProcess NFF Pump System are calibrated
automatically. Follow the instructions below to examine if your flow sensor is automati-
cally calibrated.
Step Action
1 Connect the disposable flow sensor to the electrical cabinet. Refer to

BioProcess NFF Pump System Operating Instructions for more information.

Step Action
3 Click Config. & Calib. in the Configuration Screen dialog box.
Result: The Levitronix Flow Meter - Configuration & Calibration dialog box
opens.
4 Disconnect the flow sensor from the system.

Result: The calibration parameter values are removed from the text boxes.

Step Action
5 Reconnect the flow sensor.
• If the calibration parameter values are automatically filled in, your flow
sensor is calibrated automatically.
• If the values are not automatically filled in, calibrate the flow sensor as
described in Calibrate the flow sensor, on page 327.
Calibrate the flow sensor

If your flow sensor must be calibrated manually, follow the instructions below.
Step Action
1 Connect the disposable flow sensor to the electrical cabinet. Refer to

BioProcess NFF Pump System Operating Instructions for more information.

Step Action
opens.
4 Click Set Mode (1) in the dialog box.
Result: The instrument is set in calibration mode. The Set Mode button is
highlighted.
5 Select the appropriate sensor from the Type of Sensor list (2).
Result: The sensor is connected to the software. Full Scale Range text box
is updated accordingly.

Step Action
6 Find the calibration parameter values on the flow sensor tag. Type the pa-
rameter values into the K-Factor (3) and Calibration (4) text boxes.
7 Fill the sensor with liquid. Make sure that the NFF pump is not running.
8 Click Zero Adjust Mode.
Result: The flow sensor is calibrated. The Zero Adjust Mode button is tem-
porarily highlighted, then the system returns to normal operational mode
and the Normal Mode button is highlighted.
9 Click the close button to close the Levitronix Flow Meter - Configuration
& Calibration dialog box.

Step Action
10 In the Configuration Screen dialog box, click Feedback.
Result: Flow Meter - Feedback Screen opens.

Step Action
11 On the Flow Meter - Feedback Screen, verify that the status of all items is
shown as Not Active.
12 Close the Flow Meter - Feedback Screen and the Configuration Screen by
clicking the close button .
Result: The flow sensor is ready for operation.

8.6 Adjust zero
8.6 Adjust zero
Adjust zero
Follow the instructions below to do the zero adjustment of the flow sensor.
Step Action
1 Make sure that the pump is primed. See Prime the pump and the filters, on
page 357 for instructions.
2 Fill the flow sensor with liquid (media or water).
3 Make sure that there are no air bubbles in the flow path.
4 Make sure that the NFF pump is switched off.

8.6 Adjust zero
Step Action
opens.
7 Click Zero Adjust Mode.
Result: The Zero Adjust Mode button is temporarily highlighted, then the
system returns to normal operational mode and the Normal Mode button
is highlighted.

8.6 Adjust zero
Step Action
8 On the NFF System screen, find the pump panel and verify that the flow rate
value (PV) is 0.
9 If the flow rate (PV) is not shown as 0, repeat steps 7 and 8.
10 Close the dialog boxes by clicking the close button .

Introduction
This section gives an overview of setting up process control for BioProcess NFF Pump
System.
In this section
Section See page
8.7.1 Control functions 336
8.7.2 Map to flow control 337
8.7.3 Map to pressure control 341
8.7.4 Map to flow and pressure control 345
8.7.5 Disable the control loop mapping 349

8.7.1 Control functions
8.7.1 Control functions
Control loop mechanism

See Control loop mechanism, on page 453 for overview of PID control mechanism.

8.7.2 Map to flow control
Map the pump to flow control

Follow the instructions below to set the liquid flow rate to control the pump speed.
Step Action
1 Click Configuration Screen on the NFF System overview screen.

Step Action
In the Control Selection Mode pane, click Constant Flow (1).

Result: The Constant Flow button is highlighted in blue.
3 In the Process Setpoints pane, type the applicable liquid flow rate (mL/min)
in the Constant Flow text box (2).
4 Click the close button to close the dialog box.
Result: The dialog box closes. Constant Flow Selected notification is displayed
on the NFF System screen, in the Main PID Loops pane.

Step Action
5 In the Pump Control pane, click Enable to start the pump.
Result: The pump starts to operate. The pump status is shown as Enabled
in the Pump Control pane and the pump icon turns green.
screen.
7 Find the pump faceplate and the flow control faceplate. Click A and R to set
both control loops in Auto/Remote mode.
Result: The mapping is active. The liquid flow rate controls the pump speed.

Step Action
8 Verify that the flow rate shown on the flow control panel is equal to the
Constant Flow value defined in step 3 above.

mapping
When the pump is mapped to the flow control, the liquid flow rate is kept constant by
adjusting the pump speed.
Constant Flow Selected notification is displayed in the Main PID Loops pane on the NFF
System overview screen. The pump PID faceplate shows that the PID control loop is in
Cascade mode. The PID loop name on the pump panel is highlighted in turquoise.

8.7.3 Map to pressure control
Map the pump to pressure

control
Follow the instructions below to set the pressure to control the pump speed.
Step Action

Step Action
In the Control Selection Mode pane, click Constant Pressure (1).

Result: The Constant Pressure button is highlighted in blue.
3 In the Process Setpoints pane, type the applicable pressure (psi) in the
Constant Pressure text box (2).
Result: The dialog box closes. Constant Pressure Selected notification is

displayed on the NFF System screen, in the Main PID Loops pane.

Step Action
screen.
7 Find the pump faceplate and the pressure control faceplate. Click A and R
to set both control loops in Auto/Remote mode.

Step Action
8 Verify that the pressure value shown on the filter pre-pressure panel is equal
to the Constant Pressure value defined in step 3 above:
• On PIT111 (1), if your Master PT Selection is PIT111.
• On PIT114 (2), if your Master PT Selection is PIT114.

See Section 8.4 Configure the software, on page 320 for more info about
Master PT Selection.

mapping
When the pump is mapped to the pressure control, the liquid pressure is kept constant
by adjusting the pump speed.
Constant Pressure Selected notification is displayed in the Main PID Loops pane on the
NFF System overview screen. The pump PID faceplate shows that the PID control loop
is in Cascade mode. The PID loop name on the pump panel is highlighted in turquoise.

8.7.4 Map to flow and pressure control
Map the pump to flow and

pressure control
Using this control method, the pump speed is first controlled by the liquid flow rate, until
the increasing pressure reaches the defined Changeover Pressure value. At higher
pressures, the pump speed is controlled by the system pressure.
Follow the instructions below to set both the flow and the pressure to control the pump
speed.
Step Action

Step Action
In the Control Selection Mode pane, click Constant Flow + Pressure (1).
Result: The Constant Flow + Pressure button is highlighted in blue.
3 In the Process Setpoints pane, type an applicable value in each text box (2).
Changeover Pressure defines the pressure value when the pump speed
starts to be controlled by the system pressure instead of the flow speed.
Result: The dialog box closes. Constant Flow + Pressure Selected notification
is displayed on the NFF System screen, in the Main PID Loops pane.

Step Action
screen.
7 Click A and R on each faceplate to set all three control loops (pump, flow
control, and pressure control) in Auto/Remote mode.

Step Action
8 At the process start, the pump speed is controlled by the liquid flow rate.
Verify that the flow rate shown on the flow control panel is equal to the
Constant Flow value defined in step 3 above.

mapping
When the pump is mapped to both the flow control and the pressure control, the liquid
flow rate is kept constant by first adjusting the pump speed, until the increasing pressure
reaches the defined Changeover Pressure value. After that the pump speed is adjusted
to keep the system pressure constant.
Constant Flow + Pressure Selected notification is displayed in the Main PID Loops pane
on the NFF System overview screen. The pump PID faceplate shows that the PID control
loop is in Cascade mode. The PID loop name on the pump panel is highlighted in turquoise.

8.7.5 Disable the control loop mapping
Unmap the pump control

Follow the instructions below to disable the BioProcess NFF Pump System pump speed
control.
Step Action
1 In the Pump Control pane, click Disable.
Result: The pump stops. The pump status is shown as Disabled in the Pump
Control pane and the green pump icon turns black.
screen.

Step Action
3 Click M and L on each faceplate to set all control loops in Manual/Local

mode.
Result: The BioProcess NFF Pump System pump speed control is disabled.

8.8 Operate BioProcess NFF Pump System manually
Introduction
This section provides information about manual operation of BioProcess NFF Pump
System.
In this section
Section See page
8.8.1 Start, stop and prime the pump 352
8.8.2 Collect and view flow information 361

8.8.1 Start, stop and prime the pump
Start the pump

To start the pump manually, follow the instructions below.
Step Action
1 On the NFF System overview screen, click the pump panel to open the pump
PID faceplate dialog box.

Step Action
2 On the pump PID faceplate, click M and L (1) to set the pump in Manual/Local
mode.
3 Type the applicable pump speed value into the CV text box (2).
4 Close the PID faceplate dialog box by clicking the close button .

Stop the pump

To stop the pump manually, follow the instructions below.
Step Action
1 On the NFF System overview screen, in the Pump Control pane, click Disable
to stop the pump.
2 Click the pump panel to open the pump PID faceplate dialog box.

Step Action
3 Type 0 in the CV text box.
Prime the pump

Before you start to prime, do the following:
• Prepare a container with water.
• Make sure that the water volume is sufficient to fill the tubing and the pump.
• Make sure that the water level in the container is higher than the pump head position.
Follow the instructions below to fill the pump and the tubing with water.
Step Action
1 Connect the tubing from the water container to the pump.
2 Make sure that the flow sensors and the pressure sensors are installed and
connected as specified.

Step Action
mode.
5 Type the applicable pump speed value into the CV text box (2). The recom-
mended speed is 10% to 20%.

Step Action
8 Prime the pump for approximately 3 min.
9 Make sure that no bubbles are visible in the flow sensor and the tubing.
10 Stop the pump.
Prime the pump and the filters

The pump and the filters must be filled with liquid before starting the filtration of the
process liquid.
Before you start the filling, do the following:
• Prepare a container with water.
• Make sure that the water volume is sufficient to fill the tubing, the pump, and all filters
in your specified configuration.
• Make sure that the water level in the container is higher than the pump head position.
Follow the instructions below to fill the filtration system with water.
Step Action
1 Connect the tubing from the water container to the pump.
2 Connect the filter units to the pump according to your specified configuration.
See BioProcess NFF Pump System Operating Instructions for more information.
3 Make sure that the pressure sensors are installed and connected as specified.
4 Open the vent valves on all filter units.

Step Action
mode.
7 Type the applicable pump speed value into the CV text box (2). See the filter
manufacturer's documentation for the recommended flow rate.

Step Action
10 When water emerges from the vent valve of the first filter unit, close the
valve.
11 Continue running the pump until all filter units are filled with water. Close all
vent valves, one by one, when the filter unit is filled.
12 Click Disable to stop the pump.

Step Action
13 Click the pump panel to open the pump PID faceplate dialog box.
14 Type 0 in the CV text box.
15 Connect the process liquid to the pump inlet tubing. If an air bubble is caught
in the tubing, open the vent valve on the first filter unit and prime the filter
with the process liquid as described in steps 5 to 10 above.
The BioProcess NFF Pump System is ready for filtration.

8.8.2 Collect and view flow information
Measure the liquid flow

Follow the instructions below to measure the pump flow volume.
Step Action
1 Start the pump as described in Start the pump, on page 352.

Step Action
3 Click Vol. Totalizer to open the flow volume totalizer dialog box.
Result: The flowSensor Totalizer dialog box opens.
4 Click RESET, then click START to start the flow totalizer.
text is replaced by blue TOTALIZING text. The recorded volume is continu-
ously updated in the mL text box.
5 Click STOP to stop the flow totalizer when the process is completed.
6 Click RESET to reset the flow totalizer.

Display the flow information

The information about the current status of the flow sensor is shown on the Flow Meter
- Feedback Screen.
Do the following to display the Flow Meter - Feedback Screen:
• Click the pump flow panel on the NFF System screen
or
• Click Feedback in the Configuration Screen dialog box.
Description of flow information

The following information about Levitronix flow sensor is shown on the Flow Meter -
Feedback Screen.
Function Description
Bubble Detected Bubble detected in flow sensor. Stays active during the
defined bubble detect hold time.
Measurement Error Sensor signal is incorrect. For example: empty sensor,

unplugged sensor, too many bubbles.
Reverse flow Reverse flow is active.

Function Description
F.S. vs. Pulse Length Full scale vs. pulse width active: the combination of full
scale and volume pulse setting is invalid.
Zero Adjustment Active Zero adjustment is ongoing.
Zero Adjustment Error If not active: the last zero adjustment was completed
correctly.
If active: the last zero adjustment was not completed
correctly because the sensor was empty, or there were
too many bubbles in the sensor.
Setting Mode Active Parameter set mode is active. Settings can be written
to the Hold register.
EEPROM Writing EEPROM (electrically erasable programmable read-only

memory) writing is active.
Flow Alarm High Measured flow rate is higher than the alarm High limit.
Flow Alarm Low Measured flow rate is lower than the alarm Low limit.
Volume Counter Alarm H If active: volume counter value is higher than the volume
counter alarm High limit. Volume counter alarm is en-
abled.
Volume Counter Alarm If active: volume counter value is higher than the volume
HH counter alarm High High limit. Volume counter alarm
is enabled.
Output test Analog or digital test output is active.
EEPROM Error EEPROM (electrically erasable programmable read-only

memory) error is active.
Start Up Proc./Short Cir- The flow sensor startup procedure (initial display) is on-
cuit going.
Download Mode The flow sensor built-in software is in download mode.

9 Operate remote devices
About this chapter

This chapter provides information to safely operate remote devices (pumps and scales)
from the Wonderware user interface.
In this chapter
Section See page
9.1 Operate remote pumps 366
9.2 Operate scales 370

9.1 Operate remote pumps
Start the remote pump

To start the pump follow the instructions below.
Step Action
1 Click Pumps, scales on the header toolbar. Select RemotePumpP1 to access

PID faceplates for pumps 1–10 or RemotePumpP2 for pumps 11–20.
Result: The Remote Pumps screen is displayed.
Note:
The PID faceplates are shown only for the connected pumps.

Step Action
2 Find the relevant pump PID faceplate.
• Click M and L to set the pump in Manual/Local mode.
• Click A and L to set the pump in Auto/Local mode.
3 • In Auto/Local mode: type the appropriate pump speed value into the
SP text box (1).
• In Manual/Local mode: type the appropriate pump speed value into the
CV text box (2).
Result: The pump starts.

Stop the remote pump

Follow the instructions below to stop the pump.
Step Action
1 Click Pumps, scales on the header toolbar. Select RemotePumpP1 to access

PID faceplates for pumps 1–10 or RemotePumpP2 for pumps 11–20.
Result: The Remote Pumps screen is displayed.
Note:
The PID faceplates are shown only for the connected pumps.

Step Action
2 Find the relevant pump PID faceplate.
• In Auto/Local mode: type 0 into the SP text box (1).
• In Manual/Local mode: type 0 into the CV text box (2).

9.2 Operate scales
9.2 Operate scales
Tare scales
Follow the instructions below to tare an external scale.
Step Action
1 Click Pumps, scales on the header toolbar and select RemoteScales from
the drop-down menu.
Result: The RemoteScales screen is displayed.
2 Find the dialog box for the relevant scale on the RemoteScales screen.

9.2 Operate scales
Step Action
Click Tare.
Result: The scale is tared:
• The Gross value shows total weight of the object (Net plus the tared
weight).
• The Net value is 0.000.
• The Tare value shows the initial weight at which the scale was tared.
Operate scales
Refer to the scales manufacturer's manual for more information about operating the
scales.

10 View UniFlux, ÄKTA and WAVE instruments
10 View UniFlux, ÄKTA and WAVE

instruments
Instrument overview in
Wonderware
ReadyToProcess WAVE 25, ÄKTAprocess, ÄKTA ready, and UniFlux are operated using
UNICORN software, working on the built-in or system-specific computer. General overview
of these instruments is also available in M-Station OIT via Wonderware for view-only.
See Chapter 5 Wonderware user interface: instruments, on page 101 for the overview of
Wonderware user interface.
To display the Wonderware overview screens for these instruments, click the appropriate
button on the header toolbar and select the relevant system from the drop-down menu,
if available.
Each instrument overview screen displays the current values of process parameters for
this system. An overivew of all alarms is displayed in the alarm summary pane at the
bottom of the screen.
Access UNICORN software

Wonderware displays the view-only user interface for ReadyToProcess WAVE 25,
ÄKTAprocess, ÄKTA ready, and UniFlux. The user can also bypass Wonderware and access
these instruments in UNICORN operating mode via M-Station OIT.
Follow the instructions below to access the system in UNICORN operating mode.
Step Action
1 Press the Windows key on the keyboard.

Result: The Windows taskbar is shown at the bottom of the screen.
2 Click UNICORN icon to start the application.

10 View UniFlux, ÄKTA and WAVE instruments
Step Action
3 Log in with your user name and password.
Note:
The user name and access are defined by the UNICORN administrator. See
Section 13.2 Manage UNICORN software, on page 518 for more information.
4 Select the applicable system on the displayed list.

Result: The UNICORN user interface for the selected system opens. The inter-
face is in the operating mode and reflects the primary interface on the sys-
tem-specific computer.
5 When UNICORN is running, press Alt+Tab on the keyboard to switch between

UNICORN and Wonderware.
See separate manuals for operating instructions of ReadyToProcess WAVE 25,

ÄKTAprocess, ÄKTA ready, and UniFlux.

11 Batch Control function
About this chapter

This chapter provides information about Wonderware Batch Control function. The
principles of Batch Control function are described. The instructions how to use Batch
Control are presented.
Batch Control function is available for XDR Bioreactor, XDUO Mixer, and BioProcess NFF
Pump System.
Enable the system

Make sure the operating unit is enabled before starting to work with the system. See
In this chapter
Section See page
11.1 Batch Control function description 375
11.2 Prepare the instrument 381
11.3 Create and start a batch for XDR Bioreactor and XDUO Mixer 393
11.4 Create a batch for BioProcess NFF Pump System 404
11.5 Modify a batch 415
11.6 Manage batch stops 424
11.7 Finish a batch 433

11.1 Batch Control function description
Introduction
This section describes the principles of Batch Control function. The principles are appli-
cable to XDR Bioreactor, XDUO Mixer, and BioProcess NFF Pump System.
In this section
Section See page
11.1.1 Batch Control overview 376
11.1.2 Batch schedule creation 379

11.1.1 Batch Control overview
Batch Control function

description
Batch Control function is part of the FlexFactory automation solution. The Batch Control
function allows the user to set up an automated production process (a production batch)
using previously specified recipes. The Batch Control function is provided for XDR
Bioreactor, XDUO Mixer, and BioProcess NFF Pump System.
When setting up of the process is finished, the user can start the batch. All scheduled
phases in the selected recipe are then executed in sequence according to the recipe
setup.
The liquid material (the bulk substance) must be transferred between the operating units
independently of the automated process schedule. The recipes do not control the
transfer of liquid bulk, for example transfer of the material from a bioreactor to a filter
system.
Batch Control structure

A Batch Control process is built of recipes, according to what is needed for the specified
production process. A recipe can be compared to a template. A recipe specifies a sub-
process for an operating unit: for example a recipe for filling the XDUO Mixer disposable
bag with liquid, or a recipe for BioProcess NFF Pump System filtration.
A recipe is built of phases. The phases specify parameters that the user must define
when setting up an automated production process. The parameters control the function-
ing of a specific part of the operating unit. The parameter can be for example a pressure
setpoint, an agitator speed setpoint, or a control mode. The phases can run in parallel,
for example agitator speed control and gas pressure control for a bioreactor.
Batch Control components

The following table explains the Batch Control terminology.
Term Description
Batch 1 The quantity of material that is produced by a single

production operation.
2 Identifying parameter for a production process.
Campaign Identifying parameter for a production process.
Equipment All operating units that are available for a specific batch.

Term Description
Lot Identifying parameter for a production process.
Mode The mode controls the start of all phases in a recipe. See
Batch modes, on page 377 for more information.
Phase The building blocks for recipes. The phases specify parameters
for a subprocess that the user must define when setting up
a Batch Control process.
Phase parameters The parameters control the functioning of a device of an op-

erating unit (e.g. pump).
Recipe A template for a production process performed by a

FlexFactory operating unit. A recipe identifies the operating
unit and the parameters to be used for this production pro-
cess.
Train A specified FlexFactory operating unit that performs the Batch

Control process.
Batch modes
Three batch modes are available for each batch. The batch mode controls how a batch
is started. The following table explains the Wonderware batch modes.
When the operator clicks Start and types the security clearance password, the following
happens:
Batch mode Description Function
Automatic No additional opera- The batch starts to run. The batch status
tor action is needed. changes to Run. The status of each phase
changes to Run.
Semi-Auto The operator must The batch status is Run while waiting for
acknowledge each acknowledgement. Each phase must be
phase before the started manually by the user. The status of
batch starts to run. each phase changes from Wait to Run
when acknowledged. The batch starts to
run immediately when the last phase status
changes to Run.

Batch mode Description Function
Manual The operator must The batch status is Run while waiting for
start each phase acknowledgement. Each phase must be
manually before the started manually by the user. The user must
batch starts to run. give the security clearance password for
each phase. The status of each phase
changes from Wait to Run when the securi-
ty clearance is accepted. The batch starts
to run immediately when the last phase
status changes to Run.

11.1.2 Batch schedule creation
Batch schedule creating principle

A Batch Control process can involve any number of operating units that are connected
to FlexFactory. The operating units are identified as Trains when making a batch
schedule. Batches can be scheduled for all active operating units.
When setting up an active batch, the user selects recipes from a provided list. After
defining the necessary batch identification parameters, the recipe is added to the list of
active batches.
Note: The customer automation group is responsible for the Batch Control setup.
The user starts each active batch individually. Several active batches can be run at the
same time on different operating units. Only one active batch can run on each operating
unit at a time.
One active recipe can only control and monitor one operating unit at a time. If you want
to control two parameters on two operating units (for example, pH on one bioreactor
and temperature on another bioreactor), you need two different recipes.
Batch Control setup

The operator builds a batch schedule using the M-Station OIT interface. The recipes are
selected from a list of available recipes.
A set of recipes is provided with FlexFactory. The user with Engineer access rights can
modify the recipes and create new custom recipes as needed for the specific processes.
The recipes are created by assembling and arranging phases, which operate the physical
equipment (for example, agitator, pump, or MFC). The phases can be customized, but
the basic functionality of a phase cannot be changed.
The Engineer works with creation and modification of the recipes using the Batch Control
server, via the screen and keyboard at the Server Rack.
Batch creating procedure

A batch schedule is created at the M-Station OIT using the Batch Overview screen. The
outline of this procedure is given below.
Stage Description
1 Configure the system as needed for the intended process.
2 Schedule a batch and define the identifying parameters (Campaign, Lot,

Batch).

Stage Description
3 Select a recipe for the batch.
4 Select the operating unit (Train).
5 Add the batch to the list of active batches.
6 Initialize the batch.
7 Create all active batches needed for your production process, as described
above.
8 Start the batches as needed.
Equipment selection
The operator can manually select equipment to be used in a specific batch run, if the
Equipment Selection function in the recipe is active. The function is activated when a
recipe is created (Manual Unit Selection must be selected in the Equipment Require-
ments Editor).
If the recipe requires equipment selection, the batch can be started, but the phase cannot
be completed until the operator selects the equipment.
If the Equipment Selection function in the recipe is not active, the Select Equipment
button has no effect on the batch run.
See Wonderware manufacturer's manual for more information on the Equipment Selec-
tion function.

11.2 Prepare the instrument
Introduction
The instruments must be prepared and the software functions configured before starting
to create a batch schedule. This section describes how to prepare the XDR Bioreactor,
XDUO Mixer, and BioProcess NFF Pump System for a batch run.
In this section
Section See page
11.2.1 Prepare XDR Bioreactor 382
11.2.2 Prepare XDUO Mixer 389
11.2.3 Prepare BioProcess NFF Pump System 392

11.2.1 Prepare XDR Bioreactor
Prepare the instrument

Before creating the batch schedule, the instrument must be prepared for the run. The
requirements depend on the recipe you are preparing for. Verify the specific requirements
in the recipe before starting the preparation. Follow the instructions below to set all
bioreactor components into the correct state.
Step Action
1 Verify that the disposable bag is filled and the vessel weight is shown as in-
tended.
2 Enable the agitator:

A. Click the agitator icon on the XDR Bioreactor screen.

Step Action
B.
direction arrow on the XDR Bioreactor screen points to the selected direction.
C. Close the dialog box by clicking the close button .
3 Start pump totalizers, if required in your recipe:

A. Click the relevant pump totalizer panel on the XDR Bioreactor screen to
open the pump Totalizer dialog box.

Step Action
B. Click RESET, then click START to start the pump totalizer.
uously updated in the mL text box.
C. Start all pump totalizers as described above.
4 Define each pump flow rate, if required in your recipe:

A. Click the relevant pump panel to open the pump PID faceplate.
B. Type the applicable value in the SP or CV text box.

Step Action
5 Start MFC totalizers, if required in your recipe:

A. Click the MFC icon.
Result: The MFC Totalizer dialog box opens.
B. Click RESET, then click START to start the MFC totalizer.

Result: The measurement of the pumped gas volume starts. The STOPPED
uously updated in the sL text box.

Step Action
6 Select each applicable gas valve to allow the gas flow into the vessel:
A. Click a relevant solenoid valve icon on the XDR Bioreactor screen.
Result: The valve selection dialog box opens.
B.
Click the applicable option button to select the designated destination

(Headspace, Sparge 1 or Sparge 2).
C. Click ENABLE SELECTED to enable the gas flow.

Configure the software functions

Verify the specific requirements in the recipe before starting the configuration of the
software parameters. Follow the instructions below to configure Wonderware functions
that are needed for a batch run.
Step Action
1 Make sure the XDR Bioreactor is enabled.
2 Map the control loops, if specified in your recipe. See Section 6.4 Configure
control loops, on page 147 for instructions on mapping.
screen.
4 Set all PID control loops into Auto/Local mode.
5 Click Alarm Config on the header toolbar to open the alarm configuration
screens.
6 Configure the general alarms for the operating unit as described in Configure
alarms, on page 446.
Note:
The recipe sets the necessary alarms as specified in the phases.
Verify phase requirements

Each phase has specific requirements that must be met before the phase can start.
Before running a scheduled batch, verify that the relevant conditions have been met.
The requirements for XDR Bioreactor are shown in the table below.
All PID control loops must be in Auto/Local mode.
Phase Requirement
Agitator The disposable bag must contain at least the minimum

working volume. See FlexFactory XDR Bioreactor Operat-
ing Instructions for more information.
Bolus Feed Pump control loop mapping must be disabled. 1
Continuous feed Pump control loop mapping must be disabled.1
Dissolved Oxygen Agitator must be running.
Headspace MFC control loop mapping must be disabled.1
MFC MFC control loop mapping must be disabled.1

Phase Requirement
pH Agitator must be running.
Progressive Feed-Prompt Pump control loop mapping must be disabled.1
Progressive Feed-Time Pump control loop mapping must be disabled.1
Pump Pump control loop mapping must be disabled.1
Temp Agitator must be running.
1 See Section 6.4 Configure control loops, on page 147 for more information about control loop
mapping.

11.2.2 Prepare XDUO Mixer

Before creating the batch schedule, the instrument must be prepared for the run. The
requirements depend on the recipe you are preparing for. Verify the specific requirements
in the recipe before starting the preparation. Follow the instructions below to set all
mixer components into the correct state.
Step Action
1 Using the XDUO Mixer local control software in the I/O Cabinet, set XDUO
Mixer to FlexFactory control mode.
2 Verify that the disposable bag is filled and the vessel weight is shown as in-
tended.
3 Enable the agitator:

A. Click the agitator icon on the XDUO Mixer screen.

Step Action
B.
C. Close the dialog box by clicking the close button .
Configure the software functions

Verify the specific requirements in the recipe before starting the configuration of the
software parameters. Follow the instructions below to configure Wonderware functions
that are needed for a batch run.
Step Action
1 Make sure the XDUO Mixer is enabled.
screen.
screens.
Note:

Verify phase requirements

Each phase has specific requirements that must be met before the phase can start.
Before creating batch schedule, verify that the relevant conditions have been met. The
requirements for XDUO Mixer are shown in the table below.
All PID control loops must be in Auto/Local mode.
Phase Requirement
Agitator The disposable bag must contain at least the minimum working volume.
See FlexFactory XDUO Mixer Operating Instructions for more information.
pH Agitator must be running.
Temp Agitator must be running.

11.2.3 Prepare BioProcess NFF Pump System
11.2.3 Prepare BioProcess NFF Pump System

Verify the specific requirements in the recipe before creating a batch schedule. Before
creating the batch schedule, verify that the relevant conditions have been met.
Step Action
1 Make sure the BioProcess NFF Pump System is enabled.
2 Click NFF System on the header toolbar. Select the relevant system from
the drop-down menu, if available.
Result: The NFF System screen opens.
screen.
screens.
Note:

11.3 Create and start a batch for XDR Bioreactor and XDUO Mixer
11.3 Create and start a batch for XDR Bioreactor and

XDUO Mixer
Introduction
This section describes how to create a batch schedule and start a batch for XDR Biore-
actor and XDUO Mixer.
Create batch schedule and start

a batch
Before starting to create a batch schedule, verify that the instrument is prepared for a
batch run. See Section 11.2 Prepare the instrument, on page 381 for preparation instruc-
tions.
Follow the instructions below to create a batch schedule for XDR Bioreactor or XDUO
Mixer and start the batch run.
Step Action
1 Verify that no alarms are active on the system.
2 Log in to Wonderware.
3 Click the instrument button on the header toolbar. For example, to create a
batch schedule for a bioreactor, click XDR Bioreactor and select the relevant
bioreactor from the drop-down menu, if available.
Result: The selected system screen opens.
4 Click Batch on the header toolbar to open the Batch Overview screen.

Step Action
5 On the Batch Overview screen, click BatchSchedule.
Result: BatchSchedule dialog box opens.
6 Fill in the process identification parameters in the text boxes as applicable:
• Campaign
• Lot
• Batch
Note:
Each batch process is identified by the combination of these three parameters.
At least one identifying parameter must be unique for each process.

Step Action
7 Click Select on the right of the Recipe ID text box.
Result: BatchRecipeSelect dialog box opens.
8 Click UpdateList to display all available recipes for the current process (1).
1 2
Result: All available recipes are shown for all systems that are currently
connected to FlexFactory.
9 Select the applicable recipe in the list and click Apply Recipe (2).
10 Click the close button to close the BatchRecipeSelect dialog box.

Result: The selected recipe is connected to the batch schedule.
Note:
The Size parameter is set automatically by the recipe without operator inter-
vention.

Step Action
11 Click Select on the right of the Train text box.
Result: BatchTrainSelect dialog box opens.
12 Click Update Trains to display all available systems for the current process.
13 Select the applicable system in the list and click Apply Train.
14 Click the close button to close the BatchTrainSelect dialog box.

Result: The selected system is connected to the batch schedule.

Step Action
15 Select the applicable mode in the Mode list. Select Automatic mode, if the
batch should be started automatically.
Tip:
See Batch modes, on page 377 for description of batch modes.
16 Click Add.
Result: A batch is created using the properties defined in the steps above.
The batch is shown in the Batch Schedule list with status Open.

Step Action
17 Select the batch in the Batch Schedule list and click Init Batch.
Result: The batch status changes to Ready. The batch is added to the Active
Batches list, which is shown in the BatchSchedule dialog box and on the
Batch Overview screen.
Note:
Batches in Batch Schedule list are editable. The Active Batches list in
BatchSchedule dialog box is not editable.
18 Click the close button to close the BatchSchedule dialog box.
19 Add comments to the batch if needed. See Add comments, on page 419 for
instructions.

Step Action
20 Select the batch in the Active Batches list (1) and click Start (2). Type your
password into the security clearance dialog box and click OK.
Result: The batch starts to run. The batch status changes to Run. The status
of each phase changes to Run. The PID control loops are set to Batch or
Cascade mode, depending on your recipe.
The PID loop names on the panels on the instrument overview screen are highlighted in
turquoise (Cascade mode) or in magenta (Batch mode).
See Start a semi-automatic batch, on page 400 or Start a manual batch, on page 403 for
instructions how to start batches that are not in Automatic mode (step 14 above).
See Change phase properties, on page 415 for instructions on how to change phase
properties.
See Change batch properties, on page 416 how to change batch properties, and Edit batch
list, on page 417 how to edit a batch list.
See Add comments, on page 419 how to add comments to the phase or the batch.

Start a semi-automatic batch

The batch mode is selected when a batch schedule is created. If the selected batch mode
is Semi-Auto, the details of the batch start are controlled by the operator. The operator
must acknowledge each phase before the batch can start.
Follow the instructions below to start a batch in Semi-Auto mode.
Step Action
1 Select the batch in the Active Batches list (1) and click Start (2). Type your
password into the security clearance dialog box and click OK.

Step Action
Result: The batch status changes to Run (3). The status of each phase
changes to Wait (4). The message Waiting for entry acknowledge is dis-
played in the text field below the list of phases (5). Messages for the operator
are displayed in the Messages list (6).
6
3

Step Action
2 Select a phase in the Phase Control list and click Ack. Type your password
into the security clearance dialog box and click OK.
Result: The phase status changes to Ready and then Run.

Step Action
3 Repeat step 2 to acknowledge all phases in the recipe.

Result: The batch starts to run immediately when the last phase status
changes to Run.
4 Finish the batch in the same way as a Manual batch. See instructions in
Section 11.7 Finish a batch, on page 433.
Start a manual batch

See Wonderware manufacturer's manual for information on manual batches.

11.4 Create a batch for BioProcess NFF Pump System
Create batch schedule

Follow the instructions below to create a batch schedule for BioProcess NFF Pump
System.
Step Action
1 Log in to Wonderware.
2 Click Batch on the header toolbar to open the Batch Overview screen.
3 On the Batch Overview screen, click BatchSchedule.
Result: BatchSchedule dialog box opens.

Step Action
4 Fill in the process identification parameters in the text boxes as applicable:
• Campaign
• Lot
• Batch
Note:
Each batch process is identified by the combination of these three parameters.
At least one identifying parameter must be unique for each process.
5 Click Select on the right of the Recipe ID text box.
Result: BatchRecipeSelect dialog box opens.
6 Click UpdateList to display all available recipes for the current process (1).
1 2
Result: All available recipes are shown for all systems that are currently
connected to FlexFactory.

Step Action
7 Select the applicable recipe in the list and click Apply Recipe (2).
8 Click the close button to close the BatchRecipeSelect dialog box.

Result: The selected recipe is connected to the batch schedule.
Note:
The Size parameter is set automatically by the recipe without operator inter-
vention.
9 Click Select on the right of the Train text box.
Result: BatchTrainSelect dialog box opens.
10 Click Update Trains to display all available systems for the current process.
11 Select the applicable system in the list and click Apply Train.
12 Click the close button to close the BatchTrainSelect dialog box.

Result: The selected system is connected to the batch schedule.

Step Action
13 Select the applicable mode in the Mode list. Select Automatic mode, if the
batch should be started automatically.
Tip:
See Batch modes, on page 377 for description of batch modes.
14 Click Add.
Result: A batch is created using the properties defined in the steps above.
The batch is shown in the Batch Schedule list with status Open.

Step Action
15 Select the batch in the Batch Schedule list and click Init Batch.
Result: The batch status changes to Ready. The batch is added to the Active
Batches list, which is shown in the BatchSchedule dialog box and on the
Batch Overview screen.
Note:
Batches in Batch Schedule list are editable. The Active Batches list in
BatchSchedule dialog box is not editable.
Continue editing the batch parameters as described in the next section Edit phase
properties and start the batch, on page 408.
Edit phase properties and start

the batch
When a BioProcess NFF Pump System batch has been scheduled, all phases of the recipe
should be adjusted according to the specific production process. If it is defined in the
recipe that a parameter must be specified by the user, the batch can be started, but it
cannot be completed, until the user has changed the parameter default value.
Follow the instructions below to edit the phase properties.

Step Action
1 Select the applicable batch in the Active Batches list (1) and click Start (2).
Type your password into the security clearance dialog box and click OK.
Result: The batch status changes to Run. The phase is set to status Ready.
The message Waiting to start (see item 3 in the next image) is displayed in
the message field below the list of phases, if the recipe is semi-automatic.
The batch is not running until the phase status is set to Run.

Step Action
2 In the Phase Control list (4), select the phase you want to edit.
4 5
Result: All phase parameters that are accessible for the user are displayed
in the Phase Parameters list (5). If a parameter status is shown as Required
in the Change column, the parameter value must be set by the user before
the phase can be completed.
Note:
The user can change the parameter value, if the parameter status is shown
as Required or Allowed.

Step Action
3 Select the parameter in the Phase Parameters list and type the applicable
value in the text box (6) below.
6
7
4 Click Change Parameter (7). Type your password into the security clearance
dialog box and click OK.
Result: The new parameter value is shown in the Value column. The param-
eter status is shown as Allowed in the Change column.

Step Action
5 To edit a parameter which has a predefined set of values (a discrete param-

eter), select the parameter in the Phase Parameters list, then click the arrow
to open the drop-down list in the Change Parameter field.
6 Select the applicable value for the parameter in the list.

Step Action
7 Click Change Parameter. Type your password into the security clearance
Result: The new parameter value is shown in the Value column. The param-
eter status is shown as Allowed in the Change column.
8 Add comments to the phase if needed. See Add comments, on page 419 for
instructions.

Step Action
9 Repeat steps 3-7 for all phase parameters that should be edited. When all
parameters with Required status have been set to the status Allowed, the
phase starts immediately.
Result: The batch is running. The phase status is shown as Run in the Phase
Control pane. The PID control loops are set to Batch or Cascade mode, de-
pending on your recipe.
Note:
The phase parameters can even be edited when the batch is running.
The PID loop names on the panels on the instrument overview screen are highlighted in
turquoise (Cascade mode) or in magenta (Batch mode).
See Start a semi-automatic batch, on page 400 or Start a manual batch, on page 403 for
instructions how to start batches that are not in Automatic mode.
See Change batch properties, on page 416 how to change batch properties, and Edit batch
list, on page 417 how to edit a batch list.
See Add comments, on page 419 how to add comments to the phase or the batch.

11.5 Modify a batch
11.5 Modify a batch
Change phase properties

When a batch has been started and is in the Run state, the parameters of all phases of
the recipe may be be adjusted according to the need of the specific process. The user
can change the parameter value if the parameter status is shown as Allowed in the
Change column in the Phase Parameters list.
Follow the instructions below to change the phase properties.
Step Action
1 Select the applicable batch in the Active Batches list (1).
2 3
Result: All phases included in the recipe of this batch process are shown in
the Phase Control list (2).
2 In the Phase Control list, select the phase you want to change.
Result: All phase parameters that are accessible for the user are displayed
in the Phase Parameters list (3).
3 Select the parameter you want to change. The parameter status must be
shown as Allowed in the Change column.

11.5 Modify a batch
Step Action
4 Type the applicable value in the text box (4) below the Phase Parameters
list.
4
5
5 Click Change Parameter (5). Type your password into the security clearance
Result: The new parameter value is immediately applied to the system and
is shown in the Value column.
6 Add comments to the phase if needed. See Add comments, on page 419 for
instructions.
Change batch properties

The properties of a scheduled batch can be changed using the action buttons in the
BatchSchedule dialog box, before the batch is started. The batch status must be Open
or Ready.
Follow the instructions below to change the batch properties.
Step Action
1 On the Batch Overview screen, click BatchSchedule to open the dialog box.
2 Select the batch in the Batch Schedule list.

11.5 Modify a batch
Step Action
3 Change the batch properties as needed.
4 Click Change to apply the changes. Confirm with your password.

Result: The batch properties are changed. The batch status is Open.
5 Select the batch in the Batch Schedule list and click Init Batch. Confirm with
your password.
Result: The batch status changes to Ready.
Edit batch list

Click the action buttons in the BatchSchedule dialog box to edit the Batch Schedule list.
Each action must be confirmed by typing your password in the security clearance dialog
box and clicking OK.
Use the buttons as described below.
Button Action
Add Add a new batch to the Batch Schedule list, using the batch prop-
erties specified in the text boxes. The status of the added batch is
Open.

11.5 Modify a batch
Button Action
Change Change the properties of the selected batch, using the information
specified in the text boxes. The status of the updated batch is Open.
Delete Remove the selected batch from the Batch Schedule list.
Init Batch Initialize a batch: add the selected batch to the Active Batches list.
The status of the batch is changed from Open to Ready.
Init All Initialize all batches: add all batches to the Active Batches list. The
status of each batch is changed from Open to Ready.
Cleanup Remove all batches with status Done or Aborted from the Batch
Schedule list.
Move Up Move the selected batch up in the Batch Schedule list. 1
Move Down Move the selected batch down in the Batch Schedule list.1
1 The priority of the batches is not changed.

11.5 Modify a batch
Add comments
The operator can add comments to a phase or to a batch. The comments are archived
and are included in the batch report when the report is created. Follow the instructions
below to add a comment.
Step Action
1 Select a batch in the Active Batches list (1).
2 Select a phase in the Phase Control list (2), if you want to add comment to
a phase.

11.5 Modify a batch
Step Action
3 In the list (3) below the Comment button, select as applicable:
• Select Batch to add comment to a batch.
• Select Phase to add comment to a phase.
3 4
4 Write the comment in the text box (4).
5 Click Comment (5). Type your password into the security clearance dialog
box and click OK.
Result: The comment disappears from the text box. The comment is archived
and is included in the batch report when the report is created.
Select equipment
See Equipment selection, on page380 for information on the Equipment Selection function.
Follow the instructions below to select the equipment.

11.5 Modify a batch
Step Action
1 Select a batch in the Active Batches list (1).
2 Select a phase in the Phase Control list (2).

11.5 Modify a batch
Step Action
3 Click Select Equipment.
4 In the BatchEquipSelect dialog box, select the equipment for the batch as
applicable.
5 Click Allocate. Type your password into the security clearance dialog box
and click OK.
Result: The phase status changes to Run.

11.5 Modify a batch
Step Action
6 Click the close button to close the BatchEquipSelect dialog box.

11.6 Manage batch stops
Introduction
This section describes how to manage the unscheduled batch stops. For example, a stop
due to a critical alarm, or when you want to stop a batch temporarily.
In this section
Section See page
11.6.1 Manage an alarmed batch 425
11.6.2 Hold, abort or restart a batch 428
11.6.3 Batch Timer 431

11.6.1 Manage an alarmed batch
Process alarms
If an alarm is issued that is not critical, the process continues to run.
Critical alarms are the following alarms:
• Safety alarm
• Critical low limit (LoLo)
• Critical high limit (HiHi)
• Major deviation (MAJDEV)
If a critical alarm is activated during a batch run, the batch goes into the Held state. All
phases in this batch are set into the Held state. The alarm is shown at the bottom of the
screen, in the alarm summary pane.
You have the following alternatives, depending on the severity of the alarm and the re-
quirements of your process:
• Restart the process.
• Abort the process and start a new batch run.
See Section 12.2 Alarms and alarming, on page 441 for more information about the alarm
function.

Restart a process
If a critical alarm has been issued and you want to restart the process, follow the instruc-
tions below.
Step Action
1 Clear the condition that caused the alarm.
2 Acknowledge the alarm. See View and acknowledge alarms, on page 448.
3 If the alarm was caused by the emergency stop function, the PID faceplates
are set into Manual/Local mode. Open the PID Faceplates screen and set
the PID faceplates into Auto/Remote mode.
4 Click Restart. Type your password into the security clearance dialog box
and click OK.
Result: The batch starts to run. The batch status in the Active Batches list
changes to Run. The status of each phase changes to Run.
Note:
The parameter values that were set by the user (for example, parameters
with the status Required) are still valid after the restart.

Abort a process
If a critical alarm has been issued and you want to abort the process, follow the instruc-
tions below.
Step Action
1 Click Abort. Type your password into the security clearance dialog box and
click OK.
Result: The batch run ends. The batch status in the Active Batches list is
shown as Aborted.
2 Clear the condition that caused the alarm.
3 Acknowledge the alarm. See View and acknowledge alarms, on page 448.
4 Start a new batch as appropriate.

11.6.2 Hold, abort or restart a batch
Hold, abort or restart a batch

If a process must be stopped before the product is completed, you can put the batch
on hold. You can abort or restart the batch only when the batch is in the Held state.
Follow the instructions below to stop the unfinished process.
Step Action
1 Click Hold. Type your password into the security clearance dialog box and
click OK.
Result: The batch status in the Active Batches list changes to Held. The
status of each phase changes to Held.

Step Action
2 If you want to restart the batch, click Restart. Type your password into the
security clearance dialog box and click OK.
Result: The batch starts to run. The batch status in the Active Batches list
changes to Run. The status of each phase changes to Run.
Note:
The parameter values that were set by the user (for example, parameters
with the status Required) are still valid after the restart.

Step Action
3 If you want to end the batch, click Abort. Type your password into the secu-
rity clearance dialog box and click OK.
Result: The batch run ends. The batch status in the Active Batches list is
shown as Aborted.

11.6.3 Batch Timer
11.6.3 Batch Timer
Description of Batch Timer

Batch Timer is a manually operated function and is not automatically connected to a
batch. The user must set the time (the alarm setpoint). When the specified time has
passed, an alarm event is issued and is visible in the alarm summary pane. The user can
decide if any action is needed (for example, to stop or to continue the running batch).
Use Batch Timer

Follow the instructions below to set the Batch Timer alarm and use the Batch Timer.
Step Action
1 Click Alarm Config to display the Alarm Configuration screen for the oper-
ating unit.
2 Find the alarm configuration dialog box for Batch Timer.
3 In the alarm configuration dialog box, type the applicable time value into
the Alarm SetPoint text box.
4 Make sure that the bell symbol is green.

Result: The Batch Timer alarm is set. The alarm is not activated.

11.6.3 Batch Timer
Step Action
5 To activate the Batch Timer alarm, click Batch Timer on the main overview
screen of the instrument, on the left side of the screen.
Result: The Batch Timer dialog bog is displayed.
6 In the Batch Timer dialog box, click START (1).
3
Result: The timer status is shown as RUNNING. The elapsed time counter (2)
starts. When the alarm setpoint (3) is reached, an alarm event is issued.
7 Use the Batch Timer as follows:
• Click STOP to stop the timer.
• Click RESET to reset the timer.

11.7 Finish a batch
11.7 Finish a batch
Finish a completed batch

All FlexFactory default batch recipes must be stopped by the operator. It is possible to
set up recipes that are completed automatically. See Wonderware manufacturer's
manual for more information.
See the instructions below how to stop a completed batch.
Step Action
1 Select Do you want to end this recipe? in the Questions list in the Batch
Control pane and click Yes.
Result: The question disappears and a new question is displayed.

11.7 Finish a batch
Step Action
2 Select Are any Phases running? in the Questions list (1).
3
1
3 In the Phase Control pane (2), verify if any phases are currently running.
4 • If a phase is still running, see step 5 below for instructions.
• If no phases are running, click No (3).

Result: The batch run ends. The question disappears from the Questions list.
The messages disappear from the Messages list. The batch status in the
Active Batches list is shown as Done.

11.7 Finish a batch
Step Action
5 If a phase is still running, click Yes (4). The operator must clear the conditions
that prevent the phase from stopping. Follow the instructions described in
the next steps.
6 In the Phase Control pane (5), select the phase that is in the Held state and
prevents stopping the batch.
7 Verify if any errors are shown in the Error text field (6), for example an inter-
lock may be active. Clear the conditions causing the error as appropriate.
8 In the alarm summary pane (7), verify if there are any active alarms concern-
ing this batch (7). Acknowledge the alarms. See View and acknowledge
Result: When all error conditions are cleared, the phase ends and disappears
from the Phase Control list.
9 One by one, select all remaining phases in the Phase Control pane and clear
the conditions that prevent the phases from stopping.
10 When all phases have stopped running, select Are any Phases running? in
the Questions list.

11.7 Finish a batch
Step Action
11 Click No at the right of the list.

Result: The batch run ends. The question disappears from the Question list.
The messages disappear from the Messages list. The batch status in the
Active Batches list is shown as Done.

12 Wonderware general functions
About this chapter

This chapter provides information about general functions of Wonderware software
that can be used for all FlexFactory components.
In this chapter
Section See page
12.1 Enable/Disable function 438
12.2 Alarms and alarming 441
12.3 Control loop configuration 452
12.4 Trending application 469
12.5 Dream Report 475

12.1 Enable/Disable function
Enable/Disable function
description
The Enable/Disable function is available for XDR Bioreactor, XDUO Mixer and BioProcess
NFF Pump System.
The Enable/Disable function allows the user to enable or disable an operating unit.
When the operating unit is disabled, the unit can be disconnected from FlexFactory
Automation without activating any alarms.
The following conditions apply:
• The operating unit must not be running.
• All PID control loops must be in Manual mode.
• All CVs must be set to 0%. If a PID control loop is control mapped with a split range,
the CV must be set to 50%.
• The operating unit must not be included in any running batch.
The user can create and run recipes that include a disabled operating unit even when
the operating unit is disabled, but the disabled equipment cannot run. If the user runs
a recipe on the disabled operating unit and then re-enables the equipment, the unit may
start unexpectedly.

Illustration of the Enable/Disable

function
The operating unit is enabled or disabled by clicking the Enable/Disable button, located
at the top left corner of the instrument overview screen.
The following illustration shows the location of the Enable/Disable button.

The following illustration shows an example of an overview screen for a disabled oper-
ating unit (the XDR Bioreactor screen).

12.2 Alarms and alarming
Introduction
This section provides information about how to use alarms and alarm logs to monitor
and control a run.
Enable the system

Make sure the operating unit is enabled before starting to work with the system. See
In this section
Section See page
12.2.1 Description of alarms 442
12.2.2 Set, view and acknowledge alarms 445
12.2.3 Use event and alarm logs 450

12.2.1 Description of alarms
Alarms
Alarms can be set and configured for each individual operating unit. Value based alarms
can be configured for each parameter based on pre-specified ranges. More information
about pre-specified ranges can be found in the operating unit Turnover Package.
See Wonderware manufacturer's manual for more information about alarms, alarm
states, and alarm handling, including alarm producers and consumers. The help is
available in Start:All programs:Wonderware:Books:InTouch Alarms and Events Guide,
if installed at recommended location.
Alarm functionality
The following table describes the results of alarm activation.
Alarm type Result
Critical (e.g. E-Stop) All equipment stops. All batches go to Held state.
Equipment interlock Pumps and mass flow controllers stop.

(pressure or weight)
Critical process value The recipe goes to Held state. Depending on the recipe
alarm (HiHi or LoLo) setup, the equipment may continue to run.
Process value alarm (Hi The process continues to run.

or Lo)
In all cases, a warning message is shown.
Alarm type codes

The alarm type code is shown in the Type column in the Alarm Summary and Alarm
History tables.
The alarm type codes are described in the following table.
Alarm type Alarm cause

code
DSC Discrete (possible states "on" or "off")
LGC Change initiated by the automation system

Alarm type Alarm cause

code
LoLo Variable: critical low limit
Lo Variable: warning low limit
Hi Variable: warning high limit
HiHi Variable: critical high limit
MAJDEV Major deviation (critical alarm)
MINDEV Minor deviation (warning alarm)
OPR Operator: the user name of the operator who made a change to
a value in the control system. 1
1 This information is shown only in event records.
Alarm priority codes

The alarm priority code is shown in the Prior column in the Alarm Summary and Alarm
History tables.
Each alarm has a priority code, which shows the severity of the alarm. The priority range
is 1–999. The highest priority is 1. The following table shows the alarm groups and the
corresponding alarm priority codes.
Alarm priority Alarm condition

code
1 Critical and safety alarms
300 Critical process value alarms (HiHi and LoLo)
550 Process value alarms (Hi and Lo)
998 Communication and equipment alarms
999 Information and events

Alarm colors
The following alarm colors are used on all alarm screens.
Alarm state Priority Text color Background Flashing

color
Unacknowledged, 1–300 White Red or black Yes

active
550 Black or white Yellow or black Yes
998–999 White or black Brown or white Yes
Acknowledged, active 1–300 White Red No
550 Black Yellow No
998–999 Black White No
Unacknowledged 1–999 Red White No

return 1
1 The alarm has been active. It was not acknowledged, but the parameter has returned to normal
state.

12.2.2 Set, view and acknowledge alarms
Access to alarm setup

To display the available alarms for a specific process variable follow the instructions
below.
Step Action
1 Click the appropriate instrument button on the header toolbar and select
the relevant instrument from the drop-down menu, if available.
screen for an individual instrument.
3 Find the relevant dialog box for the process variable in the Alarm Configu-
ration Page 1 or Alarm Configuration Page 2.

Configure alarms
Display the Alarm Config screen for the individual instrument as described above. Follow
the instructions below to configure the alarms.
If you want to... then...
enable or disable an click the bell icon adjacent to the alarm you want to enable
alarm or disable.
Result: The bell icon changes to indicate the status of the

alarm:
• to green if the alarm is enabled
• to red and crossed over if the alarm is disabled.

The disabled alarm value is shown in a gray text box.

define the range limits 1 make sure that the bell icons are green for the alarms
of the set alarm you want to activate
2 type the applicable values into the applicable text
boxes
3 type the deadband (DB) values for Time DB (hh:mm:ss)
and Value DB into the text boxes.
The range limits of the alarm notify the operator when a

parameter is outside of the expected range of operation.
Note:
Setting the deadband values prevents the alarm from
coming on and off ("chattering") when close to the limit.

set an alarm for devia- 1 verify that the PID control loop is in Auto mode
tion from parameter
setpoint 2 make sure that the bell icons are green for the deviation
alarms you want to activate
3 type the appropriate values into the relevant text boxes
4 type the values for Dev DB (deadband) and Settling

Period (hh:mm:ss) into the text boxes.
The limits Dev Target Minor and Dev Target Major notify
the operator when a parameter does not reach the set-
point.
Note:
Dev Target Minor is a warning alarm. Dev Target Major
is a critical process alarm.
View and acknowledge alarms

Follow the instructions below to acknowledge the alarms.
Step Action
1 • Select Flex Info:Alarm Summary on the header toolbar to display the

list of currently active alarms.
• Select Flex Info:Alarm History on the header toolbar to display all alarms
and events that are associated with the current process.

Step Action
2 To acknowledge an alarm:
• select the alarm (one alarm or multiple alarms)
• click ACK SEL (Acknowledge Selected (Acknowledge Selected)) at the

bottom of the screen
• or click ACK ALL (Acknowledge All) at the bottom of the screen to acknowl-
edge all alarms
• or right-click the selected alarm and select the applicable option from
a shortcut menu.
Result: A text box opens at the bottom of the Alarm Summary screen.
3 Type a comment in the text box if appropriate. Click OK to save the comment.
Note:
User name and time of acknowledgement are recorded automatically by the
system.
Tip:
It is good practice to provide detailed comments for alarms. This helps to keep
appropriate production records.

12.2.3 Use event and alarm logs
Apply filters to the alarm list

The filter function allows the user to display only a relevant group of alarms and events.
Follow the instructions below to apply the filter.
Step Action
1 Select Flex Info:Alarm History on the header toolbar to display all alarms
and events that are associated with the current process.
2 Choose the items you want to view: ALARMS, EVENTS, or BOTH, by clicking
the relevant button at the bottom of the screen.
3 Click FILTER.
Result: A list of all available FlexFactory operating units is displayed.
4 Click the operating unit that you want to display. Click Apply.
Result: The Alarm History table shows only the items connected to the se-
lected system.
Note:
The All filter allows the user to view platform status and system connectivity
alarms and events.
Search for an alarm or event

Follow the instructions below to perform a search.
Step Action
1 Determine on which system the alarm or event occurred. Display the alarms
and events for this system as described in steps 1-4 in Apply filters to the
alarm list, on page 450.
2 At the bottom of the screen, click Start Time and type the relevant date and
time in the dialog box.
3 At the bottom of the screen, click End Time and type the relevant date and
time in the dialog box.

Step Action
4 Click Apply.
Result: The alarms and events list is updated according to the specified limits.
Tip:
Click the Name column header or the AlarmComment column header to sort
the alarms and events alphabetically by their tag names or descriptions.

12.3 Control loop configuration
Introduction
This section gives an overview of setting up process control and describes the functioning
of some control loops. Some examples of XDR Bioreactor control loop setup are given.
The control loop mapping principles apply for XDR Bioreactor and BioProcess NFF Pump
System.
For instructions how to set up process control (map and unmap the control loops), see
Section 6.4 Configure control loops, on page 147 and Section 8.7 Configure control loops,
on page 335.
In this section
Section See page
12.3.1 Control loops 453
12.3.2 Control loop mapping description 455
12.3.3 Control loop mapping illustrations 458
12.3.4 Intermediate control elements 464
12.3.5 Examples of XDR Bioreactor control loop setup 466

12.3.1 Control loops
Control loop mechanism

PID (proportional-integral-derivative) controller is a generic control loop feedback
mechanism. A PID controller calculates the difference between a measured parameter
value (process variable, PV) and a defined setpoint (SP). The controller attempts to minimize
the error by adjusting the process control outputs.
PID controller is used to control all system modules as well as most processes. PID control
is applied using four control parameters:
• P - Proportional
• I - Integral
• D - Derivative
• DB - deadband
These four parameters regulate how much, how fast, and how close to the defined value
the control should act.
All control loops described in this chapter are PID control loops.
A PID control loop includes all following parts:
• The measurement device
• The controller
• The final output device
Types of process control loops

The control loops for XDR Bioreactor processes belong to one of the following three PID
control loop types:
PID control loop Available control loops

type
Primary • Auxiliary input 1 control
• Auxiliary input 2 control
• Dissolved oxygen (DO) control
• pH control

PID control loop Available control loops

type
Secondary • Agitator
• MFC 1-4 (optionally up to 6)
• Pumps 1 and 3 (optional pumps 2 and 4 can be used, if

included)
Note:
Any secondary control loop can also be used as a stand-alone
loop.
Stand-alone • Exhaust filter heater temperature control
• Vessel temperature control

12.3.2 Control loop mapping description
Control loop mapping principle

Mapping a PID control loop defines a connection between the controlled variable (CV)
coming from an input device (for example pH transmitter) and a final control element
(SP of the output device, for example a pump). The output of the final control element
controls the input through the mapped connection. The output device must be in Au-
to/Remote mode. The input device (main PID control loop) can be in Local, Remote, or
Batch mode.
The following mapping options are available:
Option Description
Direct mapping Any primary control loop can be directly mapped to any
secondary control loop.
Lookup table Lookup tables can be used in between primary and secondary
control loops for transforming the output of the primary
control loop before transmitting it to the setpoint of the sec-
ondary control loop.
Split range As an alternative, any primary control loop can be connected

to a split range. Split ranges are used specifically for pH
control or to create a reverse acting cascade pair (see pH
control, on page 466).
See Section 12.3.4 Intermediate control elements, on page 464 for description of lookup
table and split range.
NOTICE
The end user is responsible for developing appropriate values for
a particular process.
Control loop mapping options

Mapping PID control loops is designed to be flexible. Automated control of each PID
control loop may be enabled or disabled as necessary. Up to 20 changes per PID control
loop may be configured, and each PID control loop is configured independently.
Note: Some PID control loops are factory-configured and cannot be configured by
the user. Contact your GE representative for more information.
The following table lists possible controller mapping options.

The control loops... Can be mapped to...
• Auxiliary input 1 control • Lookup tables
• Auxiliary input 2 control • Split ranges
• Dissolved oxygen (DO) control • Directly to the devices:
• pH control - Pumps
- Mass flow controllers
Control loop mapping procedure

The mapping procedure comprises the following steps:
Stage Description
1 Identify the parameter to be controlled (the input).
2 Identify the outputs that need to be adjusted to control the input.
3 Analyze how the input and the output should be connected:
• If one output should control the input and the response is linear, you
can directly map the output to the input.
• If two different outputs are alternately used to control the upper and
the lower parts of a parameter input, you need a split range. See Split
range description, on page 464.
• If the response of the system should not be linear, you need to set up a
lookup table. The output and input are then connected in a non-linear
manner. See Lookup table description, on page 464.
4 Map the control loop: connect the process input and the output according
to your process requirements. Use the method suitable for your application:
• Direct mapping
• Split range (deadband or dead zone)
• Lookup table
See Section 6.4 Configure control loops, on page 147 for mapping instructions.

Example of mapped devices

The following illustration shows an example of the XDR Bioreactor Control screen with
two sets of mapped devices.
Part Description
1 pH control loop mapped to acid pump and base pump, using split range
dead zone
2 Dissolved oxygen (DO) control loop mapped to two lookup tables and two
output devices (MFC1 and MFC2)

12.3.3 Control loop mapping illustrations
Direct mapping
The following illustration shows a principle of direct mapping. DO PID control loop is
mapped to MFC1 (air MFC) control loop.
MFC
L/min
PV CV
L/min %
PV
CV SP
% L/min
SP
SCL
PCL
Abbreviation Definition Description
MFC Output device Mass flow controller
PCL Primary control loop DO PID control loop
SCL Secondary control loop MFC1 PID control loop

Mapping with lookup tables

The following illustration shows a principle of mapping with a lookup table. DO PID control
loop is mapped to MFC1 (air MFC) control loop, and the input to the secondary control
loop is controlled by a lookup table. Up to three lookup tables can be connected to a
primary control loop.
MFC
L/min
PV CV
L/min %
PV
CV SP
% L/min
SP
LT
SCL
PCL
LT Lookup table Intermediate control element
MFC Output device Mass flow controller

Mapping with split range

deadband
The following illustration shows a principle of split range deadband mapping. pH PID
control loop is mapped to the acid pump (AP) and the base pump (BP) control loops.
• When pH > 7, the CV < 50% and the acid pump is active.
• When pH < 7, the CV > 50% and the base pump is active.
AP
rpm
PV CV
rpm %
SP
rpm
pH > 7 SCL
PV
%
CV BP
SP rpm
PCL
pH < 7
PV CV
rpm %
SP
rpm
SCL

AP Output device Acid pump
BP Output device Base pump

Mapping with split range

dead zone
The following illustration shows a principle of split range dead zone mapping. pH PID
control loop is mapped to the acid pump (AP) and the base pump (BP) control loops. With
the split range dead zone mapping option, a lookup table is set up between each primary
and secondary control loops. One lookup table modifies the low pH range (pH < 7) and
the other lookup table modifies the high pH range (pH > 7).
• When pH > 7, the CV < 50% and the acid pump is active.
• When pH < 7, the CV > 50% and the base pump is active.
AP
rpm
PV CV
%
LT rpm
SP
rpm
pH > 7 SCL
PV
%
CV BP
SP rpm
PCL
pH < 7
PV CV
rpm %
LT
SP
rpm
SCL

AP Output device Acid pump
BP Output device Base pump
LT Lookup table Intermediate control element

12.3.4 Intermediate control elements
Introduction
Intermediate control elements connect measured parameters (for example DO or pH)
to final control elements (for example pumps or MFCs). There are two types of interme-
diate control elements:
• Split ranges
• Lookup tables
Split range description

A split range is used when one primary controller (input) must control two final control
devices (two outputs) and each final control device does the opposite of the other. The
final control devices operate alternately and control different CV ranges. The measured
input is increased by one output and decreased by the other output. Splitting the range
makes sure that the final control devices never run simultaneously.
An example is pH control, where one final control device lowers the pH (addition of acid)
and the other device raises the pH (addition of NaOH), but they should not run simulta-
neously. The pH is mapped to acid pump and NaOH pump via split range to perform the
control.
Split range mapping has two options: split range deadband (DB) or split range dead zone
(DZ).
In split range deadband option, the primary control loop is directly connected to both
final control devices. The controlling signal is linear.
In split range dead zone option, lookup tables are set in between the primary control
loop and the final control devices. Using this option, the signal from the primary control
loop to the secondary control loops is mediated in non-linear manner.
Lookup table description

Lookup tables are used to apply a stepwise-defined modification to the setpoint of the
final control device (output). The input field in a lookup table is a CV value from a primary
control loop. The output field in the lookup table is the setpoint (SP) for a final control
device, or a control variable (CV) for a split range.
The values in the lookup table are set by the user, based on the previous knowledge of
the process. Up to 20 steps can be defined in a lookup table. The output of a lookup table
is linear from one step to the next, and is proportional to the full output range.

Lookup tables are the most common method for controlling dissolved oxygen in the
bioreactor. A unique lookup table must be set up for each secondary MFC control loop.
Maximum three lookup tables can be connected to a primary control loop.
In the following example, the lookup table input is the CV of the DO control loop (%), and
the lookup table output is the flow rate of MFC (SLPM).
When the CV value of the DO control loop increases from 80% to 100%, the SP of the
MFC increases linearly from 2.5 to 4 SLPM.

12.3.5 Examples of XDR Bioreactor control loop setup
pH control
The pH PID control loop is a split range loop, where controlled variable of each half of
the split range is zero at 50% output.
A pH control loop is always set up as a primary controller in a cascade loop. The output
of the pH PID control loop is the setpoint of secondary control loops, which can be either
CO2 MFC PID control loop, or acid or base pump PID control loop.
The following table explains the process of pH regulation.
When... Then...
pH value increases base pump flow is decreased

or
CO2 flow is increased (through mass flow controller)
or
acid pump flow is increased
pH value decreases base pump flow is increased

or
CO2 flow is decreased (through mass flow controller)
or
acid pump flow is decreased
If the pH PID control loop is within the deadband range of the setpoint and calling for
neither the base nor CO2 or acid, the output of the loop is 50%. A deviation from 50%
output changes the setpoint of either the top half or the bottom half of the split range:
• If the controlled variable goes above 50%, the split range upper setpoint is increased
to bring the whole system to setpoint.
• If the controlled variable goes below 50%, the split range lower setpoint is increased
to bring the whole system to setpoint.

Dissolved oxygen (DO) control

DO control is a primary control loop. The output of the DO PID control loop is the setpoint
of the MFC control loop (the secondary control loop).
Lookup tables are used to map MFCs to the DO control, because the output of the primary
control loop is in percentage units and the setpoint of the MFCs is in SLPM. See Lookup
table description, on page 464 for more information.
Headsweep (overlay) control

Mass flow controller headsweep (overlay) control is typically configured as a stand-alone
loop, but this is not obligatory. MFC-04 is designated as the headsweep (overlay) MFC,
although any MFC can be used. Headsweep (overlay) is generally used to reduce the
amount of water vapor in the stream of exhaust gases. The same mapping functionality
is available for headsweep (overlay) air control as for all other MFCs.
Exhaust filter heater

temperature control
Exhaust filter heater temperature control is a stand-alone PID control loop. The controller
is accessed through filter heater temperature panels. The task of this PID control loop
is to maintain the exhaust filter heater temperature at setpoint.
Vessel temperature control

Vessel temperature control is a stand-alone PID control loop. The controller is accessed
through vessel temperature panel. The vessel temperature control loop maintains the
temperature of the vessel at setpoint.
Agitator speed control

Agitator speed control is a stand-alone loop, which cannot be mapped, but can be used
both in Manual or Batch modes. Agitator PID control loop maintains the speed of the
agitator at setpoint.
The following table describes agitator speed control modes.
Mode Function
Auto/Local Agitator speed is controlled to the SP defined via the agitator

PID faceplate.

Mode Function
Manual/Local Agitator speed is controlled to the CV defined via the agitator

or PID faceplate.
Manual/Remote
Auto/Remote Agitator speed is controlled to the default SP defined in the

Default PID Setpoint screen.
Auto/Batch Agitator speed is controlled to the SP defined by the Batch

Control function.

12.4 Trending application
Introduction
Trending application allows the user to display the historical process data as curves.
See also the manufacturer's general help for Trending application. The application help
is available in Start:All programs:Wonderware:Books:Historian Client User Guide, if
installed at the recommended location.
Tag naming principle

Historical data for all parameters for all FlexFactory operating units is available for
viewing in Trending application. When a group is selected in the Servers pane, all available
parameters in this group are shown in the Tags pane in alphabetical order.
The following illustration explains the principle for tag naming.
M09TC_163.PV
1 2 3
1 Operating unit abbreviation Instrument type and number in

FlexFactory.
2 Parameter tag name The tag name of the parameter. The tag
name is shown on the PID loop overview
panel on the main overview screen of the
operating unit.
3 Variable abbreviation The measured value displayed as the

trend curve.
The following table explains the operating unit abbreviations.
Abbreviation Description
AR01 1 ÄKTA ready
AP01 ÄKTAprocess
M01 XDUO Mixer

Abbreviation Description
NFF01 BioProcess NFF Pump System
P01 Remote pump
R01 XDR Bioreactor
SysPerf01 System performance
UF01 UniFlux
W01 ReadyToProcess WAVE 25
WIT01 Scale
1 01, 02 etc. identifies the system reference number in FlexFactory.
View trends
Follow the instructions below to view and configure the trends.
Step Action
1 Click Flex Info:Trending on the header toolbar.

Step Action
Result: The Trending screen opens.

Step Action
2 Click the applicable tag group in the Servers pane (1) to display the list of
the available tags.
Result: The tag list is shown in the Tags pane (2). All historical process data
are included in the list.

Step Action
3 Double-click a tag in the Tags pane to move it to the Pens pane. See Tag
naming principle, on page 469 for more information about tag names.
Result: The curve for the selected tag is shown in the trend chart.
4 Add tags to the Pens pane as needed.

Step Action
5 Click a pen in the Pens pane to connect this pen with the vertical red and
blue markers. Drag the markers left or right to read specific values at specific
times.
Tip:
Right-click a pen and select Configure on the shortcut menu to get access to
pen configuration parameters.
6 Use drop-down lists at the top of the screen for rapid selection of times and
dates for the trends.
7 Click Save on the top toolbar to save the tag configuration for future use.

12.5 Dream Report
12.5 Dream Report
Introduction
Dream Report is an independent Wonderware application for creation of production
history reports. This section provides information about how to create report templates,
and to create the reports using Dream Report.
In this section
Section See page
12.5.1 Dream Report description 476
12.5.2 Create a report template 477
12.5.3 Create and view a report 503

12.5 Dream Report
12.5.1 Dream Report description
12.5.1 Dream Report description
Application description
Dream Report is a tool for creation of customized reports of the production process
history. This application allows the user to create customized report templates, and to
produce process reports using the previously created templates. The following sections
give instructions for both template creation and report creation.
The appropriate access rights for each individual user must be defined to enable the
access to specific functions.
See also the manufacturer's help for Dream Report. Click Help on the top toolbar to access
the application help.

12.5 Dream Report
12.5.2 Create a report template
Introduction
This section gives instructions for creating a customized report template. Only an Engineer
has permission to create and design a template. The template is created using the
Wonderware Information Server WIS-1 in the Server Rack.
First, a page template is set up. The page template can be used to create different report
templates.
Then, different objects are added to the page template to create a specific report tem-
plate.
Create a page template

Follow the instructions below to create a page template.
Step Action
1 On the Server Rack keyboard, press Ctrl twice.

Result: A list of available servers is displayed.
2 Select WIS-1 on the list.
3 In the WIS-1 explorer window, click the shortcut Dream Report Studio to
open the program.
Result: The navigation window opens. The Open Project dialog box is shown.
Click OK to open the project.

12.5 Dream Report
Step Action
Result: The project navigation window opens.
6 Click New Report on the top toolbar.
Result: The Report Settings dialog box opens.
7 On the General tab (1), type the appropriate name in the Report Name text
box (2).
1
2

12.5 Dream Report
Step Action
8 On the Report File Format tab do the following:
• Select the Web and PDF check boxes.
• Select the appropriate page size and page orientation.
9 Click Apply to close the Report Settings dialog box.

Result: The report template page is created.

12.5 Dream Report
Format the header of the page

template
Follow the instructions below to add graphics and information to the page header of
the report template.
Step Action
1 Add graphics to the page header following the instruction below.
1
On the Home tab, click Picture (1) on the top toolbar.
2 Click anywhere on the report template page. The Display a picture dialog
box opens (2).
3 Browse to the appropriate folder and select the designated image file.
4 Click OK to close the dialog box. The image is placed on the page.
5 Adjust the size of the image and position the image on the template
page as appropriate.

12.5 Dream Report
Step Action
2 Add the report name to the page header following the instruction below.
1
Click Dynamic Text (1) on the toolbar on the right.
2 On the report template page, click and drag to create a selection (2).
Release the mouse button. The Dynamic text dialog box is displayed.
3 In the dialog box, select Report Name on the drop-down list.
4 Click OK. The dialog box closes and the dynamic text s#ReportName is
placed on the page.
5 Format the text size and position the object on the page as appropriate.

12.5 Dream Report
Step Action
Result:
3 Add the report generation date and time info to the page header following
the instruction below.
1
Click Date and Time on the toolbar on the right.
2 On the report template page, click and drag to create a selection. Release
the mouse button. The Date / Time Definition dialog box is displayed.
3 Type appropriate name in the Object Name text box.
4 Select the Report Generation Time option.
5 Click OK. The dialog box closes and the date and time object is placed
on the page.

12.5 Dream Report
Step Action
Result:
4 Add the user name to the page header following the instruction below.
1
Click Dynamic Text on the toolbar on the right.
the mouse button. The Dynamic text dialog box is displayed.
3 In the dialog box, select Current User on the drop-down list.
4 Click OK. The dialog box closes and the dynamic text s#User is placed
on the page.
5 Add descriptive text to the page header following the instruction below.
1
Click Text Box on the top toolbar.
the mouse button. A text box is created.
3 Type Generated on: into the text box.
4 Create a new text box.
5 Type Generated by: into the second text box.
6 Format the text size of the text objects you created, and position the
objects on the page as appropriate. See an example in the illustration
below.

12.5 Dream Report
Step Action
Result:

12.5 Dream Report
Step Action
6 Add the page number and the total number of report pages to the page
header, following the instruction below.
1
2 Create the text box as described above and type Page into the text box.
4
Click Page Number on the toolbar on the right.
the mouse button. The Page Number dialog box is displayed.
6 Select Page number option in the dialog box.
7 Click OK. The dialog box closes and the page number (1) is placed on the
page.
8 Position the number adjacent to the text "Page".
9
10 Create a new text box as described above and type of into the text box.
Position the text adjacent to the number 1.
11
Click Page Number on the toolbar on the right.
12 Open the Page Number dialog box as described above.
13 Select Total pages option in the dialog box and click OK. The number of
total pages is placed on the page (1).
14 Position the number adjacent to the text "of".

12.5 Dream Report
Step Action
Result:
7 Click the green slider in the top left-hand corner of the page creation pane.
Drag the slider downwards to lock the top part of the report page.
Result: The page header is locked and cannot be modified. The locked area
is shown as gray.
8 On the top toolbar, click Page template:Save As Page Template and save
the page template as appropriate.

12.5 Dream Report
The saved page template can be used to create different report templates. See the fol-
lowing sections for instructions on how to create a report template.
Create interactive buttons on

report template
A report template is created using the page template created in Format the header of
the page template, on page 480. Different interactive elements must be added to the page
template to create a report template.
Follow the instructions below to start creating a report template. This instruction describes
how to add interactive buttons to the page template.
Step Action
1 Open the saved report template page.
2 Click the Web Elements tab on the top toolbar.
Click Combo Box on the top toolbar. On the report template, click and
drag to create a selection. Release the mouse button.
Result: Combo Box Configuration dialog box is displayed.
4
1

12.5 Dream Report
Step Action
Modify the information in the dialog box as follows:
1 Object name: type CampaignID
2 Display Data from: select SQL Query
3 Select DSN: select Batch
4 Type the following information into SQL Query text box:

Select Distinct BatchIdLog.Campaign_ID
From BatchIdLog
Click OK to close the dialog box.
Result: A CampaignID drop-down list button is placed on the report template.
5 Position the CampaignID button on the report template as appropriate.
6 Click Combo Box on the top toolbar and display the Combo Box Configura-
tion dialog box as described above.

12.5 Dream Report
Step Action
7
1
1 Object name: type BatchID
2 Display Data from: select SQL Query
3 Select DSN: select Batch
4 Type the following information into SQL Query text box:

Select Distinct BatchIdLog.Batch_ID
From BatchIdLog where BatchIdLog.
Campaign_ID = '[cb#CampaignID]'
Result: A BatchID drop-down list button is placed on the report template.
8 Position the BatchID button on the report template as appropriate.

12.5 Dream Report
Step Action
9 Double-click CampaignID (the interactive button created in step 5 above)

on the report template to re-open the Combo Box Configuration dialog box.
10 Click Select Objects for Updates in the dialog box.

12.5 Dream Report
Step Action
11 Select the BatchID check box. Click OK to close the dialog box.
12 Click OK to close the Combo Box Configuration dialog box.

Result: The CampaignID and the BatchID drop-down lists are connected.
When creating a report (see Create a report, on page 503), the BatchID list is
updated according to available batches in the selected campaign.
13 Add descriptive text to the report template following the instruction below.
1 Click Home tab on the top toolbar.
2
Click the Text Box button.
3 On the page template, click and drag to create a selection. Release the
mouse button. A text box is created.
4 Type Campaign ID into the text box.
5 Create a new text box as described above.
6 Type Batch ID into the text box.
7 Format the text size of the text objects you created, and position the
objects on the report template as appropriate. See an example in the il-
lustration below.

12.5 Dream Report
Step Action
14
On the Web Elements tab on the top toolbar, click Action Button . On
the report template, click and drag to create a selection. Release the mouse
button.
Result: Action Button Configuration dialog box is displayed.
15
2
1

12.5 Dream Report
Step Action
1 Button Caption: type Generate
2 Select Action: select Generate Report
3 Report List: select the file name of the current template
4 Output report targets: select the appropriate check box

Result: A Generate button is placed on the report template.
16 Position the Generate button on the report template as appropriate.
Continue creating a report template following the instructions in the next section.
Create data tables on report

template
Follow the instructions below to add data tables to the report template.
Step Action
1 Click Web Elements tab on the top toolbar.

12.5 Dream Report
Step Action
2 Add the Recipe Information data table to the report template following the
instruction below.
1
Click Free SQL Query table on the toolbar on the right.
2 On the report template, click and drag to create a selection. Release the
mouse button.
Result: The Free SQL Query table dialog box is displayed.

12.5 Dream Report
Step Action
On the Data Definition tab of the Free SQL Query table dialog box, modify
the information as follows:
1 Object Description: type BatchData
2 Database Source: select Batch
3 Type the following information into the SQL Query text box:
Select BatchIdLog.Recipe_ID,
BatchIdLog.Recipe_Version,
BatchIdLog.Recipe_State,
BatchIdLog.Train_ID,
BatchIdLog.Log_Open_DT,
BatchIdLog.Log_Close_DT
FromBatchIdLog
Where BatchIdLog.Batch_ID = '[cb#BatchID]' And
BatchIdLog.Campaign_ID = '[cb#CampaignID]'
In all Free SQL Query table dialog boxes used in the current instruction, follow
this rule:
• BatchID in '[cb#BatchID]' is spelt exactly as the Object name in

Create interactive buttons on report template, on page 487, step 7.
• CampaignID in '[cb#CampaignID]' is spelt exactly as the Object

name in Create interactive buttons on report template, on page 487, step
4.

12.5 Dream Report
Step Action
On the Appearance tab of the Free SQL Query table dialog box, modify the
information as follows:
• Select the Display Table Name check box.
• Type Recipe Information in the text box below the check box.

12.5 Dream Report
Step Action
Result: The interactive data table Recipe Information is placed on the report
template.
5 To add the Batch Details data table to the report template, click Free SQL
Query table on the toolbar on the right and display the Free SQL Query
table dialog box as described above.
6 On the Data Definition tab of the Free SQL Query table dialog box, modify
1 Object Description: type Batch Details
Select BatchDetail.UnitProcedure_ID,
BatchDetail.Operation_ID,
BatchDetail.Phase_ID,
BatchDetail.DoneBy_User_ID,
CodeTable.Description,
BatchDetail.UnitOrConnection,
BatchDetail.DateTime
From BatchDetail
Inner Join BatchIdLog On BatchIdLog.Batch_Log_ID
= BatchDetail.Batch_Log_ID
Inner Join CodeTable On BatchDetail.Action_CD =
CodeTable.Code

12.5 Dream Report
Step Action
On the Appearance tab of the Free SQL Query table dialog box, modify the
• Type Batch Details in the text box below the check box.
• In the Max Number of Rows box, type or select appropriate number of

rows for the table.

12.5 Dream Report
Step Action
Result: The interactive data table Batch Details is placed on the report
template.
8 To add the Process Variables data table to the report template, click Free
SQL Query table on the toolbar on the right and display the Free SQL
Query table dialog box as described above.

12.5 Dream Report
Step Action
1 Object Description: type Process Variables
Select ProcessVar.DateTime,
ProcessVar.Phase_ID,
ProcessVar.Phase_Instance_ID,
ProcessVar.Phase_Label,
ProcessVar.Parameter_ID,
ProcessVar.Actual_Value,
ProcessVar.Target_Value,
ProcessVar.UnitOfMeasure
From ProcessVar
= ProcessVar.Batch_Log_ID
10 On the Appearance tab of the Free SQL Query table dialog box, modify the
• Type Process Variables in the text box below the check box.

12.5 Dream Report
Step Action
Result: The interactive data table Batch Details is placed on the report
template.
11 To add the Batch Questions data table to the report template, click Free
SQL Query table on the toolbar on the right and display the Free SQL
Query table dialog box as described above.

12.5 Dream Report
Step Action
1 Object Description: type Batch Questions
Select BatchQuestion.DateTime,
BatchQuestion.Question,
CodeTable.Description,
BatchQuestion.DoneBy_User_ID,
BatchQuestion.CheckBy_User_ID
From BatchQuestion
Inner Join CodeTable On BatchQuestion.Answer =
CodeTable.Code
= BatchQuestion.Batch_Log_ID
13 On the Appearance tab of the Free SQL Query table dialog box, modify the
• Select the Display Table Name check box
• Type Batch Questions in the text box below the check box
Result: The interactive data table Batch Questions is placed on the report
template.
14 Position the created data tables on the report template pages as appropriate.

12.5 Dream Report
12.5.3 Create and view a report
Introduction
This section gives instructions for creating a report of a production process. The operator
has permission to create reports, if the appropriate user access rights have been specified.
See Section 13.3.1 Dream Report user authentication, on page 532 for instructions how
to define the access rights.
The report is created from the user interface at the M-Station OIT, using the Dream Report
Web Portal. The Web Portal functionality must be activated before it can be used. See
Enable Web Portal functionality, on page 538 for instructions how to activate the Web
Portal functionality. Only an Engineer has permission to activate the Web Portal.
Create a report
The reports are created using the report templates developed as shown in Section 12.5.2
Create a report template, on page 477. Follow the instructions below to create a process
report.
Step Action
1 Open Internet Explorer on the M-Station OIT.
2 To go to the Dream Report Web Portal, type the following address in the
address bar: http://localhost/DRWeb/login.aspx.
Type your user name and password into the text boxes and click Go.

12.5 Dream Report
Step Action
Click Web Report to open the report list. Both the existing reports and the
projects available for report creation are shown on the list.
Click icon for your project to start creating a report.

Result: The report template opens on the right side of the window.
1 Select the relevant Campaign ID and Batch ID from the drop-down lists.
2 Click Generate.
Result: The report is created in both PDF and Web format, and is saved au-
tomatically.

12.5 Dream Report
Open an existing report

Follow the instructions below to open a previously created report for viewing.
Step Action
1 Go to the Dream Report Web Portal as described in Create a report, on

page 503, steps 1–4.
Click icon to open a previously created report.

Result: The report is shown in the middle pane of the window.

13 Administration
13 Administration
About this chapter

This chapter provides required information for specific management tasks of Wonderware
software and UNICORN software. General software management tasks are also described.
In this chapter
Section See page
13.1 Manage Wonderware software 507
13.2 Manage UNICORN software 518
13.3 Manage Dream Report application 531
13.4 Software security 541

13 Administration
13.1 Manage Wonderware software
Introduction
This section gives information about administrative tasks of Wonderware software.
In this section
Section See page
13.1.1 Add and remove users in Wonderware 508
13.1.2 Wonderware passwords 516

13 Administration
13.1.1 Add and remove users in Wonderware
Access rights
You must have Domain Administrator access rights perform the user management tasks
described in the following sections. The user management is done using the Domain
Controller server DC-1 in the Server Rack.
Add a user account

Follow the instructions below to add a user account.
Step Action

2 Select DC-1 on the list.
3 Press Ctrl+Alt+Delete on the keyboard.
4 Log in as Domain Administrator.

Result: The Server Manager program starts.
5 On the Start menu, click Administrative Tools:Computer Management.

Result: The Computer Management window opens.

13 Administration
Step Action
6 Right-click in the white space in the center pane, click New User on the pop-
up menu.
7 Complete the New User dialog. Set a temporary password for the new user
according to your company policy. Select the box User must change pass-
word at next logon.
Note:
For 21CFR Part 11 compliance, the user must set their own password before
using the system. The Domain Administrator may create a temporary pass-
word and provide it to the user.
8 Click Create to add the user.

Result: The dialog box closes. The new user is added to the list in the center
pane.
Configure user access

Follow the instructions below to configure the access rights of the user.
Step Action
1 Open the Computer Management window as described in Add a user ac-

count, on page 508.

13 Administration
Step Action

3 Right-click the new user in the center pane, click Properties on the pop-up
menu.
4 Select the Member of tab. Click Add.

Result: A new dialog box opens.

13 Administration
Step Action
5 Type the appropriate group names in the text box in the topmost dialog box:
• For operator access rights, type: HMI Operator.
• For supervisor access rights, type: HMI Operator, HMI Supervisor.
• For engineer access rights, type: HMI Operator, HMI Supervisor, HMI En-
gineer.
6 Click Check Names on the right of the text box.

Result: The correctly spelled group name is underlined.
7 Close the dialog boxes by clicking OK.

Result: The user access rights are defined.
8 Close the Computer Management window.
9 Log off.
Unlock a locked-out user account

Follow the instructions below to unlock a user account.
Step Action

13 Administration
Step Action

3 Navigate to System Tools:Local Users and Groups:Users.
menu.
5 Click to clear the Account is locked out check box.
6 Close the dialog box and the Computer Management window.
7 Log off.

13 Administration
Disable a user account

Follow the instructions below to disable a user account.
Step Action

menu.
5 Select the Account is disabled check box. Click OK.

13 Administration
Step Action
7 Log off.
Delete a user account

The user is permanently removed and is not able to access any password-protected
functions after this procedure. Historical data on the server are not changed.
Adding a new user with the same user name does not restore access to information
connected to the original user. Consider disabling a user account instead if the user ac-
cess might be renewed in the future.
Follow the instructions below to permanently delete a user account.
Step Action


13 Administration
Step Action
4 Right-click the user name in the center pane, click Delete on the pop-up
menu.
Result: A warning message is shown.
5 Click Yes to confirm the removal of the user account if the consequences of
the removal are acceptable.
7 Log off.

13 Administration
13.1.2 Wonderware passwords
Password policy
Passwords are bound by 21CFR Part 11 and expire according to predetermined intervals
set by the customer.
When logging in for the first time, the user needs to change the password.
When a password has expired, it needs to be changed.
Account lockout
Entering the wrong password three times results in account lockout. If your account has
been locked out:
• Wait 30 minutes for an automatic unlock
or
• Ask your Domain Administrator to unlock it.
Change the password

Follow the instructions below to change the password.
Step Action
1 Click Password on the footer toolbar.
Result: Change Password dialog box opens.
2 Type the old password.

13 Administration
Step Action
3 Type the new password.
Note:
Passwords must be at least 6 characters in length and can be used only once.
4 Type the new password to confirm.
5 Click OK.
Result: The password is changed.

13 Administration
13.2 Manage UNICORN software
Introduction
This section gives information about administrative tasks of UNICORN software.
In this section
Section See page
13.2.1 Add and remove users in UNICORN 519
13.2.2 UNICORN passwords 522
13.2.3 UNICORN database management 524

13 Administration
13.2.1 Add and remove users in UNICORN
Add a user account

All UNICORN user administration is performed in the User Setup dialog in the Adminis-
tration module. It is accessible only to authorized users.
Follow the instructions below to add or remove users.
Step Action
1 • On the Tools menu, click User Setup

or
• Click User Setup in the Administration module.
Result: The User Setup dialog box is shown.
2 Click New in the User Setup dialog.

Result: A New User is added to the Users list.
3 Enter information about the new user in the User Properties pane:
• Type a user name in the User name text box.
• Type the full name of the user in the Full name text box.
• Type the job title of the user in the Job title text box.
• Type the e-mail address of the user in the E-mail text box.

13 Administration
Step Action
4 Select the Access Groups that the user should belong to. Refer to UNICORN
Administration and Technical Manual for more information on how to set up
access groups.
5 Type a New log on password.
6 If the user should be authorized to sign electronically, type a New signature

password.
Use the Auto generate password button to generate two passwords auto-
matically.
Result: The passwords are sent to the e-mail address set in step 3.
Note:
These passwords are used only the first time the user logs on. The user is then
asked to create new passwords.
7 If desired, select the option to lock the account on a certain date.
8 • Click Apply to save the entered settings and continue working in the
User Setup
or
• Click OK to save the entered settings and close the dialog box.
Lock a user account

A user account may be locked for log on either by UNICORN (based on a set expiration
time), or manually by the system administrator. The user with a locked account does not
have access to UNICORN until another user unlocks the account. To unlock an account,
the user must be assigned to an Access Group with User Setup access.
Note: It is recommended that User Setup access is limited to administrators and
similar user groups only, to avoid unauthorized user property changes, includ-
ing the unlocking of locked accounts.
Follow the instructions below to lock a user account.
If... Then...
you want to lock the us- select the User account locked check box in the User
er account manually Properties for the relevant user.
Result: At the next log on the user cannot access UNICORN.

13 Administration
If... Then...
you want to lock the ac- • select the check box for Lock account on in the User
count after a set time Setup dialog box
• click the down arrow by the date field and click a date
in the pop-up calender.
Result: The account is automatically locked at the chosen
date.
Tip: You may select a check box to have UNICORN generate an e-mail to a specified
administrator mail address whenever a user account is locked. This check box
is available only if a receiving mail address has been set up. See UNICORN
Administration and Technical Manual for more information.
Delete a user account

Follow the instructions below to delete a user account.
Step Action
1 • On the Tools menu, click User Setup

or
• Click User Setup in the Administration module.
Result: The User Setup dialog box is shown.
2 • Select the user from the Users list and click Delete.
Result: A confirmation dialog is shown, asking you to verify that the user
has no active runs, or no runs placed in a system queue, before the user
account is deleted.
• Click OK in the confirmation dialog to confirm that the user can be
deleted.
Note:
You can delete all users except the last user with User Setup access. This
ensures that at least one user has the right to perform administration func-
tions.
3 Click OK to close the User Setup dialog box.
Note: When you delete a user, the user's method and result files are not deleted.

13 Administration
13.2.2 UNICORN passwords
Password rules and

recommendations
The list below summarizes rules and recommendations for UNICORN passwords.
• The system can be set up to operate without required passwords.
• The minimum number of password characters is set in Password Policy in UNICORN
User Setup.
• Passwords can be any combination of letters and numbers.
• Passwords are case sensitive.
• Obvious passwords should be avoided.
• User name cannot be used as password (except for the Default user).
• Expiration time for passwords is set in Password Policy in UNICORN User Setup.
However, passwords should be changed regularly by the users, even if the user
profile is set up without a password expiration time.
Change the passwords

When passwords have expired, the user is requested to enter new passwords at log on.
The user may also choose to change passwords at other times. Follow the instructions
below to change passwords.
Note: This procedure is similar to how to change expired passwords at log on.

13 Administration
Step Action
1 In any UNICORN module, on the Tools menu, click Change Passwords.

Result: The Change Passwords dialog box opens.
2 • Type the old log on password in the Current text box under the Log on
password heading.
Note:
The passwords are shown as asterisks on the screen.
• Type a new password in the New text box.
• Repeat the new password exactly in the Confirm new text box.
3 To define an electronic signature password, repeat step 2 under the Signa-

ture password heading.
Note:
The signature password cannot be the same as the log on password.
4 Click OK.

13 Administration
13.2.3 UNICORN database management
Database backup
A target folder for the regular, scheduled backup is set up when the database server is
installed. By default, backups are also scheduled at the installation. The default backup
settings are as follows:
• Daily backup
• At 03:00 local time
• To the selected target folder
• With the last 14 recent backup files kept
(When additional files are saved, the oldest backup is deleted.)
For information how to verify or edit the current backup schedule settings, refer to
UNICORN Administration and Technical Manual.
Manual backups
If necessary, you can make extra backups manually between the scheduled backups.
Follow the instructions below to make a manual backup.
Step Action
1 Click Database Management in the Administration module.

Result: The Database Management dialog box opens.
2 Click the Backup tab, then click Backup Now.

Result: A Backup Now confirmation dialog box opens.
3 Click OK to start the backup.
Note:
This process may take several minutes. A progress dialog is displayed while
the backup is performed.
Result: A Backup confirmation dialog box opens when the backup is com-
pleted. The backup file is named UNICORN_MANUAL_BACK-
UP_<Date>_<Time>.BAK by default.

13 Administration
Step Action
4 Verify that the backup has been performed in the default folder. Then choose
one option:
• Click Close
or
• Click Go To Backup File to open the backup folder and access the files.
Note:
The backup folder is created by the program when performing a backup for
the first time.
Tip: It is recommended that you either copy or move the backup files to an external
storage device to minimize the risk for loss of data. The backup includes the
UNICORN database content as well as a log report about the backup action.
Data can be restored

If necessary, you may restore data from a previous backup, for example if data has been
deleted by mistake. The restored data replaces all the current data in the database with
the data generated up to the point of time when the backup was made. All changes
performed after the time of the backup will be lost.
You can use this procedure to move data from one database instance to another. Con-
sider that all existing data in the database where the backup is restored are overwritten.
Restore backup data

Follow the instructions below to restore data from a previous backup.
Step Action


13 Administration
Step Action
2 Click the Restore tab. All available backup files are shown in the displayed
list.
Note:
Select the Show only backup files check box, if you do not want to see the
backup log files.
3 Select the backup file to restore and click Restore.

Result: A warning dialog opens. This dialog suggests that you create a
backup of the database before restoring the previous backup. This makes
sure that all essential data is saved before it is replaced with the data from
the backup.

13 Administration
Step Action
4 Choose one option:
• Click Yes to create a backup before restoring

or
• Click No to proceed without making a new backup.
Result: A second warning dialog opens. This dialog shows the backup file
that will be restored and explains the implications for the current data. All
other UNICORN modules are closed and no other actions may be performed
during the restoration.
Note:
All other client computers connected to this database instance must be logged
off from UNICORN during the restoration.
5 Click OK to proceed.
Result: A progress dialog is displayed during the restoration. The restoration
is complete when the dialog closes.
Note: The Restore operation resets the user Default in the Administrator user group,
with the password default. To preserve access security, the user Default
should be deleted after each restoration of backup data. See UNICORN Admin-
istration and Technical Manual for more information.
Data can be archived

When your UNICORN database size reaches a level where performance is affected and
the remaining space is not enough for the immediate storage needs, you can archive
selected parts of the result data. This can either be the entire result contents from before
a specified date, or selected results. You can also archive logs. It is normally a good idea
to archive data at regular intervals, if the data is not immediately needed.
Archiving reduces the size of the database. It is not the same as exporting result data,
which creates copies of the results and does not reduce the size of the database at all.
Archive complete set of data

Follow the instructions below to archive complete result data or logs.
Step Action


13 Administration
Step Action
2 Click the Archive tab.
Note:
The Archive tab is hidden if the check box Enable Archiving is cleared in the
UNICORN Configuration Manager tool. See UNICORN Administration and
Technical Manual for more information.
The archive directory and a suggested archive file name are shown in the
dialog. The directory was selected at the installation and cannot be edited
here. The file name can be changed. The default name suggested by
UNICORN includes the date of the archiving, and shows if the selected con-
tent is results or logs.
3 Choose the data to be archived:

If you click Result files:
• Click a date in the Older than list

or
• Click Free selection and then click Pick Result.
(The Pick Result dialog is described in Archive selected results, on page529)
If you click UNICORN and System logs:
• Click a date in the Older than list

then
• Click the log to archive (UNICORN or a system log) in the For log list.

13 Administration
Step Action
4 Click Archive.
Result: A warning dialog box opens. This dialog suggests that you create a
backup of the database before archiving the selected data.
Note:
It is recommended to always make a backup before archiving.

or
Result: A progress dialog box opens while the data is archived. Depending
on the selections above, this may take several minutes. When the archiving
is completed, a confirmation dialog box opens.
6 Click Close to close the confirmation dialog box.
Note: It is recommended to save the archived data on another storage media than
where the active database is stored.
Archive selected results

Follow the instructions below to select individual results for archiving.
Step Action
1 In the Database Management dialog box, click the Archive tab.

Result: The Pick Result dialog box opens.
2 • Click Result files.
• Click Free selection.
• Click Pick Result.

13 Administration
Step Action
3 In the Pick Result dialog box:
• Find and select the result you want archive.
• Click the arrow button to add it to the To Archive list.
4 Repeat steps 2 and 3 until you have added all results you wish to archive to
the list.
Tip:
You can remove results from the list by selecting them and clicking Remove
From List at the bottom of the dialog box.
5 Click Archive.
Result: A warning dialog box opens. This dialog suggests that you create a
backup of the database before archiving the selected data.

or
Result: A progress dialog box opens while the data is archived. Depending
on the selections above, this may take several minutes. When the archiving
is completed, a confirmation dialog box opens.
7 Click Close to close the confirmation dialog box.

13 Administration
13.3 Manage Dream Report application
Introduction
Dream Report is an independent Wonderware application for creation of production
history reports. This section provides information about how to handle the user access
and the project access for Dream Report.
In this section
Section See page
13.3.1 Dream Report user authentication 532
13.3.2 Manage project access 536

13 Administration
13.3.1 Dream Report user authentication
Dream Report user access rights

Access rights need to be configured for each Dream Report application user. Only a
Domain Administrator has permission to configure user access rights. Dream Report
user management is performed using the Wonderware Information Server WIS-1 in the
Server Rack.
Configure user access

First, a user list is created and all intended users are added to the list. The access rights
for each user on the list are then configured according to the specific needs.
Follow the instructions below to define project users and configure user access rights.
Step Action

open the program.


13 Administration
Step Action
6
On the Project tab, click General on the top toolbar.
Result: The Project Settings dialog box opens.
7
On the Project tab, click Edit project users on the top toolbar.
Result: The User Management dialog box opens.
8
1
On the Users And Groups tab (1) in the User Management dialog box, do
the following:
1 In the Windows Authentication (2) pane, select the Use Windows Au-
thentication check box.
2 Click Configure.
Result: The Select Users or Groups dialog box opens.

13 Administration
Step Action
9 Define all user names who need to have access to the current project. The
individual access rights for each user are specified later.
Follow the instructions below:
1 Type the user name into the text box.
2 Click Check Names.
3 Add the next user.
4 Click OK when the list is complete.

Result: The dialog box closes.
10
11
In the User Management dialog box, click Authorization.

13 Administration
Step Action
12
On the Authorization tab, define the individual access rights for each user
as follows:
1 In the List of Users And Groups pane, click a user name.
2 In the User access rights pane, modify the access rights as needed.
3 In the Project Reports pane, select the relevant check boxes for this user.
4 Repeat steps 1–3 for each user.
5 Click Apply when all user access rights have been defined.
Result: The dialog box closes.
13 In the Project Settings dialog box, click OK to close the dialog box.
Result: The user list has been set up and the user access rights for each user
have been defined.

13 Administration
13.3.2 Manage project access
Set project in Running state

The project state in the , Dream Report application must be defined as Running to allow
the users to create reports. Only a Domain Administrator has permission to modify the
project state. The project state can be modified using the Wonderware Information
Server WIS-1 in the Server Rack.
Follow the instructions below to verify and change the project state in Dream Report.
Step Action

open the program.

6
On the Project tab, click Run Project on the toolbar on the left.
Result: The Runtime Management Console dialog box opens.

13 Administration
Step Action
Select the relevant project on the project list.
1
2

13 Administration
Step Action
• If the state of the project (2) is shown as Project is running, click Close
(3).
• If the state of the project is shown as No Project is running, do the fol-
lowing:
1 Click Start (1).
2 Wait until the project is loaded. When the loading is complete, the
state of the project is shown as Project is running.
3 Click Close (3).
Result: The project is in Running state.
Enable Web Portal functionality

It is necessary to enable the Web Portal functionality to allow creation of process reports
from the user interface at the M-Station OIT. Only a Domain Administrator has permission
to activate the Web Portal. The Web Portal is activated using the Wonderware Information
Server WIS-1 in the Server Rack.
Follow the instructions below to activate the Web Portal functionality.
Step Action

open the program.

13 Administration
Step Action

6
On the Project tab, click Run Project on the toolbar on the left.
Result: The Runtime Management Console dialog box opens.
On the Project Access list, click Configure IIS.

13 Administration
Step Action
In the IIS Configuration dialog box, click Configure IIS.

Result: The configuration starts.
9 Wait until the message Configure ASP.net of your Windows installation

closes and the next message IIS configuration has been successfully
completed is shown.
10
Click OK.
11 Close the Runtime Management Console dialog box.

13 Administration
13.4 Software security
Anti-virus software
NOTICE
Use anti-virus software on all server and workstation computers
within your instrument package.
Below is a summary of the Wonderware policy on anti-virus protection.

New viruses are discovered almost every day. To protect yourself from virus attacks,
Wonderware suggests:
• Isolate the plant control network (PCN) from the corporate network.
• Virus scan your systems on a regular basis.
• Wonderware does not endorse any particular anti-virus package as there is a large
number of such products available on the market.
• Stay current on information related to virus protection trends.
Conflicts with anti-virus software

If your Wonderware application conflicts with anti-virus software:
• Make sure that you have the latest version of the anti-virus software.
• Run the anti-virus software to make sure that no viruses are present on your com-
puter.
• Disable the anti-virus software, and then run your application.
• If possible, periodically re-run the anti-virus software during scheduled maintenance
times (planned downtime).
• When the anti-virus software is disabled, do not run any applications that could
transfer a virus (for example e-mail or file sharing). Do not insert USB flash drives
because they can be a source of viruses.
Wonderware will post warnings on any significant anti-virus software conflicts with our
software products. Consult the web site at www.wonderware.com\support\mmi for the
most current information.

13 Administration
Microsoft Windows operating

system security updates
Below is a summary of the Wonderware policy on Windows security updates.
• Wonderware understands the need to keep current with Windows security updates.
• Due to the frequency and number of Windows security updates it is not practical to
extensively test all Wonderware products with all updates.
• Wonderware Technical Support advises customers to back up their systems prior
to loading any security updates.
• Wonderware support customers to install Windows security updates. If any conflicts
arise with Wonderware software as a result of Windows security updates, report the
issues via normal support channels.
• Wonderware follows a process to proactively notify customers of any known conflicts
between Wonderware software and Windows security updates via warnings posted
on www.wonderware.com/support/mmi.

Index
Index
A access UNICORN, 372
description, 29
Abbreviations, 12 illustration, 30
Abort tagname, 125
batch, 427–428 ÄKTA ready screen
Active batches pane, 60, 63 description, 123
description, 74 illustration, 124
illustration, 74 Alarm Config screen
Active panels, 64 description, 61, 69
Add Alarm configuration
liquids, 292 illustration, 94
solids, 299 Alarm filters, 450
Add comment Alarm History screen
batch or phase, 419 description, 61, 84
Add user events, 86
UNICORN, 519 Filter, 83
Wonderware, 508 footer, 85
Adjust zero illustration, 84
flow sensor, NFF, 332 Alarm History table, 81
Agitator Alarms
change direction, 239, 283 access, 445
control, 234 acknowledge, 448
control loop, 454 acknowledged, 444
icon, 105, 113 activate, 446
incorrect installation, 236, activated, 442
279 batch, 425
incorrect positioning, 236, colors, 444
279 comment, 449
interlock, 139, 265 configure, 442, 446
noise, 236, 279 critical, 96, 425, 442, 448
panel, 235 deactivate, 446
start, XDR, 234 define range, 447
stop, 237 deviation alarm, 448
stop, XDUO, 281 disable, 446
Agitator speed display, 80, 84, 445
control, 234, 277 enable, 446
control loop, 467 filtering, 450
ÄKTAprocess logs, 450
access UNICORN, 372 overview, 61
description, 31 priority codes, 443
illustration, 32 process, 442
Wonderware software, 126 properties, 81
ÄKTAprocess screen result, 442
description, 126 search for, 450
illustration, 127 state, 82
ÄKTA ready summary pane, 63

Index
type codes, 442 Held, 425, 428

unacknowledged, 444 list, edit, 417
viewing, 448 Manual mode, 377
warning, 96, 442, 448 Manual mode, start, 403
Alarm Summary screen mode, 377
description, 61, 80 on hold, 428
illustration, 80 phase, 376
Alarm Summary table, 81 phase properties, 387, 391,
Anti-virus protection, 541 415
Archive data phase requirements, 387,
UNICORN , 527, 529 391
Auto log off, 145, 270 PID loops, 387, 391–392
Automatic mode, 377 prepare BioProcess NFF
start batch, 393, 408 Pump System, 392
Auto mode, 91 prepare instrument, 381
Auxiliary inputs prepare XDR Bioreactor, 382
control loop, 453 prepare XDUO Mixer, 389
mapping options, 456 properties, 416
AxiChrom Master recipe, 376, 379
description, 40 restart, 426, 428
illustration, 41 Semi-Auto mode, 377
Semi-Auto mode, start, 400
B start, BioProcess NFF Pump
Bag System, 408
add liquids, 292 start, XDR Bioreactor , 393
add solids, 299 start, XDUO Mixer, 393
fill with gas, 228 timer, 431
fill with media, 233 XDR Bioreactor , 393
remove, 309 Batch Control
Bag pressure access to parameters, 379
interlock, 139 description, 376
tare, 227 operate, 379
tare sensor, 227 overview, 374
Batch, 376 phase, 379
abort, 427–428 security levels, 56
add comment, 419 setup, 379
alarms, 425 structure, 379
Automatic mode, 377 BatchEquipSelect
Automatic mode, description, 98
start, 393, 408 Batch mode, 92
BioProcess NFF Pump Batch Overview screen
System, 404, 408 description, 61, 70
change properties, 416 illustration, 71
create schedule, 379, 393, BatchSFC screen
404 description, 97
edit, 416 illustration, 97
edit list, 417 Batch Timer dialog box, 431
edit recipe, 379 BioProcess NFF Pump System
end, 433 configure software, 320
finish, 433 control loop mapping, 335

Index
control mode, 316 Controlled variable

define interlocks, 317 high limit (CVHL), 93
description, 33 input text box, 91
Flow Meter - Feedback limits, 93
Screen, 363 low limit (CVLL), 93
flow sensor, 325, 363 output text box, 91
flow sensor, adjust zero, 332 preset limits, 93
flow sensor, automatic, 325 Control loop
flow sensor, calibrate, 327 configure, 147, 335, 452,
illustration, 34 455
manual operation, 351 intermediate control ele-
map to flow and pres- ments, 464
sure, 345 mapping, 147–148, 156,
map to flow control, 337 168, 177, 335, 452, 455, 457
map to pressure con- mapping options, 455
trol, 341 mapping procedure, 456
measure flow, 361 mechanism, 453
prepare batch run, 392 preset, 455
prime pump, 355 types, 453
prime pump and filters, 357 unmap, 188, 192, 198, 203
start pump, 352 Control loop mapping, 148,
stop pump, 354 156, 168, 177, 316, 335, 455
unmap, 349 illustration, 457–460, 462
Wonderware software, 115 options, 455
Bioreactor unmap NFF, 349
description, 24 Control mode notification, 316
Wonderware software, 102 Control screen
description, 60, 108
C illustration, 109–110
Calibrate Critical alarms, 425
DO probe, 250 Cross-flow filtration
DO probe temperature, 251 description, 35
flow sensor, NFF, 327 CVHL, 93
pH probe, 248 CVLL, 93
pumps, 211
Campaign, 376 D
Cascade mode, 92 Data
Close button, 62 historical, 22
Collect product, 304 view, 469, 475
Comment Database backup
batch, 419 manual, UNICORN, 524
phase, 419 UNICORN, 524
Configuration Screen Deadband, 96, 447
access, 117 Default PID Setpoint
Configure access, 106
alarms, 442 illustration, 76
before batch run, 387, 390 Define interlocks
trends, 470 BioProcess NFF Pump
user account, System, 317
Wonderware, 509 Delete user account

Index
UNICORN, 521 Dream Report

Wonderware, 514 application, 475
Dialog boxes, 88 create report, 503, 536
Direct mapping, 148, 458 create template, 477
unmap, DO, 188 maintenance, 531
Disable equipment, 439 open report, 505
Disable mapping, 188 overview, 476
lookup tables, 192 project access, 536
split range deadband, 198 project state, 536
split range dead zone, 203 user authentication, 532
Disable user account user management, 532
Wonderware, 513 Web Portal, enable, 538
Disconnect Duplicate probes
lines, 305 selection, 240, 288
probe, 305
Display panels, 64 E
Disposable bag Enable/Disable
add liquids, 292 button, 104, 112, 118
add solids, 299 function, 438
decontaminate, 311 Enable equipment, 439
fill with gas, 228 End batch, 433
fill with media, 233 Engineer, 52–53
remove, 309 Equipment
tare pressure, 227 enable and disable, 439
uninstall, 309 Equipment Selection func-
XDR, manage contents, 210 tion, 380
XDUO, manage con- Events
tents, 272 description, 86
Dissolved oxygen display, 84–85
control, 243 filtering, 450
control loop, 453, 467 logs, 450
mapping, 465 search for, 450
mapping, direct, 148 Exhaust filter heater
mapping, lookup tables, 157 temperature control
mapping options, 456 loop, 454, 467
DO Exhaust filter valve
control, 243 automatic operation, 226
control loop, 453, 467 manual operation, 225
mapping, 465
mapping, direct, 148 F
mapping, lookup tables, 157 Fill the bag
mapping options, 456 preparation, 233
unmap, lookup tables, 192 with air, 228
Door with media, 233
install, XDUO Mixer, 296 Filter, 83
remove, XDUO Mixer, 294 Filter heater
DO probe temperature control
calibration, 250 loop, 454
temperature calibra- Filters
tion, 251 prime, 357

Index
Finish batch, 433 L

Flex Info
description, 77 Liquid addition, 292
Flow and pressure control Local mode, 92
map NFF, 345 Lock user account
Flow control UNICORN, 520
map NFF, 337 Log in
Flow Meter - Feedback Wonderware, 142, 267
Screen, 363 Log out
Flow path Wonderware, 145, 270
change, 224 Lookup tables
dialog box, 224 description, 464
select, 224 map control loop, 157, 459
Flow sensor unmap, 192
adjust zero, NFF, 332 Lot, 377
automatic, NFF, 325 M
calibrate, NFF, 327
NFF, 325, 363 Maintenance
Footer toolbar, 60, 62 UNICORN, 518
Wonderware, 507
G Manual mode, 92, 377
Gases start batch, 403
change flow path, 224 Map control loop
fill the bag, 228 direct mapping, 148, 458
Gas flow flow, 337
colors, 107 flow and pressure, 345
pressure, 341
H pump speed, 337, 341, 345
split range deadband, 168,
Header toolbar, 60, 62
460
Headsweep control, 467
split range dead zone, 177,
Held
462
batch, 425, 428
with lookup tables, 156, 459
Historian
Mapping
server, 22, 50, 78
disable, 188, 192, 198, 203
Historical data
Mass flow controllers
view, 469, 475
control loop, 454
I mapping options, 456
measure the flow, 222
Install door start gas flow, 221
XDUO Mixer, 296 Measure
Intended use, 8 gas flow, 222
Interlocks liquid flow, 220, 361
agitator, 265 MFC
define, BioProcess NFF colors, 107
Pump System, 317 illustration, 107
high weight, 139, 265 Mixer
low weight, 139, 265 description, 38
over-volume, 139, 265 Wonderware software, 111
XDR Bioreactor, 139 Mode, 377
XDUO Mixer, 265

Index
batch, 377 policy, UNICORN, 522

Modes policy, Wonderware, 516
Auto, 91 requirements, 517
Batch, 92 pH
Cascade, 92 control loop, 453, 466
Local, 92 mapping, split range, 168,
Manual, 92 177
PID loop control, 91 mapping options, 456
Remote, 92 Phase, 376–377, 379
M-Station OIT add comment, 419
description, 20 change properties, 415
illustration, 21 edit, 393, 408, 415
pH control
N XDUO, start, 284
NFF XDUO, stop, 287
configure software, 320 pH probe
control mode, 316 calibration, 248
define interlocks, 317 standardization, 248
description, 33 PID control, 453
Flow Meter - Feedback PID Default Setpoints
Screen, 363 access, 113
flow sensor, 325, 363 PID faceplate
measure flow, 361 access, 67, 89, 240, 288
prime filters, 357 PID faceplate dialog box
prime pump, 355, 357 description, 89
start pump, 352 illustration, 90
stop pump, 354 PID Faceplates screen
unmap, 349 description, 61, 67
Wonderware software, 115 illustration, 68
NFF System screen PID loop
description, 115 control modes, 91
illustration, 116 default setpoints, 76
Noise overview panels, 64
agitator, 236, 279 range defining parame-
Normal flow filtration ters, 93
description, 33 Platform Status screen
Notes and tips, 9 description, 87
illustration, 87
O Pressure control
Operator, 52–53 map NFF, 341
Overlay control, 467 Prime
Overview screen, 60 filters, 357
Wonderware, 59 Probe
disconnect, 305
P DO probe, calibration, 250
Panels DO probe, temperature cali-
Wonderware, 64 bration, 251
Passwords selection, 240, 288
change, UNICORN, 522 standardization, 248
change, Wonderware, 516 Process control, 47

Index
Product Remote Pumps screen

collect, 304 description, 120
Project access illustration, 120
Dream Report, 536 Remote Scales screen
Pumps description, 121
calibrate, 211 illustration, 121–122
change flow direction, 218, Remove
273 disposable bag, 309
control loop, 454 door, XDUO Mixer, 294
description, 43 probe, 305
external, 120 Remove door
for pH control, 466 XDUO Mixer, 294
icon, 104, 112 Report
mapping, 168, 177 create, 503
measure flow volume, 220, create template, 477, 487
361 Dream Report, 503
panel, 104, 112 open, 505
prime, NFF, 355, 357 page template, 477, 480
remote, 43 Web Portal , 503
start, NFF, 352 Restart
start, XDR, 215 batch, 426, 428
stop, NFF, 354 Restore backup data
stop, XDR, 217 UNICORN, 525
unmap, 198, 203 RTP WAVE screen
Pumps, remote description, 130
description, 43 illustration, 131
illustration, 43
start, 366 S
stop, 368 Safety notices, 9
Wonderware software, 120 Sampling, 244
Pump speed Scale, remote
control, 337, 341, 345 description, 44
mapping, 337, 341, 345 tare, 370
Purpose of manual, 7 Wonderware software, 121
Scope of manual, 7
R Security
ReadyToProcess WAVE 25 levels, 52
access UNICORN, 372 symbol, 144–145, 269–270
description, 26 Select
illustration, 27 alternative probe, 240, 288
Wonderware software, 130 Select Equipment
Recipe, 376–377, 379 button, 380
create, 379 instruction, 420
edit, 379 Semi-Auto mode, 377
end, 433 start batch, 400
Remote devices Set interlocks
Wonderware software, 119 BioProcess NFF Pump
Remote mode, 92 System, 317
Remote pump Setpoints
Wonderware software, 120 high limit (SPHL), 93

Index
input text box, 91 Trending screen

limits, 93 description, 61, 78
low limit (SPLL), 93 illustration, 79
output text box, 91 Turn off
preset limits, 93 XDUO Mixer, 312
Shut down Typographical conventions, 7
software, 261, 312
XDUO Mixer, 312 U
Software UNICORN
maintenance, 541 access via M-Station
navigation, 59 OIT, 372
overview, 46 add user, 519
security, 542 archive data, 527
Solids addition, 299 archive selected results, 529
Sparge discs, 224, 253 database, 50
SPHL, 93 database backup, manu-
Split range al, 524
description, 464 delete user account, 521
map control loop, 168, 177, lock user account, 520
460, 462 maintenance, 518
mapping, DB, 168, 460 overview, 49
mapping, DZ, 177, 462 password change, 522
unmap, DB, 198 restore backup data, 525
unmap, DZ, 203 UniFlux
SPLL, 93 description, 35
Standardize pH probe, 248 illustration, 36
Start tagname, 136
gas flow, 221 Wonderware software, 134
Supervisor, 52–53 UniFlux screen
description, 134
T illustration, 135
Take sample, 244 Unlock user account
Tare Wonderware, 511, 516
bag pressure, 227 Unmap
remote scale, 370 direct mapping, 188
XDR vessel, 232 lookup tables, 192
XDUO vessel, 275 split range deadband, 198
TCU split range dead zone, 203
description, 42 User
illustration, 42 access, Dream Report, 532
Temperature control access, Wonderware, 509
exhaust filter heater, 467 add, Dream Report, 532
vessel, 467 add, UNICORN, 519
XDR vessel, 242 add, Wonderware, 508
XDUO mixer, 290 configure, Wonderware, 509
Temperature control unit delete account,
description, 42 UNICORN, 521
Train, 377 delete account,
Trending, 469 Wonderware, 514
view trends, 470

Index
disable account, dialog boxes, 88

Wonderware, 513 disable account, 513
lock account, UNICORN, 520 display panels, 64
locked out, 516 illustration, 50
unlock account, maintenance, 507
Wonderware, 511 operation mode, 53
User account overview, 47
delete, UNICORN, 521 overview screen, 59
delete, Wonderware, 514 password change, 516
disable, Wonderware, 513 remote devices, 119
lock, UNICORN, 520 screens, 60
unlock, Wonderware, 511 security levels, 52
User information security modes, 52
important, 8, 137, 263, 314 software policy, 541–542
User interface unlock user account, 511,
control functions, 335, 452 516
User management user management, 508
Wonderware, 508 view only, 52
V X
Valves, solenoid XDR Bioreactor
colors, 107 batch requirements, 387
illustration, 107 description, 24
Vessel temperature end batch run, 255
control loop, 454, 467 illustration, 25
Vessel weight interlocks, 139
interlock, 139, 265 prepare batch run, 382
tare, 232, 275 XDR Bioreactor screen
View data curves, 469 description, 60, 103
icons, 104
W illustration, 104
Web Portal panels, 104
enable, 538 XDUO Mixer, 393
report, create, 503 batch requirements, 391
report, open, 505 description, 38
Weight illustration, 39
monitoring, 276 interlocks, 265
Wonderware prepare batch run, 389
access, 59 XDUO Mixer screen
active panels, 64 description, 60, 111
add user, 508 icons, 112
configure user account, 509 illustration, 112
delete account, 514 panels, 112

GE, the GE Monogram, ÄKTA, ÄKTAprocess, AxiChrom, BioProcess, FlexFactory,
For local office contact information, visit ReadyToProcess, UNICORN, UniFlux, ReadyToProcess WAVE and Xcellerex are
www.gelifesciences.com/contact trademarks of General Electric Company.
ArchestrA and Wonderware are registered trademarks of Schneider Electric.
GE Healthcare Bio-Sciences AB Dream Report is a trademark of Ocean Data Systems. Levitronix is a registered
trademark of Levitronix. Mettler-Toledo is a trademark of Mettler-Toledo Inc.
Björkgatan 30 Microsoft and Windows are registered trademarks of Microsoft Corporation.
751 84 Uppsala PROFIBUS is a trademark of PROFIBUS Nutzerorganisation e.V. Tri-Clamp is a
trademark of Alfa Laval. WindowViewer is a trademark of Schneider Electric.
Sweden All other third party trademarks are the property of their respective owner.
www.gelifesciences.com/flexfactory Any use of the Wonderware software is subject to GE Healthcare Standard
Software End-User License Agreement for Life Sciences Software Products. A
copy of this Standard Software End-User License Agreement is available on re-
quest.
Any use of the Xcellerex configuration of the Wonderware software is subject
to a valid Software Licence Agreement with Schneider Electric. The purchase of
the product from GE Healthcare includes an implied license.
Any use of UNICORN is subject to GE Healthcare Standard Software End-User
License Agreement for Life Sciences Software Products. A copy of this Standard
Software End-User License Agreement is available on request.
Patents; please visit www.pall.com/patents.
© 2016 General Electric Company.
First published Nov. 2016
All goods and services are sold subject to the terms and conditions of sale of
the company within GE Healthcare which supplies them. A copy of these terms
and conditions is available on request. Contact your local GE Healthcare repre-
sentative for the most current information.
GE Healthcare Europe GmbH
Munzinger Strasse 5, D-79111 Freiburg, Germany
GE Healthcare UK Limited
Amersham Place, Little Chalfont, Buckinghamshire, HP7 9NA, UK
GE Healthcare Bio-Sciences Corp.
100 Results Way, Marlborough, MA 01752, USA
GE Healthcare Dharmacon, Inc.
2650 Crescent Dr., Lafayette, CO 80026, USA
HyClone Laboratories, Inc.
925 W 1800 S, Logan, UT 84321, USA
GE Healthcare Japan Corporation
Sanken Bldg. 3-25-1, Hyakunincho Shinjuku-ku, Tokyo 169-0073, Japan
29164188 AA 11/2016 a473

FlexFactory Users Manual 29164188AA

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

FlexFactory Users Manual 29164188AA

Uploaded by

Copyright:

Available Formats

FlexFactory™ Automation

2 System overview .................................................................................................. 14

3 FlexFactory description ...................................................................................... 18

4 Wonderware user interface: description ......................................................... 51

2 FlexFactory Automation User Manual 29164188 AA

4.4.2 Alarm Summary ............................................................................................................................ 80

5 Wonderware user interface: instruments ....................................................... 101

6 Operate XDR Bioreactor ..................................................................................... 137

FlexFactory Automation User Manual 29164188 AA 3

7 Operate XDUO Mixer ........................................................................................... 263

8 Operate BioProcess NFF Pump System ............................................................ 314

9 Operate remote devices ..................................................................................... 365

10 View UniFlux, ÄKTA and WAVE instruments .................................................... 372

11 Batch Control function ........................................................................................ 374

4 FlexFactory Automation User Manual 29164188 AA

12 Wonderware general functions ........................................................................ 437

13 Administration ...................................................................................................... 506

FlexFactory Automation User Manual 29164188 AA 5

About this chapter

Section See page

1.1 About this manual 7

1.2 Important user information 8

1.3 Associated documentation 10

6 FlexFactory Automation User Manual 29164188 AA

1.1 About this manual

Purpose of this manual

Scope of this manual

FlexFactory Automation User Manual 29164188 AA 7

1.2 Important user information

Read this before operating

Intended use of FlexFactory

8 FlexFactory Automation User Manual 29164188 AA

Notes and tips

FlexFactory Automation User Manual 29164188 AA 9

1.3 Associated documentation

Document Main contents

FlexFactory User Manual Instructions on how to operate FlexFactory, and the

XDR Bioreactor Operating Instructions on how to install, operate and maintain

ReadyToProcess WAVE™ 25 Instructions needed to install, operate and maintain

ReadyToProcess WAVE 25 Detailed system descriptions and instructions on how

ÄKTAprocess™ Operating Instructions on how to install, operate and maintain

10 FlexFactory Automation User Manual 29164188 AA

Document Main contents

UniFlux™ System Operating Instructions on how to install, operate and maintain

AxiChrom™ 300-1000 Instructions on how to install, operate and maintain

UNICORN manual package • The manuals contain detailed instructions on how

Wonderware user documen- The manuals contain descriptions of components of

FlexFactory Automation User Manual 29164188 AA 11

CVHL controlled variable high limit

CVLL controlled variable low limit

1 An interval of a signal where no action occurs (the

HMI user interface (human machine interface)

I/O Cabinet Input/Output Cabinet

MFC Mass Flow Controller

NFF normal flow filtration

OIT operator interface terminal

PID proportional integral derivative

12 FlexFactory Automation User Manual 29164188 AA

PLC programmable logic controller

SAT Site Acceptance Test

SCADA supervisory control and data acquisition

SLPM standard liters per minute

SPHL setpoint high limit

SPLL setpoint low limit