BIOTECH

Palltronic® Flowstar V Integrity Test Instrument

USD 3483

Filter Integrity Testing Reaches a Whole New Level:

Higher Safety Margins with a Plug-and-Play Network Integration

The Palltronic Flowstar V integrity test instrument ensures

accurate filter integrity testing with a further reduction
in test time, full compliance with 21 CFR Part 11, advanced
automation capabilities and simplified network integration
saving the user time while improving process efficiency.

Designed to be used in any cleanroom environment, the

Palltronic Flowstar V integrity test instrument has been
developed and validated in accordance to the current
GAMPu guidelines. It has complete technological controls
and features required for operating in a 21 CFR Part 11-
compliant environment, and includes quality risk management
features such as data integrity controls and electronic
records/signatures.

The instrument has been designed to ensure that the The human machine interface is a large, intuitive, easily
measuring block and the internal components, where the adjustable screen designed to aid user experience and
gas flows, are manufactured from FDA-listed material. operation. The instrument also includes status indicating
LED strips, providing feedback to operators during use.

Features and Benefits

Features Benefits
Technology Direct flow measurement n Faster testing
n High accuracy of test results
n Calibration based on traceable flow references
Ease-of-Use Automatic control of the test system n Reduced test time under stable test conditions
Storage of test parameters and recipes n Reduced setup times
n Avoids input errors
Light instrument with a small footprint n Portable
n Easy to locate close to point of use
Intuitive user interface with 12 in. (1280 x 800) n Enhanced readability
color touch screen and adjustable screen angle n Intuitive design improving ease of use for data entry and navigation
n Adjustable positioning of display angle to improve ease of interaction
and aid comfort when in use
LED alarm strip n Enables quick check of instrument status whilst in operation,

even from a distance

Quality and Developed in accordance with GAMP 5 n Assurance instrument complies with GAMP standard
Regulatory
IP54 rated design n Robust and easy to clean
Compliance to 21 CFR Part 11 n Meets regulatory requirements
Electronic records and electronic signature n Requirement for electronical batch documentation
Automated data entry through barcode reader n Mitigates risks of manual entry errors of test parameters

(quality risk management)

Test repeat control feature
Data security and audit trail
Test parameters and records can be stored
electronically
Fade resistant printouts
n Ensures compliance with the work instructions (SOP)
n Mitigates risks of entry errors
n Improves ease of use
n Facilitates the detection of unauthorized record editing
n Ensures permanent records
n Ensures permanent records
Features and Benefits (Continued)

Features Benefits

Network Integration Possibility to connect to OPC-UA, Profibusu, n Faster and simplified integration to local network
and Automation DeviceNetu, ProfiNETu n Improved flexibility for remote connection

Lightweight Directory Access Protocol (LDAP) n Increased safety margins with lower risks in forgetting user ID

and password

USB and LAN networking connectivity n Connectivity ease of use for flash drives, printers and LAN networking

Secures Optimal Compliance to Data Integrity and 21 CFR Part 11 Requirements

Electronic Records and Electronic Signature (ERES) Features

The instrument has all features and requirements required

to be operated in accordance with 21 CFR Part 11 and other
guidelines like the Medicines and Healthcare Products
Regulatory Agency (MHRA) related to data integrity and
electronic signature safety.
Access management prevents uncontrolled access to
critical functions on the Palltronic Flowstar V integrity test
instrument.
Access management and password management allows
the electronic signing of test records. The Palltronic
Flowstar V integrity test instrument allows:
■ Configurable access control management (four access
levels – Super Administrator, Administrator, Supervisor,
and Operator)
■ Configurable password management

Audit Trail Features

The instrument captures all data needed for audit purposes,
facilitating the review process regardless of frequency, while
complying with all data integrity requirements issued by
the FDA, MHRA, and Pharmaceutical Inspection Cooperation
Scheme (PIC/S). This ease of review plays a major role for
regulated companies that are expected to regularly review
data with a direct impact on batch release and patient safety.
The Palltronic Flowstar V integrity test instrument fulfils The primary records of the Palltronic Flowstar V integrity
ALCOA PLUS principles which require that data be test instrument, including the test results, cannot be altered
attributable, legible, contemporaneous, original, accurate, after generation and storage. Only signatures and any
complete, consistent, enduring, and available. ALCOA has comments with the signature can be added. With this
served as a framework for guaranteeing data integrity and approach, the test result is a static record.
good documentation practice (GDP) by regulated industries. Finally, with the different data backup possibilities, including
In addition, the Palltronic Flowstar V integrity test instrument manual and automatic backup options, and the expanded
has an event audit trail which logs activities on the instrument data storage capacity on the instrument, the Palltronic
and a record audit trail which includes test program records, Flowstar V integrity test instrument ensures compliance
access management records, user records, date/time change with all data backup, retention and retrieval requirements.
records and configuration records.

2
State-of-the-Art Automation Protocols and Remote Control

Remote Operation and Data Logging Remote Printing

The Palltronic Flowstar V test instrument guarantees Palltronic Flowstar V integrity test instrument allows the
industry communication standards along the path to use of either an external printer connected directly to the
digitalization. It can be automated through several optional instrument via the USB port, or a network printer to which
interfaces, optimizing ease of use and reducing time and the data can be sent. The instrument is also capable of
costs. It provides: generating the printout as a file, using common data
■ An interface to a network (ethernet) to download results formats, such as PDF and/or XML.
for backup or archiving
■ Interfaces to SCADA/MES for remote control, transmission
of results and data collection (OPC UA)
■ Interfaces for control levels for other systems (ProfiBus,
DeviceNet, OPC UA)

Technical Specifications

Physical Dimensions n Weight: 10.5 kg (23.1 lb)

n Width x height x depth: 348 x 205 x 483 mm (13.7 x 8.1 x 19 in.)

Filter Tests n Forward flow test (FF)

n Bubble point test (BP)
n Combined forward flow / bubble point test (FF/BP)
n Water intrusion test (WIT)

Other Tests n Leak test (LT) (flow measurement based for volume < 50 L)
n Pressure decay test (PD) (leak test for volumes up to 200 L)

Function Tests n Self test

n Flow check test
n Network test
n Printer test

Other Functions n Test program transfer function

n Configuration export/import function
n Access management export/import function
n User list export/import function
n Test result export function
n Full back up function (including all above functions)

Operating System n Linuxu*

Data Capacity n Test program storage: > 500 programs

n Test result storage: > 10,000 tests
n Active user storage: > 250 users

Language Options ** n US English n French n Italian n Russian n Japanese

n English n German n Spanish n Portuguese n Chinese

Communication Ports n 1x CAN

n 1x ethernet port (RJ45)
n 2x USB (standard)
n 1x USB (under screen on the front panel)
n 1x custom printer interface

Automation Protocols n OPC-UA

n Industry standard Profibus, DeviceNet, and ProfiNET (via external USB modules)

Measuring Range n Forward flow test: 0.1 – 1,000 mL/min

n Water intrusion test: 0.03 – 50 mL/min water
n Bubble point test: 400 – 6,500 mbar (5.8 – 94.3 psi)

Accuracy n Forward flow test: ± 3% of measurement or ± 0.05 mL/min, whichever is greater

n Water intrusion test: ± 3% of measurement or ± 0.02 mL/min, whichever is greater
Resolution n Forward flow test 0.1 mL/min
n Water intrusion test 0.01 mL/min
n Bubble point test 50 mbar (0.7 psi)
n Pressure decay test: 1 mbar

3
Technical Specifications (Continued)

External Network Printer n Printer should be capable to handle the printer language PCL5e or PostScriptu

Calibration Limits n Flow measurement: ± 3% of measurement

n Pressure measurement: ± 30 mbar (10 bar full scale output, calibrated up to 7 bar)

Electrical Data n Voltage: automatically adjusted between 100 and 240 V AC

n Input frequency: 50 Hz / 60 Hz
n Power: typically 75 W, peak 150 W
n Fuse: 3.15 A, slow blow
n External vent valve: 24 V DC
n External pressure transducer: relative (to gauge) pressure measurement, 4 – 20 mA signal

Touch Screen
Size: 12.1 in. LCD (1280 x 800) n

Features: Stylus pen, capacitive touch, 30° adjustable angle, color, illuminated background,
n

adjustable contrast, enclosed multicolour LED strip

Pneumatic Specifications
Maximum gas supply pressure: 8,000 mbar (116 psi) n

Minimum gas supply: n

– Self test: 3,000 mbar (43.5 psi)

– Flow range 0.01 – 149 mL/min 1,000 mbar (14.5 psi) above test pressure
– Flow range 150 – 1,000 mL/min 2,000 mbar (29.0 psi) above test pressure
n Test pressure range: 50 to 6,500 mbar (0.7 to 94.3 psi)

Pneumatic Connections n 1x Staubliu IN male DN3

n 1x Staubli OUT female DN3
n 1x Staubli male DN 0.5
n 1x external vent
n 1x internal vent

Accessory Printer n Palltronic Flowstar printer accessory connected via custom printer interface
n Lifetime of the printout > 10 years depending on storage conditions
n Paper width: 112 mm (4.4 in.)
n Paper roll diameter: 50 mm (1.9 in.)

Peripherals n One digital out for external vent valve

n Power and control via CAN bus connector
n Automation connectivity to network via USB adapter box

Environmental Conditions n Splash proof: IP54***

n Operating temperature: +5 to +40 °C
n Storage temperature: -20 to +50 °C
n Humidity: 80% up to 31 °C, 50% at 40 °C
n Cleaning fluid compatibility – 70% /30% ethanol/water, 70% /30% isopropyl alcohol/water
n Altitudes up to 3,000 m**** (9,800 ft)

* The source code which falls under the GNU General Public License (GPL) is stored on the USB flash drive supplied with the instrument. ** Contact your local
Pall representative for other languages. *** To meet the full requirements of IP54, splash proof electrical connections to the instrument are necessary.
These are available as accessories; please contact your local Pall representatives for details. **** For altitudes higher than 2000 m, we recommend an on-site
calibration for best accuracy of measurement.

4
Ordering Information

Part Number Description

FFS05 Palltronic Flowstar V filter integrity tester

FFS-PRNT Palltronic Flowstar V accessory printer

FFS-BARCODE Palltronic Flowstar V barcode reader

FFS-AUTADAPTBUS Palltronic Flowstar V with automation adapter

(Profibus)

FFS-AUTADAPTDNET Palltronic Flowstar V with automation adapter

(DeviceNet)

FFS-AUTADAPTPNET Palltronic Flowstar V with automation adapter

(ProfiNET)

FFS-TC Palltronic Flowstar V protective transportation case

FFS-PRNTP Palltronic Flowstar V thermal printer paper rolls

FFS-PCEU Palltronic Flowstar V power cable EU

FFS-PCUK Palltronic Flowstar V power cable UK

FFS-PCUS Palltronic Flowstar V power cable US

Protect Your Equipment and Optimize
FFS-PCJP Palltronic Flowstar V power cable Japan
Productivity
FFS-PCCH Palltronic Flowstar V power cable Switzerland
Pall has over 70 years of experience in providing maintenance,
FFS-PCAUS Palltronic Flowstar V power cable Australia calibration and repair, ensuring seamless operation with
FFS-PCZH Palltronic Flowstar V power cable China minimal downtime and regulatory compliance throughout
the lifecycle of your critical equipment.
FFS-USB Palltronic Flowstar V USB stick
Our range of service packages keeps your equipment
FFS-PEN Palltronic Flowstar V touchscreen pen
protected and well maintained, and includes itemized
FFS-BHVALVE Palltronic Flowstar V external vent valve pay-as-you-go services, start-up care and training packages
and a variety of post-warranty service plans that include
priority response times, discounts for emergency repairs
and flexible payment options. Pall service plans provide
total peace of mind and worry-free support throughout
the coverage period.

Visit us on the Web at www.pall.com/biotech

Contact us at www.pall.com/contact

Corporate Headquarters Pall Corporation has offices and plants throughout the world. To locate the Pall office or distributor
Port Washington, NY, USA nearest you, visit www.pall.com/contact.

+1-800-717-7255 toll free (USA) The information provided in this literature was reviewed for accuracy at the time of publication.
+1-516-484-5400 phone Product data may be subject to change without notice. For current information, consult your local Pall
distributor or contact Pall directly.

European Headquarters Please contact Pall Corporation to verify that the product conforms to your national legislation and/or
Fribourg, Switzerland regional regulatory requirements for water and food contact use.
+41 (0)26 350 53 00 phone
© Copyright 2021, Pall Corporation. Pall, and Palltronic are trademarks of Pall Corporation.
 DeviceNet is a trademark of Odva, Inc. GAMP is a trademark of International Society for
Asia-Pacific Headquarters Pharmaceutical Engineering, Inc​. Linux is a registered trademark of Linus Torvalds in the United
Singapore States. Modbus Is a trademark of Modicon. PostScript is a trademark of Adobe Systems, Inc. Profibus
+65 6389 6500 phone and ProfiNet are trademarks of Profibus Nutzerorganisation E.v. Staubli is a trademark of Staubli
International AG. ® Indicates a trademark registered in the USA.

9/21, GN 21.10400 USD 3483