Building Automation

with System 800xA

© ABB - 1 -
2005
 Building Automation with 800xA

 Introduction and overview

 Clean rooms
 GMP relevant environment and
process data
 Engineering, operation and control
 Arching and reporting
 Validation services
© ABB - 2
 Life Sciences Industry: Clean Rooms Protect
The The The
Operator Product Environment
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 Life Sciences Building and Facilities
 Room conditions are critical factors
 Drug production
 Packaging
 Storage
 System 800xA monitors and controls
 HVAC system
 Room temperature
 Humidity
 Air pressure
 Dust, particles, and microorganisms
 …
 System 800xA benefits
 Reduce validation effort
 Allows reuse of engineering
 Integrates electronic recording and
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reporting
 Value Preposition
 Growing demand for validated
Building Automation System
 Convergence of Industrial and
Building Automation
 More efficiency using same
technology/spare parts etc for
 Process automation
 Building automation
 Integration of FDA relevant data
with the building automation
system, if the process automation
tasks do not justify investments for
DCS or PLC type automation
 Secondary pharmaceutical
manufacturing plants
 Packaging plants
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 Floor Plan and Phases
© ABB - 6
 Building Automation with 800xA

 Introduction and overview

 Clean rooms
 GMP relevant environment and
process data
 Engineering, operation and control
 Arching and reporting (environmental
and compliance reports)
 Validation services
© ABB - 7
 Needs of Clean Room Spaces

Needs: Products:
 Air cleanliness control  Air handling units EU 2000
 Air flow control  Air flow controllers
 Pressure control  Blue duct
 Temperature control  Laminar flows/units
 Humidity control  Diffusors
 Running security  Air locks
 Incubators
Solutions:
 HVAC four level concept
 Building Automation with System 800xA
 Heating / Cooling recovery with System 800xA
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 Clean Rooms from Class 100 to 100,000

CORRIDOR
PAL MAL

STERILE
CLASSIFIED Air Locks
ROOM

MAL

CORRIDOR
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 4 Level Concept

 Level 1: Fresh Air

 Level 2: Recirculation Air

 Level 3: Space Control Unit

 Level 4: Air Distribution Filtration

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 Level 4: Air Distribution Filtration

 Level 1: Fresh Air

 Level 2: Recirculation Air

 Level 3: Space Control Unit

EU 15 EU 15
© ABB - 11
 Level 4 + Level 3: Space Control Unit

 Level 1: Fresh Air

 Level 2: Recirculation Air

P
EU 15 EU 15
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 Level 3-4 + Level 2: Recirculation Air

 Level 1: Fresh Air

P EU-2000 P

P
EU 15 EU 15
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 Level 2-4 + Level 1: Fresh Air

EU-2000
EU-2000 EU 13
+

+ + - +
-

EU9EU4
P
Extraction Air EU9 EU 13
-

P EU-2000 P

P
EU 15 EU 15
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 Building Automation with System 800xA
Conditions are continuously monitored:
 Alarms and Events indicate
 Predefined limits are exceeded
 Conditions are violated
 Alarms
 Automatically created
 Visible in all displays
 Single alarm and alarm group indication
 Graphic Display
 Example: Air Unit Ground Floor
 Schedule
 Weekly
 User Access Control
 Change Control
 Reporting
© ABB - 15
 Building Automation with 800xA

 Introduction and overview

 Clean rooms
 GMP relevant environment and
process data
 Engineering, operation and control
 Arching and reporting (environmental
and compliance reports)
 Validation services
© ABB - 16
 GMP - Buildings and Facilities

 Suitable location
 Suitable construction
 Suitable size/layout (to
prevent
cross-contamination)
 Adequate HVAC
 Adequate lighting
 Maintainable
 Cleanable
Glossary:
GMP: Good Manufacturing Practice
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 GMP - Buildings and Facilities Issues

Contamination Material Flow

Micro-organisms Cross-contamination
Dirt
Particles

Process/Product Personnel Flow

Moisture Cross-contamination
Temperature
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 GMP Relevant Environment and Process Data
Applications for Control and
Monitoring of the Environment of
GMP relevant data:

 Process Buildings
 Process Rooms / Production
Suites
 Environment Parameters
 Utility Areas
 Environment and Process
Parameters

• Monitoring and Display

• Control including
Building Automation
Devices
• Alarm and Event Handling
• Comments (to be signed)
• Archiving
• Reporting
© ABB - 19
 Building Automation with 800xA

 Introduction and overview

 Clean rooms
 GMP relevant environment and
process data
 Engineering, operation and control
 FDA 21 CFR Part 11 Support
 Arching and reporting (environmental
and compliance reports)
 Validation services
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 Extending Automation Solutions
 Workstations
 Located in plant or offices
 Online view on site plan
 Zoom in to more details and floor plan
 Real-time measurement of all sensors
 Integrate package units
 User Permissions, e.g.
 Supervise status at a glance
 Operate and schedule

Automation Network  Engineering

PLCs /  Controllers and I/O

Package Units  Local or remote I/O
 Remote S900 I/O (Ex)
 HART, Profibus PA/DP,
FOUNDATION Fieldbus H1/HSE
 IEC 61131-3
 Automation Libraries
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 Building Automation and Management
Corporate
Utility Quality
Manager Director

Site Site Site

Utility Quality
Manager Manager

Plant Plant
Operator

Air Handling Units

© ABB - 22

Chillers, ...
 800xA Library Concept
Air Handler Control
Air Handling Unit
 Damper Control Device
 Fan Control Device
 Fan Duty Standby Device
 Air Filter Monitor Device
Room Monitoring
 Temperature Monitor Device
 Relative Humidity Device
 Differential Pressure Device
 Particle Monitor Device
General Functions
 Time Switch Device
 Day, Week, Month
 Energy Management Interface Device
 Life Safety Interface Device
-
 Fire Smoke Detection Interface Device
 Access Control and Monitoring Interface
Device
 Emissions Control Analyzer Control
Interface (LON/OPC)

• AC 800 and PCDeviceLib

Control Modules
Faceplate(s)
• Graphic Objects
© ABB - 23
 Building Automation with 800xA

 Introduction and overview

 Clean rooms
 GMP relevant environment and
process data
 Engineering, operation and control
 FDA 21 CFR Part 11 Support
 Arching and reporting (environmental
and compliance reports)
 Validation services
© ABB - 24
 System 800xA Information Management
 Automated recording of e.g.
 Temperatures
 Concentration values and measurements
 Operator actions
 Collected information is electronically
managed
 Different views and reports on e.g.
 Building, environment and process data
 Tag, sensor, device and machine specific
signals, events and alarms
 Information management and web-
based reporting tools for:
 Environment reports
 Shift, daily, weekly, monthly reports
 Charts and statistics
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 Critical Data Recording System (CDRS)
Control,
Read Intranet
Monitor,
on-line data Site/HQ
Alarms
Air Handling
Units
... HVAC

Building Zone Lighting Control Energy

Lightening, Energy Mgmnt... Management
System 800xA
Weather/Hazard Signaling ... Life Trace and Track,
Safety
Report,
HVAC smoke/heat sensors ... Compliance
Fire Detect
Records
Security
Security
Office History
Time Keeping

Clean Steam Utility

Purified H2O
Vacuum
© ABB - 26

Hydrogen
... Plant-Areas Plant/Site Site/Corporate
 Examples: Standard Report Templates in Excel

 Trip
 20 pre-trip and 10 post-trip
values with 10 seconds between
values.
 Trend
 Hourly - one minute values
 Shift - eight one hour values
 Daily - one hour values per
 Monthly - daily values
 Event
 One hour time span with filtering
 Snapshot
 Standard - 20 signal values from
the historian
 Real-time - 20 current signal
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values
 Building Automation with 800xA

 Introduction and overview

 Clean rooms
 GMP relevant environment and
process data
 Engineering, operation and control
 FDA 21 CFR Part 11 Support
 Arching and reporting (environmental
and compliance reports)
 Validation services
© ABB - 28
 Facility and Equipment Validation Options

 Full Validation Service – Management and Execution

 Watchdog Service – Independence and Assurance
 Document Review Service – Low Cost Option
 Consultancy – Risk Based Approach
 Qualification including Performance Qualification
 Training
 Validation Procedures
© ABB - 29
 Customer Benefits

 Achievement of product quality and safety in the

manufacturing process
 Meeting of GMP, validation and FDA 21 CFR Part 11
requirements
 Coupling of manufacturing and building automation
allows integrated reporting and reporting
 Reduces validation effort
 Reduces costs of compliance
 Our customers find the partner who
 is committed to open systems, and can integrate it
 with the Manufacturing Executions System for secondary
pharmaceutical production
 with control systems in the primary / bulk production area
 has worldwide support capabilities
© ABB - 30
 Thank You!

Please visit us at
www.abb.com/LifeSciences
© ABB - 31