1. Building Automation with System 800xA

2. Building Automation with 800xA
Introduction and overview
Clean rooms
GMP relevant environment and process data
Engineering, operation and control
Arching and reporting
Validation services x

3. Life Sciences Industry: Clean Rooms Protect
The
Operator
The
Product
The
Environment

4. 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 reporting

5. 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

6. Floor Plan and Phases

7. 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 x

8. Needs of Clean Room Spaces
Air cleanliness control
Air flow control
Pressure control
Temperature control
Humidity control
Running security
Products:
Air handling units EU 2000
Air flow controllers
Blue duct
Laminar flows/units
Diffusors
Air locks
Incubators
Solutions:
HVAC four level concept
Building Automation with System 800xA
Heating / Cooling recovery with System 800xA

9. Clean Rooms from Class 100 to 100,000
CORRIDOR
PAL
MAL
STERILE CLASSIFIED ROOM
Air Locks
MAL
CORRIDOR

10. 4 Level Concept Level 1: Fresh Air Level 2: Recirculation Air
Level 3: Space Control Unit
Level 4: Air Distribution Filtration

11. Level 4: Air Distribution Filtration
Level 1: Fresh Air
Level 2: Recirculation Air
Level 3: Space Control Unit
EU 15

12. Level 4 + Level 3: Space Control Unit
Level 1: Fresh Air
Level 2: Recirculation Air P
EU 15

13. Level 3-4 + Level 2: Recirculation Air
Level 1: Fresh Air
EU-2000 P - P
EU 15

14. Level 2-4 + Level 1: Fresh Air
EU-2000
Extraction Air - P
EU 13
EU4
EU9 +
EU-2000 P - P
EU 15

15. 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

16. 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 x

17. 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

18. GMP - Buildings and Facilities Issues
Contamination
Micro-organisms
Dirt
Particles
Material Flow
Cross-contamination
Process/Product
Moisture
Temperature
Personnel Flow
Cross-contamination

19. 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

20. 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 x

21. 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
Engineering
Controllers and I/O
Local or remote I/O
Remote S900 I/O (Ex)
HART, Profibus PA/DP, FOUNDATION Fieldbus H1/HSE
IEC
Automation Libraries
Automation Network
PLCs /
Package Units

22. Building Automation and Management
Corporate
Utility
Manager
Quality
Director
Site
Utility
Manager
Site
Quality
Manager
Site
Plant
Operator
Plant
Air Handling Units
Chillers, ...

23. 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

24. 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 x

25. 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

26. Critical Data Recording System (CDRS)
Control,
Monitor,
Alarms
Read
on-line data
Intranet
Site/HQ
Air Handling
Units
...
HVAC
Building Zone Lighting Control
Lightening, Energy Mgmnt...
Energy
Management
System 800xA
Trace and Track,
Report,
Compliance
Records
Life
Safety
Weather/Hazard Signaling ...
HVAC smoke/heat sensors ...
Fire Detect
Security
Office
Security
History
Time Keeping
Utility
Clean Steam
Purified H2O
Vacuum
Hydrogen
...
Site/Corporate
Plant-Areas
Plant/Site

27. 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 values

28. 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 x

29. 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
PQ = Performance Qualification
EPC = Engineering, Procurement Construction companies

30. 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

31. Thank You!
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