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Building Automation with System 800xA

Building Automation with System 800xA. Building Automation with 800xA. Introduction and overview Clean rooms GMP relevant environment and process data Engineering, operation and control Arching and reporting Validation services. Life Sciences Industry: Clean Rooms Protect. The Operator.

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Building Automation with System 800xA

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  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

  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

  8. Needs: 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 Needs of Clean Room Spaces Solutions: • HVAC four level concept • Building Automation with System 800xA • Heating / Cooling recovery with System 800xA

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

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

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

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

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

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

  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

  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

  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 61131-3 • Automation Libraries Automation Network PLCs / Package Units

  22. Building Automation and Management Corporate Utility Manager Quality Director Site Quality Manager Site Utility 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

  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 Intranet Site/HQ Read on-line data 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 History Security Office Security Time Keeping Utility Clean Steam Purified H2O Vacuum Hydrogen ... Site/Corporate Plant/Site Plant-Areas

  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

  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

  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! Please visit us at www.abb.com/LifeSciences

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