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 x

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

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

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

Floor Plan and Phases

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Building Automation and Management Corporate Utility Manager Quality Director Site Utility Manager Site Quality Manager Site Plant Operator Plant Air Handling Units 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

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

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

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

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

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

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

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

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