Скачать презентацию ABB — 1 2005 Building Automation with Скачать презентацию ABB — 1 2005 Building Automation with

df2063e8fbe1c9ad856900d3eafa78f3.ppt

  • Количество слайдов: 31

© ABB - 1 2005 Building Automation with System 800 x. A © ABB - 1 2005 Building Automation with System 800 x. A

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

Life Sciences Industry: Clean Rooms Protect The Operator © ABB - 3 The Product Life Sciences Industry: Clean Rooms Protect The Operator © ABB - 3 The Product Environment

Life Sciences Building and Facilities n Room conditions are critical factors n n Packaging Life Sciences Building and Facilities n Room conditions are critical factors n n Packaging n n Drug production Storage System 800 x. A monitors and controls n n Room temperature n Humidity n Air pressure n Dust, particles, and microorganisms n n HVAC system … System 800 x. A benefits Reduce validation effort n © ABB - 4 n Allows reuse of engineering n Integrates electronic recording and reporting

Value Preposition n Growing demand for validated Building Automation System n Convergence of Industrial Value Preposition n Growing demand for validated Building Automation System n Convergence of Industrial and Building Automation n More efficiency using same technology/spare parts etc for n n n 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 © ABB - 5 n Secondary pharmaceutical manufacturing plants n Packaging plants

© ABB - 6 Floor Plan and Phases © ABB - 6 Floor Plan and Phases

Building Automation with 800 x. A Introduction and overview n Clean rooms n GMP Building Automation with 800 x. A Introduction and overview n Clean rooms n GMP relevant environment and process data n Engineering, operation and control n Arching and reporting (environmental and compliance reports) n © ABB - 7 n Validation services

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

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

4 Level Concept Level 1: Fresh Air n Level 2: Recirculation Air n Level 4 Level Concept Level 1: Fresh Air n Level 2: Recirculation Air n Level 3: Space Control Unit n © ABB - 10 n Level 4: Air Distribution Filtration

Level 4: Air Distribution Filtration n Level 1: Fresh Air n Level 2: Recirculation Level 4: Air Distribution Filtration n Level 1: Fresh Air n Level 2: Recirculation Air n Level 3: Space Control Unit © ABB - 11 EU 15

Level 4 + Level 3: Space Control Unit n Level 1: Fresh Air n Level 4 + Level 3: Space Control Unit n Level 1: Fresh Air n Level 2: Recirculation Air P © ABB - 12 EU 15

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

Level 2 -4 + Level 1: Fresh Air EU-2000 + EU-2000 EU 13 + Level 2 -4 + Level 1: Fresh Air EU-2000 + EU-2000 EU 13 + - + + - P Extraction Air EU 13 EU 9 - P EU-2000 P P © ABB - 14 EU 15 EU 9 EU 4

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

Building Automation with 800 x. A Introduction and overview n Clean rooms n GMP Building Automation with 800 x. A Introduction and overview n Clean rooms n GMP relevant environment and process data n Engineering, operation and control n Arching and reporting (environmental and compliance reports) n © ABB - 16 n Validation services

GMP - Buildings and Facilities n Suitable location n Suitable construction n Suitable size/layout GMP - Buildings and Facilities n Suitable location n Suitable construction n Suitable size/layout (to prevent cross-contamination) n Adequate HVAC n Adequate lighting n Maintainable © ABB - 17 n Cleanable Glossary: GMP: Good Manufacturing Practice

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

GMP Relevant Environment and Process Data Applications for Control and Monitoring of the Environment GMP Relevant Environment and Process Data Applications for Control and Monitoring of the Environment of GMP relevant data: Process Buildings Process Rooms / Production Suites n Environment Parameters n Utility Areas n Environment and Process Parameters © ABB - 19 n n • Monitoring and Display • Control including Building Automation Devices • Alarm and Event Handling • Comments (to be signed) • Archiving • Reporting

Building Automation with 800 x. A Introduction and overview n Clean rooms n GMP Building Automation with 800 x. A Introduction and overview n Clean rooms n GMP relevant environment and process data n Engineering, operation and control n FDA 21 CFR Part 11 Support n Arching and reporting (environmental and compliance reports) n © ABB - 20 n Validation services

Extending Automation Solutions n Workstations n Located in plant or offices n Online view Extending Automation Solutions n Workstations n Located in plant or offices n Online view on site plan n Zoom in to more details and floor plan n Real-time measurement of all sensors n Integrate package units n User Permissions, e. g. Automation Network n Supervise status at a glance n Operate and schedule PLCs / Package Units n Engineering n Controllers and I/O Local or remote I/O n Remote S 900 I/O (Ex) n © ABB - 21 n HART, Profibus PA/DP, FOUNDATION Fieldbus H 1/HSE n IEC 61131 -3 n Automation Libraries

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

800 x. A Library Concept © ABB - 23 Air Handler Control n. Air 800 x. A Library Concept © ABB - 23 Air Handler Control n. Air Handling Unit n Damper Control Device n Fan Duty Standby Device n Air Filter Monitor Device n. Room Monitoring n Temperature Monitor Device n Relative Humidity Device n Differential Pressure Device n Particle Monitor Device n. General Functions n Time Switch Device n Day, Week, Month n Energy Management Interface Device n Life Safety Interface Device n Fire Smoke Detection Interface Device n Access Control and Monitoring Interface Device n Emissions Control Analyzer Control Interface (LON/OPC) • AC 800 and PCDevice. Lib Control Modules Faceplate(s) • Graphic Objects

Building Automation with 800 x. A Introduction and overview n Clean rooms n GMP Building Automation with 800 x. A Introduction and overview n Clean rooms n GMP relevant environment and process data n Engineering, operation and control n FDA 21 CFR Part 11 Support n Arching and reporting (environmental and compliance reports) n © ABB - 24 n Validation services

System 800 x. A Information Management n Automated recording of e. g. n Temperatures System 800 x. A Information Management n Automated recording of e. g. n Temperatures n Concentration values and measurements n Operator actions n Collected information is electronically managed n Different views and reports on e. g. n n n 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 n © ABB - 25 n Shift, daily, weekly, monthly reports n Charts and statistics

Critical Data Recording System (CDRS) Control, Monitor, Alarms Air Handling Units. . . Read Critical Data Recording System (CDRS) Control, Monitor, Alarms Air Handling Units. . . Read on-line data Intranet Site/HQ HVAC Building Zone Lighting Control Lightening, Energy Mgmnt. . . Weather/Hazard Signaling. . . HVAC smoke/heat sensors. . . Security Office Energy Management Life Safety Fire Detect System 800 x. A Trace and Track, Report, Compliance Records Security History Time Keeping © ABB - 26 Clean Steam Purified H 2 O Vacuum Hydrogen. . . Utility Plant-Areas Plant/Site/Corporate

Examples: Standard Report Templates in Excel n Trip n n 20 pre-trip and 10 Examples: Standard Report Templates in Excel n Trip n n 20 pre-trip and 10 post-trip values with 10 seconds between values. Trend n n Shift - eight one hour values n Daily - one hour values per n n Hourly - one minute values Monthly - daily values Event n n One hour time span with filtering Snapshot © ABB - 27 n Standard - 20 signal values from the historian n Real-time - 20 current signal values

Building Automation with 800 x. A Introduction and overview n Clean rooms n GMP Building Automation with 800 x. A Introduction and overview n Clean rooms n GMP relevant environment and process data n Engineering, operation and control n FDA 21 CFR Part 11 Support n Arching and reporting (environmental and compliance reports) n © ABB - 28 n Validation services

Facility and Equipment Validation Options Full Validation Service – Management and Execution n Watchdog Facility and Equipment Validation Options Full Validation Service – Management and Execution n Watchdog Service – Independence and Assurance n Document Review Service – Low Cost Option n Consultancy – Risk Based Approach n Qualification including Performance Qualification n Training n © ABB - 29 n Validation Procedures

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

Thank You! © ABB - 31 Please visit us at www. abb. com/Life. Sciences Thank You! © ABB - 31 Please visit us at www. abb. com/Life. Sciences