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The design of facilities used in the manufacturing of dietary supplements must meet strict requirements for preventing mix-ups and cross contamination. This presentation describes how this can be done.
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InstantGMP Compliance Seriesfor cGMP Dietary Supplements
Facility Design
Electronic cGMP Manufacturing Execution System
Facility Design Principles
• Design should focus on meeting future production needs
• Storage areas should be optimized for flow, cleanliness and prevention of cross-contamination
• All areas should be labeled for intended use
• Design of walls, floors, ceilings, ledges, drains, air supply, should prevent build-up of dirt and dust to avoid unnecessary risks of contamination
Electronic cGMP Manufacturing Execution System
Premises Considerations
• Location
• Design
• Construction
• Adaptation
• Maintenance
Electronic cGMP Manufacturing Execution System
Location
• Geography, climate, noise and economic factors
• Neighbours– What do they do?– What impact can they have on
the business?
• Pollution/effluent control• Minimize risk for contamination of products
Electronic cGMP Manufacturing Execution System
Layout and Design
• Minimize risks of errors
• Permit effective cleaning
• Permit effective maintenance
• Avoid cross-contamination, build-up of dirt and dust
• Avoid any adverse effect on the quality of products
Electronic cGMP Manufacturing Execution System
Facility Flow
• Process flow – ensure the sequence of production events prevents cross-contamination
• Material flow – ensures routing of materials through plant does not promote mix-ups or confusion about their status
• People flow – how people move around the plant should be planned to prevent crossing of critical activities or materials
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Small ScaleGMP Manufacturing Facility
Material flow
Electronic cGMP Manufacturing Execution System
Construction
• Suitable materials to ensure proper cleaning• Consistent, reliable electrical supply • Suitable lighting (especially for visual on-line
checks)• Temperature and relative humidity control• Appropriate and effective ventilation• All these may affect products during
manufacture or storage
Electronic cGMP Manufacturing Execution System
Walls, Floors, Ceilings
• Walls, floors, ceilings – smooth and easy to clean
• No ledges or areas where dust can accumulate
• Prevention of build-up of dirt and dust to avoid unnecessary risks of contamination
Electronic cGMP Manufacturing Execution System
Avoid Cross-Contamination
• Special precautions should be taken to prevent generation and dissemination of dust
• Proper air control – supply and extraction, suitable quality
• Prevent uncontrolled release of dust, gas, particles, vapours, sprays, organisms, residue, insects
Electronic cGMP Manufacturing Execution System
Ventilation systems and airlocks
• Appropriately designed ventilation system with air supply and extraction systems
• Supply or incoming air should be filtered• Recirculation of air versus 100% fresh air supply• Proper airflow patterns • Pressure differentials • Appropriately designed airlocks
Electronic cGMP Manufacturing Execution System
Closed processing systems
• For example: totally enclosed water purification systems
• Tanks fitted with appropriate filtration - without removable lids
• Clean-in-place (CIP) systems
InstantGMP Room Log
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Room Log
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Room Log
InstantGMP™
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