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cGMP Facilities, Also known as HVAC, Facilities maintained in clean…
cGMP Facilities
Design and Construction
General Requirements
1) Suitable size, construction and location to facilitate cleaning + maintenance
Primary space:
- Key equipment + operations
- High traffic of material + personnel
- Overcrowding can result in production errors
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Support space:
- Holds supporting operation/equipment
- Few to no personnel
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Floors
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Materials: PVC, Epoxy-Terrazzo
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Extra
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Services, pipework, ducting preferably within walls or above ceiling voids
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Ventilation, air filtration, air heating and cooling
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Considerations
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Design considerations
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Desired room conditions
(T, P, RH)
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Sanitation
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How it is achieved
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Programs
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Pest Control program
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Maintain facility condition, proper sanitation
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Containment
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Dust Collection System
Pharmaceutical dust
- Hazardous ingredients
- Explosive nature of particulates
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Cleanroom
A room with controlled temperature, relative humidity, pressure and airborne particles
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Types of classification:
- Federal Standard 209E
- ISO 14644 standard
- Pharmaceutical cleanroom
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