clean room
- Guideline or reference source
- ECA GAMP5 Approach and Risk Management
- FDASDP Sterile drug products produced by asceptic processing - CGMP
- Definition
- A room designed, maintained, and controlled to prevent particle and microbiological contamination of drug products. Such a room is assigned and reproducibly meets an appropriate air cleanliness classification.
- Related Term
- clean area
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