clean area
- ECA GAMP5 Approach and Risk Management
- WHOGMP Quality assurance of pharmaceuticals volume 2
- Definition
- An area with defined environmental control of particulate and microbial contamination, constructed and used in such a way as to reduce the introduction, generation and retention of contaminants within the area. NOTE: The different degrees of environmental control are defined in the Supplementary Guidelines for the Manufacture of sterile medicinal products.
- Used For
- clean zone
- Related Term
- aseptic area
- clean contained area
- clean room
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