isolator
- Guideline or reference source
- FDASDP Sterile drug products produced by asceptic processing - CGMP
- Definition
- A decontaminated unit, supplied with Class 100 (ISO 5) or higher air quality, that provides uncompromised, continuous isolation of its interior from the external environment (e.g., surrounding cleanroom air and personnel).
- Narrower Term
- closed isolator systems
- open isolator systems
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