open isolator systems
- Guideline or reference source
- FDASDP Sterile drug products produced by asceptic processing - CGMP
- Definition
- are designed to allow for the continuous or semi-continuous ingress and/or egress of materials during operations through one or more openings. Openings are engineered (e.g., using continuous overpressure) to exclude the entry of external contamination into the isolator.
- Broader Term
- isolator
- Related Term
- closed isolator systems
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