This standard specifies requirements and provides guidance for the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems for the aseptic processing of healthcare products and the processing of cell-based healthcare products.
This standard does not specify requirements for restricted access barrier systems (RABS). This standard does not replace or replace national regulatory requirements such as Good Manufacturing Practices (GMPs) or, in particular, summary requirements for national or regional jurisdictions.
This standard does not specify requirements for isolators used for sterility testing; however, some of the principles and information in this document may apply to this application. This standard does not define biosafety containment requirements.
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