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ISO 13408-6

Aseptic processing of health care products — Part 6: Isolator systems

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Organization: ISO
Publication Date: 1 April 2021
Status: active
Page Count: 32
ICS Code (Sterilization and disinfection in general): 11.080.01
scope:

This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related to aseptic processing of health care products and processing of cell-based health care products.

This document does not specify requirements for restricted access barrier systems (RABS).

This document does not supersede or replace national regulatory requirements such as Good Manufacturing Practices (GMPs) and/or compendia requirements that pertain in particular to national or regional jurisdictions.

This document does not specify requirements for isolators used for sterility testing; however, some of the principles and information in this document could be applicable to this application.

This document does not define biosafety containment requirements.

Document History

ISO 13408-6
April 1, 2021
Aseptic processing of health care products — Part 6: Isolator systems
This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related...
March 15, 2013
Aseptic processing of health care products - Part 6: Isolator systems AMENDMENT 1
A description is not available for this item.
June 15, 2005
Aseptic processing of health care products - Part 6: Isolator systems
This part of ISO 13408 specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of...

References

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