ISO-13408-6 Aseptic processing of health care products - Part 6: Isolator systems

ISO-13408-6 - 2ND EDITION - CURRENT -- See the following: ISO-13408-6-AM1
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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.

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Document Number

ISO 13408-6:2021

Revision Level

2ND EDITION

Status

Current

Publication Date

April 1, 2021

Committee Number

ISO/TC 198