Abstract

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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.


General information 

  • Status
     : Published
    Publication date
     : 2021-04
  • Edition
     : 2
    Number of pages
     : 25
  • Technical Committee
     : ISO/TC 198 Sterilization of health care products
  • ICS
     :
    11.080.01 Sterilization and disinfection in general

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Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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