Abstract

ISO 13408-6:2005 specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products.

ISO 13408-6:2005 is focused on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials.

ISO 13408-6:2005 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain in particular to national or regional jurisdictions.


General information 

  • Status
     :  Withdrawn
    Publication date
     : 2005-06
  • Edition
     : 1
    Number of pages
     : 17
  • Technical Committee
     : ISO/TC 198 Sterilization of health care products
  • ICS
     :
    11.080.01 Sterilization and disinfection in general

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal:

3
Good Health and Well-being

Life cycle


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