Abstract Preview

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

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