ISO 13408-6:2005 Aseptic processing of health care products — Part 6: Isolator systems

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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.
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Status: Active ChangeNumber: 1 InternationalClassificationCodeOfStandards: 11.080.01 TechnicalCommittee: ISO/TC 198 ActivatedDate: 13.04.2021 PagesCount: 17 Language: en

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