ISO 13408-2:2003 Aseptic processing of health care products — Part 2: Filtration

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ISO 13408-2:2003 specifies requirements for sterilizing filtration as part of aseptic processing of health care products. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process, to be used for aseptic processing of health care products. ISO 13408-2:2003 is not applicable to removal of viruses. Sterilizing filtration is not applicable to fluids containing particles as effective ingredient larger than the pore size of a filter (e.g. bacterial whole-cell vaccines).
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Status: Active ChangeNumber: 1 InternationalClassificationCodeOfStandards: 11.080.01 TechnicalCommittee: ISO/TC 198 ActivatedDate: 09.01.2018 PagesCount: 11 Language: en

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