Abstract
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).
General information
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Status: WithdrawnPublication date: 2003-03Stage: Withdrawal of International Standard [95.99]
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Edition: 1Number of pages: 11
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Technical Committee :ISO/TC 198ICS :11.080.01
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Life cycle
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Now
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Revised by
PublishedISO 13408-2:2018