SS-EN-ISO-13408-2 › Historical Revision Information
Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)

SS-EN-ISO-13408-2 - 2011 EDITION - SUPERSEDED
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This part of ISO 13408 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. This part of ISO 13408 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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Designation Name

SS-EN ISO 13408-2:2011

Revision Level

2011 EDITION

Status

Superseded

Publication Date

July 12, 2011

Language(s)

English

Page Count

28

International Equivalent

EN ISO 13408-2:2011(IDT); ISO 13408-2:2003(IDT)