SS-EN-ISO-13408-2 Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)

SS-EN-ISO-13408-2 - 2018 EDITION - CURRENT
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ISO 13408-2:2018 specifies requirements for sterilizing filtration as part of aseptic processing of health care products conducted in accordance with ISO 13408-1. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process. ISO 13408-2:2018 is not applicable to removal of viruses. Sterilizing filtration is not applicable to fluids that intentionally contain particles larger than the pore size of the filter (e.g. bacterial whole-cell vaccines). ISO 13408-2:2018 is not applicable to high efficiency particulate air (HEPA) filters. ISO 13408-2:2018 does not specify requirements for the development, validation and routine control of a process for removing the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.

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Designation Name

SS-EN ISO 13408-2:2018

Revision Level

2018 EDITION

Status

Current

Publication Date

March 26, 2018

Language(s)

English

Page Count

56

International Equivalent

EN ISO 13408-2:2018(IDT); ISO 13408-2:2018(IDT)