ISO 13408-2
Aseptic Processing of Health Care Products - Part 2: Filtration
inactive
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| Organization: | ISO |
| Publication Date: | 15 March 2003 |
| Status: | inactive |
| Page Count: | 18 |
| ICS Code (Sterilization and disinfection in general): | 11.080.01 |
scope:
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).
Document History
January 1, 2018
Aseptic processing of health care products - Part 2: Sterilizing filtration
This document 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...
ISO 13408-2
March 15, 2003
Aseptic Processing of Health Care Products - Part 2: Filtration
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...