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BS EN ISO 13408-2:2018

Current

Current

The latest, up-to-date edition.

Aseptic processing of health care products Sterilizing filtration

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

10-04-2018

€285.14
Excluding VAT

DocumentType
Standard
Pages
44
PublisherName
British Standards Institution
Status
Current
Supersedes

This document specifies requirements for sterilizing filtration as part of aseptic processing of health care products conducted in accordance with ISO13408‑1. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process.

This document 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).

This document is not applicable to high efficiency particulate air (HEPA) filters.

This document 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.

Standards Relationship
ISO 13408-2:2018 Identical
EN ISO 13408-2:2018 Identical

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