UNLIMITED FREE ACCESS TO THE WORLD'S BEST IDEAS

close
Already an Engineering360 user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your Engineering360 Experience

close
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

ISO 13408-2

Aseptic processing of health care products - Part 2: Sterilizing filtration

active, Most Current
Buy Now
Organization: ISO
Publication Date: 1 January 2018
Status: active
Page Count: 42
ICS Code (Sterilization and disinfection in general): 11.080.01
scope:

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 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.

Document History

ISO 13408-2
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...
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...

References

Advertisement