Standard: AAMI 13408-2

ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: FILTRATION

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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).

Organization: Association for the Advancement of Medical Instrumentation
Document Number: aami 13408-2
Publish Date: 2003-01-01
Page Count: 25
Change Type: REAF
Available Languages: EN
DOD Adopted: NO
ANSI Approved: YES
Most Recent Revision: YES
Current Version: YES
Status: Active

Document History

Document # Change Type Update Date Revision Status
AAMI 13408-2 Change Type: STCH Update Date: 2003-01-01 Revision: 03 Status: ACTV

This Standard References

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