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Full Description

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 selection, set up, validation and routine operation of a sterile-filtration process to be used for aseptic processing of health care products. This document does not apply to removal of mycoplasma or viruses by filtration nor to filtration of whole cell vaccines.
 

Document History

  1. AAMI/ISO 13408-2:2018

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

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  2. AAMI/ISO 13408-2:2003/(R)2013


    Aseptic processing of health care products - Part 2: Filtration

    • Historical Version