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ANSI/AAMI/ISO 13408-2:2018

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

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 or to filtration of whole cell vaccines.

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Association for the Advancement of Medical Instrumentation [aami]

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