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.
AAMI 13408-2-2003 history
2008AAMI 13408-2-2003 Aseptic Processing of health care products - Part 2: Filtration