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ANSI/AAMI/ISO 13408 – Aseptic Processing of Health Care Products Package
The ANSI/AAMI/ISO 13408 – Aseptic Processing of Health Care Products Package provides guidance and the requirements on processes, programs and procedures to develop, validate and control the manufacturing process of a aseptically-processed health care products. An alternative to terminal sterilization, asseptic processing enables the sterility of pre-sterilized components and products during assembly allowing the final product to be sterile in its final container (resulting in an terminally sterilized product). In addition to the general requirement, the ANSI/AAMI/ISO 13408 – Aseptic Processing of Health Care Products Package provides the various processes to attain a terminally sterilized product. The process include the filtration, lyophilization (drying process), clean-in-place technology (CIP), sterilization in place (SIP) and isolator system used to maintain aseptic conditions. The package includes:
ANSI/AAMI/ISO 13408-1:2023
ANSI/AAMI/ISO 13408-2:2018
ANSI/AAMI/ISO 13408-3:2006 (R2015)
ANSI/AAMI/ISO 13408-4-2005 (R2014)
ANSI/AAMI/ISO 13408-5-2006 (R2015)
ANSI/AAMI/ISO 13408-6:2005 (R2013)/A1:2013
ANSI/AAMI/ISO 13408-7:2012 (R2018)
ANSI/AAMI/ISO 13408 – Aseptic Processing of Health Care Products Package includes:
ANSI/AAMI/ISO 13408-1:2023
ANSI/AAMI/ISO 13408-2:2018
ANSI/AAMI/ISO 13408-3:2006 (R2015)
ANSI/AAMI/ISO 13408-4-2005 (R2014)
ANSI/AAMI/ISO 13408-5:2006 (R2015)
ANSI/AAMI/ISO 13408-6:2005 (R2013)/A1:2013
ANSI/AAMI/ISO 13408-7:2012 (R2018)
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