Specifies the general requirements for sterilization in place (SIP) applied to product contact surfaces of the equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control. This standard applies to processes where sterilizing agents are delivered to the internal surfaces of equipment that can come in contact with the product.
ANSI/AAMI/ISO 13408-5:2006 history
2006ANSI/AAMI/ISO 13408-5:2006 Aseptic Processing of health care products - Part 5: Sterilization in place