ISO 13408-5:2006 Preview
Aseptic processing of health care products -- Part 5: Sterilization in place
This standard was last reviewed and confirmed in 2015. Therefore this version remains current.
ISO 13408-5:2006 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.
ISO 13408-5:2006 applies to processes where sterilizing agents are delivered to the internal surfaces of equipment that can come in contact with the product.
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