ISO 13408-5:2006

Aseptic processing of health care products — Part 5: Sterilization in place

Aseptic processing of health care products — Part 5: Sterilization in place

Digital Document2021 edition2006Purchase Options

Referenced standards

ISO 11138ISO 11140ISO 13408-1ISO 13408-4ISO 14161
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ISO 13408-5:2006

Aseptic processing of health care products — Part 5: Sterilization in place

Aseptic processing of health care products — Part 5: Sterilization in place

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.

Edition2021
Published Date2021
Published ByInternational Standardization Organisation
Page Count1