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ANSI/AAMI/ISO 13408-5-2006 (R2012)

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

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. NOTE SIP can be achieved by using steam or other gaseous or liquid sterilizing agents. Specific guidance on steam sterilization in place, which is the most common method used, is given in.1.2

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Association for the Advancement of Medical Instrumentation [aami]

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