AAMI/ISO 13408-5:2006/(R)2015

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

standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization , 09/23/2008

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Full Description

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 document applies to processes where sterilizing agents are delivered to the internal surfaces of the equipment that can come in contact with the product. See more

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Product Details

Published:

09/23/2008

ISBN(s):

157020330X

ANSI:

ANSI Approved

Number of Pages:

31

Same As:

ISO 13408-5:2006