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

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

Summary

This document 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. Annex 3

Technical characteristics

Publisher Association for the Advancement of Medical Instrumentation (AAMI)
Publication Date 01/01/2006
Confirmation Date 01/01/2015
Page Count 0
Themes Sterilization—Industrial
EAN ---
ISBN ---
Weight (in grams) ---
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