ANSI/AAMI/ISO 13408-3:2006/(R)2015
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ANSI/AAMI/ISO 13408-3:2006/(R)2015

Aseptic processing of health care products—Part 3: Lyophilization

Summary

This document specifies requirements for and offers guidance on equipment, processes, programs and procedures for the control and validation of lyophilization as an aseptic process. It does not address the physical/chemical objectives of a lyophilization process. 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
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ISBN ---
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