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

Aseptic processing of health care products—Part 3: Lyophilization
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AAMI ANSI/AAMI/ISO 13408-3:2006/(R)2015

Aseptic processing of health care products—Part 3: Lyophilization

PUBLISH DATE 2015
AAMI ANSI/AAMI/ISO 13408-3:2006/(R)2015
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.
SDO AAMI: Assoc. for the Advancement of Medical Instrumentation
Document Number 13408-3
Publication Date July 1, 2015
Language en - English
Page Count 24
Revision Level
Supercedes
Committee
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