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AAMI 13408-3
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AAMI 13408-3 6th Edition, January 1, 2006 Aseptic processing of health care products - Part 3: Lyophilization
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Description / Abstract:
This part of ISO 13408 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.