Historical

ANSI/AAMI/ISO 13408-3:2006/(R)2012

Aseptic processing of health care products - Part 3: Lyophilization

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.

CONTENT PROVIDER
Association for the Advancement of Medical Instrumentation [aami]

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