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ANSI/AAMI/ISO 13408-5:2006 (R2015)

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

Specifies requirements for, and offers guidance on, equipment, processes, programs and procedures for the control and validation of lyophilization as an aseptic process.

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Association for the Advancement of Medical Instrumentation [aami]

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