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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.
Content Provider
Association for the Advancement of Medical Instrumentation [aami]