AAMI 13408-3

AAM 13408-3 2006-JAN-01 Aseptc processng of health care products - Part 3 Lyophlzaton

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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.

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  • AAMI 13408-5 : Aseptic processing of health care products - Part 5: Sterilization in place
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