ISO 13408-3:2006 specifies requirements for, and offers guidance on, equipment, processes, programmes 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.
Status: PublishedPublication date: 2006-09
Edition: 1Number of pages: 11
Technical Committee: ISO/TC 198 Sterilization of health care products
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