ISO-13408-3 Aseptic processing of health care products - Part 3: Lyophilization

ISO-13408-3 - 1ST EDITION - CURRENT


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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.

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11.080.01 (Sterilization and disinfection in general Including sterilization methods, air quality of surgery rooms, etc.)

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Document Number

ISO 13408-3:2006

Revision Level

1ST EDITION

Status

Current

Publication Date

Sept. 15, 2006

Committee Number

ISO/TC 198