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ISO 13408-3:2006

Aseptic processing of health care products — Part 3: Lyophilization

Publication date:   Sep 1, 2006

General information

90.20   Standard under periodical review   Jul 15, 2026

ISO

ISO/TC 198 Sterilization of health care products

International Standard

11.080.01   Sterilization and disinfection in general

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Scope

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.

Life cycle

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PUBLISHED
ISO 13408-3:2006
90.20 Standard under periodical review
Jul 15, 2026