Published
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.
PUBLISHED
ISO 13408-3:2006
90.20
Standard under periodical review
Jul 15, 2026
Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
60.60 Standard published
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