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
90.93
Standard confirmed
Jul 1, 2021
Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
60.60 Standard published