ISO 13408-3:2006 Preview
Aseptic processing of health care products -- Part 3: Lyophilization
This standard was last reviewed and confirmed in 2016. Therefore this version remains current.
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.