CEN - EN ISO 13408-3
Aseptic processing of health care products - Part 3: Lyophilization
|Publication Date:||1 June 2011|
|ICS Code (Sterilization and disinfection in general):||11.080.01|
This part of ISO 13408 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.