International standard
Aseptic processing of health care products — Part 3: Lyophilization
Published Sep 1, 2006
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.
Contains information from ISO Open Data (https://www.iso.org/open-data.html), made available under the ODC Attribution License (ODC-By) v1.0.