Aseptic processing of health care products -- Part 3: Lyophilization
This standard was last reviewed and confirmed* in 2016.
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.
Document published on: 2006-09 Edition: 1 (Monolingual) ICS: 11.080.01 Status: Published Stage: 90.93 (2016-01-27) TC/SC: ISO/TC 198 Number of Pages: 11
This standard has not been revised
No corrigenda or amendments available