Historical
ANSI/AAMI/ISO 13408-3:2006/(R)2012
Aseptic processing of health care products - Part 3: Lyophilization
Specifies requirements for, and offers guidance on, equipment, processes, programs 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.
Content Provider
Association for the Advancement of Medical Instrumentation [aami]