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]

Others Also Bought
Cleanrooms and associated controlled environments - Part 5: Operations
Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing ...
Aseptic processing of health care products - Part 1: General requirements
Document History
Included in Packages
This standard is not included in any packages.
Amendments & Corrections
We have no amendments or corrections for this standard.