Customer Service:
Mon - Fri: 8:30 am - 6 pm EST

 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.
ANSI Logo

As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.

CUSTOMER SERVICE
NEW YORK OFFICE
ANSI HEADQUARTERS