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EVS-EN ISO 13408-3:2011

Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)

General information

Valid from 03.08.2011
Base Documents
ISO 13408-3:2006; EN ISO 13408-3:2011
Directives or regulations
None

Standard history

Status
Date
Type
Name
03.08.2011
Main
Main
EVS-EN 13824:2005
This part of ISO 13408 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.

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