DS/EN ISO 13408-3:2011
Aseptic processing of health care products - Part 3: Lyophilization

Standard No.

DS/EN ISO 13408-3:2011

Release Date

2011

Published By

Danish Standards Foundation

Latest

DS/EN ISO 13408-3:2011

Replace

DS/EN 13824:2005

Scope

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.

DS/EN ISO 13408-3:2011 history

• 2011 DS/EN ISO 13408-1:2011 Aseptic processing of health care products - Part 1: General requirements
• 0000 DS/EN 13824:2005