Standard

NS-EN ISO 13408-3:2011

Sept 2011 Published

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Language English

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Abstract

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.

Document information

Standard from SN
Published: 1 September 2011
Edition: 1
Version: 1
Document type: NAT
ISBN:

ICS 11.080.01
National Committee CEN/TC 204

Legal references

EU law: 90/385/EEC, 93/42/EEC, 98/79/EC

Product Relations

Replaces: NS-EN 13824:2004
Adopted from: EN ISO 13408-3:2011 , 0

Product life cycle

Previous product

Withdrawn

NS-EN 13824:2004
Current product

Published

NS-EN ISO 13408-3:2011

NS-EN ISO 13408-3:2011

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