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EN ISO 13408-3:2011 Standard

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  Keywords:

#lyophilization #process #objectives #address #physical

  Directive

Active implantable medical devices Directive (90/385/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

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

  Purpose

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.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN 13824:2004"

Anyway is still possible use the "EN 13824:2004" until December 31st, 2011

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