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EVS-EN ISO 13408-3:2011
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Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
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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