DS DS/EN ISO 13408-3
DS DSEN SO 13408-3 2011-AUG-16 Aseptc processng of health care products - Part 3 Lyophlzaton
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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.