标准编号：ISO 13408-3:2006
中文名称：保健产品的无菌处理 第3部分 冻干法
英文名称：Aseptic processing of health care products — Part 3: Lyophilization
发布日期：2006-09
标准范围
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 notaddress the physical/chemical objectives of a lyophilization process.
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