标准号:ISO 13408-3-2006
中文标准名称:卫生保健产品的无菌工艺.第3部分:冻干法
英文标准名称:Aseptic processing of health care products - Part 3: Lyophilization
标准类型:C50
发布日期:1999/12/31 12:00:00
实施日期:1999/12/31 12:00:00
中国标准分类号:C50
国际标准分类号:11.080.01
引用标准:ISO 9001;ISO 13408-1;ISO 13408-4;ISO 13408-5
适用范围: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.