标准摘要
[中文适用范围]： ISO 13408 的这一部分规定了冻干作为无菌过程的控制和验证的设备、工艺、程序和程序的要求，并提供了指导。 它不涉及冻干过程的物理/化学目标。 [外文原描述]： 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.
英文名称Aseptic processing of health care products — Part 3: Lyophilization