标准编号：ISO 13408-1:2023
中文名称：医疗保健产品的无菌处理 第1部分：一般要求
英文名称：Aseptic processing of health care products — Part 1: General requirements
发布日期：2023-08
标准范围
This document specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of aseptic processing of health care products. This document includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to sterilizing filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in the other parts of the ISO 13408 series.
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