环氧乙烷灭菌再鉴定
栏目：灭菌确认
发布时间：2026-01-20
关于环氧乙烷灭菌再鉴定，按标准的要求“应每年评审安装鉴定、运行鉴定、性能鉴定和后续已完成的再鉴定,以确定必要的再鉴定范围”。
Requalification
IQ, OQ, PQ and subsequent requalification(s) shall be reviewed annually to determine the extent of requalification that is necessary. This shall include an assessment of the need to reconfirm the product SAL through microbiological studies. The outcome of this review, including the rationale for decisions reached, shall be documented.
应每年评审安装鉴定、运行鉴定、性能鉴定和后续已完成的再鉴定,以确定必要的再鉴定范围。应包括是否需要通过微生物研究重新确定产品无菌保证水平的评估。应记录评审结果,包括所做决定的理由。
