YHMOSSP111A辐照灭菌过程控制规范

每年至少一次；在产品不连续生产阶段，质量法规部负责在生产正式产品前应完成剂量审核。剂量审核按照ISO11137-2要求需完成生物负载实验、剂量实验及无菌实验。如剂量审核成功，则灭菌剂量持续有效。РРAfterthesterilizationdoseisestablished,inthecontinuousproductionphaseoftheРРproduct,theQualityandLawDepartmentshallorganizerepresentativeproductstobedosedevery3monthsforadoseaudit.ThefrequencyreductioncanbeaslowashalfaРРyear,butatleastonceayear.Inthediscontinuousproductionstageoftheproduct,theРРqualityregulationsdepartmentisresponsibleforcompletingthedoseauditbeforeproducingtheformalproduct.Thedoseauditshallcompletethebioburdentest,dosetestРРandsterilitytestinaccordancewiththerequirementsofISO11137-2.Ifthedoseauditissuccessful,thesterilizationdosewillcontinuetobeeffectiveРР产品族的保持ProductfamilyretentionРР质量法规部每年应对产品族进行审查，以确保产品族和代表产品族的产品持续有效。РР生产过程中，应对生产条件、生产工艺发生改变的产品及新产品应进行初始污染检测，确РР保代表产品的持续有效。