摘要
目的医疗器械生产企业生产一次性使用耗材时需使用环氧乙烷灭菌柜进行灭菌处理,为保证产品产品质量,根据GMP要求必须对灭菌过程进行验证。该文介绍了环氧乙烷灭菌柜使用要求与技术参数,灭菌验证包括灭菌设备安装、运行和最终产品性能确认,各项确认试验的内容及方法。简述了灭菌验证流程及需要考虑的参数设置。
The medical device production enterprise production of disposable consumables required epoxy eth- ane sterilizing cabinet for sterilizing, to ensure product quality, according to the requirements of the GMP must be the sterilization process validation. This paper introduces requires the use of ethylene oxide sterilization cabinet and the technical parameters, including validation of sterilization equipment installation, operation and performance of the final products, confirm the content and method of the test. The need to set the parameters and the sterilization validation process.
出处
《生物医学工程学进展》
CAS
2014年第1期60-62,共3页
Progress in Biomedical Engineering
关键词
环氧乙烷
灭菌
灭菌验证
ethylene oxide , sterilization, sterilization validation
