超临界二氧化碳技术用于医疗器械灭菌的探讨

Discussion on the Application of Supercritical Carbon Dioxide Technology for Sterilization of Medical Devices

传统的医疗器械灭菌工艺成熟,但其应用于新型材料的医疗器械灭菌时均有限制。随着环保关注的日益增加,广泛使用环氧乙烷灭菌受到各国环境保护行政机构的限制,探索医疗器械的新灭菌方式需求迫切。通过整理业界人员的探索性工作对超临界二氧化碳灭菌技术进行综述,依次介绍了超临界二氧化碳灭菌技术的学说、微生物灭活能力、材料影响研究、设备,并从良好生产质量规范的角度论述该技术应用于医疗器械工业的关注点与可能性。

Traditional medical device sterilization processes are mature, but there are constraints when using on medical devices by new materials. With increasing environmental concerns, using of ethylene oxide sterilization has been limited by global environmental protection administrations. Exploring new sterilization methods for medical devices is urgently needed. This paper reviews the supercritical carbon dioxide sterilization technology by arranging the exploratory work of industry researchers. In the paper, we introduce the theory of supercritical carbon dioxide sterilization technology, microbial inactivation ability, material influence research and sterilization equipment. Then we discuss the concerns and possibilities of the technology applied to the medical device industry basing on the good manufacturing practices.