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.
Keywords: good manufacturing practices; medical device; sterilization; supercritical carbon dioxide.