Plasma Sterilization: Opportunities and Microbial Assessment Strategies in Medical Device Manufacturing

Non-thermal gas discharge plasmas have significant potential as novel sterilization/decontamination agents in medical device manufacturing, and such agents may well be accepted by regulatory agencies. A number of aspects of plasma technology are currently under active investigation by many institutions and companies in order to obtain a thorough understanding of plasma sterilization as an alternative to conventional sterilization methods for heat sensitive medical devices. This paper focuses on the use of plasmas in microbial inactivation in medical-device manufacturing, describing some of the opportunities and microbial assessment strategies, as well as a possible surrogate for assessing microbial inactivation by plasma.