| A new process for the generation and application of gaseous chlorine dioxide has been proven efficacious for sterilization. A chlorine dioxide sterilization system has been designed and patented that generates chlorine dioxide gas from two-percent chlorine gas and solid sodium chlorite at the point of use. With this system, a variety of spore carriers were exposed to gaseous chlorine dioxide resulting in rapid and complete inactivation. In the product and packaging systems studied, efficacy was demonstrated at low concentration, ambient temperature and at processing pressures ranging from deep vacuum to atmospheric. The automated sterilization system provided continuous, real-time chlorine dioxide concentration monitoring, assuring process reproducibility and documentation appropriate to support parametric product release. Residual chlorine dioxide was extremely low due to minimal absorption and rapid degassing. Recent studies have demonstrated that gaseous chlorine dioxide can be applied in non-traditional processes for the sterilization of isolation systems or other sealed enclosures under mild conditions and at atmospheric pressure. This dissertation is focused on the exploration and subsequent development of chlorine dioxide for use as a gaseous chemosterilizing agent. |
