Low Temperature Sterilization Alternatives in the 1990's, 1993 Polymers, Laminations & Coatings Conference Proceedings

Philip M. Schneider

Sterilization of medical devices and device materials plays a major role in the delivery of modern healthcare services. The widespread use of plastics, specialized polymers and electronic components in the fabrication of these devices continues to increase as healthcare technology advances. Single use, thermally sensitive medical devices are generally sterilized in industrial facilities with either ionizing radiation or ethylene oxide (EO) gas. Healthcare institutions, on the other hand, have had to rely on EO as the only alternative for on-site sterilization of reusable, heat sensitive medical materials. Concerns for worker and patient safety, environmental awareness and lengthy processing times, however, led to intensified research during the 1980’s to identify new methods for low temperature sterilization. Several of these technologies, including vapor phase hydrogen peroxide, gas plasma, ozone and peracetic acid have either been commercialized or are in the process of commercialization. These new methods are examined with special emphasis on packaging material compatibility. Due to the inherent limitations of these new technologies as well as concurrent advances in EO emission control, none of these alternatives are viewed as a total replacement for EO.