Abstract
This chapter discusses sterilization of plastic medical devices by ϒ-irradiation. In the past, flexible, clear medical plastics PVC devices were generally sterilized by the use of ethylene oxide. For many manufacturers, ethylene oxide sterilization has become an environmental liability because of the gas involved in the process. Often, this leaves sterilization by gamma irradiation as the most favorable alternative. Exposure to gamma radiation has a negative effect on the appearance of flexible PVC. While physical properties and viscosity remain unchanged, immediately after sterilization the material tends to darken or yellow. Compound darkening is autocatalytic, and continues after irradiation during the typical shelf-life period between sterilization and product use. The chapter describes an investigation that aims at determining ways of improving the gamma stability of flexible PVC. The variables of interest were resin molecular weight, plasticizer loading, stabilizer type, and choice of antioxidant. By screening resins, plasticizers, stabilizers, lubricants, and antioxidants, a promising candidate formulation was identified and optimized by a statistically designed experiment, with hardness added as an additional variable.
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