Minimizing material damage using low temperature irradiation

Abstract

Scientific advancements in healthcare driven both by technological breakthroughs and an aging and increasingly obese population have lead to a changing medical device market. Complex products and devices are being developed to meet the demands of leading edge medical procedures.Specialized materials in these medical devices, including pharmaceuticals and biologics as well as exotic polymers present a challenge for radiation sterilization as many of these components cannot withstand conventional irradiation methods. The irradiation of materials at dry ice temperatures has emerged as a technique that can be used to decrease the radiation sensitivity of materials.The purpose of this study is to examine the effect of low temperature irradiation on a variety of polymer materials, and over a range of temperatures from 0°C down to −80°C. The effectiveness of microbial kill is also investigated under each of these conditions.The results of the study show that the effect of low temperature irradiation is material dependent and can alter the balance between crosslinking and chain scission of the polymer. Low temperatures also increase the dose required to achieve an equivalent microbiological kill, therefore dose setting exercises must be performed under the environmental conditions of use.