Radiosterilization of thermolabile material

A methodology for radiosterilizing thermolabile material for biomedical use was established in Cuba. The material is packed with double nylon wrapping, and then hermetically sealed in order to assure that there is a minimal amount of air inside. In order to establish the conditions for radiosterilization of the material, irradiation tests were conducted in batches of nylon for sterile-product packing and batches of surgical instruments. The total count of microorganisms prior to batch irradiation was always below 103 CFU per sample. The evaluations of the doses needed for sterilization were carried out with a program pack designed by our Laboratory. The optimum sterilization dose for the processed thermolabile material was 8 kGy with a security factor of 2. Using the irradiation methodology described in this paper, non-reusable plastic syringes, flasks and plates for different types of cellular structures were radiosterilized. The value of optimum sterilization dose proved to be efficient for all treated material; no contamination of any of the processed material was reported. (author)