Speaker
Description
Due to the growing demands for medical device supplies in the world today, more effective, and efficient techniques for sterilization are currently being evaluated. Sterilization based on ionizing radiation is a widely used method globally for reducing disease-causing microorganisms in healthcare products. Currently, the Philippines is entering the market for radiation sterilization as the upgrading of its irradiation facilities to cater to commercial-scale demands is coming to completion. To aid in this endeavor, a case study on a locally produced intravenous fluid delivery system made up of distinct polymers (polyvinyl chloride, polypropylene, acrylonitrile butadiene styrene, polycarbonate) was conducted. The impact of ionizing radiations, gamma and electron beam, on the physicochemical (FT-IR, TGA, Tensile) and functional properties (JIS T 3211-2011) of the medical device at different absorbed doses were assessed. The result of the characterizations was used for the establishment of radiation sterilization dose (RSD) according to the ISO 11137-2:2013. Result indicated that at an absorbed dose of 15 kGy and 25 kGy, most properties were unaffected, except for the discoloration of some parts. Bioburden analyses showed an average of 0 colonies forming unit per gram; thus, 0 kGy verification dose was used for confirmation. Subsequent sterility tests were conducted to substantiate absorbed doses in the range of 15-25 kGy, which have the potential to serve as the RSD for the infusion set device.
