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Abstract
Medical polymers require sterilization and must be able to maintain material properties for a specified shelf life. Sterilization can be achieved by using gamma or e-beam exposure. In this study, accelerated aging tests of poly(ether-block-amide) (PEBA) copolymer samples is presented. PEBA copolymer samples with different polyether content that result in Shore hardness of 35D to 72D, were sterilized using e-beam radiation followed by accelerated aging at 55oC. E-beam sterilization effect on molecular weight and mechanical property has performed and analyzed. The average molecular weight significantly reduced as a result of ageing. The enlarged proportion of low molecular weight chains in the aged samples is consistent with the generation of degradation products produced by oxidative chain scission. Also E-beam materials have shown decreased tensile strength and elongation. Overall, this study demonstrated that the medical grade PEBA was significantly affected by radiation exposure over aging time, particularly at high irradiation doses. For medical use in case of radiation sterilization required, it is recommended to avoid Pebax material. If Pebax material must be in use for medical device, recommend to use alternate sterilization method such as Ethylene Oxide sterilization.
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Table 1.
Material and e-beam radiation dose information.
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