| description abstract | This presents the influence of gamma irradiation on Pharmacopeia specifications, mechanical and flow parameters of polypropylene (PP) syringes. There has been significant progress in the terminal sterilization of single-use, disposable medical devices with gamma radiation sterilization due to the growing awareness of toxic residues during the ethylene oxide (EtO) sterilization. PP is a widely used polymer for the production of syringes because of its excellent mechanical and thermal properties and has expanded continuously over the last decade. Although 25 kGy was generally recommended for the gamma radiation sterilization of medical products, this radiation dose is high enough to produce substantial damage. Electron spin resonance (ESR) characteristics of irradiated syringes were also studied at normal (25 °C, 60% relative humidity) and accelerated (40 °C, 75% relative humidity) stability test conditions. It was found that the chemical and radiolytic changes and sterility assurance levels (SAL) after gamma radiation sterilization were different in PP syringes. It was shown that for two commercial syringes, E1 and E3, a SAL of 10−4 could be attained with only 10 kGy, with there being less detrimental radiation effects on E1. The differences in the radiosensitivity of the propylene syringes could be due to the different formulations and manufacturing processes. The results indicated that a commercial syringe, identified as E1 could be safely sterilized with gamma irradiation as the radicals decay over a period of days under normal conditions and quenched much faster under stability conditions. Furthermore, ESR technique could be used successfully in monitoring the radiosterilization of this material. Additionally, the confirmation and validation of the SAL doses which are below 25 kGy, will decrease the time and cost of the sterilization with less damaging effects of ionizing irradiation. | |
