Effects of Ethylene Oxide Sterilization on 82

Abstract

Bioabsorbable devices are generally susceptible to some form of degradation or alteration of material properties in response to exposure to the terminal sterilization cycle. In addition to affecting the material strength, sterilization can also increase the rate of hydrolysis, both of which can impact clinical performance. The impact of sterilization on the material/device is unpredictable and must be empirically determined. This study examined the effects of ethylene oxide treatment on the material properties of LactoSorb 82:18 poly(l-lactic acid)-poly(glycolic acid) craniofacial plates. Compared with untreated control plates, there was no effect on the initial inherent viscosity (1.3 dL/g), the glass transition temperature (58°C), or on the flexural mechanical properties. Furthermore, there was no effect on the in vitro rate of hydrolysis and mechanical strength loss profile. This provides evidence that the ethylene oxide sterilization cycle is compatible with these copolymer plates and that such treatment should not affect the clinical performance.