Emission characteristics of plastic syringes sterilized with ethylene oxide--a controlled study.

Abstract

This study examined the emission characteristics of ethylene oxide (EO)-sterilized syringes under various environmental conditions, aiming to develop control strategies to minimize worker exposure. Experiments were performed in a facility in which temperature, relative humidity (RH), and air change rate (ACR) were controlled. Analytical results indicate that the main effects of the four test variables on kinetic parameters were statistically significant (p < 0.05), except for the effect of the product on the decay rate constant, the effect of ACR on maximum EO concentration, and effect of RH on the area under the curve-days 1 and 2. The interactive effects among test variables were also evident, indicating complex emission behaviors. The mean EO emission factors during the days 1 and 2 and at the 48th hour for the 1- and 30-ml products were 2302, 1301, and 1031 mg/m(3)/h, and 871, 490, and 381 mg/m(3)/h, respectively. The times required for air EO concentrations from tested products to return to approximately 0 and 1 ppm (permissible limit) were 417 and 218 h, respectively. Plastic content, temperature, RH, and ACR affected EO emissions. ACR is an achievable means of control; however, the aeration area/system should be isolated to ensure adequate ventilation is achieved.