Study on electron beam radiation sterilization process for disposable medical protective clothing

Abstract

The outbreak of COVID-19 has led to a sharp increase in the demand for disposable medical protective clothing in the short term. In order to shorten the marketing cycle, a large number of domestic disposable medical protective clothing products have been sterilized by electron beam irradiation, which is more efficient than ethylene oxide sterilization. However, the performance of such clothing must adhere to strict requirements and the process parameters of this sterilization method still lack systematic data support. In order to ensure the reliability of electron beam sterilization of disposable medical protective clothing, research on a corresponding process was carried out. Typical disposable medical protective clothing available on the market made of polypropylene (PP) and coated with polyethylene (PE) was selected as the material studied. An appropriate method was selected to establish the corresponding sterilization dose with reference to the standard methods—“Disposable medical protective clothing irradiation sterilization emergency specification (temporary)” and “ISO 11137-2:2013 Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose.” The change in material properties after irradiation sterilization with different absorbed doses was studied. Based on the obtained parameters, an algorithm for the average absorbed dose on irradiation by an irradiation electron linac was proposed. Results showed that absorbed doses of 20.3 kGy and 31.5 kGy allowed the products to achieve sterility assurance levels of 10-3 and 10-6, respectively. The material performance of the products after irradiation at 25.0 kGy, 30.0 kGy and 35.0 kGy were able to meet national standard requirements such as elongation at break, breaking strength, impermeability, and filtration efficiency. Thus, a satisfactory electron beam irradiation sterilization process for medical disposable protective clothing has been established.

Keywords

• irradiation electron linac
• electron beam
• sterilization dose
• disposable medical protective clothing