Journal of Isotopes (Feb 2021)
Study on γ Radiation Sterilization Process of Disposable Medical Protective Clothing
Abstract
The novel coronavirus pneumonia (NCP/Coronavirus disease 2020, COVID-19) outbreak in the world. The requirement of disposable medical protective clothing has been increasing sharply. The sterilization process is an important part in the production of protective clothing. In order to resolve the residual harmful ethylene oxide to meet the relevant standards, usually, medical disposable protective clothing using ethylene oxide sterilization process requires at least 7 to 14 days. Gamma radiation is faster and more efficient disinfection and sterilization technology. Therefore, it is of great significance to study the irradiation sterilization technology of medical disposable protective clothing. In this study, two typical PET (polyethylene terephthalate) materials for disposable medical protective clothing were selected, one with PU (polyurethane) coating and one without PU coating. Combined with Emergency Specification for Irradiation Sterilization of Medical Disposable Protective Clothing (Provisional) and ISO 11137, The bioburden test was conducted on them respectively. On the basis of bioburden level results appropriate method was selected to establish sterilization dose for each sample. The sterilization dose was validated using BFT V-type gamma irradiation facility of Suzhou CNNC Huadong Radiation Co., Ltd. For the PU-coated protective clothing. Validation results show for sterility assurance level (SAL=10-6) the medical protective clothing with PU sterilization dose is 30.6 kGy and the medical protective clothing without PU coating sterilization dose is 30.8 kGy. The PET protective medical clothing samples were treated with 20.0 kGy, 30.0 kGy and 50.0 kGy radiation dose. After irradiation, the breaking strength did not change significantly, and it still complied with the requirements of the national standard GB 19082-2009. The results proved that the gamma irradiation sterilization process established for PET medical disposable protective clothing was effective and it could achieve a sterility assurance level (SAL=10-6). Finally, some suggestions on the application of irradiation sterilization of disposable protective clothing were put forward.
