医用一次性防护服γ辐照灭菌工艺研究  

Study on γ Radiation Sterilization Processof Disposable Medical Protective Clothing

作　　者：崔磊 郭丽莉 尹玉吉 王宏伟 王贵超 顾俊 祝军 CUI Lei;GUO Lili;YIN Yuji;WANG Hongwei;WANG Guichao;GU Jun;ZHU Jun(China Isotope&Radiation Corporation,Beijing 100089,China;China Isotope&Radiation Association,Beijing 100089,China;Suzhou CNNC Huadong Radiation CO.,LTD,Suzhou 215200,China)

机构地区：[1]中国同辐股份有限公司,北京100089 [2]中国同位素与辐射行业协会,北京100089 [3]苏州中核华东辐照有限公司,江苏苏州215200

出　　处：《同位素》2021年第1期1-9,I0001,共10页Journal of Isotopes

基　　金：国家国防科技工业局核技术推广应用项目(科工二司[2020]343号):医用防护服材料辐照灭菌工艺标准研究。

摘　　要：2020年新型冠状病毒疫情在全世界爆发,在短期内需要大量一次性医用防护服,其中防护服的灭菌工艺是一个重要环节。医用一次性防护服若采用传统的环氧乙烷灭菌工艺需要至少7~14 d时间。γ辐照技术是一种可以对医用一次性防护服实施快速消毒灭菌的方法。因此,开展医用一次性防护服的辐照灭菌工艺研究有重要意义。选取两种典型的PET(聚对苯二甲酸乙二醇酯)材料的医用一次性防护服,一种有PU(聚氨酯)涂层,一种没有PU涂层。参考《医用一次性防护服辐照灭菌应急规范(临时)》和ISO 11137,分别进行生物负载实验。根据实验结果选择合适的方法建立灭菌剂量。使用苏州中核华东辐照有限公司BFTⅤ型γ辐照装置进行灭菌剂量验证。验证结果为满足无菌保证水平(SAL=10-6)的有PU涂层的防护服灭菌剂量为30.6 kGy,没有PU涂层的防护服灭菌剂量为30.8 kGy。对PET材料医用一次性防护服样品分别使用20.0 kGy、30.0 kGy和50.0 kGy的剂量辐照处理,材料断裂强力没有发生显著变化,且符合国家标准GB 19082-2009的相关要求。研究结果表明,对于以PET为主材的医用一次性防护服建立的γ辐照灭菌工艺有效,无菌保证水平为(SAL=10-6),同时对一次性防护服的辐照灭菌应用提出一些建议。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

关 键 词：辐照技术 医用一次性防护服 灭菌剂量 

分 类 号：TL99[核科学技术—核技术及应用]