医用一次性防护服电子束辐照灭菌工艺研究  

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

作　　者：崔磊 郭丽莉 曹立安 康四清 尹玉吉 王宏伟 陈天宝 王贵超 CUI Lei;GUO Lili;CAO Lian;KANG Siqing;YIN Yuji;WANG Hongwei;CHEN Tianbao;WANG Guichao(China Isotope&Radiation Corporation,Beijing 100089,China;China Isotope&Radiation Association,Beijing 100089,China;Beijing Atom Hightech Jinhui Radiation Technology Application Co.,Ltd.,Beijing 102412,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]北京原子高科金辉辐射技术应用有限责任公司,北京102412 [4]苏州中核华东辐照有限公司,苏州215200

出　　处：《辐射研究与辐射工艺学报》2021年第1期71-80,共10页Journal of Radiation Research and Radiation Processing

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)资助。

摘　　要：新冠肺炎的暴发导致短期内医用一次性防护服的需求剧增。为缩短上市周期,国内大量医用一次性防护服产品从以前的环氧乙烷灭菌方式,改用更高效的电子束辐照灭菌。但是医用一次性防护服的性能有严格要求,使用该灭菌方式的工艺参数尚缺乏系统性的资料支撑。为保证医用一次性防护服电子束灭菌的有效性,对其工艺进行了研究。选取市面上典型的聚丙烯(PP)+聚乙烯(PE)覆膜材料的医用一次性防护服作为研究对象,参考《医用一次性防护服辐照灭菌应急规范(临时)》和《ISO 11137-2:2013医疗保健产品灭菌-辐射灭菌-第二部分:灭菌剂量的确定》,选取合适的方法建立对应的灭菌剂量,并对不同吸收剂量辐照灭菌后材料性能变化进行研究。依据相关参数,提出简易电子直线加速器辐照货物平均吸收剂量算法。结果表明:20.3 kGy和31.5 kGy的灭菌剂量可分别使产品达到10^-3和10^-6无菌保证水平(SAL)。经过25.0 kGy、30.0 kGy和35.0 kGy这几组吸收剂量辐照后产品的断裂伸长率、断裂强力、抗渗水性、过滤效率等性能符合国标要求。最后建立医用一次性防护服电子束辐照灭菌工艺。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.

关 键 词：辐照电子直线加速器 电子束 灭菌剂量 医用一次性防护服 

分 类 号：TL99[核科学技术—核技术及应用]