血气交换器(氧合器)无菌检查方法适用性研究  

Study on the Suitability of the Sterility Test Method for the Blood Gas Exchanger(Oxygenator)

作　　者：钟静[1] 杨立峰[1] 杨文润[1] ZHONG Jing;YANG Li-feng;YANG Wen-run(Guangdong Medical Devices Quality Surveillance and Test Institute,Guangdong Guangzhou 510663)

机构地区：[1]广东省医疗器械质量监督检验所,广东广州510663

出　　处：《中国医疗器械信息》2023年第9期20-22,70,共4页China Medical Device Information

基　　金：广东省药品监督管理局科技创新项目(项目名称:体外循环器械重点实验室项目研究,项目编号:2021ZDZ01);广东省重点领域研发计划项目(项目名称:ECMO相关体外循环设备临床前大动物安全性、有效性评价体系建设和规范制定,项目编号:2020B1111490002)。

摘　　要：目的:建立适宜的血气交换器(氧合器)无菌检查方法学。方法:血气交换器目前执行的行业标准为YY0604-2016《心肺转流系统血气交换器(氧合器)》,该标准5.1.1要求:血液通道应无菌和无热源;标准方法6.2.1无菌检查按GB/T14233.1-2005的规定进行试验,而GB/T14233.1-2005无菌检检测方法最终引用的标准是《中华人民共和国药典》,根据《中华人民共和国药典》(2020版)通则1101项下规定需对方法进行适用性验证,建立适合本产品的无菌检验方法。所以文章依据《中华人民共和国药典》(2020版)四部通则1101无菌检查法,通过对两种不同型号规格的氧合器采用薄膜过滤法进行方法适用性试验,采用一次性成品硫乙醇酸盐流体培养基作为厌氧菌和需氧菌的培养,一次性成品胰酪大豆胨液体培养基作为真菌和需氧菌的培养,并依据《中华人民共和国药典》(2020版)四部通则1101规定的6种菌株进行了方法适用性试验。结果:两种不同型号规格的血气交换器(氧合器)经pH7.0无菌氯化钠-蛋白胨缓冲液冲洗300mL/膜冲洗后,试验组均生长良好,与阳性对照组一致。结论:采用薄膜过滤法可用于血气交换器(氧合器)无菌检查。Objective:To establish an appropriate aseptic testing method of blood gas exchanger(oxygenator).Methods:The current industry standard for blood gas exchanger is YY0604-2016,Cardiopulmonary bypass systems-blood-gas exchangers(oxygenators),the standard 5.1.1 requirements:blood channels should be sterile and no heat source;Standard method 6.2.1 Sterility test shall be tested as specified in GB/T14233.1-2005,the final standard of GB/T14233.1-2005 aseptic test is the Pharmacopoeia of the People’s Republic of China,according to the applicability verification of the general rules 1101 of the Pharmacopoeia of the People’s Republic of China(2020 edition),establish a suitable sterility test method suitable for this product.Therefore in this paper according to the“Chinese Pharmacopoeia”(2020 edition)four general rules 1101 aseptic inspection method,through the two different specifications of oxygenator using film filter method,using disposable sulfate and liquid medium as anaerobic bacteria culture,disposable pancreatic cheese soybean liquid medium as the culture of fungi and aerobic bacteria,and according to the four general rules 1101 of the Pharmacopoeia of the People’s Republic of China Pharmacopoeia(2020 edition).Results:After the blood gas exchanger(oxygenator of two different models)were washed 300mL/membrane in pH7.0 sterile sodium chloride-protein buffer,the test group grew well,consistent with the positive control group.Conclusion:The membrane filtration method can be used for the sterilization of blood gas exchanger(oxygenator).

关 键 词：血气交换器(氧合器) 无菌检查 方法适用性 薄膜过滤法 

分 类 号：R187[医药卫生—流行病学]