Objective:To study the differences between the direct inoculation method and the membrane filtration method of the sterility inspection method of aseptic medical devices.Methods:By washing the inner cavity of the unsterilised syringes with an elution solution and then preparing a test solution for membrane filtration in a single unit,and then dividing the syringes with microorganisms removed into two groups for sterility testing according to the direct inoculation method 1(the product is disassembled and put into the culture medium)and the direct inoculation method 2(the culture medium is injected directly into the inner lumen of the product).Results:The positive detection rates of the sterility testing of the samples using the direct inoculation method 1,the direct inoculation method 2,and the membrane filtration method are 68%,8%,and 0%,respectively.Conclusion:In the aseptic examination of medical device products,as long as the conditions of the test material allow,the direct inoculation method should be preferred to put all the samples into the culture medium after disassembling;when the test material itself is not suitable for all the inoculation into the culture medium or only require the product to be sterile in the inner cavity,considering the culture medium to be infused into the inner cavity of the product;if the above is not applicable,then consider the use of extractive solution to elute microorganisms from the product and prepare the test liquid into the test solution after membrane filtration.
关键词
无菌医疗器械/无菌检查/直接接种法/薄膜过滤法
Key words
sterile medical devices/sterility check/direct inoculation method/membrane filtration method
维普
万方数据