无菌医疗器械的无菌检查方式验证与分析  

Validation and Analysis of Sterility Inspection Methods for Sterile Medical Devices

作　　者：刘雯 李爱梅 胡海涛 LIU Wen;LI Aimei;HU Haitao(Shandong Weigao Group Medical Polymer Products Inc.,Weihai 264210,China)

机构地区：[1]山东威高集团医用高分子制品股份有限公司,山东威海264210

出　　处：《生物化工》2024年第4期138-141,共4页Biological Chemical Engineering

摘　　要：目的:研究无菌医疗器械无菌检查法中直接接种法和薄膜过滤法的差异性。方法:未灭菌的注射器用洗脱液涮洗内腔后以单支为单位制备供试液用于薄膜过滤,将已经移除过微生物的注射器分成两组,分别按照直接接种法1(产品拆解后投入培养基)和直接接种法2(将培养基直接灌注到产品内腔)进行无菌性检查。结果:直接接种法1、直接接种法2、薄膜过滤法进行无菌检查的阳性检出率分别为68%、8%、0%。结论:在对医疗器械产品进行无菌检查时,只要供试品条件允许,应首选将全部样品拆解后投入培养基的直接接种法;当供试品本身不适合全部接种到培养基或者只要求产品内腔无菌时,考虑将培养基灌注到产品内腔;若上述均不适用,再考虑用浸提液将微生物从产品上洗脱下来制备成供试液后使用薄膜过滤法检查。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 

分 类 号：R197.39[医药卫生—卫生事业管理]