医用一次性防护服微生物指标检验方法的研究与探讨

目的:尝试用薄膜过滤检查法对医用一次性防护服微生物指标中的菌落计数进行方法学验证,并用建立的新方法与平皿法进行对比.方法:根据《中华人民共和国药典》2015年版四部,通过3次独立的平行试验,分别计算各试验菌每次试验的回收率.结果:在对需氧菌总数、霉菌和酵母菌总数方法验证的3次独立平行试验中,供试品组的菌回收率均在50％...

Studies and Discussions on Microbial Limit Test for Disposible Medical Protective Clothing

Objective:To verify the method of bacterial count in disposable protective clothing by membrane filtration test,and to compare the new method with plate method.Methods:According to the fourth part of Chinese Pharmacopoeia 2015 version,through three independent parallel experiments,the recovery rate of each experiment was calculated.Results:The recoveries of aerobic bacteria,mould and yeast were all between 50%and 200%in 3 independent parallel tests,therefore,the method can be used to determine the total bacterial count of disposable protective clothing.The results showed that the qualified rate was 96.9%,and there was no significant difference between 32 batches of products.However,because of the large amount of samples collected by membrane filtration,and the medium is more sensitive,the bacteria count precision is higher.Conclusion:The method is suitable for the detection of microorganism index in disposable protective clothing,and it can ensure the accuracy and validity of the detection.