药品检验机构对纯化水微生物监测的分析与探讨

Analysis and Discussion on Microbiological Monitoring of Purified Water by Drug Inspection Institutions

摘要: 目的：对药品检验机构的纯化水系统进行微生物监测，了解试验用水微生物情况。方法：在纯化水总出水口、总回水口和各使用点进行取样，按《中国药典2015年版•二部》纯化水项下微生物检测方法进行检测，连续3个月定期进行微生物监测。结果：纯化水总出水口和总回水口，微生物限度均符合规定；38个使用点，仅有9个使用点在13次检验中微生物限度符合规定。结论：纯化水的制备、储存和分配应能防止微生物的滋生和繁殖，为确保试验用水质量，保障各纯化水使用点均可使用，需全面控制纯化水微生物限度合格。

Abstract: Objective: Microbial monitoring of the purified water system of the drug inspection agency to un-derstand the microbes of the test water. Methods: Sampling was conducted at the main outlet, the main return outlet and each use point of the purified water, the test was conducted according to the microbial detection method under the purified water section of Pharmacopoeia of the People’s Republic of China 2015 Part II, and microbial monitoring was conducted regularly for 3 months. Results: The total outlet and total return outlet of purified water, microbiological limit are in line with the provisions; at 38 points of use, only 9 points of use are in compliance with the microbiological limit in 13 tests. Conclusion: The preparation, storage and distribution of purified water should be able to prevent the breeding and reproduction of microorganisms. In order to ensure the quality of test water and ensure that all points of use of purified water can be used, comprehensive control of purified water microorganism limits is required.