制药用水系统中主要微生物类型及控制措施

Types of Major Microorganisms in Pharmaceutical Water Systems and Control Measures

目的对制药用水中主要微生物类型及控制措施进行分析,为制药用水系统的有效控制提供指导。方法分析饮用水、纯化水、注射用水中主要微生物种类、丰度及其危害性,并探讨制药用水中微生物的控制措施。结果制药用水中主要微生物类型存在差异,洋葱伯克霍尔德菌复合体和皮氏罗尔斯顿菌是潜在的条件致病菌,可造成生物安全隐患。结论制药企业可通过建立各级水系统微生物数据库及常见微生物菌种库,应基于警戒限和行动限进行趋势分析,从而加强对水系统中微生物的控制。

OBJECTIVE To analyze the types and control measures of major microorganisms in pharmaceutical water systems,so as to provide guidance for effective control of pharmaceutical water systems.METHODS The main microbial species,abundance and harmfulness of drinking water,purified water and water for injection were reviewed,and the control measures on microorganisms in pharmaceutical water were discussed.RESULTS There were differences in the main microbial types in pharmaceutical water.Burkholderia cepacia complex and Ralstonia pickettii were conditioned pathogens in pharmaceutical water,thus causing certain biological safety hazards.CONCLUSION Pharmaceutical companies can strengthen the control of microorganisms in the water system by establishing microbial databases and common microbial strain banks at all levels.Trend analysis should to be conducted based on alert limits and action limits,so as to strengthen the control of microorganisms in the water system.