| 引用本文: | 李樱红,张林爽,李珏,郑小玲,王征南,王银环,陈君豪,洪亮,陶巧凤,陈欢.制药用水系统中主要微生物类型及控制措施[J].中国现代应用药学,2024,41(3):415-419. |
| LI Yinghong,ZHANG Linshuang,LI Jue,ZHENG Xiaoling,WANG Zhengnan,WANG Yinhuan,CHEN Junhao,HONG Liang,TAO Qiaofeng,CHEN Huan.Types of Major Microorganisms in Pharmaceutical Water Systems and Control Measures[J].Chin J Mod Appl Pharm(中国现代应用药学),2024,41(3):415-419. |
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| 制药用水系统中主要微生物类型及控制措施 |
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李樱红1, 张林爽1, 李珏1, 郑小玲1, 王征南1, 王银环1, 陈君豪1, 洪亮2, 陶巧凤1, 陈欢3
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1.浙江省食品药品检验研究院，NMPA微生物检测与预警重点实验室，浙江省药品接触材料质量控制研究重点实验室，杭州 310052;2.台州市药品检验研究院，浙江 台州 318000;3.杭州微数生物科技有限公司，杭州 311231
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| 摘要: |
| 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。 |
| 关键词: 制药用水 微生物 洋葱伯克霍尔德菌复合体 皮氏罗尔斯顿菌 控制措施 |
| DOI：10.13748/j.cnki.issn1007-7693.20221460 |
| 分类号:R927.1 |
| 基金项目:浙江省药品监督管理局科技计划项目(2021002) |
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| Types of Major Microorganisms in Pharmaceutical Water Systems and Control Measures |
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LI Yinghong1, ZHANG Linshuang1, LI Jue1, ZHENG Xiaoling1, WANG Zhengnan1, WANG Yinhuan1, CHEN Junhao1, HONG Liang2, TAO Qiaofeng1, CHEN Huan3
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1.Zhejiang Institute for Food and Drug Control, NMPA Key Laboratory for Testing and Warning of Pharmaceutical Microbiology, Key Laboratory of Drug Contacting Materials Quality Control of Zhejiang Province, Hangzhou 310052, China;2.Taizhou Institute for Drug Control, Taizhou 318000, China;3.Hangzhou Digital-Micro Biothch Co., Ltd., Hangzhou 311231, China
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| Abstract: |
| 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. |
| Key words: pharmaceutical water microbiology Burkholderia cepacia complex Ralstonia pickettii control measures |
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