生物制药用原水的质量控制研究  

Study on Quality Control of Raw Water for Biopharmaceutical Use

作　　者：郭心怡 张学成 何宗文 林燕 刘小勇 王猛 张宝献 GUO Xinyi;ZHANG Xuecheng;HE Zongwen;LIN Yan;LIU Xiaoyong;WANG Meng;ZHANG Baoxian(Hualan Biologogical Engineering Chongqing Co.,Ltd.,Chongqing 408100,China)

机构地区：[1]华兰生物工程重庆有限公司,重庆408100

出　　处：《生物化工》2024年第3期79-84,共6页Biological Chemical Engineering

摘　　要：目的:对长江水源和红星水库水源进行为期14个月质量指标检测,并对其监测数据进行对比分析,为生物制药用水质量控制提供理论依据。方法:对两种水源的pH值、电导率、浑浊度、硬度、总有机碳、细菌内毒素、菌落总数等指标进行考察并进行了趋势分析。结果:通过14个月对长江水源和红星水库水源的各项质量指标检测,发现两种水源水受季节、环境因素等变化影响较大,但经过制水工艺处理后均能达到国家水质标准要求。结论:两种水源来源的原水的理化检测指标数据各有差异,企业需要根据实际情况避开不利因素进行合理用水,为药品用水安全提供质量保障。Objective:To detect the quality indexes of water sources from Yangtze River and Hongxing Reservoir for 14 months,and to compare and analyze the monitoring data,so as to provide safety basis for water quality control of biopharmaceutical.Methods:The pH value,conductivity,turbidity,hardness,total organic carbon,total number of colonies of the two water sources are investigated and the trend analysis is carried out.Results:After 14 months of the Yangtze River water source and Hongxing Reservoir water source quality index detection,it is found that the two water sources are greatly changed by seasonal changes,environmental factors and so on,but after water preparation process treatment,all of these can meet the national water quality standards.Conclusion:The physical and chemical test index data of raw water from two sources are different.Enterprises need to avoid adverse factors and rational water use according to the actual situation,so as to provide quality assurance for drug water safety.

关 键 词：制药用水 趋势分析 质量控制 检测指标 

分 类 号：X832[环境科学与工程—环境工程]