推荐回答(3个)
1、名称不同。纯水又称去离子水,是指以符合生活饮用水卫生标准的水为原水,可直接饮用的水,也可以称为纯净物(在化学上),在试验中使用较多,又因多是以蒸馏等方法制作,故又称蒸馏水。注射用水指符合中国药典注射用水项下规定的水。
2、制取工艺不同。纯化水工艺是指饮用水经蒸馏法、离子交换法、反渗透法或其他适宜方法制备得到的制药用水。在医疗方面主要的作用是医疗器械清洗、药剂的生产、试验用水等。纯化水通过电渗析器法、离子交换器法、反渗透法、蒸馏法及其他适当的加工方法,制得的密封于容器内,且不含任何添加物,无色透明,
3、微生物含量不同。注射用水与纯化水的主要区别是水中不含微生物和热原物质,是纯化水经蒸馏所得。一般情况下为了有效控制微生物污染且同时控制细菌内毒素的水平,纯化水、注射用水系统的设计和制造有两大特点:一是在系统中越来越多地采用消毒、灭菌设施;二是管路分配系统从传统的送水管路演变为循环管路。
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扩展资料
纯化水和制药用水宜采用易拆卸清洗、消毒的不锈钢泵输送。在需用压缩空气或氮气压送的纯化水和注射用水的场合,压缩空气和氮气须净化处理。
纯化水宜采用循环管路输送。管路设计应简洁,应避免盲管和死角。管路应采用不锈钢管或经验证无毒、耐腐蚀、不渗出污染离子的其他管材。阀门宜采用无死角的卫生级阀门,输送纯化水应标明流向。输送纯化水和注射用水的管道、输送泵应定期清洗、消毒灭菌,验证合格后方可投入使用。
压力容器的设计,须由有许可证的单位及合格人员承担,须按中华人民共和国国家标准《钢制压力容器》(GB150-80)及"压力容器安全技术监察规程"的有关规定办理。
净得瑞为您解答:
纯化水 注射用水
微生物 <100CFU/mL <10CFU/100mL
热原 - <0.25EU/mL
制备方式:
蒸馏、离子交换、反渗透或其它适当的方法
纯化水经蒸馏或超滤或其它适当的方法
使用保存:一般应临用前制备
>80℃保温
65℃循环保温
<4℃无菌状态存放,制备后12 小时内使用。
另外,医疗器械行业使用分析实验室用水时,其管理依据为《分析实验室用水用水规格和试验方法》(GB/T6682-2008)。体外诊断试剂的配制可使用I 级、II 级、III 级实验室用水。
纯化水是和注射用水的主要区别:
1、出水水质有差别,正常的情况下注射用水的水质要好很多,但是国内的多效蒸馏水机的技术大部到要求,其残夜排放能力相对较低,故水质单纯以电导率记录的化差别不大。用国外多效蒸馏水机如芬纳夸和斯蒂莫斯的化基本上注射用水能到1个电导率以下。
2、出水温度的差别,纯化水一般常温20度左右,注射用水在85度。
3、最重要的区别就是类毒素和热原质的区别。
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