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                医疗器械纯化水设备

                医疗器械纯化水设备

                 详情说明


                医疗器械纯化水设备标准规范:

                1.法规
                (1)中华人民共和国药品管理法实施条例
                (2)中华人民共和国药典(2010版)
                (3)药品生产质量管理规范(GMP) (2010版)

                2.参照标准
                (1)JB/T20093-2007制药机械行业标准
                (2)GB 9706.1-1995医用电气设备第一部分安全通用要求
                (3)JGJ71-90洁净室施工及验收规范
                (4)YYT_1244-2014_体外诊断试剂用水标准
                (5)JB/T 2932-1999水处理设备 技术条件
                (6)GB150钢制压力容器
                (7)NB/T47003.1—2009钢制焊接常压容器 
                (8)GB50236-98现场设备、工业管道焊接工程施工及验收规范     
                (9)GB/T 5226.1-96机械产品电气安全要求通用要求
                (10)GB-52261-2002 机械安全机械电气设备第一部分:通用技术条件


                纯化水指标:

                1.电导率 ≤2μS/cm ( 电阻率 ≥ 0.5 M Ω *CM)
                2.卫生学检查:微生物 10CFU/100ml 
                3.内毒素 0.25EU/ml


                医疗器械纯化水设备GMP认证要求:

                1.结构设计应简单、可靠、拆装简便。
                2.为便于拆装、更换、清洗零件,执行机构的设计尽量采用的标准化、通用化、系统化零部件。
                3.设备内外壁表面,要求光滑平整、无死角,容易清洗、灭菌。零件表面应做镀铬等表面处理,以耐腐蚀,防止生锈。设备外面避免用油漆,以防剥落。
                4.制备纯化水设备应采用低碳不锈钢或其他经验证不污染水质的材料。制备纯化水的设备应定期清洗,并对清洗效果验证。
                5.注射用水接触的材料是低碳不锈钢或其他经验证不对水质产生污染的 材料。制备注射用水的设备应定期清洗,并对清洗效果验证。
                6.纯化水储存周期不宜大于24小时,其储罐宜采用不锈钢材料或经验证无毒,耐腐蚀,不渗出污染离子的其他材料制作。保护其通气口应安装不脱落纤维的疏水性除菌滤器。储罐内壁应光滑,接管和焊缝不应有死角和沙眼。应采用不会形成滞水污染的显示液面、温度压力等参数的传感器。对储罐要定期清洗、消毒灭菌,并对清洗、灭菌效果验证。
                7.制药用水的输送
                1)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。
                2)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。
                3)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。
                8.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。


                医疗器械纯化水设备应用行业:

                药品、生物制剂、保健品、医疗器械、医用大输液、注射剂等行业。


                卫生级管道自动焊接纯化水设备医疗器械纯化水设备

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