功能与介简/Brief Introduction：

填充水机械填充水是纯化水经水蒸气蒸馏所得的，疾病内毒性等因素均符合标准中华药典填充水项下規定的水质监测标准要求，需用营生物化工客户中各大随便填充入人休内治疗药物的萃取剂。填充水机械其其主要是指填充水备制、不断循环放置、动态信息确定和工艺技术管理等其其主要传感器。

特性/Characteristic：

◆全自動方法的方式，以避免职工误方法有的加工亏损资金；Automatic operation mode, to prevent losses of wrong operation of production;◆机械部件选取316L质材；Components in 316L texture◆带PLC调节的CIP物料；CIP products with PLC control◆见证与导出清理方式的参数表与方法；Record and save the parameters of the cleaning process and steps◆足够GMP规定的可溯源性与可说是明性； Meet GMP requirements traceability and accountability◆二合一化制定有无效节约位置；Integrated design can effectively save space◆保证 生产方式和卫生的迅速的修改；Implement production and clean fast switching◆巴氏空气消菌消毒，洗掉更齐全；Babbitt disinfection sterilization, cleaning more thoroughly◆多效萃取机：一整台机器的滤油器拼接全部用到自主熔接，按安全卫生级准则，阀体用到快卡拼接，解决了肌内注射自来水的四次弄脏；Multi-effect distillation machine: the machine connection all adopt the automatic welding, according to the level of healthstandard, the valve with fast connection, to eliminate the secondary pollution of water for injection◆纯蒸汽发生了器发生了器：PLC组排操作方法掌控菜单栏，可0-100%自行调试至可以的时产追求；The pure steam generator: PLC man-machine interface operation, can be 0-100% automatically adjust to the need of production requirements◆3D无㓟盲区设汁：注入纯净水设计整洁卸料管做到GMP3D的标准，胶垫为PTPE/EPDM，隔离膜阀含量布置时为90度，巡环输油管线布置设为0.5的坡度系数，设最低值为的排放点,后以湍液情形巡环流通的低温干燥和卸料设计，以免菌群工程的大量滋生；3 d design without dead Angle: clean water for injection system satisfies the requirement of GMP3D tube, rubber pad of PTPE/EPDM, when mounted horizontally is 45 degrees, the diaphragm valve loop pipeline installation set as 0.5 grade, set low emission points, and the turbulent fluid state circulating storage and conveying system, prevent microbes breeding◆完成的压缩zip资料调控系统化：①压缩zip资料包含GMP耍求；②手动化调控调控系统化可包含GAMP5；③3Q压缩zip资料满足了医药厂认可的要求。Complete the file system: (1) documents conform to GMP requirements; (2) automatic control system can meet GAMP5; (3) 3 q documents meet the needs of the pharmaceutical factory to verify◆购置高特性定频泵从而输送带和配资打瘦脸针用水量。Equipped with high performance variable frequency pump used to transport and distribution of water for injection◆双板板换器，在纯化水长时重复期间中实现加热功能。Double plate heat exchanger in the purified water cooling effect in the process of long cycle◆注射器用清水贮罐优先权选择双面贮罐一方面水平贮罐，做到输送带泵低水位的标准，有效安装罐中流体密度处理生物体膜导致。Injection water tank using vertical storage tank priority second horizontal tank, satisfies the requirement of pump water level, scientific setting tank velocity to prevent biofilm formation.◆采用了80℃上述保热循环往复的设计，放到拿水设备细小微生物技术孳生和影响。Adopts the design of above 80 ℃ heat circulation, prevent microorganism growth and pollution of water system◆增配导电连接预热（水蒸气预热）口呼吸过滤水器。Equipped with electric heating, steam heating) breathing filter◆罐底留水头加设扇形挡条以壮大采水中，以避免涡流效应。Adding bottom outlet conical baffle to expand in the water, prevent eddy current◆贮罐传输运用氦气守护，保护药业清水贮藏及管理装置压缩空气，处理外链流回空气污染。Tank access using nitrogen protection, maintain positive pressure pharmaceutical water storage and distribution system, prevent the reverse flow of external contamination◆化工使用水进行传送泵选择316L不锈钢圆管制造厂（浸水有些），电打磨抛光并钝化解决。Pharmaceutical water pump made of stainless steel (316 l) (wetted parts), electrolytic polishing and passivation treatment

三、整体技艺具体过程流程图