应用场景与概述/Brief Introduction：

肌注拿水机械肌注拿水是纯化水经萃取得到的，革兰氏阴性菌内毒物等目标均达到我们药典肌注拿水项下规程的地表水想要，能作营生物药业公司企业中种类单独肌注入人内口服药的溶液。肌注拿水机械具体具有肌注拿水准备、无限循环存贮、日常动态计算和新工艺抑制等具体组件。

性能/Characteristic：

◆全一键运行方式英文，处理人员管理误运行产生的种植伤害；Automatic operation mode, to prevent losses of wrong operation of production;◆部位主要采用316L原材料；Components in 316L texture◆带PLC设定的CIP產品；CIP products with PLC control◆记录表与保持刷洗的过程的产品参数与步聚；Record and save the parameters of the cleaning process and steps◆无法GMP规范要求的追朔到性与顾忌明性； Meet GMP requirements traceability and accountability◆集成化方案可以有效节约了办公空间；Integrated design can effectively save space◆保证生产制造和洁净的迅速的切换桌面；Implement production and clean fast switching◆巴氏清洁除菌，的洗涤更完全彻底；Babbitt disinfection sterilization, cleaning more thoroughly◆多效蒸溜机：裸机滤油器接触所有用半自动不锈钢焊接，按卫生情况级标准的，闸阀用快卡接触，坚决杜绝了打针纯净水的分批污染破坏；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◆纯水蒸气会出现器：PLC人与机器操作流程控制界面显示，可0-100%自动的调试至必须的产出量想要；The pure steam generator: PLC man-machine interface operation, can be 0-100% automatically adjust to the need of production requirements◆3D无方位设汁：打瘦脸针用水量系统化软件洁净车间压缩空气管道够满足GMP3D的标准，胶垫为PTPE/EPDM，pu气管阀级别重新安裝时为50度，配置的管道重新安裝设为0.5的道路倾斜度，设底点为产生点,同时以湍液状况配置分子运动的储存和输送管系统化软件，解决微海洋生物的出现；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◆全面的文件夹格式夹设备：①文件夹格式夹合适GMP要；②自行化调整设备可合适GAMP5；③3Q文件夹格式夹足够医药集团厂证实的需用。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◆合理配置电源管理方面直流变频泵借以气流输送和确定打针用热水。Equipped with high performance variable frequency pump used to transport and distribution of water for injection◆双板热交换器，在纯化水长期限不断循环具体步骤中做到放置冷却意义。Double plate heat exchanger in the purified water cooling effect in the process of long cycle◆肌内注射使用水进行贮罐先行选用开式贮罐首先其次离心式贮罐，够满足输送机泵地下水位需求，科学研究设置成罐里空气流速放置生物制品膜变成。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.◆通过80℃综上所述恒温重复方案，控制使用水系统微生物菌种学孳生和的污染。Adopts the design of above 80 ℃ heat circulation, prevent microorganism growth and pollution of water system◆增配通电的加熱（过热蒸汽加熱）吸过虑器。Equipped with electric heating, steam heating) breathing filter◆罐底冒水部位加设球形侧板以壮大采水底，必免涡流效应。Adding bottom outlet conical baffle to expand in the water, prevent eddy current◆贮罐接入使用分为氢气保护措施，维护制药业饮用水储放及分摊系统的负压，解决办法外部链接流入废弃物。Tank access using nitrogen protection, maintain positive pressure pharmaceutical water storage and distribution system, prevent the reverse flow of external contamination◆制药业使用水进行输料泵选择316L不锈钢304手工制造（浸水要素），电镜面抛光并钝化办理。Pharmaceutical water pump made of stainless steel (316 l) (wetted parts), electrolytic polishing and passivation treatment

三、整体新工艺具体流程