的主要用途是什么与概况/Brief Introduction：

肌注用清水装备肌注用清水是纯化水经蒸溜所得额，大肠杆菌内内毒素等的指标均符合标准国内药典肌注用清水项下规范的水的硬度规范，可以作为谋生物医药公司企业中各大马上肌注入身休内口服药的有机溶剂。肌注用清水装备最具体的涉及肌注用清水配制、循环系统补充、新动态都分配好和施工工艺管理等最具体的版块。

优点和缺点/Characteristic：

◆全自動实操策略，以防止人误实操产生的研发损害；Automatic operation mode, to prevent losses of wrong operation of production;◆部位主要采用316L材料；Components in 316L texture◆带PLC有效控制的CIP好产品；CIP products with PLC control◆统计与留存进行维护清洁过程中的因素与步；Record and save the parameters of the cleaning process and steps◆考虑GMP标准要求的可产品追溯性与可聊明性； Meet GMP requirements traceability and accountability◆内置式化方案可以效节约开支位置；Integrated design can effectively save space◆实现目标产出和清扫的快速的修改；Implement production and clean fast switching◆巴氏空气消毒消菌，家电清洗更彻底删除文件；Babbitt disinfection sterilization, cleaning more thoroughly◆多效分馏机：整套装置管道连到所有用到系统自动焊接方法，按环保级原则，球阀用到快卡连到，遏制了注射器自来水的再次环境破坏；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◆纯蒸气发现器：PLC组队运行控住操作界面，可0-100%全自动调理至需要的销售量的要求；The pure steam generator: PLC man-machine interface operation, can be 0-100% automatically adjust to the need of production requirements◆3D无盲区设计制作：打使用水控制系统性洁净度内部管道拥有GMP3D必须，胶垫为PTPE/EPDM，隔阂阀水准进行安装使用时为50度，重复供水管进行安装使用设为0.5的道路倾斜度，设最低值为污染物点,同时以湍液的情形重复外流的储存和运送控制系统性，处理微生物培养基学的产生；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◆完好的文书名称控住软件系统：①文书名称契合GMP需求；②自主化控住控住软件系统可契合GAMP5；③3Q文书名称够满足生物饲料厂校验的必须要。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◆选用高耐磨性交流变频泵对其进行传送和安排皮下注射使用水进行。Equipped with high performance variable frequency pump used to transport and distribution of water for injection◆双板板换器，在纯化水长时光不断循环全过程中产生散热效果。Double plate heat exchanger in the purified water cooling effect in the process of long cycle◆注射器水贮罐原则通过双面贮罐前者臥式贮罐，充分满足运输泵液位特殊要求，学科软件设置罐体流动速度严防生物制品膜演变成。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.◆主要采用80℃上保溫巡环设计方案，避免清水机系统细菌工程形成和生态破坏。Adopts the design of above 80 ℃ heat circulation, prevent microorganism growth and pollution of water system◆选用通电的微波采暖器（蒸气微波采暖器）呼气过滤装置器。Equipped with electric heating, steam heating) breathing filter◆罐底水流口加设扇形隔板以提高采河面，避免 电磁。Adding bottom outlet conical baffle to expand in the water, prevent eddy current◆贮罐对接主要包括N2守护，达到制作药品拿水处理及配置机系统压缩空气，制止外部链接流回空气污染。Tank access using nitrogen protection, maintain positive pressure pharmaceutical water storage and distribution system, prevent the reverse flow of external contamination◆医药化工需要用水卸料泵应用316L不锈钢材质的制造出（浸水环节），电打磨抛光并钝化正确处理。Pharmaceutical water pump made of stainless steel (316 l) (wetted parts), electrolytic polishing and passivation treatment

三、软件系统加工过程流程步骤图