注射用水设备

用途与简介/Brief Introduction：

注射用水设备注射用水是纯化水经蒸馏所得，细菌内毒素等指标均符合中国药典注射用水项下规定的水质要求，可作为生物制药企业中各类直接注射入人体内药物的溶剂。注射用水设备主要包括注射用水制备、循环储存、动态分配和工艺控制等主要模块。

特点/Characteristic：

◆全自动操作方式，防止人员误操作带来的生产损失；

Automatic operation mode, to prevent losses of wrong operation of production;

◆部件采用316L材质；

Components in 316L texture

◆带PLC控制的CIP产品；

CIP products with PLC control

◆记录与保存清洗过程的参数与步骤；

Record and save the parameters of the cleaning process and steps

◆满足GMP要求的可追溯性与可说明性； 

Meet GMP requirements traceability and accountability

◆一体化设计可有效节省空间；

Integrated design can effectively save space

◆实现生产和清洁的快速切换；

Implement production and clean fast switching

◆巴氏消毒杀菌，清洗更彻底；

Babbitt disinfection sterilization, cleaning more thoroughly

◆多效蒸馏机：整机管路连接全部采用自动焊接，按卫生级标准，阀门采用快卡连接，杜绝了注射用水的二次污染；

Multi-effect distillation machine: the machine connection all adopt the automatic welding, according to the level of health

standard, the valve with fast connection, to eliminate the secondary pollution of water for injection

◆纯蒸汽发生器：PLC人机操作控制界面，可0-100%自动调节至需要的产量要求；

The pure steam generator: PLC man-machine interface operation, can be 0-100% automatically adjust to the need of production requirements

◆3D无死角设计：注射用水系统洁净管路满足GMP3D要求，胶垫为PTPE/EPDM，隔膜阀水平安装时为45度，循环管线安装设为0.5的坡度，设低点为排放点,并以湍液状态循环流动的贮存和输送系统，防止微生物的滋生；

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

◆完整的文件系统：①文件符合GMP要求；②自动化控制系统可符合GAMP5；③3Q文件满足制药厂验证的需要。

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

◆配备高性能变频泵用以输送和分配注射用水。

Equipped with high performance variable frequency pump used to transport and distribution of water for injection

◆双板换热器，在纯化水长时间循环过程中起到冷却作用。

Double plate heat exchanger in the purified water cooling effect in the process of long cycle

◆注射用水贮罐优先采用立式贮罐其次卧式贮罐，满足输送泵水位要求，科学设置罐内流速防止生物膜形成。

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.

◆采用80℃以上保温循环设计，防止用水系统微生物滋生和污染。

Adopts the design of above 80 ℃ heat circulation, prevent microorganism growth and pollution of water system

◆配备带电加热（蒸汽加热）呼吸过滤器。

Equipped with electric heating, steam heating) breathing filter

◆罐底出水口加设锥形挡板以扩大采水面，防止涡流。

Adding bottom outlet conical baffle to expand in the water, prevent eddy current

◆贮罐接入采用氮气保护，维持制药用水储存及分配系统正压，防止外部回流污染。

Tank access using nitrogen protection, maintain positive pressure pharmaceutical water storage and distribution system, prevent the reverse flow of external contamination

◆制药用水输送泵采用316L不锈钢制造（浸水部分），电抛光并钝化处理。

Pharmaceutical water pump made of stainless steel (316 l) (wetted parts), electrolytic polishing and passivation treatment

三、系统工艺流程图