一． 设备简介

1、 Equipment introduction

注射用水指符合《中国药典》注射用水项下规定的水。注射用水为蒸馏水或去离子经蒸馏所得的水，故又称重蒸馏水。为了有效控制微生物污染且同时控制内毒素的水平，纯化水、注射用水系统的设计和制造出现了两大特点：一是在系统中越来越多地采用消毒/灭菌设施；二是管路分配系统从传统的送水管路演变为循环管路。

Water for injection refers to the water that meets the requirements of water for injection in Chinese Pharmacopoeia. Water for injection is distilled water or deionized distilled water, so it is also weighed distilled water. In order to effectively control microbial contamination and the level of endotoxin at the same time, there are two characteristics in the design and manufacture of purified water and water for injection systems: one is that more and more disinfection / sterilization facilities are used in the system; the other is that more and more disinfection / sterilization facilities are used in the system; Second, the pipeline distribution system has evolved from the traditional water supply pipeline to the circulation pipeline.

注射用水的制备、贮存和分配应能防止微生物的滋生和污染。贮罐和输送管道所用材料应无毒、耐腐蚀。管道的设计和安装应避免死角、盲管。贮罐和管道要规定清洗、灭菌周期。注射用水贮罐的通气口应安装不脱落纤维的疏水性除菌滤器。注射用水的贮存可采用80℃以上保温、70℃以上保温循环或4℃以下存放。

The preparation, storage and distribution of water for injection should be able to prevent the breeding and pollution of microorganisms. The materials used for storage tanks and pipelines shall be non-toxic and corrosion resistant. The design and installation of pipeline shall avoid dead angle and blind pipe. The cleaning and sterilization cycle of storage tank and pipeline shall be specified. The vent of the water for injection tank should be equipped with a hydrophobic sterilizing filter without shedding fiber. Water for injection can be stored above 80 ℃, above 70 ℃ or below 4 ℃.

J9九游国际真人水务在满足用户用水标准的基础上，在设备系统中水箱均设有液位控制系统、水泵均设有压力保护装置、在线水质检测控制仪表、电气采用PLC可编程控制器，真正做到了无人职守，同时在工艺选材上采用推荐和客户要求的方法，使设备与其它同类产品相比较，具有更高的性价比和设备可靠性。

On the basis of meeting the user's water use standard, Hongjie water has set up liquid level control system in the water tank of the equipment system, pressure protection device in the water pump, online water quality detection and control instrument, and PLC programmable controller in the electrical system, so that no one is on duty. At the same time, the method of recommendation and customer requirements is adopted in the process of material selection, so that the equipment is compared with other similar products, It has higher cost performance and equipment reliability.

二． 设计标准及依据

2、 Design standard and basis

1. 根据用户提供的详细水质报告“量身定制”。

1. According to the detailed water quality report provided by the user, "customized".

2. 体外诊断试剂用纯化水《YY/T 1244-2014》

2. Purified water for in vitro diagnostic reagent YY / T 1244-2014

3. 水处理设备技术条件《JB/T 2932-1999》

3. Technical conditions of water treatment equipment JB / T 2932-1999

4. 反渗透水处理设备标准《CJ/T119-2000》

4. Standard for reverse osmosis water treatment equipment CJ / t119-2000

5. 制药机械行业标准《JB/T20093-2007》

5. Pharmaceutical machinery industry standard JB / t20093-2007

6. 流体输送用不锈钢焊接钢管《GB/T 12771-2008 》

6. Stainless steel welded steel pipe for fluid transportation GB / T 12771-2008

标准：微生物50CFU/100ml；TOC≤500ug/L；电导率≤1μS/cm ( 电阻率≥1.0MΩ*cm)

Standard: microorganism 50cfu / 100ml; TOC≤500ug/L； Conductivity ≤ 1 μ S / cm (resistivity ≥ 1.0m) Ω* cm)

三． 工艺流程

3、 Process flow

1、 原水－原水加压泵－多介质过滤器－活性炭过滤器－软水器－精密过滤器－级反渗透 －PH调节－中间水箱－级反渗透－中间水箱－中间水泵－EDI系统－纯化水箱－纯水泵－紫外线杀菌器－ 微孔过滤器－巴氏消毒—用水点

1. Raw water - raw water booster pump - multi media filter - activated carbon filter - water softener - precision filter - stage reverse osmosis - pH regulation - intermediate water tank - stage reverse osmosis - intermediate water tank - intermediate water pump - EDI system - purified water tank - pure water pump - ultraviolet sterilizer - microporous filter - pasteurization - water point

四． 设计特点

4、 Design features

1. 系统采用全自动控制(同时亦可采用手动控制），系统运行时可设定自动反洗、再生程序；

1. The system adopts full automatic control (manual control is also available), and automatic backwashing and regeneration procedures can be set during system operation;

2. 各单元接线均在工厂内完成，减少安装调试时间；

2. The wiring of each unit is completed in the factory to reduce the installation and debugging time;

3. 一级反渗透和二级反渗透设有回流管道，反渗透设备设有化学清洗装置和消毒装置；

3. The primary RO and secondary ro are equipped with return pipes, and the RO equipment is equipped with chemical cleaning device and disinfection device;

4. 管道分别采用304/316L材质；卫生和非卫生级设计；

4. The pipes are made of 304 / 316L materials; Hygienic and non hygienic design;

5. 超纯水的处理设备整个系统也都由全不锈钢材质组合而成，光滑平整、无死角，容易清洗灭菌，并能耐腐蚀，以防生锈。

5. The whole system of ultra pure water treatment equipment is also made of all stainless steel materials, which is smooth, flat, no dead angle, easy to clean and sterilize, and can resist corrosion to prevent rust.

6. 直接用自来水制成无菌超纯水，能完全替代蒸馏水及双蒸水。

6. The sterile ultrapure water made directly from tap water can completely replace distilled water and double distilled water.

7. 不锈钢管自动焊接、内窥检测；

7. Automatic welding and endoscopic detection of stainless steel tube;

8. 纯化水储水罐带呼吸过滤器，输送管道装有紫外线杀菌器和微孔过滤器，保证纯水符合卫生要求；

8. The purified water storage tank is equipped with breathing filter, and the transmission pipeline is equipped with ultraviolet sterilizer and microporous filter to ensure that the pure water meets the sanitary requirements;

9. 集成控制系统和集成仪表系统等，方便操作管理。

9. Integrated control system and instrument system to facilitate operation and management.

10. 具备在线监控定时打印和水质超标报警功能，为您的生产用水保驾护航。

10. It has the functions of on-line monitoring, regular printing and water quality exceeding standard alarm to protect your production water.