一．    設(shè)備簡介

One Equipment introduction

注射用水指符合《中國藥典》注射用水項下規(guī)定的水。注射用水為蒸餾水或去離子經(jīng)蒸餾所得的水，故又稱重蒸餾水。為了有效控制微生物污染且同時控制內(nèi)毒素的水平，純化水、注射用水系統(tǒng)的設(shè)計和制造出現(xiàn)了兩大特點：一是在系統(tǒng)中越來越多地采用消毒/滅菌設(shè)施；二是管路分配系統(tǒng)從傳統(tǒng)的送水管路演變?yōu)檠h(huán)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.

注射用水的制備、貯存和分配應(yīng)能防止微生物的滋生和污染。貯罐和輸送管道所用材料應(yīng)無毒、耐腐蝕。管道的設(shè)計和安裝應(yīng)避免死角、盲管。貯罐和管道要規(guī)定清洗、滅菌周期。注射用水貯罐的通氣口應(yīng)安裝不脫落纖維的疏水性除菌濾器。注射用水的貯存可采用80℃以上保溫、70℃以上保溫循環(huán)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 ℃.

宏潔水務(wù)在滿足用戶用水標(biāo)準(zhǔn)的基礎(chǔ)上，在設(shè)備系統(tǒng)中水箱均設(shè)有液位控制系統(tǒng)、水泵均設(shè)有壓力保護(hù)裝置、在線水質(zhì)檢測控制儀表、電氣采用PLC可編程控制器，真正做到了無人職守，同時在工藝選材上采用推薦和客戶要求的方法，使設(shè)備與其它同類產(chǎn)品相比較，具有更高的性價比和設(shè)備可靠性。

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．    設(shè)計標(biāo)準(zhǔn)及依據(jù)

2 Design standard and basis

1. 根據(jù)用戶提供的詳細(xì)水質(zhì)報告“量身定制”。

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

2. 體外診斷試劑用純化水《YY/T 1244-2014》

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

3. 水處理設(shè)備技術(shù)條件《JB/T 2932-1999》

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

4. 反滲透水處理設(shè)備標(biāo)準(zhǔn)《CJ/T119-2000》

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

5. 制藥機(jī)械行業(yè)標(biāo)準(zhǔn)《JB/T20093-2007》

5. Pharmaceutical machinery industry standard JB / t20093-2007

6. 流體輸送用不銹鋼焊接鋼管《GB/T 12771-2008 》

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

標(biāo)準(zhǔn)：微生物50CFU/100ml；TOC≤500ug/L；電導(dǎo)率≤1μS/cm ( 電阻率≥1.0MΩ*cm)

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

三．    工藝流程

Three technological process

1、 原水－原水加壓泵－多介質(zhì)過濾器－活性炭過濾器－軟水器－精密過濾器－級反滲透 －PH調(diào)節(jié)－中間水箱－級反滲透－中間水箱－中間水泵－EDI系統(tǒng)－純化水箱－純水泵－紫外線殺菌器－ 微孔過濾器－巴氏消毒—用水點

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．    設(shè)計特點

Four Design features

1. 系統(tǒng)采用全自動控制(同時亦可采用手動控制），系統(tǒng)運行時可設(shè)定自動反洗、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. 各單元接線均在工廠內(nèi)完成，減少安裝調(diào)試時間；

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

3. 一級反滲透和二級反滲透設(shè)有回流管道，反滲透設(shè)備設(shè)有化學(xué)清洗裝置和消毒裝置；

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. 管道分別采用304/316L材質(zhì)；衛(wèi)生和非衛(wèi)生級設(shè)計；

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

5. 超純水的處理設(shè)備整個系統(tǒng)也都由全不銹鋼材質(zhì)組合而成，光滑平整、無死角，容易清洗滅菌，并能耐腐蝕，以防生銹。

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. 直接用自來水制成無菌超純水，能完全替代蒸餾水及雙蒸水。

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

7. 不銹鋼管自動焊接、內(nèi)窺檢測；

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

8. 純化水儲水罐帶呼吸過濾器，輸送管道裝有紫外線殺菌器和微孔過濾器，保證純水符合衛(wèi)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. 集成控制系統(tǒng)和集成儀表系統(tǒng)等，方便操作管理。

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

10. 具備在線監(jiān)控定時打印和水質(zhì)超標(biāo)報警功能，為您的生產(chǎn)用水保駕護(hù)航。

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