PW和WFI系统维护.doc

COMPANY STANDARD OPERATING PROCEDURE标准操作程序
C O N F I D E N T I A L保密文件

SUBJECT:
PW/WFI SYSTEM PREVENTIVE MAINTENANCE
Effective Date生效日:

SOP Number:SOP号
PM-01-0001
PW/WFI系统预维护
Page:
Page 11 of 15
Supersedes Date:更换日期
Dec.05, 2001

1. SCOPE
范围

1.1. To ensure correct maintenance of water preparation systems and continuous production of PW/WFI quality water.
保证水制备系统的正常维护，持续生产符合PW/WFI要求的水。

2. DEFINITIONS
定义

2.1. PW – USP Purified Water
PW–符合美国药典的纯水

2.2. WFI – USP Water for Injection
WFI–符合美国药典的注射用水

3. REFERENCES
参考
3.1. United States Pharmacopeia ， current revision
美国药典，当前版本

3.2 PW/WFI System Manual
PW/WFI系统使用手册

4. RESPONSIBILITY - Maintenance/Engineering， QA
职责–维护、工程、QA人员

5. ATTACHMENTS
附录

5.1. MF-01-0001-01: PW/WFI System Daily Maintenance Check
MF-01-0001-01: PW/WFI 系统日常维护检查

5.2. MF-01-0001-02: Maintenance Record of PW System
MF-01-0001-02: PW 系统维护记录

5.3. MF-01-0001-03: Maintenance Record of WFI System
MF-01-0001-03: WFI 系统维护记录

6. PROCEDURES
程序

6.1. Maintenance of Pumps
泵的维护

6.1.1. The radiator of the pump motor， the cover and the shaft of cooling fan shall be checked daily. Please replace when any damage occurs.
泵电机散热片，冷却风扇盖板和叶片应保持完整，如有损坏应立即更换。

6.1.2. The pump shall be cleaned daily.
泵应每日保持清洁。
6.1.3. The operation of motor bearing and shaft shall be checked by rob every day. Any abnormity shall be treated immediately.
泵的电机轴及轴承应每天用听棒检查运行声响，任何异常情况都应及时处理。

6.1.4. The oiling point shall be lubricated with high temperature grease once a year.
各加油点应定期（每年）补充高温润滑油脂。

6.2. Contamination and Cleaning of RO Film
反渗透膜的使用及清洗

6.2.1. First Use of RO Film:
新反渗透膜的初次使用

The RO Film is kept in sealed plastic bags with storage mixture of 1% sodium bisulflate and 20% hydroxy-pyruvate. The bags shall have no damage before it is opened in time of installation. The film shall be put into film tube as soon as it is opened and could be used after cleaning.
反渗透膜保存在密封的塑料袋中，袋内为1%亚硫酸氢钠和20%羟基丙脂的混合液在安装前袋子应完整无损。拆封后应马上放入膜管内，清洗后即可使用。

6.2.2. There may be some Residual material on the RO film after long time operation of pure water. The reasons could be ineffective pre-treatment， improper control， polluted inlet water or wrong chemicals. The RO film must be cleaned in the following procedures
由于净水长时间在RO膜上运行，RO膜上会结垢。结垢的原因有:预处理系统失效，控制不当，进水污染或使用错误的化学品。RO膜按下列程序清洗:

6.2.2.1. Prepare suitable cleaning solution with correct pH value per section 6.2.5. Be sure that all chemicals in the solution have been fully dissolved and evenly mixed to be transparent and clear solution before it is filled into the film.
准备适当的清洗液，准确的PH值依照6.2.5节.在加入清洗液之前，确认所有的化学品已完全溶解混合均匀。

6.2.2.2. The solution is filled into the film tube by low pressure and flow of pump. The pressure shall be low enough that no osmosis happens. The cleaning solution shall be first discharged and then circulated.
用泵的低压流量打入膜管，低压控制在无渗透液产生.清洗液先排放后循环。

6.2.2.3. The acid will be consumed when it dissolves the inorganic sediment and its pH value shall rise by 0.5 unit. Add acid at that time until the pH value drops by 0.5..
当酸溶解无机物沉淀时酸会消耗，PH值升高0.5个单位时，需加酸直到PH值下降0.5个单位。

6.2.2.4. Dipping: Shut off the pump. Dip the components in the solution for 1 hour or longer for dirt difficult to dissolve.
浸泡:关掉泵.将元件浸泡在溶液中1小时，如有难溶污垢可延长浸泡时间。

6.2.2.5. High-speed Flushing: High-speed water flow in about 30 to 40 minutes will clear the dirt on the surface of the film.
高速冲洗:用高速水流冲洗30到40分钟，将膜表面污垢冲洗出去。

6.2.2.6. The used solution will be discharged and sampled to compare with pure solution for analysis of the cleaning effect.
排除清洗液，取样与原液分析比较，确认清洗效果。

6.2.2.7. The flushing water shall be purified water in temperature of at least 20°C. The cleaning solution in the film must be cleared before normal operation of the system.
用不低于20°C的纯化水冲洗，在正常操作之前必须把膜内清洗液冲掉。

6.2.2.8. Clean Again: The film shall be flushed by purified water in at least 10 minutes. Normal production can begin only after it is rinsed clean.
再清洗:用纯化水冲洗膜至少10分钟.冲洗干净后才能开始正常的生产。

6.2.3. Contamination of Reverse Osmosis Film Module
反渗透膜污染

6.2.3.1. After a period of normal operation， the complex polyamide reverse osmosis film module could be contaminated by some suspends or matters difficult to dissolve in water supply such as calcium carbonate， calcium sulfate， metal oxide， silicon sediment， organic or inorganic sediments.
运行一段时期后，复合反渗透膜会受到水中悬浮物和难溶物的污染，如碳酸钙，硫酸钙，金属氧化物，硅沉积，无机物和有机物沉积物。

The character of pollutant and contaminating speed depends on the quality of the water supply. The contamination can happen quickly and needs to be monitored because the film module can be damaged in a short period of time. 污染物的性质及污染速度与给水有关.污染发生很快需监控，因为污染会在很短的一段时间损坏膜。

6.2.4. Elimination of Pollutant
污染物的去除

The pollutant can be eliminated either chemically or physically. Therefore， the RO system shall be cleaned after daily operation in physical way of low pressure operation for 15 minutes in order to get rid of the surface dirt. But chemical cleaning must be done if any of the following happens:
污染物能够用化学或物理的方法去除.因此，RO系统每天运行后可以用物理冲洗的方法去除膜表面的沉积物。

6.2.4.1. The flow reduces by 10% of the normal flow even in normal pressure and temperature.
在正常的压力和温度下流量降低正常值的10%。

6.2.4.2. The conductivity of the produced water has been more than double of the original conductivity in condition that the working pressure and inlet conductivity remains the same.
在原水电导率和工作压力不变时，产品水电导率超过初期两倍时。

6.2.4.3. The difference of working pressure and the concentrated water has been more than double of the original value.
工作压力和浓缩水超过初期两倍时。

6.2.4.4. The system has been stopped for a long time and needs to be sealed.
系统长时间停用需要封存。

6.2.5. Cleaning Agent of the Reverse Osmosis Film Module
反渗透组件清洗剂

Several varied cleaning agents are prepared for pollutants of different reasons. Listed below are some agents often used:
根据不同的原因配制了不同的清洗剂.常用的清洗剂见下表:

No.
Cleaning Agent
Filling Quantity in Preparation of 30L Solution
PH Regulation
1
Citric Acid
柠檬酸
RO Production Water
反渗透产品水
60g

30L

Use NH4OH
For PH=4.0
用氨水调节至pH值为4
2
STPP
三聚磷酸钠
EDIT Sodium Tetra-hydrochloride
EDIT四钠盐
RO Production Water
反渗透产品水
60g

30g

30L

Use H2SO4
For PH=10.0
用硫酸调节至pH值为 10.0

3
STPP
三聚磷酸钠
Emulsifier ABSCa
十二烧基苯磺酸钠
RO Production Water
反渗透产品水
60g

30g

30L

Use H2SO4
For
PH=10.0
用硫酸调节至pH值为10

4
30% H2O2

30%的双氧水
RO Production Water
反渗透产品水
0.2L

Add to 30L
加至30升
Use NH4OH
For
PH=4.0
用氨水调节至pH值为4

Choose the best cleaning agent after chemical analysis has been done on the pollutant and careful comparison of the results. The ordinary choice is as follows:
对污染物分析和比较分析结果，选择最好的清洗剂。一般选择见下表:

Pollutant 污染物
Common Phenomenon 常见现象
Treatment 处理方法
Calcium or
Magnesium Sediment (CaCO3Ca2P04)
钙镁沉积物
Distinct Reduce of Desalination;
脱盐率明显下降
Increase of System Pressure Drop;
系统压降增加
Lower Water Production
系统产水量稍降
Use 1# Cleaning Agent
用1号清洗液
Oxide
(iron， nickel， copper， etc.)
氧化物
（铁、镍、铜等）
Distinct Reduce of Desalination;
脱盐率明显下降
Distinct Increase of System Pressure Drop;
系统压降明显升高
Much Lower Water Production
系统产水量明显降低

Use 1# Cleaning Agent
用1号清洗液
Various Colloid (iron， organic matters and colloid)
各种胶体
（铁、有机体及胶体）
Some Reduce of Desalination;
脱盐率稍有降低
Steady Increase of System Pressure Drop;
系统压降渐上升
Steadily Lower Water Production
系统产水量逐渐减少
Use 2# Cleaning Agent
用2号清洗液
Calcium Sulfate
硫酸钙
Distinct Reduce of Desalination;
脱盐率明显下降
Some Increase of System Pressure Drop;
系统压降稍有适度增加
Steadily Lower Water Production
系统产水量稍有降低
Use 2# Cleaning Agent
用2号清洗液
Organic Dirt
有机物沉积
Possible Reduce of Desalination;
脱盐率可能降低
Steady Increase of System Pressure Drop;
系统压降逐渐升高
Steadily Lower Water Production
系统产水量逐渐降低
Normally Use 2# Cleaning Agent but 3# for severe contamination
用2号清洗液，污染严重时用3号清洗液

6.2.6. Bactericide and Protective Agent of Reverse Osmosis Film Module;
反渗透膜组件杀菌剂和保护液:

The kind of film module shall be clarified before any storage agents or bactericide is applied to it since the module could be acetic film or STPP complex. The film module provided by our company is normally complex film. If there is any sulfured hydrogen or dissolving iron ion or manganese ion， hydrogenated bactericide (chlorine or hydrogen peroxide) shall not be used. The free chlorine shall only be applied to acetic film or it will damage the complex film module. STPP complex film shall use proper bactericide as follows:
在对膜组件储存和杀菌之前确认膜组件是醋酸膜还是STPP复合膜.本公司一般是复合膜。如果给水含有任何硫化氢或溶解性的铁或锰离子，则不应使用氧化性杀菌剂(氯气和双氧水).游离氯仅用于醋酸膜，它会损坏复合膜。下面是STPP复合膜适用的杀菌剂。

6.2.6.1. Formaldehyde solution in 0.5~1.0% solution is used as bactericide and daily protective agent.
5%-10%甲醛溶液杀菌和常用的保护液。

6.2.6.2. Sodium bisulfate in 1% solution is used as protection agent of the film module.
1%的硫酸氢钠溶液用于膜组件的保护液。

6.2.6.3 Hydrogen peroxide is used in a <2% solution in temperature <25 degree. There shall be no dissolvable iron or manganese ion in the water supply otherwise the film surface will be oxidized， which will cause degradation of film module. Hydrogen peroxide shall not be used as protective system when the is shut down for an extended period. 双氧水浓度小于%2，温度低于25度.给水中不含溶解性铁或锰离子.否则会引起膜表面氧化而使膜组件降解.不应将双氧水作为长期停运时的保护液。

The reverse osmosis film module could be used for >3 years when it is kept in good condition and cleaned regularly.
反渗透膜组件有良好的工作条件和有规律的清洗可以使用3年以上。

6.3. Maintenance of Reverse Osmosis Device
反渗透装置维护

6.3.1. If the reverse osmosis system is down for no more then 3 days，The reverse Osmosis device (STPP film) shall be flushed for half an hour every day with water from the safety filter in low pressure. There must be 0.5ppm active chlorine in the water. And all valves shall be shut off to ensure that water has fully immersed the module.
如果反渗透装置停运不超过三天，反渗透膜(STPP膜)装置每天用保安过滤器出低压水冲洗半个小时，水中保证0.5ppm活性氯气，然后关闭所有的阀门确保组件中充满水。

6.3.2. If the reverse device needs to stopped for a long period (more than 3 days)， the module shall be immersed in 1% formaldehyde solution with all valves shut off. The device shall be checked every month. The environment temperature shall be kept proper free of mildew in summer and being frozen in winter (10% to 20% glycerin could be applied when necessary).
如果反渗透装置需长期(超过3天)停运，反渗透膜组件浸泡在1%甲醛溶液中，关闭所有阀门。每月检查一次.夏天控制环境温度以防霉变，冬季防冻(必要时加入10-20%甘油)。

6.3.3. The water for storage should be reverse osmosis water applied to formaldehyde reagent.
保存水用反渗透水稀释甲醛试剂。

6.4. The sand filter and carbon filter shall be flushed with water after daily use until the outlet water becomes clear.
每天用水冲洗砂滤和活性炭过滤器直到出水变清。

6.5. The core of the safety filter shall be replaced if the pressure difference between the inlet and outlet rises more than 0.15MPa.
保安过滤器进出口压差超过0.15Mpa时更换滤芯。

6.6. Periodical test and check shall be made to ensure the proper workings of every instrument.
定期试验和检查各仪表能准确工作。

6.7. Periodical check shall be made to ensure the proper work of control head. Besides， the control head shall be adjusted and relocated every month.
定期检查控制头的操作应准确无误，每隔一个月需对控制头重新进行设定及调整。

6.8. The light tube of the ultraviolet bacterial killer shall be replaced regularly. The imported tube can be used for 5，000 hours while the domestic product can be used for 3，000 hours.
紫外线杀菌器应定期更换，进口灯管的使用寿命规定为5000小时，国产灯管的使用寿命规定为3000小时。

6.9. Check and Repair of High Pressure Pump
高压泵的检查维修

6.9.1 The reasons of failure of the high pressure pump could be one of the following:
高压泵的故障有以下原因:

a. The motor temperature getting too high
电机温度过高
b. Too high voltage
电压太高
c. Lack of phase
缺相
d. Break of power supply
电源断路
e. Numerous restarts
多次重新启动
f. Too much electricity leakage
漏电太高
g. Overload
超载
h. The signal of sensors is out of specification (4-20mA)
传感器的信号超过信号范围(4-20毫安)
i. The fixed signal is out of specification (4-20ma)
设置信号超过信号范围(4-20毫安)
j. Outside failure
外部故障
k. Empty run
干运转
6.9.2. A display of failure could be reset by either of the following ways
一个故障显示可用下列方法之一复原:

· Simply press the button “+” or “-” of the pump. But this way could be no use if the button is locked.
简单地按压泵上的按钮 “+” 或 “-” ，如果按钮被锁定，则此方法不能使用。

· Simply cut off the power supply of the pump.
简单地切断泵的电源。

6.10. Repair and maintenance of Conductometer
电导仪的维护及保养

6.101. The monitor shall be free of exposure to the sun.
防止显示面板被曝晒。

6.10.2. The monitor shall be repeatedly checked to ensure best effect of operation and to get rid of possible problem.
重复检查监控程序以确保得到满意的操作效果和防止可能的故障。

6.10.3. All cable connections shall be checked to be safe and free of moisture or contamination.
检查全部电缆的连接是否安全，并防止潮湿和受污染。

6.10.4. The circuit components and cable fittings shall be checked and replaced if damaged.
检查和更换被损坏的电路元件和电缆装置。

6.11. The hydrophobic filter in storage tank of pure water and injection water shall be replaced every year and completely tested every 3 months.
纯水和注射用水储罐上的疏水性过滤器每年必须更换一次。每隔三个月需进行一次完整性测试。

6.12. The reverse osmosis system shall be run at least half an hour in winter and separately half an hour in the morning and evening in summer in order to ensure the normal operation and water quality of the system free of bacteria.
为了防止反渗透系统滋生细菌，影响系统的正常运行和产水水质，冬天每天至少要运行半小时，夏天必须早晚各运行半小时。

6.13. The chlorine content in reverse inlet water shall be controlled under 0.1mg/L. The inlet water quality shall be periodically checked. If the chlorine content exceeds the standard， the RO film will be oxidized and decomposed. Therefore， the active carbon shall be replaced in a timely manner.
反渗透进水余氯含量必须控制在小于0.1毫克/升，必须定期检测反渗透进水的水质，当余氯含量超过规定值时，会导致RO膜的氧化分解，所以，活性炭失效后需及时更换。

6.14. The heating steam supplied to the distiller shall be saturated and dry steam in invariable pressure without caustic chemicals. The pressure of the steam should be above 0.3 MPa and below 0.6 MPa. It is recommended to fix steam filter (above 40 holes)， pressure reducing system and drainage system in pipes that will go into the distiller.
给蒸馏水机供应的加热蒸汽一般应是饱和干燥的，不含腐蚀性化学物质，且应保持蒸汽压力恒定不波 动。蒸汽压力应大于0.3 Mpa，小于0.6 MPa， 建议用户在进入蒸馏水机前的管道上安装蒸汽过滤器 (40目以上) 、减压系统、疏水系统。
6.15. The inlet water of distiller shall be purified water with conductivity <2.0 µs/cm without silicon dioxide or chlorine ion.
蒸馏水机的进料水应是纯化水，电导率<2.0 µs/cm，不含二氧化硅和氯离子。

6.16. Periodical check shall be made to steam trap and filter. The inlet water filter shall be cleaned after 1 week at the beginning and be cleaned twice very year thereafter.
疏水器和过滤器应定期检查.经一周时间的运转后，清洗进料水过滤器，此后每年清洗过滤器两次。

6.17. The cooling water shall be purified water with inlet pressure no less than 0.2 MPa. The outlet temperature of cooling water is about 85°C.
冷却水用纯化水，要求进水压力不小于0.2 Mpa，冷却水排出后温度约在85°C左右。

6.18. In