PW和WFI系統(tǒng)維護(hù)

1、* COMPANY STANDARD OPERATING PROCEDURE標(biāo)準(zhǔn)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 MAINTENANCEEffective Date生效日:SOP Number:SOP號PM-01-0001PW/WFI系統(tǒng)預(yù)維護(hù)Page:Page 11 of 15Supersedes Date:更換日期Dec.05, 20011. SCOPE范圍1.1. To ensure correct maintenance of water preparation systems and con

2、tinuous production of PW/WFI quality water.保證水制備系統(tǒng)的正常維護(hù)，持續(xù)生產(chǎn)符合PW/WFI要求的水。2. DEFINITIONS定義2.1. PW USP Purified WaterPW符合美國藥典的純水2.2. WFI USP Water for InjectionWFI符合美國藥典的注射用水3. REFERENCES參考3.1.United States Pharmacopeia ， current revision美國藥典，當(dāng)前版本3.2 PW/WFI System Manual PW/WFI系統(tǒng)使用手冊4. RESPONSIBILITY

3、- Maintenance/Engineering， QA職責(zé)維護(hù)、工程、QA人員5. ATTACHMENTS附錄5.1. MF-01-0001-01: PW/WFI System Daily Maintenance Check MF-01-0001-01: PW/WFI 系統(tǒng)日常維護(hù)檢查5.2. MF-01-0001-02: Maintenance Record of PW System MF-01-0001-02: PW 系統(tǒng)維護(hù)記錄5.3. MF-01-0001-03: Maintenance Record of WFI System MF-01-0001-03: WFI 系統(tǒng)維護(hù)記錄6

4、.PROCEDURES程序6.1. Maintenance of Pumps泵的維護(hù)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.泵電機(jī)散熱片，冷卻風(fēng)扇蓋板和葉片應(yīng)保持完整，如有損壞應(yīng)立即更換。6.1.2. The pump shall be cleaned daily.泵應(yīng)每日保持清潔。6.1.3. The operation of motor bearing

5、and shaft shall be checked by rob every day. Any abnormity shall be treated immediately. 泵的電機(jī)軸及軸承應(yīng)每天用聽棒檢查運(yùn)行聲響，任何異常情況都應(yīng)及時(shí)處理。6.1.4. The oiling point shall be lubricated with high temperature grease once a year.各加油點(diǎn)應(yīng)定期每年補(bǔ)充高溫潤滑油脂。6.2. Contamination and Cleaning of RO Film反滲透膜的使用及清洗6.2.1. First Use of RO

6、 Film:新反滲透膜的初次使用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

7、滲透膜保存在密封的塑料袋中，袋內(nèi)為1%亞硫酸氫鈉和20%羥基丙脂的混合液。在安裝前袋子應(yīng)完整無損。拆封后應(yīng)馬上放入膜管內(nèi)，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 clean

8、ed in the following procedures:由于凈水長時(shí)間在RO膜上運(yùn)行，RO膜上會結(jié)垢。結(jié)垢的原因有:預(yù)處理系統(tǒng)失效，控制不當(dāng)，進(jìn)水污染或使用錯誤的化學(xué)品。RO膜按以下程序清洗:. 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 so

9、lution before it is filled into the film.準(zhǔn)備適當(dāng)?shù)那逑匆?，?zhǔn)確的PH值依照6.2.5節(jié).在參加清洗液之前，確認(rèn)所有的化學(xué)品已完全溶解混合均勻。. 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 circulat

10、ed.用泵的低壓流量打入膜管，低壓控制在無滲透液產(chǎn)生.清洗液先排放后循環(huán)。. 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.當(dāng)酸溶解無機(jī)物沉淀時(shí)酸會消耗，PH值升高0.5個(gè)單位時(shí)，需加酸直到PH值下降0.5個(gè)單位。. Dipping: Shut off the pump. Dip the co

11、mponents in the solution for 1 hour or longer for dirt difficult to dissolve.浸泡:關(guān)掉泵.將元件浸泡在溶液中1小時(shí)，如有難溶污垢可延長浸泡時(shí)間。. High-speed Flushing: High-speed water flow in about 30 to 40 minutes will clear the dirt on the surface of the film.高速沖洗:用高速水流沖洗30到40分鐘，將膜外表污垢沖洗出去。. The used solution will b

12、e discharged and sampled to compare with pure solution for analysis of the cleaning effect.排除清洗液，取樣與原液分析比擬，確認(rèn)清洗效果。. 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&

13、#176;C的純化水沖洗，在正常操作之前必須把膜內(nèi)清洗液沖掉。. 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:用純化水沖洗膜至少10分鐘.沖洗干凈后才能開始正常的生產(chǎn)。6.2.3. Contamination of Reverse Osmosis Film Module反滲透膜污染. After a period of norm

14、al 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.運(yùn)行一段時(shí)期后，復(fù)合反滲透膜會受到水中懸浮物和難溶物的污染，如碳酸鈣，硫酸鈣，金屬氧

15、化物，硅沉積，無機(jī)物和有機(jī)物沉積物。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. 污染物的性質(zhì)及污染速度與給水有關(guān).污染發(fā)生很快需監(jiān)控，因?yàn)槲廴緯诤芏痰囊欢螘r(shí)間損壞膜。6.2.4. Elimina

16、tion 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 f

17、ollowing happens:污染物能夠用化學(xué)或物理的方法去除.因此，RO系統(tǒng)每天運(yùn)行后可以用物理沖洗的方法去除膜外表的沉積物。. The flow reduces by 10% of the normal flow even in normal pressure and temperature.在正常的壓力和溫度下流量降低正常值的10%。. The conductivity of the produced water has been more than double of the original conductivity in condition that

18、 the working pressure and inlet conductivity remains the same.在原水電導(dǎo)率和工作壓力不變時(shí)，產(chǎn)品水電導(dǎo)率超過初期兩倍時(shí)。. The difference of working pressure and the concentrated water has been more than double of the original value.工作壓力和濃縮水超過初期兩倍時(shí)。. The system has been stopped for a long time and needs to be seale

19、d.系統(tǒng)長時(shí)間停用需要封存。6.2.5. Cleaning Agent of the Reverse Osmosis Film Module反滲透組件清洗劑Several varied cleaning agents are prepared for pollutants of different reasons. Listed below are some agents often used:根據(jù)不同的原因配制了不同的清洗劑.常用的清洗劑見下表:No.Cleaning AgentFilling Quantity in Preparation of 30L SolutionPH Regulat

20、ion1Citric Acid檸檬酸RO Production Water反滲透產(chǎn)品水60g30LUse NH4OHFor PH=4.0用氨水調(diào)節(jié)至pH值為42STPP三聚磷酸鈉EDIT Sodium Tetra-hydrochlorideEDIT四鈉鹽RO Production Water反滲透產(chǎn)品水60g30g30LUse H2SO4For PH=10.0用硫酸調(diào)節(jié)至pH值為 10.03STPP三聚磷酸鈉Emulsifier ABSCa十二燒基苯磺酸鈉RO Production Water反滲透產(chǎn)品水60g30g30LUse H2SO4ForPH=10.0 用硫酸調(diào)節(jié)至pH值為10430%

21、 H2O230%的雙氧水RO Production Water反滲透產(chǎn)品水0.2LAdd to 30L加至30升Use NH4OHForPH=4.0用氨水調(diào)節(jié)至pH值為4Choose 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:對污染物分析和比擬分析結(jié)果，選擇最好的清洗劑。一般選擇見下表:Pollutant 污染物Common Pheno

22、menon 常見現(xiàn)象Treatment 處理方法Calcium orMagnesium Sediment (CaCO3Ca2P04)鈣鎂沉積物Distinct Reduce of Desalination; 脫鹽率明顯下降Increase of System Pressure Drop; 系統(tǒng)壓降增加Lower Water Production系統(tǒng)產(chǎn)水量稍降Use 1# Cleaning Agent用1號清洗液Oxide(iron， nickel， copper， etc.)氧化物鐵、鎳、銅等Distinct Reduce of Desalination;脫鹽率明顯下降Distinct Inc

23、rease of System Pressure Drop;系統(tǒng)壓降明顯升高M(jìn)uch Lower Water Production系統(tǒng)產(chǎn)水量明顯降低Use 1# Cleaning Agent用1號清洗液Various Colloid (iron， organic matters and colloid)各種膠體鐵、有機(jī)體及膠體Some Reduce of Desalination;脫鹽率稍有降低Steady Increase of System Pressure Drop;系統(tǒng)壓降漸上升Steadily Lower Water Production系統(tǒng)產(chǎn)水量逐漸減少Use 2# Cleanin

24、g Agent用2號清洗液Calcium Sulfate硫酸鈣Distinct Reduce of Desalination;脫鹽率明顯下降Some Increase of System Pressure Drop;系統(tǒng)壓降稍有適度增加Steadily Lower Water Production系統(tǒng)產(chǎn)水量稍有降低Use 2# Cleaning Agent用2號清洗液Organic Dirt有機(jī)物沉積Possible Reduce of Desalination;脫鹽率可能降低Steady Increase of System Pressure Drop;系統(tǒng)壓降逐漸升高Steadily Lo

25、wer Water Production系統(tǒng)產(chǎn)水量逐漸降低Normally Use 2# Cleaning Agent but 3# for severe contamination用2號清洗液，污染嚴(yán)重時(shí)用3號清洗液6.2.6. Bactericide and Protective Agent of Reverse Osmosis Film Module;反滲透膜組件殺菌劑和保護(hù)液:The kind of film module shall be clarified before any storage agents or bactericide is applied to it since

26、 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 a

27、pplied to acetic film or it will damage the complex film module. STPP complex film shall use proper bactericide as follows:在對膜組件儲存和殺菌之前確認(rèn)膜組件是醋酸膜還是STPP復(fù)合膜.本公司一般是復(fù)合膜。如果給水含有任何硫化氫或溶解性的鐵或錳離子，那么不應(yīng)使用氧化性殺菌劑(氯氣和雙氧水).游離氯僅用于醋酸膜，它會損壞復(fù)合膜。下面是STPP復(fù)合膜適用的殺菌劑。. Formaldehyde solution in 0.51.0% solution is used

28、 as bactericide and daily protective agent.5%-10%甲醛溶液殺菌和常用的保護(hù)液。. Sodium bisulfate in 1% solution is used as protection agent of the film module.1%的硫酸氫鈉溶液用于膜組件的保護(hù)液。 Hydrogen peroxide is used in a <2% solution in temperature <25 degree. There shall be no dissolvable iron or mangane

29、se 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. 雙氧水濃度小于%2，溫度低于25度.給水中不含溶解性鐵或錳離子.否那么會引起膜外表氧化而使膜組件降解.不應(yīng)將雙氧水作為長期停運(yùn)時(shí)的保護(hù)液。The reverse

30、 osmosis film module could be used for >3 years when it is kept in good condition and cleaned regularly. 反滲透膜組件有良好的工作條件和有規(guī)律的清洗可以使用3年以上。6.3. Maintenance of Reverse Osmosis Device反滲透裝置維護(hù)6.3.1. If the reverse osmosis system is down for no more then 3 days，The reverse Osmosis device (STPP film) shall

31、 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.如果反滲透裝置停運(yùn)不超過三天，反滲透膜(STPP膜)裝置每天用保安過濾器出低壓水沖洗半個(gè)小時(shí)，水中保證0.5ppm活性氯氣，然后關(guān)閉所有的閥門確保組件

32、中充滿水。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 fro

33、zen in winter (10% to 20% glycerin could be applied when necessary).如果反滲透裝置需長期(超過3天)停運(yùn)，反滲透膜組件浸泡在1%甲醛溶液中，關(guān)閉所有閥門。每月檢查一次.夏天控制環(huán)境溫度以防霉變，冬季防凍(必要時(shí)參加10-20%甘油)。6.3.3. The water for storage should be reverse osmosis water applied to formaldehyde reagent.保存水用反滲透水稀釋甲醛試劑。6.4. The sand filter and carbon filter sh

34、all be flushed with water after daily use until the outlet water becomes clear.每天用水沖洗砂濾和活性炭過濾器直到出水變清。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.保安過濾器進(jìn)出口壓差超過0.15Mpa時(shí)更換濾芯。6.6. Periodical test and check shall be m

35、ade to ensure the proper workings of every instrument.定期試驗(yàn)和檢查各儀表能準(zhǔn)確工作。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.定期檢查控制頭的操作應(yīng)準(zhǔn)確無誤，每隔一個(gè)月需對控制頭重新進(jìn)行設(shè)定及調(diào)整。6.8. The light tube of the ultraviolet bacter

36、ial 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.紫外線殺菌器應(yīng)定期更換，進(jìn)口燈管的使用壽命規(guī)定為5000小時(shí)，國產(chǎn)燈管的使用壽命規(guī)定為3000小時(shí)。6.9. Check and Repair of High Pressure Pump高壓泵的檢查維修6.9.1. The reasons of failure of the high pressure pump co

37、uld be one of the following:高壓泵的故障有以下原因:a. The motor temperature getting too high 電機(jī)溫度過高b. Too high voltage電壓太高c. Lack of phase缺相d. Break of power supply電源斷路e. Numerous restarts屢次重新啟動f. Too much electricity leakage漏電太高g. Overload超載h. The signal of sensors is out of specification (4-20mA)傳感器的信號超過信號范圍

38、(4-20毫安)i. The fixed signal is out of specification (4-20ma)設(shè)置信號超過信號范圍(4-20毫安)j. Outside failure外部故障k. Empty run干運(yùn)轉(zhuǎn)6.9.2. A display of failure could be reset by either of the following ways;一個(gè)故障顯示可用以下方法之一復(fù)原:· Simply press the button “+ or “- of the pump. But this way could be no use if the butt

39、on is locked.簡單地按壓泵上的按鈕 “+ 或 “- ，如果按鈕被鎖定，那么此方法不能使用。· Simply cut off the power supply of the pump.簡單地切斷泵的電源。6.10. Repair and maintenance of Conductometer電導(dǎo)儀的維護(hù)及保養(yǎng)6.10.1. The monitor shall be free of exposure to the sun.防止顯示面板被曝曬。6.10.2. The monitor shall be repeatedly checked to ensure best effe

40、ct of operation and to get rid of possible problem.重復(fù)檢查監(jiān)控程序以確保得到滿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.檢查全部電纜的連接是否平安，并防止潮濕和受污染。6.10.4. The circuit components and cable fittings shall be checked and replaced if damaged.檢查和更換被損壞的

41、電路元件和電纜裝置。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.純水和注射用水儲罐上的疏水性過濾器每年必須更換一次。每隔三個(gè)月需進(jìn)行一次完整性測試。6.12. The reverse osmosis system shall be run at least half an hour in winter and separately half an ho

42、ur in the morning and evening in summer in order to ensure the normal operation and water quality of the system free of bacteria.為了防止反滲透系統(tǒng)滋生細(xì)菌，影響系統(tǒng)的正常運(yùn)行和產(chǎn)水水質(zhì)，冬天每天至少要運(yùn)行半小時(shí)，夏天必須早晚各運(yùn)行半小時(shí)。6.13. The chlorine content in reverse inlet water shall be controlled under 0.1mg/L. The inlet water quality shall b

43、e 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.反滲透進(jìn)水余氯含量必須控制在小于0.1毫克/升，必須定期檢測反滲透進(jìn)水的水質(zhì)，當(dāng)余氯含量超過規(guī)定值時(shí)，會導(dǎo)致RO膜的氧化分解，所以，活性炭失效后需及時(shí)更換。6.14. The heating steam supplied to the d

44、istiller 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 distill

45、er.給蒸餾水機(jī)供給的加熱蒸汽一般應(yīng)是飽和枯燥的，不含腐蝕性化學(xué)物質(zhì)，且應(yīng)保持蒸汽壓力恒定不波 動。蒸汽壓力應(yīng)大于0.3 Mpa，小于0.6 MPa， 建議用戶在進(jìn)入蒸餾水機(jī)前的管道上安裝蒸汽過濾器 (40目以上) 、減壓系統(tǒng)、疏水系統(tǒng)。6.15. The inlet water of distiller shall be purified water with conductivity <2.0 µs/cm without silicon dioxide or chlorine ion.蒸餾水機(jī)的進(jìn)料水應(yīng)是純化水，電導(dǎo)率<2.0 µs/cm，不含二氧化硅和氯離

46、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.疏水器和過濾器應(yīng)定期檢查.經(jīng)一周時(shí)間的運(yùn)轉(zhuǎn)后，清洗進(jìn)料水過濾器，此后每年清洗過濾器兩次。6.17. The cooling water shall be purified water with inlet pressure no less tha

47、n 0.2 MPa. The outlet temperature of cooling water is about 85°C.冷卻水用純化水，要求進(jìn)水壓力不小于0.2 Mpa，冷卻水排出后溫度約在85°C左右。6.18. Installation and Commission of Water Pump: The rotating direction of the water pump shall be correct when the pump is installed for the first time or replaced. The pump shall be

48、 checked to determine whether there is air in pump or if there is no water when the pump starts. In this case， remove the end cap at outlet of the pump and filled the pump fully with water. Then replace the cap and start the pump again. The maintenance of the pump shall follow the brochure of pump e

49、xplanation. Be sure to periodically fill lubricating oil.水泵的安裝和調(diào)試:水泵的初次安裝和更換新泵時(shí)，應(yīng)注意水泵葉輪的轉(zhuǎn)向，假設(shè)水泵啟動后不出液，那么應(yīng)檢查水泵內(nèi)是否有氣體。翻開水泵出水口一側(cè)的堵頭放氣，放出水泵內(nèi)氣體并充滿水，重新裝填堵 頭，啟動水泵即可出水。水泵的保養(yǎng)應(yīng)按水泵的說明書進(jìn)行，并定期加注潤滑油。6.19. Be sure that no water gets on the motor using the sampling valve.使用取樣閥時(shí)應(yīng)防止將水滴濺到電機(jī)上。6.20. The pipes connected

50、to the pump shall be cleaned before installation. 外接管道需仔細(xì)清洗后安裝。6.21. The feed water shall be checked often to reach the quality standard of pure water specified by US Pharmacopoeia (24th edition).要經(jīng)常監(jiān)測進(jìn)料水的水質(zhì)情況，使之到達(dá)美國藥典(第24版)中關(guān)于純化水的質(zhì)量標(biāo)準(zhǔn)。6.22. The distiller shall be cleaned in the following conditions

51、:蒸餾水機(jī)出現(xiàn)以下情況時(shí)，需要進(jìn)行清洗:When the production capability of the distiller is distinctly low; when there is dirt on the surface of the heat exchanger. The distiller shall be chemically cleaned by manufacturer.當(dāng)蒸餾水機(jī)的生產(chǎn)能力顯著下降時(shí)，當(dāng)確信有污垢沉積在換熱器的外表時(shí)，對蒸餾水機(jī)進(jìn)行的化學(xué)清洗需要由制造廠來進(jìn)行。6.23. Periodical monitoring shall be done w

52、hen the system is in normal operation. The inlets and outlets of pure water and water for injection shall be sampled and tested and each point shall be tested at least once a month. The use points of the water for injection shall be alternatively sampled and tested at each point and at least once a

53、week.系統(tǒng)正常運(yùn)行后應(yīng)定期對水質(zhì)進(jìn)行監(jiān)測:純化水及注射水進(jìn)、回水口應(yīng)每天取樣檢測，純化水用水點(diǎn)應(yīng)輪流取樣，必須保證各個(gè)用水點(diǎn)每月至少取樣一次，注射水用水點(diǎn)應(yīng)輪流取樣， 必須保證各個(gè)用水點(diǎn)每周至少取樣一次。6.24. Chemicals Preparation:藥液配置:Chemicals put into purified water for pretreatment shall be a flocculant and scale inhibitor both in concentration of 1.0 ppm.純化水預(yù)處理加藥：絮凝劑、阻垢劑濃度均為1.0ppm。Alkali lye

54、 shall be added after class I reverse osmosis for pH=14.一級反滲透后加堿液：pH=14。7. RECORDS 記錄RECORD記錄LOCATION存放位置MINIMUM RETENTION保存期限MF-01-0001-01Maintenance, Engineering10 Yrs.MF-01-0001-02Maintenance, Engineering10 Yrs.MF-01-0001-03Maintenance, Engineering10 Yrs.MF-01-0001-04Maintenance, Engineering10 Yrs.8. CHANGE HISTORY:變更歷史8.1.Last Change: Dec.05, 2001上次變更：2001年12月5日8.2.Summary of Current Revisions Made本次修訂概述8.2.1. Add an attachment IV: Cleaning Record of RO Membrane.增加附錄 IV ：反滲透膜清洗記錄QA Review By:QA審核人Date:日期 Issued By:發(fā)行人Date: 日期PW/WFI DAILY MAINTENANCE