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1、Document No.文件編號VP-Revision No.版本號00Purified Water System Validation Protocol純化水系統(tǒng)驗證方案純化水系統(tǒng)驗證方案Date 日期20090301Company Name公司名稱Page 頁碼Page 1 of 40Purified Water System Validation Protocol純化水系統(tǒng)驗證方案純化水系統(tǒng)驗證方案Approval of the Purified Water System Validation Protocol純化水系統(tǒng)驗證方案的審批純化水系統(tǒng)驗證方案的審批Title 職務職務Name

2、姓名姓名Signature 簽字簽字Date 日期日期Written By 起草人起草人Reviewed By 復核人復核人Approved By 批準人批準人Document No.文件編號Revision No.版本號00Purified Water System Validation Protocol純化水系統(tǒng)驗證方案純化水系統(tǒng)驗證方案Date 日期20090301Company Name公司名稱Page 頁碼Page 2 of 40TABLE OF CONTENTS1 Summarize/概述.32 Purpose/驗證目的.43Validation Team and Responsi

3、bilities/驗證人員及職責.43.1Validation Team Member/項目驗證小組成員 .43.2 Responsibilities/職責 .44 Content, Method and Criterion/驗證內容、方法及合格標準.54.1Beforehand Qualification/預確認（安裝前確認）.54.2 Installation qualification/安裝確認.74.3 Operation qualification/運行確認.114.4 Performance Qualification/性能確認 .125 Deviation and deal wi

4、th method/驗證過程中的偏差及處理.146 Validation Conclusion/驗證結果評定與結論.147.Revalidation Periods/再驗證周期.158Validation Schedule/驗證時間安排 .159.Attachment/ 附件 .16Document No.文件編號Revision No.版本號00Purified Water System Validation Protocol純化水系統(tǒng)驗證方案純化水系統(tǒng)驗證方案Date 日期20090301Company Name公司名稱Page 頁碼Page 3 of 401 Summarize/概述概述

5、The company commissioned the Jiaxing Jiame Water Treatment Engineering Co., Ltd. for the purified water system design and installation, the system product capacity of water is 1.0m3 / h, using of two grade reverse osmosis process to obtain purified water.Tap water after adding coagulant (PAC) was pu

6、mped by original water pump through multimedia filters, activated carbon filter for filtration and adsorption treatment to remove particulate impurities, colloid, chlorine, organic matter, etc. The free chlorine content of the water is less than 0.1ppm, SDI 4.Then Via precision filter to remove part

7、icles greater than 5u, entered the two grade reverse osmosis system use of membrane separation technology, desalinate the majority of ions in water, SiO2, organic colloids and other impurities, water production stored in a purified water storage tank, by ultraviolet sterilizers to kill bacteria that

8、 may exist in the terminal, after the booster pumps and precision filters, through the stainless steel pipe to various purified water use points, used for ingredients, equipment and containers cleaning, washing clothes and so on. Parts of the purified water through the circulation pipe back to the p

9、urified water storage tank.Simple process as follows: raw water (drinking water) original water tank flocculant dosing system multi-medium filter activated carbon filter Soft Water systems Filters a high-pressure pump reverse osmosis unit alkali dosing two high-pressure pump system reverse osmosis u

10、nit purified water tank and water pumps ultraviolet disinfection Terminal filter use point.公司純化水系統(tǒng)為委托嘉興嘉美水處理工程有限公司設計安裝，制水能力為 1.0m3/h，利用二級反滲透工藝來制取純化水。飲用水加入絮凝劑(PAC)后由原水泵增壓后進多介質過濾器、活性炭過濾器的過濾和吸附處理，除去水中顆粒狀雜質、膠體、余氯、有機物等，使出水游離氯含量小于 0.1ppm，SDI4，再經精密過濾器除去水中大于 5u 的顆粒后進入二級反滲透系統(tǒng)，利用膜分離技術的高脫鹽率，除去水中大部份離子、SiO2、有機物膠

11、體等雜質，二級反滲透系統(tǒng)產水貯存于一只純化水貯罐，經紫外線殺菌器殺死可能存在的細菌等后由終端水泵增壓并經微孔過濾器過濾，通過不銹鋼管道送至各純化水用水點，用于配料用水、設備及容器具清洗、工作服清洗等。部份純化水通過循環(huán)管道回至純化水貯罐。簡易流程為：原水（飲用水）原水箱絮凝劑加藥系統(tǒng)多介質過濾器活性炭Document No.文件編號Revision No.版本號00Purified Water System Validation Protocol純化水系統(tǒng)驗證方案純化水系統(tǒng)驗證方案Date 日期20090301Company Name公司名稱Page 頁碼Page 4 of 40過濾器阻垢劑加

12、藥系統(tǒng)保安濾器一級高壓泵一級反滲透裝置堿加藥系統(tǒng)二級高壓泵二級反滲透裝置純化水箱送水泵紫外線殺菌裝置終端微孔過濾器使用點。2 Purpose/驗證目的驗證目的Through purified water system installation, operation and performance qualification to prove its ability to steady provided supply of quality and quantity qualified water.對純化水系統(tǒng)的安裝、運行和性能進行驗證，以證明其有能力穩(wěn)定地供應規(guī)定數量和質量的合格用水。3Vali

13、dation Team and Responsibilities/驗證人員及職責驗證人員及職責3.1Validation Team Member/項目驗證小組成員項目驗證小組成員Project validation team comprises of Production Management Department, Quality Management Department, Equipment Engineering Division and the operator, maintenance worker, QC personnel. The manager of the product

14、ion management department is the leader of this validation team. Validation team members see attachment 2.項目驗證小組由生產管理部、質量管理部、設備工程科和操作工、維修工、QA、QC 組成，由生產管理部經理任項目驗證組組長，驗證小組成員見附件 2。3.2 Responsibilities/職責職責Equipment Engineering Division: Draft the validation protocol, Technical document qualification an

15、d implemented the validation, draft the validation report.Production Management Department: Review the validation protocol; Assist the engineering Division implementation the validation work.Quality Management Department: Review the validation protocol, finished the relative analytical work.Validati

16、on Committee Director: Approved the validation protocol and the validation report.設備工程科：負責設備驗證方案的起草及驗證工作的具體實施，起草驗證報告。生產部：復核驗證方案，協(xié)助設備工程科進行驗證工作的實施。質量部：負責驗證文件的審核，負責相關檢驗任務。驗證委員會主任：負責設備及公用工程系統(tǒng)驗證方案及報告的批準。Document No.文件編號Revision No.版本號00Purified Water System Validation Protocol純化水系統(tǒng)驗證方案純化水系統(tǒng)驗證方案Date 日期200

17、90301Company Name公司名稱Page 頁碼Page 5 of 40Validation process should be strictly in accordance with the approved validation protocol, if need to change for special reasons, they should fill out the the validation protocol change application and approval forms (attachment 1), according to the original r

18、eview and approval procedures for the approval before the Executive the change.驗證過程應嚴格按照本方案規(guī)定的內容進行，若因特殊原因確需變更時，應填寫驗證方案變更申請及批準書(附件 1)，按原審批程序批準后執(zhí)行。4 Content, Method and Criterion/驗證內容、方法及合格標準驗證內容、方法及合格標準4.1Beforehand Qualification/預確認（安裝前確認）預確認（安裝前確認）4.1.1 Document Qualification/資料確認Confirmed that the

19、 relevant document to support the verification is complete, fill out confirm records in attachment 3./確認支持本驗證的相關資料是否齊全，確認記錄填寫于附件 3Document name/資料名稱Confirm method/確認方法Purified water system, the detailed design requirements and technical parameters of major equipment純化水系統(tǒng)詳細設計要求及主要設備技術參數Consult equipm

20、ent archives查閱技術檔案Ordering the contract, specifications and related technical information純化水系統(tǒng)主要組成設備訂貨合同、說明書及相關技術資料Consult equipment archives查閱技術檔案Mainly equipments Certificates各設備檢驗合格證Consult equipment archives查閱技術檔案Purified water quality standards純化水質量標準Consult CP-2005查閱技術檔案查閱藥典 2005 版純化水標準Purifie

21、d Water System Flow Chart純化水系統(tǒng)工藝流程圖Consult equipment archives and attached attachment 4.查閱技術檔案查閱并附于附件 4Purified water system operation and maintenance standard operation procedures純化水系統(tǒng)操作和維護保養(yǎng)標準操作規(guī)程Consult the relative SOP查閱技術檔案Purified water system sample standard operating procedures純化水取樣標準操作規(guī)程Con

22、sult the relative SOP查閱技術檔案Purified water system cleaning standard operating procedures純化水系統(tǒng)清潔標準操作規(guī)程Consult the relative SOP查閱技術檔案Out of the box inspection records開箱驗收記錄Consult equipment archives查閱技術檔案Document No.文件編號Revision No.版本號00Purified Water System Validation Protocol純化水系統(tǒng)驗證方案純化水系統(tǒng)驗證方案Date 日期

23、20090301Company Name公司名稱Page 頁碼Page 6 of 40Installation and commissioning records安裝調試記錄Consult equipment archives查閱技術檔案Test Run Record試運行記錄Consult equipment archives查閱技術檔案Pipeline Pressure Test Record管道試壓記錄Consult equipment archives and attached attachment 5.查閱并附于附件 5Pipe cleaning records before use

24、管道使用前清洗記錄Consult equipment archives and attached attachment 6.查閱并附于附件 6Pipeline passivation Records管道鈍化記錄Consult equipment archives and attached attachment 7.查閱并附于附件 7Pipe disinfection record before use管道使用前消毒記錄Consult equipment archives and attached attachment 8.查閱并附于附件 8Water purification water sy

25、stem network diagram純化水系統(tǒng)用水網絡圖Consult equipment archives and attached attachment 9.查閱附于附件 9Qualification proof of the equipment supplier各設備生產企業(yè)資質證明材料Consult equipment archives and attached attachment 10.查閱附于附件 10The equipment inspection reports各設備檢驗報告Consult equipment archives and attached attachmen

26、t 11.查閱附于附件 114.1.2 Instrument calibration verification/儀器、儀表的檢定或校驗確認Instruments used in System such as Pressure gauges, conductivity meter, etc. shall be calibrated, and within the validity period. The confirm records be filled in attachment 12. Instruments as follow must be calibrated.系統(tǒng)所用的壓力表等及檢測

27、所用的電導率儀等須經檢定或檢驗合格，并在檢定有效期內，確認記錄填寫于附件 12。下列儀器儀表必須經過校驗。Instrument Name/名 稱Specification/型 號（規(guī)格）Count/數 量Pressure gauges/耐振壓力表0-2.5MPa4Pressure gauges/耐振壓力表0-1MPa7conductivity meter/電導率儀/1PH meter /PH 計/14.1.3 After service Qualification/售后服務確認Document No.文件編號Revision No.版本號00Purified Water System Vali

28、dation Protocol純化水系統(tǒng)驗證方案純化水系統(tǒng)驗證方案Date 日期20090301Company Name公司名稱Page 頁碼Page 7 of 40Check the purified water system supplier after service information and assure it is complete. The information include supplier name, address, phone, should filled in the attachment 13.檢查各主要設備售后服務資料是否齊全。包括單位名稱、地址、聯(lián)系電話、

29、保修及維修等詳細資料，確認記錄填寫于附件 13。4.2 Installation qualification/安裝確認安裝確認4.2.1 Public Media Connect, confirmation records fill in attachment 14.公用介質連接確認，確認記錄填寫于附件 14。4.2.1.1 Power Supply Installation confirmation/電源安裝確認Item/項目Standard/合格標準Method/確認方法electric voltage/電壓380V20 VMultimeter test/萬用表檢測Three-phase

30、five-wire/三相五線On-site inspection/現場檢查the line of electricity demand/進線要求YJV-42.5+BVR-12.5On-site inspection/現場檢查Ground Protection/接地保護Grounding resistance is less than 4/接地電阻小于 4Ohmmeter measurements/歐姆表測量4.2.1.2 Water supply installation confirmation/進水安裝確認Item/項目Standard/合格標準Method/確認方法Water quali

31、ty requirements/水質要求Should meet drinking water health standards (GB 5749-2006)/應符合生活飲用水衛(wèi)生標準（GB 5749-2006）See Water Quality Test Report/見水質檢測報告Pressure/壓力0.4MpaMeasured with pressure gauge/壓力表測量Pipe diameter/管道管徑DN32Measured with vernier caliper/游標卡尺測量Pipe material/管道材質PPInspection by Visual/目測Docume

32、nt No.文件編號Revision No.版本號00Purified Water System Validation Protocol純化水系統(tǒng)驗證方案純化水系統(tǒng)驗證方案Date 日期20090301Company Name公司名稱Page 頁碼Page 8 of 404.2.2 Purified water pipeline and Valves installation confirmation, the records fill in attachment 15./純化水管道及閥門(3 路)安裝確認，確認記錄填寫于附件 15.Item/項目Standard/合格標準Method/確認方

33、法Work press/操作壓力0.4MpaMeasured with pressure gauge/壓力表測量Pipe diameter/管道管徑DN322 Measured with vernier caliper/游標卡尺測量Pipe material/管道材質SS304 Consult pipe material certificate document and attach it in attachment16./檢查材質證明并附于附件 16Valves material/閥門材質SS304 Consult pipe material certificate document and

34、 attach it in attachment16./檢查材質證明并附于附件 16Installation requirement/ 安裝要求Using hot-melt-type welding joint connecting the health-quick, circular layout, smooth, no dead ends; each water point of use of diaphragm valves, the water intake point and the outlet layout drawings based on design requirement

35、s./采用熱熔式氬弧焊與衛(wèi)生快裝接頭連接，循環(huán)布置，光滑、無死角；每個用水點采用隔膜閥，各取水點及出水口的布置依據圖紙設計要求。Inspection by Visual and check the relative records./目測及檢查相關記錄4.2.3 purified water tank installation (A total of 1, water storage capacity of 1m3)/純化水儲罐安裝確認(一只，貯水量為 1m3) 4.2.3.1 Method: Inspection by Visual, Measured with vernier calipe

36、r and Consult material certificate document and attach it in attachment16, records fill in attachment 17.確認方法：目測、游標卡尺測量、檢查材質證明(附于附件 16),確認記錄填寫于附件 17。4.2.3.2 Standards/合格標準：（1）Tank inside and outside surface is polished, smooth surface./儲罐內外表面經過拋光，表面光潔。（2）Inside surface and sealed head: Material SS30

37、4 stainless steel, thickness 4mm/內筒體及封頭：材質 SS304 不銹鋼，厚度 4mm。（3）Connectors and related auxiliary equipment/連接口及相關配套設備： Purified water Inlet(top)/ 純化水入口(頂部)：DN15 Purified water Outlet(bottom)/純化水出口(底部)：DN20Document No.文件編號Revision No.版本號00Purified Water System Validation Protocol純化水系統(tǒng)驗證方案純化水系統(tǒng)驗證方案Date

38、 日期20090301Company Name公司名稱Page 頁碼Page 9 of 40 Limber hole(bottom of the lowest)/排污口（底部最低位置）：DN15 Clean hole (at the top of the middle position): DN32 With 3600 rotary cleaning ball, material SS304./清洗口(頂部正中位置)：DN32，配 3600旋轉清洗球，材質 SS304不銹鋼。 Breath hole (top)/呼吸口(頂部)：DN154.2.4 purified water storage

39、tank SCBA installation/純化水儲罐空氣呼吸器安裝確認.The record fill in attachment 18./確認記錄填寫于附件 18。Item/項目Standard/合格標準Method/確認方法Body material/殼體材質SS304 Consult material certificate document and attach it in attachment16./檢查材質證明并附于附件 16Filter material/過濾材質Polypropylene/聚丙烯Consult material certificate document an

40、d attach it in attachment16./檢查材質證明并附于附件 16Seal method/密封方法Melt together/熱熔合Consult certificate document and attach it in attachment16./檢查證明并附于附件 16Hole Diameter/孔徑0.22mConsult certificate document and attach it in attachment16./檢查證明并附于附件 164.2.5 Critical parts material qualification./關鍵部位材質確認.The r

41、ecords fill in attachment19./確認記錄填寫于附件 19。Requirement/要求Parts name/部件Body material/殼體材質Media and requirements/介質及要求Method/確認方法Original water pump/原水泵Stainless steel/不銹鋼/Consult material certificate document and attach it in attachment16./檢查材質證明并附于附件 16Multi-media filter/多介質過濾器FRPQuartz sand, anthrac

42、ite/石英砂、無煙煤Consult material certificate document and attach it in attachment16./檢查材質證明并附于附件 16Activated carbon filters/活性炭過濾器FRPActivated carbon/活性炭Consult material certificate document and Document No.文件編號Revision No.版本號00Purified Water System Validation Protocol純化水系統(tǒng)驗證方案純化水系統(tǒng)驗證方案Date 日期20090301Com

43、pany Name公司名稱Page 頁碼Page 10 of 40attach it in attachment16./檢查材質證明并附于附件 16Security filters/保安濾器Stainless steel/不銹鋼Polyethylene fiber/聚乙烯纖維Consult material certificate document and attach it in attachment16./檢查材質證明并附于附件 16High-pressure pump/高壓泵Stainless steel/不銹鋼/Consult material certificate document

44、 and attach it in attachment16./檢查材質證明并附于附件 16Cleaning Pumps/清洗泵Stainless steel/不銹鋼/Consult material certificate document and attach it in attachment16./檢查材質證明并附于附件 16reverse osmosis system element/一、二級反滲透元件Stainless steel/不銹鋼TFCConsult material certificate document and attach it in attachment16./檢查

45、材質證明并附于附件 16UV sterilizers/紫外線殺菌器Stainless steel/不銹鋼/Consult material certificate document and attach it in attachment16./檢查材質證明并附于附件 16Microporous filter (the number is 2)/微孔過濾器(2 個)Stainless steel/不銹鋼0.22m nylon filter /0.22m 尼龍液體過濾芯Consult material certificate document and attach it in attachment

46、16./檢查材質證明并附于附件 16Terminal pump/ 終端水泵Stainless steel/不銹鋼/Consult material certificate document and attach it in attachment16./檢查材質證明并附于附件 164.2.6 Pipeline pressure test, clean, passivation and disinfect qualification./管道分配系統(tǒng)的試壓、清洗、鈍化、消毒確認4.2.6.1 Qualification method/確認方法Inspect the pipeline pressure

47、 test record(attachment 5), clean record before use(attachment 6),pipeline passivation records(attachment 7) and pipeline disinfect records(attachment 8)./檢查純化水管路試壓記錄(附件 5)、純化水管道使用前清洗記錄(附件 6)、純化水管道鈍化記錄(附件 7)、純化水管道使用前消毒記錄(附件 8)4.2.6.2 Standards/合格標準（1）Pipeline pressure test/管路試壓：Pressure test with Wa

48、ter, experimental pressure is 0.6Mpa which is 1.5 times working pressure (0.4MPa); the pipeline should be no leakage under the pressure./用水Document No.文件編號Revision No.版本號00Purified Water System Validation Protocol純化水系統(tǒng)驗證方案純化水系統(tǒng)驗證方案Date 日期20090301Company Name公司名稱Page 頁碼Page 11 of 40試壓，實驗壓力為工作壓力（0.4MP

49、a）的 1.5 倍即 0.6Mpa，整個管路在實驗壓力下應無滲漏發(fā)生。（2）Pipeline clean, passivation and disinfect/管道清洗、鈍化、消毒 Purified water cycle pipeline Pre-washed: The purified water tank, pump and pipeline to connect into a cycle path, add sufficient amount of purified water to purified tank, open the pump to cycle for 15 minute

50、s, open the drain valve, and then continue cycle./純化水循環(huán)預沖洗：將純水罐、水泵與管路連接成一個循環(huán)通路，在純水罐中注入足夠量的純化水，開啟水泵進行循環(huán)，循環(huán) 15 分鐘后，打開排水閥，邊循環(huán)邊排放。 Alkaline Cleaning: The sodium hydroxide (chemically pure and above) with hot water (temperature 90 or above) preparation of 1% (w / v) solution (500L), with the circulation

51、pump more than 30 minutes (after 30 minutes opening Each water point of the valve for 10 seconds to wash their), open the drain valve, discharge lye./ 堿液清洗：將氫氧化鈉（化學純以上）用熱水（溫度 90以上）配制成1%（w/v）的溶液(500L)，用水泵循環(huán) 30 分鐘以上（期間隔 30 分鐘后開啟每個用水點閥門 10 秒鐘對其進行清洗） ，打開排水閥，排放堿液。 Rinse: Add purified water to purified wa

52、ter storage tank, start the pump, open the drain valve, rinse while discharge, discharge time should be no less than 30 minutes, until the conductivity of the water in the tank and the conductivity of outlet water is the same. / 沖洗：將純化水加入純水罐，啟動水泵，打開排水閥，邊沖洗邊排放，排放時間應不少于 30 分鐘，直至各出水口水的電導率與純水罐中水的電導率一致。

53、Passivation: The nitric acid (chemically pure and above) preparation of 5% of the acid (500kg), injection of pure water tank, recycling 120 minutes, using sodium hydroxide adjust PH=7 and discharge./鈍化：將硝酸（化學純以上）配制成 5%的酸液(500kg)，注入純水罐，循環(huán) 120 分鐘，用氫氧化鈉中和后排放。 Rinse: Rinse with purified water, no less t

54、han 30 minutes, until the conductivity of import and export purified water is the same./沖洗：用純化水沖洗，時間不少于 30 分鐘，直至進出口純化水的電導率一致。 Disinfection: preparation of 3% hydrogen peroxide disinfecting solution, add Document No.文件編號Revision No.版本號00Purified Water System Validation Protocol純化水系統(tǒng)驗證方案純化水系統(tǒng)驗證方案Date

55、日期20090301Company Name公司名稱Page 頁碼Page 12 of 40it to the pure water tank and start the pump, loop for 30 minutes (every 10 minutes opening discharge valve for each water point 10 seconds of its disinfection)./消毒：配制 3%的雙氧水消毒液，注入純水罐，啟動水泵，循環(huán) 30 分鐘（期間每隔 10 分鐘開啟每個用水點閥門排放 10 秒對其進行消毒） 。 Rinse: Rinse with pu

56、rified water, no less than 30 minutes, until the conductivity of import and export purified water is the same./沖洗：用純化水沖洗，時間不少于30 分鐘，直至進出口純化水的電導率值一致。4.3 Operation qualification/運行確認運行確認4.3.1 Control and safety protection performance confirmation/控制及安全保護性能確認Records fill in attachment 20./確認記錄填寫于附件 204

57、.3.1.1 Qualification Method/確認方法Check and assure that the control system and the corresponding direction is normal; over-voltage protection function, the water level automatic control functions, overload and short-circuit protection function, STOP function is accurate and effective.檢查控制系統(tǒng)運行及相應指示是否正常

58、；過壓保護功能、水位自動控制功能、過載及短路保護功能、 “急?！惫δ苁欠駵蚀_有效。4.3.1.2 Standards/合格標準The control system and the corresponding directions is normal; over-voltage protection function, the water level automatic control functions, overload and short-circuit protection function, E-STOP function are accurately and efficiently.

59、控制系統(tǒng)運行及相應指示正常；過壓保護功能、水位自動控制功能、過載及短路保護功能、“急?！惫δ軠蚀_有效。4.3.2 Two grade reverse osmosis low-pressure cleaning qualification/二級反滲透裝置低壓清洗確認4.3.2.1Qualification method/確認方法Measured with stopwatch and inspection by visual/用秒表測量、目測4.3.2.2 Standard/合格標準Every normal run, automatic low-pressure washing, original

60、 water pump start and low-pressure washing Two grade reverse osmosis systerm, the high-pressure pump 3-Document No.文件編號Revision No.版本號00Purified Water System Validation Protocol純化水系統(tǒng)驗證方案純化水系統(tǒng)驗證方案Date 日期20090301Company Name公司名稱Page 頁碼Page 13 of 40minute delay to start. The records fill in attachment

61、21.每次正常開機，裝置自動進行低壓沖洗，原水泵開啟對二級反滲透裝置低壓沖洗后，高壓泵延時 3 分鐘啟動，確認記錄填寫于附件 21。4.4 Performance Qualification/性能確認性能確認4.4.1Qualification method/確認方法（1）Operation according to the SOP No.（HS/SOP-CF-001）按純化水系統(tǒng)操作、維護保養(yǎng)標準操作規(guī)程 （HS/SOP-CF-001）操作和清洗消毒。（2）Open the purified water system in operation continuous 3 days, after

62、 running 1 hour every day, every use point open 10 minutes, the rest purified water returned to purified water storage tank for recycling. Sample the purified water of the purified water storage tank, the total outlet, the total return hole and test. All items should be qualified before start the ne

63、xt validation step.開啟純化水系統(tǒng)連續(xù)運行 3 天，每天運行制水 1 小時后，各用水點依次放水 10 分鐘，其余純水分別回到純化水貯罐進行循環(huán)，純化水貯罐、總出水口、總回水口依次取樣，檢測全部合格后再進行下步驗證。（3）Under normal circumstances, the verification process should monitor the water quality continued for 21 days, running the system 8 hours per day, sample and detect the purified water

64、 every day after the system running 1 hour, all water points open in turn for 10 minutes, the rest were returned to water purified storage tank to cycle./正常情況下，驗證過程的水質監(jiān)控持續(xù) 21 天，每天運行 8 小時，每天運行制水 1 小時后，各用水點依次放水 10 分鐘，其余純水分別回到純化水貯罐進行循環(huán)。（4）The sampling method is as follows (the distribution of water poi

65、nts see water purification water system network diagrams, attachment 10):/具體取樣方法如下（各取水點的分布見純化水系統(tǒng)用水網絡圖,附件 10）： Sample the purified storage, the total outlet, the total return hole every day during the validation./純化水貯罐、總出水口，總回水口在確認的全過程中每天取樣檢測。Document No.文件編號Revision No.版本號00Purified Water System Val

66、idation Protocol純化水系統(tǒng)驗證方案純化水系統(tǒng)驗證方案Date 日期20090301Company Name公司名稱Page 頁碼Page 14 of 40 Each cycle, the water sampling points, to take turns to ensure that all water points, rounds to take a times, each time samples were marked and recorded water intake numbers/每個周期，各用水點每天輪流取樣，保證各用水點輪取 1 次，每次取樣均注明取水口編號并記錄。 If due to sampling, testing and other factors, resulting in the individual water quality failure, we must consider re-sampling test. The re-sample as follows:由于取樣，化驗等因素，會出現個別水質不合格現象，必須考慮重新取樣化驗。方