Document No.文件編號(hào)VP-Revision No.版本號(hào)00Purified Water System Validation Protocol純化水系統(tǒng)驗(yàn)證方案純化水系統(tǒng)驗(yàn)證方案Date 日期20090301Company Name公司名稱Page 頁(yè)碼Page 1 of 40Purified Water System Validation Protocol純化水系統(tǒng)驗(yàn)證方案純化水系統(tǒng)驗(yàn)證方案Approval of the Purified Water System Validation Protocol純化水系統(tǒng)驗(yàn)證方案的審批純化水系統(tǒng)驗(yàn)證方案的審批Title 職務(wù)職務(wù)Name 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(fù)核人復(fù)核人Approved By 批準(zhǔn)人批準(zhǔn)人Document No.文件編號(hào)Revision No.版本號(hào)00Purified Water System Validation Protocol純化水系統(tǒng)驗(yàn)證方案純化水系統(tǒng)驗(yàn)證方案Date 日期20090301Company Name公司名稱Page 頁(yè)碼Page 2 of 40TABLE OF CONTENTS1 Summarize/概述.32 Purpose/驗(yàn)證目的.43Validation Team and Responsibilities/驗(yàn)證人員及職責(zé).43.1Validation Team Member/項(xiàng)目驗(yàn)證小組成員 .43.2 Responsibilities/職責(zé) .44 Content, Method and Criterion/驗(yàn)證內(nèi)容、方法及合格標(biāo)準(zhǔn).54.1Beforehand Qualification/預(yù)確認(rèn)（安裝前確認(rèn)）.54.2 Installation qualification/安裝確認(rèn).74.3 Operation qualification/運(yùn)行確認(rèn).114.4 Performance Qualification/性能確認(rèn) .125 Deviation and deal with method/驗(yàn)證過(guò)程中的偏差及處理.146 Validation Conclusion/驗(yàn)證結(jié)果評(píng)定與結(jié)論.147.Revalidation Periods/再驗(yàn)證周期.158Validation Schedule/驗(yàn)證時(shí)間安排 .159.Attachment/ 附件 .16Document No.文件編號(hào)Revision No.版本號(hào)00Purified Water System Validation Protocol純化水系統(tǒng)驗(yàn)證方案純化水系統(tǒng)驗(yàn)證方案Date 日期20090301Company Name公司名稱Page 頁(yè)碼Page 3 of 401 Summarize/概述概述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 pumped 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 particles 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 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 purified 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 unit 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(shè)計(jì)安裝，制水能力為 1.0m3/h，利用二級(jí)反滲透工藝來(lái)制取純化水。飲用水加入絮凝劑(PAC)后由原水泵增壓后進(jìn)多介質(zhì)過(guò)濾器、活性炭過(guò)濾器的過(guò)濾和吸附處理，除去水中顆粒狀雜質(zhì)、膠體、余氯、有機(jī)物等，使出水游離氯含量小于 0.1ppm，SDI4，再經(jīng)精密過(guò)濾器除去水中大于 5u 的顆粒后進(jìn)入二級(jí)反滲透系統(tǒng)，利用膜分離技術(shù)的高脫鹽率，除去水中大部份離子、SiO2、有機(jī)物膠體等雜質(zhì)，二級(jí)反滲透系統(tǒng)產(chǎn)水貯存于一只純化水貯罐，經(jīng)紫外線殺菌器殺死可能存在的細(xì)菌等后由終端水泵增壓并經(jīng)微孔過(guò)濾器過(guò)濾，通過(guò)不銹鋼管道送至各純化水用水點(diǎn)，用于配料用水、設(shè)備及容器具清洗、工作服清洗等。部份純化水通過(guò)循環(huán)管道回至純化水貯罐。簡(jiǎn)易流程為：原水（飲用水）原水箱絮凝劑加藥系統(tǒng)多介質(zhì)過(guò)濾器活性炭Document No.文件編號(hào)Revision No.版本號(hào)00Purified Water System Validation Protocol純化水系統(tǒng)驗(yàn)證方案純化水系統(tǒng)驗(yàn)證方案Date 日期20090301Company Name公司名稱Page 頁(yè)碼Page 4 of 40過(guò)濾器阻垢劑加藥系統(tǒng)保安濾器一級(jí)高壓泵一級(jí)反滲透裝置堿加藥系統(tǒng)二級(jí)高壓泵二級(jí)反滲透裝置純化水箱送水泵紫外線殺菌裝置終端微孔過(guò)濾器使用點(diǎn)。2 Purpose/驗(yàn)證目的驗(yàn)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(duì)純化水系統(tǒng)的安裝、運(yùn)行和性能進(jìn)行驗(yàn)證，以證明其有能力穩(wěn)定地供應(yīng)規(guī)定數(shù)量和質(zhì)量的合格用水。3Validation Team and Responsibilities/驗(yàn)證人員及職責(zé)驗(yàn)證人員及職責(zé)3.1Validation Team Member/項(xiàng)目驗(yàn)證小組成員項(xiàng)目驗(yàn)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 production management department is the leader of this validation team. Validation team members see attachment 2.項(xiàng)目驗(yàn)證小組由生產(chǎn)管理部、質(zhì)量管理部、設(shè)備工程科和操作工、維修工、QA、QC 組成，由生產(chǎn)管理部經(jīng)理任項(xiàng)目驗(yàn)證組組長(zhǎng)，驗(yàn)證小組成員見(jiàn)附件 2。3.2 Responsibilities/職責(zé)職責(zé)Equipment Engineering Division: Draft the validation protocol, Technical document qualification and 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.Validation Committee Director: Approved the validation protocol and the validation report.設(shè)備工程科：負(fù)責(zé)設(shè)備驗(yàn)證方案的起草及驗(yàn)證工作的具體實(shí)施，起草驗(yàn)證報(bào)告。生產(chǎn)部：復(fù)核驗(yàn)證方案，協(xié)助設(shè)備工程科進(jìn)行驗(yàn)證工作的實(shí)施。質(zhì)量部：負(fù)責(zé)驗(yàn)證文件的審核，負(fù)責(zé)相關(guān)檢驗(yàn)任務(wù)。驗(yàn)證委員會(huì)主任：負(fù)責(zé)設(shè)備及公用工程系統(tǒng)驗(yàn)證方案及報(bào)告的批準(zhǔn)。Document No.文件編號(hào)Revision No.版本號(hào)00Purified Water System Validation Protocol純化水系統(tǒng)驗(yàn)證方案純化水系統(tǒng)驗(yàn)證方案Date 日期20090301Company Name公司名稱Page 頁(yè)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 review and approval procedures for the approval before the Executive the change.驗(yàn)證過(guò)程應(yīng)嚴(yán)格按照本方案規(guī)定的內(nèi)容進(jìn)行，若因特殊原因確需變更時(shí)，應(yīng)填寫驗(yàn)證方案變更申請(qǐng)及批準(zhǔn)書(附件 1)，按原審批程序批準(zhǔn)后執(zhí)行。4 Content, Method and Criterion/驗(yàn)證內(nèi)容、方法及合格標(biāo)準(zhǔn)驗(yàn)證內(nèi)容、方法及合格標(biāo)準(zhǔn)4.1Beforehand Qualification/預(yù)確認(rèn)（安裝前確認(rèn)）預(yù)確認(rèn)（安裝前確認(rèn)）4.1.1 Document Qualification/資料確認(rèn)Confirmed that the relevant document to support the verification is complete, fill out confirm records in attachment 3./確認(rèn)支持本驗(yàn)證的相關(guān)資料是否齊全，確認(rèn)記錄填寫于附件 3Document name/資料名稱Confirm method/確認(rèn)方法Purified water system, the detailed design requirements and technical parameters of major equipment純化水系統(tǒng)詳細(xì)設(shè)計(jì)要求及主要設(shè)備技術(shù)參數(shù)Consult equipment archives查閱技術(shù)檔案Ordering the contract, specifications and related technical information純化水系統(tǒng)主要組成設(shè)備訂貨合同、說(shuō)明書及相關(guān)技術(shù)資料Consult equipment archives查閱技術(shù)檔案Mainly equipments Certificates各設(shè)備檢驗(yàn)合格證Consult equipment archives查閱技術(shù)檔案Purified water quality standards純化水質(zhì)量標(biāo)準(zhǔn)Consult CP-2005查閱技術(shù)檔案查閱藥典 2005 版純化水標(biāo)準(zhǔn)Purified 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(shù)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(hù)保養(yǎng)標(biāo)準(zhǔn)操作規(guī)程Consult the relative SOP查閱技術(shù)檔案Purified water system sample standard operating procedures純化水取樣標(biāo)準(zhǔn)操作規(guī)程Consult the relative SOP查閱技術(shù)檔案Purified water system cleaning standard operating procedures純化水系統(tǒng)清潔標(biāo)準(zhǔn)操作規(guī)程Consult the relative SOP查閱技術(shù)檔案Out of the box inspection records開(kāi)箱驗(yàn)收記錄Consult equipment archives查閱技術(shù)檔案Document No.文件編號(hào)Revision No.版本號(hào)00Purified Water System Validation Protocol純化水系統(tǒng)驗(yàn)證方案純化水系統(tǒng)驗(yàn)證方案Date 日期20090301Company Name公司名稱Page 頁(yè)碼Page 6 of 40Installation and commissioning records安裝調(diào)試記錄Consult equipment archives查閱技術(shù)檔案Test Run Record試運(yùn)行記錄Consult equipment archives查閱技術(shù)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 system network diagram純化水系統(tǒng)用水網(wǎng)絡(luò)圖Consult equipment archives and attached attachment 9.查閱附于附件 9Qualification proof of the equipment supplier各設(shè)備生產(chǎn)企業(yè)資質(zhì)證明材料Consult equipment archives and attached attachment 10.查閱附于附件 10The equipment inspection reports各設(shè)備檢驗(yàn)報(bào)告Consult equipment archives and attached attachment 11.查閱附于附件 114.1.2 Instrument calibration verification/儀器、儀表的檢定或校驗(yàn)確認(rèn)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(cè)所用的電導(dǎo)率儀等須經(jīng)檢定或檢驗(yàn)合格，并在檢定有效期內(nèi)，確認(rèn)記錄填寫于附件 12。下列儀器儀表必須經(jīng)過(guò)校驗(yàn)。Instrument Name/名 稱Specification/型 號(hào)（規(guī)格）Count/數(shù) 量Pressure gauges/耐振壓力表0-2.5MPa4Pressure gauges/耐振壓力表0-1MPa7conductivity meter/電導(dǎo)率儀/1PH meter /PH 計(jì)/14.1.3 After service Qualification/售后服務(wù)確認(rèn)Document No.文件編號(hào)Revision No.版本號(hào)00Purified Water System Validation Protocol純化水系統(tǒng)驗(yàn)證方案純化水系統(tǒng)驗(yàn)證方案Date 日期20090301Company Name公司名稱Page 頁(yè)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(shè)備售后服務(wù)資料是否齊全。包括單位名稱、地址、聯(lián)系電話、保修及維修等詳細(xì)資料，確認(rèn)記錄填寫于附件 13。4.2 Installation qualification/安裝確認(rèn)安裝確認(rèn)4.2.1 Public Media Connect, confirmation records fill in attachment 14.公用介質(zhì)連接確認(rèn)，確認(rèn)記錄填寫于附件 14。4.2.1.1 Power Supply Installation confirmation/電源安裝確認(rèn)Item/項(xiàng)目Standard/合格標(biāo)準(zhǔn)Method/確認(rèn)方法electric voltage/電壓380V20 VMultimeter test/萬(wàn)用表檢測(cè)Three-phase five-wire/三相五線On-site inspection/現(xiàn)場(chǎng)檢查the line of electricity demand/進(jìn)線要求YJV-42.5+BVR-12.5On-site inspection/現(xiàn)場(chǎng)檢查Ground Protection/接地保護(hù)Grounding resistance is less than 4/接地電阻小于 4Ohmmeter measurements/歐姆表測(cè)量4.2.1.2 Water supply installation confirmation/進(jìn)水安裝確認(rèn)Item/項(xiàng)目Standard/合格標(biāo)準(zhǔn)Method/確認(rèn)方法Water quality requirements/水質(zhì)要求Should meet drinking water health standards (GB 5749-2006)/應(yīng)符合生活飲用水衛(wèi)生標(biāo)準(zhǔn)（GB 5749-2006）See Water Quality Test Report/見(jiàn)水質(zhì)檢測(cè)報(bào)告Pressure/壓力0.4MpaMeasured with pressure gauge/壓力表測(cè)量Pipe diameter/管道管徑DN32Measured with vernier caliper/游標(biāo)卡尺測(cè)量Pipe material/管道材質(zhì)PPInspection by Visual/目測(cè)Document No.文件編號(hào)Revision No.版本號(hào)00Purified Water System Validation Protocol純化水系統(tǒng)驗(yàn)證方案純化水系統(tǒng)驗(yàn)證方案Date 日期20090301Company Name公司名稱Page 頁(yè)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(rèn)，確認(rèn)記錄填寫于附件 15.Item/項(xiàng)目Standard/合格標(biāo)準(zhǔn)Method/確認(rèn)方法Work press/操作壓力0.4MpaMeasured with pressure gauge/壓力表測(cè)量Pipe diameter/管道管徑DN322 Measured with vernier caliper/游標(biāo)卡尺測(cè)量Pipe material/管道材質(zhì)SS304 Consult pipe material certificate document and attach it in attachment16./檢查材質(zhì)證明并附于附件 16Valves material/閥門材質(zhì)SS304 Consult pipe material certificate document and attach it in attachment16./檢查材質(zhì)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 requirements./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(wú)死角；每個(gè)用水點(diǎn)采用隔膜閥，各取水點(diǎn)及出水口的布置依據(jù)圖紙?jiān)O(shè)計(jì)要求。Inspection by Visual and check the relative records./目測(cè)及檢查相關(guān)記錄4.2.3 purified water tank installation (A total of 1, water storage capacity of 1m3)/純化水儲(chǔ)罐安裝確認(rèn)(一只，貯水量為 1m3) 4.2.3.1 Method: Inspection by Visual, Measured with vernier caliper and Consult material certificate document and attach it in attachment16, records fill in attachment 17.確認(rèn)方法：目測(cè)、游標(biāo)卡尺測(cè)量、檢查材質(zhì)證明(附于附件 16),確認(rèn)記錄填寫于附件 17。4.2.3.2 Standards/合格標(biāo)準(zhǔn)：（1）Tank inside and outside surface is polished, smooth surface./儲(chǔ)罐內(nèi)外表面經(jīng)過(guò)拋光，表面光潔。（2）Inside surface and sealed head: Material SS304 stainless steel, thickness 4mm/內(nèi)筒體及封頭：材質(zhì) SS304 不銹鋼，厚度 4mm。（3）Connectors and related auxiliary equipment/連接口及相關(guān)配套設(shè)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(hào)Revision No.版本號(hào)00Purified Water System Validation Protocol純化水系統(tǒng)驗(yàn)證方案純化水系統(tǒng)驗(yàn)證方案Date 日期20090301Company Name公司名稱Page 頁(yè)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(zhuǎn)清洗球，材質(zhì) SS304不銹鋼。 Breath hole (top)/呼吸口(頂部)：DN154.2.4 purified water storage tank SCBA installation/純化水儲(chǔ)罐空氣呼吸器安裝確認(rèn).The record fill in attachment 18./確認(rèn)記錄填寫于附件 18。Item/項(xiàng)目Standard/合格標(biāo)準(zhǔn)Method/確認(rèn)方法Body material/殼體材質(zhì)SS304 Consult material certificate document and attach it in attachment16./檢查材質(zhì)證明并附于附件 16Filter material/過(guò)濾材質(zhì)Polypropylene/聚丙烯Consult material certificate document and attach it in attachment16./檢查材質(zhì)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(guān)鍵部位材質(zhì)確認(rèn).The records fill in attachment19./確認(rèn)記錄填寫于附件 19。Requirement/要求Parts name/部件Body material/殼體材質(zhì)Media and requirements/介質(zhì)及要求Method/確認(rèn)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(zhì)證明并附于附件 16Multi-media filter/多介質(zhì)過(guò)濾器FRPQuartz sand, anthracite/石英砂、無(wú)煙煤Consult material certificate document and attach it in attachment16./檢查材質(zhì)證明并附于附件 16Activated carbon filters/活性炭過(guò)濾器FRPActivated carbon/活性炭Consult material certificate document and Document No.文件編號(hào)Revision No.版本號(hào)00Purified Water System Validation Protocol純化水系統(tǒng)驗(yàn)證方案純化水系統(tǒng)驗(yàn)證方案Date 日期20090301Company Name公司名稱Page 頁(yè)碼Page 10 of 40attach it in attachment16./檢查材質(zhì)證明并附于附件 16Security filters/保安濾器Stainless steel/不銹鋼P(yáng)olyethylene fiber/聚乙烯纖維Consult material certificate document and attach it in attachment16./檢查材質(zhì)證明并附于附件 16High-pressure pump/高壓泵Stainless steel/不銹鋼/Consult material certificate document and attach it in attachment16./檢查材質(zhì)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(zhì)證明并附于附件 16reverse osmosis system element/一、二級(jí)反滲透元件Stainless steel/不銹鋼TFCConsult material certificate document and attach it in attachment16./檢查材質(zhì)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(zhì)證明并附于附件 16Microporous filter (the number is 2)/微孔過(guò)濾器(2 個(gè))Stainless steel/不銹鋼0.22m nylon filter /0.22m 尼龍液體過(guò)濾芯Consult material certificate document and attach it in attachment16./檢查材質(zhì)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(zhì)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(rèn)4.2.6.1 Qualification method/確認(rèn)方法Inspect the pipeline pressure 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(biāo)準(zhǔn)（1）Pipeline pressure test/管路試壓：Pressure test with Water, 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(hào)Revision No.版本號(hào)00Purified Water System Validation Protocol純化水系統(tǒng)驗(yàn)證方案純化水系統(tǒng)驗(yàn)證方案Date 日期20090301Company Name公司名稱Page 頁(yè)碼Page 11 of 40試壓，實(shí)驗(yàn)壓力為工作壓力（0.4MPa）的 1.5 倍即 0.6Mpa，整個(gè)管路在實(shí)驗(yàn)壓力下應(yīng)無(wú)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 minutes, open the drain valve, and then continue cycle./純化水循環(huán)預(yù)沖洗：將純水罐、水泵與管路連接成一個(gè)循環(huán)通路，在純水罐中注入足夠量的純化水，開(kāi)啟水泵進(jìn)行循環(huán)，循環(huán) 15 分鐘后，打開(kāi)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 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(xué)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(kāi)啟每個(gè)用水點(diǎn)閥門 10 秒鐘對(duì)其進(jìn)行清洗） ，打開(kāi)排水閥，排放堿液。 Rinse: Add purified water to purified water 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(dòng)水泵，打開(kāi)排水閥，邊沖洗邊排放，排放時(shí)間應(yīng)不少于 30 分鐘，直至各出水口水的電導(dǎo)率與純水罐中水的電導(dǎo)率一致。 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(xué)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 than 30 minutes, until the conductivity of import and export purified water is the same./沖洗：用純化水沖洗，時(shí)間不少于 30 分鐘，直至進(jìn)出口純化水的電導(dǎo)率一致。 Disinfection: preparation of 3% hydrogen peroxide disinfecting solution, add Document No.文件編號(hào)Revision No.版本號(hào)00Purified Water System Validation Protocol純化水系統(tǒng)驗(yàn)證方案純化水系統(tǒng)驗(yàn)證方案Date 日期20090301Company Name公司名稱Page 頁(yè)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(dòng)水泵，循環(huán) 30 分鐘（期間每隔 10 分鐘開(kāi)啟每個(gè)用水點(diǎn)閥門排放 10 秒對(duì)其進(jìn)行消毒） 。 Rinse: Rinse with purified 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(shí)間不少于30 分鐘，直至進(jìn)出口純化水的電導(dǎo)率值一致。4.3 Operation qualification/運(yùn)行確認(rèn)運(yùn)行確認(rèn)4.3.1 Control and safety protection performance confirmation/控制及安全保護(hù)性能確認(rèn)Records fill in attachment 20./確認(rèn)記錄填寫于附件 204.3.1.1 Qualification Method/確認(rèn)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(yùn)行及相應(yīng)指示是否正常；過(guò)壓保護(hù)功能、水位自動(dòng)控制功能、過(guò)載及短路保護(hù)功能、 “急?！惫δ苁欠駵?zhǔn)確有效。4.3.1.2 Standards/合格標(biāo)準(zhǔn)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.控制系統(tǒng)運(yùn)行及相應(yīng)指示正常；過(guò)壓保護(hù)功能、水位自動(dòng)控制功能、過(guò)載及短路保護(hù)功能、“急?！惫δ軠?zhǔn)確有效。4.3.2 Two grade reverse osmosis low-pressure cleaning qualification/二級(jí)反滲透裝置低壓清洗確認(rèn)4.3.2.1Qualification method/確認(rèn)方法Measured with stopwatch and inspection by visual/用秒表測(cè)量、目測(cè)4.3.2.2 Standard/合格標(biāo)準(zhǔn)Every normal run, automatic low-pressure washing, original water pump start and low-pressure washing Two grade reverse osmosis systerm, the high-pressure pump 3-Document No.文件編號(hào)Revision No.版本號(hào)00Purified Water System Validation Protocol純化水系統(tǒng)驗(yàn)證方案純化水系統(tǒng)驗(yàn)證方案Date 日期20090301Company Name公司名稱Page 頁(yè)碼Page 13 of 40minute delay to start. The records fill in attachment 21.每次正常開(kāi)機(jī)，裝置自動(dòng)進(jìn)行低壓沖洗，原水泵開(kāi)啟對(duì)二級(jí)反滲透裝置低壓沖洗后，高壓泵延時(shí) 3 分鐘啟動(dòng)，確認(rèn)記錄填寫于附件 21。4.4 Performance Qualification/性能確認(rèn)性能確認(rèn)4.4.1Qualification method/確認(rèn)方法（1）Operation according to the SOP No.（HS/SOP-CF-001）按純化水系統(tǒng)操作、維護(hù)保養(yǎng)標(biāo)準(zhǔn)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 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 next validation step.開(kāi)啟純化水系統(tǒng)連續(xù)運(yùn)行 3 天，每天運(yùn)行制水 1 小時(shí)后，各用水點(diǎn)依次放水 10 分鐘，其余純水分別回到純化水貯罐進(jìn)行循環(huán)，純化水貯罐、總出水口、總回水口依次取樣，檢測(cè)全部合格后再進(jìn)行下步驗(yàn)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 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(yàn)證過(guò)程的水質(zhì)監(jiān)控持續(xù) 21 天，每天運(yùn)行 8 小時(shí)，每天運(yùn)行制水 1 小時(shí)后，各用水點(diǎn)依次放水 10 分鐘，其余純水分別回到純化水貯罐進(jìn)行循環(huán)。（4）The sampling method is as follows (the distribution of water points see water purification water system network diagrams, attachment 10):/具體取樣方法如下（各取水點(diǎn)的分布見(jiàn)純化水系統(tǒng)用水網(wǎng)絡(luò)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(rèn)的全過(guò)程中每天取樣檢測(cè)。Document No.文件編號(hào)Revision No.版本號(hào)00Purified Water System Validation Protocol純化水系統(tǒng)驗(yàn)證方案純化水系統(tǒng)驗(yàn)證方案Date 日期20090301Company Name公司名稱Page 頁(yè)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(gè)周期，各用水點(diǎn)每天輪流取樣，保證各用水點(diǎn)輪取 1 次，每次取樣均注明取水口編號(hào)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(yàn)等因素，會(huì)出現(xiàn)個(gè)別水質(zhì)不合格現(xiàn)象，必須考慮重新取樣化驗(yàn)。方