【文章內(nèi)容簡介】 水池PW33四樓理化室水池PW34二樓水制備間 總出水點PW35二樓水制備間 總回水點 Operation and Design Features運行和設(shè)計特點The PW distribution system is designed for circulating 24 hours at normal temperature, and storage tank has installed pressure gauge, level sensor, temperature sensor and respirator. PW generation system can supply water automatically for level variations. The generation system start to work when water level of the tank is below 30%. When water level of the tank is up to 80%, it stopped. Rotary spray ball is installed on the water return inlet of storage tank to avoid cleaning deadlegs within the tank.該純化水分配系統(tǒng)設(shè)計為24小時常溫循環(huán)運行，純化水儲罐上安裝有壓力表、液位傳感器、溫度傳感器和呼吸器，純化水制備系統(tǒng)可根據(jù)液位的變化自動給儲罐補水。當(dāng)儲罐液位低于30%，制備系統(tǒng)開始工作，當(dāng)儲罐液位高于80%，制備系統(tǒng)停止供水。儲罐回水口安裝有旋轉(zhuǎn)噴淋球避免儲罐內(nèi)出現(xiàn)清洗死角。Pressure gauge is installed after the circulation pump to monitor the supplied water pressure. Pressure gauge, temperature sensor, conductivity and flow meter are installed on the loop. Circulation pump is interlocked with the flow meter for return water, so the return water flow rate can be frequencycontrolled automatically and maintained above 1m/s. Liquid level, conductivity, flow volume, temperature are monitored by PLC and HMI with appropriate alarming. The data can be printed and downloaded on puter.循環(huán)泵后安裝有壓力表監(jiān)測供水壓力，回路安裝有壓力表、溫度傳感器、電導(dǎo)率、流量計。循環(huán)泵與回水流量計連鎖控制，可自動變頻以維持回水流速大于1m/s。儲罐液位、電導(dǎo)率、流量、溫度參數(shù)均是由PLC和HMI進(jìn)行監(jiān)控并設(shè)置有適當(dāng)?shù)膱缶?，?shù)據(jù)可打印并用電腦下載。The PW Distribution System adopts pasteurization, and UV lamp installed on return water pipe can inhibit the growth of microorganism. The entire system is installed with assurance of drainage.分配系統(tǒng)可以通過一個自動控制的程序進(jìn)行巴氏消毒，回水管路安裝有UV燈可抑制微生物的滋生。整個系統(tǒng)的安裝被保證具有排水能力。System instruments which can be monitored via PLC of PW Generation and Distribution System and alarming can be generated, include: 純化水制備和分配系統(tǒng)通過可編程控制器（PLC）進(jìn)行監(jiān)控并可生成報警的系統(tǒng)儀表包括：l Storage tank level and temperature儲罐液位和溫度l PW return water temperature純化水回水溫度l PW return water conductivity純化水回水電導(dǎo)率l PW return water flow rate純化水回水流量l PW return water TOC 純化水回水TOCPW tank and distribution pipeline pressure can be indicated only on site, but can not be monitored via PLC純化水儲罐和分配管網(wǎng)壓力只能現(xiàn)場指示，不能進(jìn)行可編程控制器（PLC）監(jiān)控。Critical operation parameters of PW Storage and Distribution System can be stored and printed, such as conductivity and operation temperature純化水儲存和分配系統(tǒng)的關(guān)鍵運行參數(shù)電導(dǎo)率、運行溫度可進(jìn)行存儲并打印。9. Validation Strategy驗證策略 Performance Qualification Flow性能確認(rèn)流程. IQ、OQ Review: Review the IQ and OQ of this sytem before PQ beginning. PQ can begin after IQ and OQ pleted successfully.IQ、OQ 審核 :在開始性能確認(rèn)前審核該系統(tǒng)的安裝和運行確認(rèn)，成功完成后才能開始性能確認(rèn)。. Standard Operating Procedure (SOP) and training document verification: before PQ execution, System Operation and Maintenance Procedure shall be available. Revew the application of SOP and update it in time during PQ execution.標(biāo)準(zhǔn)操作流程（SOP）和培訓(xùn)文件確認(rèn) ：在性能確認(rèn)前應(yīng)具備至少為草稿版的系統(tǒng)運行維護(hù)操作規(guī)程，在性能確認(rèn)期間審核系統(tǒng)SOP的適用性，如需要及時更新。. Calibration review: to verify that all the test equipments have been calibrated and within due date.校驗審核 ：確認(rèn)所有測試設(shè)備都經(jīng)過校驗。. System performance and water quality verification: to verify the operation of PW system is conforming to the requirements, and it can consistently produce PW conforming to the relevant requirements specified in CP2010.系統(tǒng)性能和水質(zhì)確認(rèn) ： 確定純化水系統(tǒng)的操作符合規(guī)定，能持續(xù)生產(chǎn)符合CP 2010對純化水的要求。. Sampling plan of Phase 1 and phase 2 see Performance Sampling Plan.純化水系統(tǒng)的性能確認(rèn)將為階段階段2階段進(jìn)行。. Record the critical online operation parameters of PW System once a day during PQ Phase 1 and 2, so as to verify the system is running consistently without any faults.在性能確認(rèn)階段階段2期間每天記錄一次純化水制備、儲存和分配系統(tǒng)的關(guān)鍵在線運行參數(shù)，確認(rèn)系統(tǒng)持續(xù)運行而不能出現(xiàn)故障。 PQ sampling plan性能確認(rèn)取樣計劃PW system PQ is performed in three phases:純化水系統(tǒng)性能確認(rèn)將分為三個階段進(jìn)行：Phase 1: it is an intensive sampling period of three weeks (21 days). The purpose is to verify the new PW system can consistently produce and supply PW conforming to the requirements. During Phase 1, the system shall be running continuously without any faults or performance deviations. Phase 1 sampling plan is listed in Table 1, including:階段1：階段1是一個為期三周（21天）的密集取樣期，目的是證明新建的純化水系統(tǒng)能夠持續(xù)生產(chǎn)和分配符合要求的純化水，在此期間，系統(tǒng)需要持續(xù)運行而不能出現(xiàn)故障或性能偏差。階段1取樣計劃在表1中詳細(xì)列出，包括： Testing the feed water once a quarter in three phases working period for PW system PQ. 在PQ取樣三階段內(nèi)，每季度測試一次供水。 Testing the SDI of waterproducded by multimedia, testing the free chlorine of waterproducded by the active carbon filter and testing the hardness of waterproducded by softer once weekly over a three weeks at sampling point to assess the efficacy of the multimedia, active carbon filter and softening units. 在多介質(zhì)過濾器取樣點測試產(chǎn)水的SDI，在活性炭取樣點測試產(chǎn)水的余氯，在軟化器取樣點測試產(chǎn)水的硬度，在連續(xù)三周取樣時，每周測試一次。從而評估供水處的多介質(zhì)過濾器、活性炭和軟化單元的效率。 Sampling at outlet of PW Generation everyday.在純化水機(jī)產(chǎn)水口處每天進(jìn)行取樣。 Total feed water outlet () and total return water outlet () of PW Storage and Distribution Loop shall be sampled everyday.純化水儲存和分配環(huán)路總供水口（）和總回水口（）每天進(jìn)行取樣。 Each PW user point shall be sampled everyday.純化水每個使用點每天進(jìn)行取樣。After two weeks testing, a summary of test results will be produced. If the test results form to the requirements and the identified deviations are closed, PW can be used for process validation and/or other equipment qualification.完成二周的測試之后，對測試結(jié)果進(jìn)行總結(jié)。如果測試結(jié)果符合要求并且已經(jīng)解決所發(fā)現(xiàn)的偏差情況，系統(tǒng)產(chǎn)品可供進(jìn)行工藝驗證或其它設(shè)備的驗證使用。. Phase 2: the purpose is to verify system can consistently produce and distribute qualified PW if the system operates as per the corresponding SOP. Sampling period is same with the one of Phase 1, as consistently sampling three weeks 21 days. During this period, system needs to consistently run without any faults or performance deviation. The detailed Phase 2 sampling plan is listed in Table 2, including:階段2：階段2的目的是證明系統(tǒng)在按照相應(yīng)的SOP操作后能持續(xù)生產(chǎn)和分配符合要求的純化水。取樣周期和階段1保持一致同樣為三周21天連續(xù)取樣，在此期間，系統(tǒng)需要持續(xù)運行而不能出現(xiàn)故障或性能偏差。 階段2取樣計劃在表2中詳細(xì)列出，包括： Testing the feed water once a quarter in three phases working period for PW system PQ. 在PQ取樣三階段內(nèi)，每季度測試一次供水。 Testing t