純化水系統(tǒng)操作確認(rèn)OQ(中英文)

1、execution approval signatures 批準(zhǔn)執(zhí)行簽名批準(zhǔn)執(zhí)行簽名 the signatures below indicate approval of this protocol and its attachments and indicate that it is ready for execution. any changes or modifications to the intent or the acceptance criteria of this protocol, following approval, requires the generation of a

2、n amendment which must be approved prior to execution. 下面的簽名表示批準(zhǔn)本文件及其附件，且表明已經(jīng)為執(zhí)行作好了準(zhǔn)備。在批準(zhǔn)后，對本文件的目的或驗(yàn)收標(biāo)準(zhǔn) 進(jìn)行的任何改變或修正都必須起改善的作用，在執(zhí)行以前就必須取得批準(zhǔn)。 department current good manufacturing practice for finished pharmaceuticals 21 cfr 第 210 和 211 部分：聯(lián)邦條例法典，成品藥 cgmp usp 32 - united states pharmacopeia usp 32 美國藥典

3、nist - national institute of standards and technology nist 美國國家標(biāo)準(zhǔn)技術(shù)研究所 draft sop of the pw system 純化水系統(tǒng)的 sop 草案 6.0responsible parties and responsibilities 責(zé)任方及其責(zé)任責(zé)任方及其責(zé)任 shanghai baoju fluid equipment engineering co., ltd. 上海寶鉅流體設(shè)備工程有限公司. writing, of this protocol. 編寫本文件 review and approval of the

4、original protocol. 審核和批準(zhǔn)原始文件 review and approval of the completed protocol package 審核和批準(zhǔn)完成的文件包 engineering / maintenance responsibilities: 工程/維護(hù)責(zé)任 supply support and technical expertise needed in the preparation and execution of the protocol. 準(zhǔn)備和執(zhí)行文件時(shí)提供支持和技術(shù)意見 supply all documents, data, procedures,

5、 manuals, and drawings needed to generate and execute the protocol 提供編寫和執(zhí)行本文件時(shí)所需要的所有文件、數(shù)據(jù)、程序、手冊和圖紙 manufacturing responsibilities: 生產(chǎn)責(zé)任 execution of qualification packages 執(zhí)行確認(rèn)文件包 supply all procedures, data, manuals, drawings, and documentation needed to generate and execute the protocol 提供文件編寫和執(zhí)行時(shí)

6、所需的所有程序、數(shù)據(jù)、手冊、圖紙和文件 yung shin pharm. ind. (ks) co., ltd： 永信藥品工業(yè)（昆山）有限公司: oversee the validation process. 監(jiān)督驗(yàn)證程序 supply support needed in the preparation and execution of the protocol. 準(zhǔn)備和執(zhí)行文件時(shí)提供支持 review and approval of the original protocol. 審核和批準(zhǔn)原始文件 review and approval of the completed protocol p

7、ackage. 審核和批準(zhǔn)完成的文件包 7.0system description 系統(tǒng)說明系統(tǒng)說明 general description 總說明總說明 1)production capacity 產(chǎn)能 production capacity of the pw system is specified at 1000 liters per hour purified water (pw). 純化水系統(tǒng)的產(chǎn)能定為每小時(shí) 1000 升純化水（pw）。 2)quality standard of pw system 純化水系統(tǒng)的質(zhì)量標(biāo)準(zhǔn) the pw system will meet the fo

8、llowing criteria: 純化水系統(tǒng)將達(dá)到以下標(biāo)準(zhǔn)： pw quality standards as defined in usp 28 water for pharmaceutical purposes usp 28 制藥用水定義的純化水質(zhì)量標(biāo)準(zhǔn) meet gmp and fda requirements and pass appropriate qualification/validation 達(dá)到 gmp 和 fda 的要求，通過相關(guān)的確認(rèn)/驗(yàn)證。 3)distribution loop 分配回路 the pw system distribution loop will be

9、constructed of 316l stainless steel pipe with orbital welded joints. complete specifications for the pipe, valves, pumps, and connectors are provided in the technical specification of purified water system for yung shin pharm.ind.(ks)co.,ltd. project. the pw system distribution loop distributes puri

10、fied water to the use points listed below. 純化水系統(tǒng)的循環(huán)回路由帶軌道自動焊接焊點(diǎn)的 316l 不銹鋼管道建造。 永信藥品工業(yè)（昆山）有限公司純化水系統(tǒng)技術(shù)規(guī)范中說明了關(guān)于管道、閥門、泵和接頭的詳細(xì)規(guī)范。 純化水系統(tǒng)循環(huán)回路分配純化水到下面列出的使用點(diǎn)。 4)purified water (pw) loop 純化水回路 一樓軟膏調(diào)劑室 一樓洗滌室 一樓混合造粒室 一樓洗滌室 一樓洗滌室 三樓洗盤室 三樓洗烘衣 m130 三樓潔具 三樓洗滌 三樓洗滌 m110 色水罐 三樓洗手 三樓手消 三樓洗手 pretreatment unit 預(yù)處理單元預(yù)處理單

11、元 the pretreatment unit consists of the following components, listed in the order of process flow: 預(yù)處理單元包含以下部件，按流程圖的順序列出依次為： 1)chemical container and dosing pump 化學(xué)容器和計(jì)量泵 a 80 liter pe tanks and dosing pumps are used to add flocculating and anti-scaling agents to the raw water. 用一個(gè) 80 升的 pe 箱和計(jì)量泵在原水

12、中加入絮凝劑和反垢劑。 2)sandfilter 沙濾器 the sand filter unit employs quartz sand in a 304 stainless steel housing to remove suspended solids and colloidal materials from the incoming water. 沙濾器單元利用 304 不銹鋼罐體中的石英砂來除去進(jìn)水中的懸浮物質(zhì)和膠質(zhì)材料。 3)heat exchanger (pretreatment)熱交換器 (預(yù)處理) a heat exchanger is used to maintain wa

13、ter temperature at 25oc for optimum purification performance. and also it is used to maintain water temperature at 80 when sterilizing the carbon filter。 為了達(dá)到最佳凈化性能，使用熱交換器使水溫保持在 25oc 。在碳過濾器滅菌時(shí)，使用熱交換器使水溫 保持在 80，達(dá)到滅菌效果。 4)activated carbon filter 活性炭過濾器 the activated carbon filter uses activated carbon

14、 in a 304 stainless steel housing to remove organic compounds, chlorine, odors, and reduce turbidity from the incoming water. 活性炭過濾器在 304 不銹鋼罐體內(nèi)使用活性炭來除去進(jìn)水中的有機(jī)化合物、氯、氣味和減少濁度。 5)softener 軟化器 to reduce raw water hardness by softener. 用軟化器降低原水的硬度。 6)brine tank 鹽水箱 the auto control valve on the top of sof

15、tener periodically adopts brine from the brine tank for the use of softener regeneration. 軟化器上的自動頭定時(shí)從鹽箱中抽鹽水,以再生軟化器. 7)precision filter 精細(xì)過濾器 the precision filter employs a 5-micron membrane filter to remove any remaining particles to prevent contamination of the reverse osmosis (ro) membranes. 精細(xì)過濾器

16、采用 5 微米膜過濾來除去任何殘留的微粒，以防止對反滲透（ro）膜的污染。 reverse osmosis (ro) system 反滲透反滲透 (ro) 系統(tǒng)系統(tǒng) the r.o system is supplied from a standard water softener and pre-treatment system. r.o 系統(tǒng)的水來自標(biāo)準(zhǔn)水軟化器和預(yù)處理系統(tǒng)。 1)booster pump 增壓泵 a 4 kw pumps are used to pressurize the ro system. 用一個(gè) 4 kw 的泵來給 ro 系統(tǒng)增壓。 2)ro cleaning ta

17、nk ro 藥洗箱 a 120 liter pe tank is used to feed cleaning agents, during period ro membrane cleaning process. 在 ro 膜潔凈程序中用一個(gè) 120 升 pe 箱來補(bǔ)充清潔劑。 3)ro water storage tank ro 貯水箱 the ro water storage tank will be constructed of 304 stainless steel. the tank capacity shall be 2 tons. ro 貯水箱由 304 不銹鋼制造。容量為 2

18、噸。 mixed bed system 混床混床系統(tǒng)系統(tǒng) 1）mixed bed 混床 the mixed bed system adopts anion resin and cation resin to remove the cation and anion in the water and thus to reduce water conductivity. 混床系統(tǒng)利用陰陽離子樹脂來除去水中的陽離子和陰離子,降低水的電導(dǎo)率. 2）acid tank and alkali tank 酸堿水箱 the acid and alkali in the acid tank and alkali

19、tank is used to regenerate the anion and cation in the mixed bed. 酸堿水箱中的酸和堿用于再生混床中的陰陽離子. 3）mixed bed regeneration pump 混床再生泵 the system adopts dual 480w regeneration pumps to feed acid and alkali separately into the mixed bed for generation. 系統(tǒng)使用兩個(gè) 480w 的再生泵分別將酸和堿打入混床進(jìn)行再生. 4）micro filter 微濾器 the pre

20、cision filter employs a 1-micron membrane filter to remove any remaining particles following the mixed bed system. 精細(xì)過濾器在混床后,采用 1 微米膜過濾來除去任何殘留的微粒， 核子級樹脂交換系統(tǒng) 1)feed water tank 原水箱 the feed water tank is constructed of 316l with a capacity of 1000 liters. 給水箱材料為 316l，容量為 1000 升。 2)feed water pumps 進(jìn)料水

21、泵 one 0.48 kw pumps provide feed water to the system. 一個(gè) 0.48 kw 的泵為系統(tǒng)給水。 3)nucleon-class resin tank 核子級樹脂罐 a fre nucleon-class resin tank with pe liner is adopted for ion exchange. 用一個(gè) fre 襯 pe 的核子級樹脂罐中的核子級樹脂進(jìn)行離子交換。 4)the precision filter 微濾器 the precision filter employs a 0.22-micron membrane filt

22、er to remove any remaining particles. 精細(xì)過濾器采用 0.22 微米膜過濾來除去任何殘留的微粒。 4)ultraviolet sterilizer 紫外線消毒器 an ultraviolet sterilizer is installed to eliminate bacteria. 安裝一個(gè)紫外線消毒器來除去細(xì)菌。 monitor and control system 監(jiān)視和控制系統(tǒng)監(jiān)視和控制系統(tǒng) the entire pw/wfi system shall be automatically monitored and automatically con

23、trolled by plc (programmable logic control). 整個(gè) pw/wfi 系統(tǒng)應(yīng)該由 plc（可編程邏輯控制）自動監(jiān)視和自動控制。 8.0testing procedures 檢驗(yàn)程序檢驗(yàn)程序 the operational qualification will be performed using the protocol attachments. all pertinent information will be recorded on these forms. copies of the forms may be made as necessary.

24、document results and data concurrently with the execution of this protocol. mark through any unused spaces with a single line and initial and date. mark spaces that do not apply to the system being qualified with not applicable (n/a) and provide an explanation where appropriate. document any deviati

25、ons or abnormalities observed during the execution of the protocol. 進(jìn)行操作鑒定要用到文件附件。所有相關(guān)信息都將會記錄在這些表格上。如果需要可以復(fù)印這些表格。 記錄下執(zhí)行文件時(shí)的結(jié)果和數(shù)據(jù)。用單線劃過不用的地方，簽名且注明日期。用不合適（n/a）標(biāo)明 不適合系統(tǒng)的地方，并且在合適的地方寫明理由。記錄下執(zhí)行文件時(shí)發(fā)現(xiàn)的任何偏差或不正常的情況。 note: any exceptions to this protocol must be fully investigated and documented. this oq can b

26、e considered acceptable with exceptional data only if the cause of the exception has been determined or an assignable cause can be attributed to it and it can be proven that such data will not invalidate the protocol studies. quality assurance is responsible for determining the acceptability of any

27、exceptional data 備注：備注： 對本文件中的任何例外進(jìn)行完全調(diào)查和記錄。只有當(dāng)例外的原因已經(jīng)確定，或可以歸結(jié)為特定的原因， 且能證明該數(shù)據(jù)不會使文件無效時(shí)，這個(gè)有例外數(shù)據(jù)的 oq 才可以接受，qa 有權(quán)決定是否接受例外 數(shù)據(jù)。 9.0 acceptance criteria 驗(yàn)收標(biāo)準(zhǔn)驗(yàn)收標(biāo)準(zhǔn) test equipment and materials - all test equipment used during protocol execution must be documented. if the test equipment is not calibrated, a r

28、eason must be recorded and justified. 檢驗(yàn)設(shè)備和材料- 文件執(zhí)行過程中的所有檢驗(yàn)設(shè)備都必須有記錄。如果檢驗(yàn)設(shè)備沒有校驗(yàn)，必須寫 明并說明理由。 all data forms required for execution of the protocol must be completely, accurately, and properly filled out. 執(zhí)行文件時(shí)所有必需的數(shù)據(jù)表都必須完整、準(zhǔn)確，且正確填寫。 all criteria specified on the data sheets must be met. 符合數(shù)據(jù)表中指定的所有標(biāo)準(zhǔn)。

29、 all validation tests outlined in the protocol attachments must be successfully executed with the results noted on the appropriate pages. all verifications must be answered “yes” or a protocol deviation must be documented. re-testing must be described and justified. 文件附件指定的所有驗(yàn)證測試都必須成功的進(jìn)行，并在相關(guān)頁面上記錄結(jié)果

30、。所有的審核都必須 回答“是”，否則記錄為文件偏差。進(jìn)行重新測試時(shí)必須進(jìn)行記錄，證明其合理性。 all deviations must have been corrected or an action plan for correction of the deviation(s) must have been developed 所有的偏差必須糾正，或提出一個(gè)糾偏計(jì)劃。 attachment 1 - validation test equipment and materials 附件附件 1驗(yàn)證驗(yàn)證測試設(shè)備和材料測試設(shè)備和材料 list the instruments/equipment/ma

31、terials not installed on or part of the equipment and/or system being qualified that are used for the installation qualification. 在下表中列出安裝確認(rèn)中要使用，但未安裝的儀器/設(shè)備/材料，或需鑒定的設(shè)備和/或系統(tǒng)的一部分。 note: this sheet may be copied, if necessary.注：如果需要，該表可以復(fù)印。page _ of _第_頁 共_頁 description 說明說明 calibrated (y/n) 已校驗(yàn)已校驗(yàn) （是（是

32、/否）否） id no./ serial no. . id 號號 系列號系列號 calibration date 校驗(yàn)日期校驗(yàn)日期 calibration due date 校驗(yàn)到期日校驗(yàn)到期日 copies of the most recent calibration reports for applicable instruments are: 儀器的最近校驗(yàn)報(bào)告復(fù)印件在 ( ) attached附件中 comments: 注釋： acceptance criteria: all test equipment used during protocol execution must be d

33、ocumented. if the test equipment is not calibrated, a reason must be recorded and justified. 驗(yàn)收標(biāo)準(zhǔn)：驗(yàn)收標(biāo)準(zhǔn)：記錄下文件執(zhí)行過程中所有的檢測設(shè)備。如果檢測設(shè)備沒有校驗(yàn)，則記錄原因，說明理由。 meets acceptance criteria 符合驗(yàn)收標(biāo)準(zhǔn)符合驗(yàn)收標(biāo)準(zhǔn): yes 是是( ) no 否否 ( ) compiled by編輯: _date日期: _ attachment 2 - sand filter data sheet 附件附件 2 砂砂濾器數(shù)據(jù)表濾器數(shù)據(jù)表 equipment no

34、./id tag 設(shè)備編號./id 標(biāo)簽: _ backwash cycle verification 反沖循環(huán)檢驗(yàn) manually initiate the backwash cycle. record the time when the cycle starts. record the time when the backwash phase for the filter unit ends and the rinse phase for the filter unit starts. record the time when the rinse phase for the filter

35、 unit ends and the unit returns to service. 手動開啟反沖循環(huán)。記下循環(huán)開始的時(shí)間。記下過濾器單元反沖階段結(jié)束的時(shí)間和沖洗階段開始的時(shí) 間。記下過濾器沖洗階段結(jié)束的時(shí)間和重新工作的時(shí)間。 cycle start time 循環(huán)開始的時(shí)刻: backwash start time反沖開始的時(shí)間: _ backwash end time 反沖結(jié)束的時(shí)刻: _length of backwash 反沖時(shí)間的長短: _ rinse end time 沖洗結(jié)束的時(shí)刻: _length of rinse 沖洗持續(xù)的時(shí)間: _ cycle end time 循環(huán)結(jié)束

36、的時(shí)刻: _length of cycle 循環(huán)持續(xù)的時(shí)間:_ upstream of sand filter 砂過濾器的上游 turbidity 濁度: _ downstream of sand filter 砂過濾器的下游 turbidity 濁度: _ operational specification: the downstream turbidity will less than 1ntu 操作規(guī)范操作規(guī)范: 砂過濾器下游的濁度少于 1ntu。 acceptance criteria: the turbidity will meet the operational specifica

37、tion on the downstream side of the sand filter. 驗(yàn)收標(biāo)準(zhǔn)驗(yàn)收標(biāo)準(zhǔn): 砂過濾器下游水的濁度符合操作規(guī)范 meets acceptance criteria 符合驗(yàn)收標(biāo)準(zhǔn)符合驗(yàn)收標(biāo)準(zhǔn): yes 是是( ) no 否否 ( ) verified by 檢驗(yàn)人: date 日期: attachment 3 - carbon filter data sheet 附件附件 3 - 碳濾器數(shù)據(jù)表碳濾器數(shù)據(jù)表 equipment no./id tag 設(shè)備編號./id 標(biāo)簽: _ backwash cycle verification 反沖循環(huán)檢驗(yàn) manual

38、ly initiate the backwash cycle. record the time when the cycle starts. record the time when the backwash phase for the filter unit ends and the rinse phase for the filter unit starts. record the time when the rinse phase for the filter unit ends and the unit returns to service. 手動開啟反沖循環(huán)。記下循環(huán)開始的時(shí)間。記下

39、過濾器單元反沖階段結(jié)束的時(shí)間和沖洗階段開始的時(shí) 間。記下過濾器沖洗階段結(jié)束的時(shí)間和重新工作的時(shí)間。 cycle start time 循環(huán)開始的時(shí)刻: backwash start time反沖開始的時(shí)間: _ backwash end time 反沖結(jié)束的時(shí)刻: _length of backwash 反沖時(shí)間的長短: _ rinse end time 沖洗結(jié)束的時(shí)刻: _length of rinse 沖洗持續(xù)的時(shí)間: _ cycle end time 循環(huán)結(jié)束的時(shí)刻: _length of cycle 循環(huán)持續(xù)的時(shí)間:_ upstream of carbon filter 碳過濾器的上游

40、 total chlorine 總氯: _ free chlorine 游離氯: _ downstream of carbon filter 碳過濾器的下游 total chlorine 總氯: _ free chlorine 游離氯: _ operational specification: the total chlorine count will less than 0.1 ppm total chlorine 操作規(guī)范操作規(guī)范: 總氯少于 0.1 ppm。 acceptance criteria: the total chlorine count will meet the opera

41、tional specification on the downstream side of the carbon filter. 驗(yàn)收標(biāo)準(zhǔn)驗(yàn)收標(biāo)準(zhǔn): 碳過濾器下游水的總氯的量符合操作規(guī)范 meets acceptance criteria 符合驗(yàn)收標(biāo)準(zhǔn)符合驗(yàn)收標(biāo)準(zhǔn): yes 是是( ) no 否否 ( ) verified by 檢驗(yàn)人: date 日期: attachment 4 - softener data sheet 附件附件 4 軟化軟化器數(shù)據(jù)表器數(shù)據(jù)表 equipment no./id tag 設(shè)備編號./id 標(biāo)簽: _ regeneration cycle verificat

42、ion 再生循環(huán)檢驗(yàn) manually initiate the regeneration cycle. record the time when the cycle started. record the time when the backwash phase for the softener unit ends and the brine soak phase for the unit starts. record the time when the brine soak phase for the softener unit ends and the rinse phase for t

43、he unit starts. record the time when the rinse phase for the softener unit ends and the brine tank fill phase for the unit starts. record the time when the brine tank fill phase for the unit ends and the softener system returns to service. add a drop of indicator into 50ml of softener downstream sam

44、ple， which is acceptable if it turns blue。 手動開啟再生循環(huán)。記下循環(huán)開始的時(shí)間。記下軟化器單元反沖階段結(jié)束的時(shí)間和單元中鹽水沖洗階 段開始的時(shí)間。記下軟化器單元 鹽水沖洗結(jié)束的時(shí)間和鹽箱注水開始的時(shí)間。記下單元中鹽箱注水結(jié) 束的時(shí)間和軟化器系統(tǒng)重新工作的時(shí)間。完成后取 50ml 軟化器后水樣，加入 1 滴軟水指示劑并搖晃， 觀察其顏色，水呈藍(lán)色則為合格。 cycle start time 循環(huán)開始的時(shí)刻: backwash start time反沖開始的時(shí)間: _ backwash end time 反沖結(jié)束的時(shí)刻: _length of backw

45、ash 反沖時(shí)間的長短: _ brine cycle end time 鹽水循環(huán)結(jié)束時(shí)刻: _ length of brine cycle 鹽水循環(huán)的時(shí)間長短 _ rinse end time 沖洗結(jié)束的時(shí)刻: _length of rinse 沖洗時(shí)間的長短: _ brine tank fill end time 鹽箱注水結(jié)束的時(shí)刻: _ length of brine tank fill 鹽箱注水時(shí)間長短: _ cycle end time 循環(huán)結(jié)束的時(shí)刻:length of cycle 循環(huán)的時(shí)間長短: _ hardness before regeneration 再生前的硬度: _ h

46、ardness after regeneration 再生后的硬度: _ water is blue with indicator dropped 加入指示劑后水樣顏色為藍(lán)色：（ ）yes 是 （ ）否 no field notes: 現(xiàn)場注釋 acceptance criteria: all required data will be collected and recorded. all the yes/no questions should be answered with yes. 驗(yàn)收標(biāo)準(zhǔn)驗(yàn)收標(biāo)準(zhǔn): 所有必須的數(shù)據(jù)都已經(jīng)收集到且記錄下來。所有的是/否問題都回答為是。 meets ac

47、ceptance criteria 符合驗(yàn)收標(biāo)準(zhǔn)符合驗(yàn)收標(biāo)準(zhǔn): yes 是是( ) no 否否 ( ) verified by 檢驗(yàn)人: date 日期: attachment 5 - 5.0 m micron filter data sheet 附件附件 5 - 5.0 微米過濾器數(shù)據(jù)表微米過濾器數(shù)據(jù)表 equipment no./id tag 設(shè)備編號./id 標(biāo)簽: _ use 用途: ( )pre-filter 前過濾 ( )post-filter 后過濾 ( )point of use 使用點(diǎn) ( )vent 通風(fēng)口 ( )other 其他 type 類型:( ) sock 筒形(

48、) plate and frame 板架型 ( ) other 其他 date filter element installed 濾芯安裝日期: inlet pressure 入口壓力: outlet pressure 出口壓力: _ differential pressure 壓 差: field notes 現(xiàn)場注釋: acceptance criteria: filter differential pressure is between 00.1mpa, and all recorded data meets the attached specifications of the filt

49、er manufacturer. 驗(yàn)收標(biāo)準(zhǔn)驗(yàn)收標(biāo)準(zhǔn): 過濾器的壓差在 00.1mpa 之間，所有記錄的數(shù)據(jù)達(dá)到附件中過濾器生產(chǎn)商的規(guī)范。 meets acceptance criteria 符合驗(yàn)收標(biāo)準(zhǔn)符合驗(yàn)收標(biāo)準(zhǔn): yes 是是( ) no 否否 ( ) verified by 檢驗(yàn)人: date 日期: attachment 6 - reverse osmosis unit data sheet 附件附件 6 - 反滲透單元數(shù)據(jù)表反滲透單元數(shù)據(jù)表 equipment no./id tag 設(shè)備編號./id 標(biāo)簽: _ inlet pressure: 入口壓力 outlet pressure

50、 出口壓力: pressure differential 進(jìn)出口壓差: (要求： 0.3mpa） outlet flow rate 出口流量: reject flow rate 廢水流量: effluent testing: 出水檢測: toc level: toc 水平_（要求：不超過 500 ppb） conductivity: 電導(dǎo)率_（要求：不超過 50s/cm，25） ph: _（要求：57） microbial: 微生物_（要求： 100 cfus/ml） field notes: 現(xiàn)場注釋 acceptance criteria: all recorded data meets

51、the ro system manufacturer. 驗(yàn)收標(biāo)準(zhǔn)驗(yàn)收標(biāo)準(zhǔn): 所有記錄的數(shù)據(jù)都達(dá)到 ro 系統(tǒng)的要求。. meets acceptance criteria 符合驗(yàn)收標(biāo)準(zhǔn)符合驗(yàn)收標(biāo)準(zhǔn): yes 是是( ) no 否否 ( ) verified by 檢驗(yàn)人: date 日期: attachment 7 mixed bed unit data sheet 附件附件 7 混床混床單元數(shù)據(jù)表單元數(shù)據(jù)表 equipment no./id tag 設(shè)備編號./id 標(biāo)簽: _ inlet pressure: 入口壓力 outlet pressure 出口壓力: outlet flow ra

52、te 入口電導(dǎo): effluent testing: 出水檢測: toc level: toc 水平_（要求：不超過 500 ppb） conductivity: 電導(dǎo)率_（要求：不超過 1.3s/cm，25） ph: _（要求：57） microbial: 微生物_（要求： 2s/cm mixed bed outflow flows back to intermediate tank. otherwise it flows into 4t tank. low level and 4t tank is not at high level 當(dāng)中間水箱不處于低液位時(shí)而 且 4t 水箱不處于高液位時(shí)

53、， 打開混床上進(jìn)水閥，出水閥， 純水兩位三通閥，和混床進(jìn)水 泵 當(dāng) 4t 水箱進(jìn)水電導(dǎo)2s/cm 時(shí)，混床出水流回中間水箱， 當(dāng) 4t 水箱進(jìn)水電導(dǎo)2s/cm 時(shí)，混床出水流進(jìn) 4t 純水箱 open mixed bed lower drain valve and shut off mixed bed outlet valve 打開混床下排水閥，關(guān)閉混床 出水閥 water flows out from mixed bed drain pipe. 混床排水口有水排出 open mixed bed upper drain valve and shut off mixed bed lower dr

54、ain valve 打開混床上排水閥，關(guān)閉混床 下排水閥 water flows out from mixed bed drain pipe. 混床排水口有水排出 open mixed bed middle drain valve and shut off mixed bed upper drain valve 打開混床中排水閥，關(guān)閉混床 上排水閥 water flows out from mixed bed drain pipe. 混床排水口有水排出 open mixed bed lower inlet valve and shut off mixed bed upper inlet val

55、ve 打開混床下進(jìn)水閥，關(guān)閉混床 上進(jìn)水閥 water flows out from mixed bed drain pipe. 混床排水口有水排出 shut off mixed bed lower inlet valve and feed pump. open mixed bed naoh valve, naoh regeneration pump. open naoh manual adjust valve 關(guān)閉混床下進(jìn)水閥和混床進(jìn)料 水泵，打開混床 naoh 閥， naoh 再生泵和上進(jìn)水閥，手 動打開 naoh 調(diào)節(jié)閥 mixed bed will draw fluid from na

56、oh tank. 混床從 naoh 箱中抽液 verified by 檢驗(yàn)人: date 日期: attachment 10 -pw unit manual start-up data sheet continued 附件附件 10 純化水單元手動啟動數(shù)據(jù)表（續(xù)表）純化水單元手動啟動數(shù)據(jù)表（續(xù)表） test method 測試方法 expected results 預(yù)期的結(jié)果 actual results 實(shí)際結(jié)果 verified by 檢驗(yàn)人 date 日期 open mixed bed hcl valve, hcl regeneration pump, ,and upper inlet

57、valve. open hcl manual regulation valve 打開混床 hcl 閥, hcl 再生泵 和上進(jìn)水閥，打開 hcl 手動 調(diào)節(jié)閥 mixed bed will draw fluid from hcl tank 混床從 hcl 箱中抽液 shut off all the valves and pumps in mixed bed unit. open upper air exhaust valve upper air exhaust valve and lower gas inlet valve open. gas flows into mixed bed. and

58、 lower gas inlet valve. 關(guān)閉混床單元所有閥門和泵， 打開上排氣閥和下進(jìn)氣閥 上排氣閥打開，下進(jìn)氣閥打 開，有氣體進(jìn)入 push 4t pw circulation pump button when 4t pw tank is at low level 當(dāng) 4t 純水箱處于低液位時(shí)打 開 4t 純水循環(huán)泵 4t pw circulation pump wont start. 4t 純水循環(huán)泵不啟動 push 4t pw circulation pump button when 4t pw tank is not at low level 當(dāng) 4t 純水箱不處于低液位時(shí) 打

59、開 4t 純水循環(huán)泵 4t circulation pump starts. water flows out after opening 4t tank back water sample valve 4t 純水循環(huán)泵啟動，4t 純水 箱回水取樣口閥門打開有水 push inlet water booster pump 1 button when 4t pw tank is at low level or 1t tank is at high level 當(dāng) 4t 純水箱處于低液位時(shí)或 1t 純水箱處于高液位時(shí)打開 進(jìn)水增壓泵 1 inlet water booster pump 1 wont

60、 start. 進(jìn)水增壓泵 1 不啟動 push inlet water booster pump 1 button when 4t tank is not at low level and 1t tank is not at high level. 當(dāng) 4t 純水箱不處于低液位時(shí) 而且 1t 純水箱不處于高液位 時(shí)打開進(jìn)水增壓泵 1 inlet water booster pump 1 start. water flows from 4t tank to 1t tank. 進(jìn)水增壓泵 1 啟動，有水從 4t 純水箱流進(jìn) 1t 純水箱 push inlet water booster pump