【正文】 歲月是有情的，假如你奉獻(xiàn)給她的是一些色彩，它奉獻(xiàn)給你的也是一些色彩。Check that the installation has been cleaned and passivated once the installation is finished and before the starting up of the system.步驟 No. 測(cè)試步驟Step description通過(guò)標(biāo) 準(zhǔn) Acceptance criteria 試驗(yàn)結(jié)果 Observed results合格與否C/NC偏差報(bào)告編號(hào)Anomaly reference1有執(zhí)行清洗和鈍化的方案There is a protocol for the execution of the cleaning and passivation有相關(guān)文件Document is available編號(hào)Ref : ……………2有清洗鈍化的測(cè)試結(jié)果報(bào)告There is a report with the result of the cleaning and passivation有相關(guān)文件Document is available編號(hào)Ref : …………….. .. .. ..步驟/No. 備注/ Comments測(cè)試操作人/Test performed by: 簽名/Signature 日期/Date測(cè)試所用計(jì)量?jī)x器/List of equipments used : 附件列表 /List of attachments測(cè)試審核人/ Test reviewed by: 簽名/Signature 日期/Date.. .. .. ..合格 / Conform ? 不合格 / Non conform ?備注 / Comments :1. 若不給 自己設(shè)限，則人生中就沒(méi)有限制你發(fā)揮的藩籬。ID drawings.在 圖 上 用 黃 色 標(biāo) 示 出 已 查 過(guò) 的 部 分 。簽字并注明日期以證明已經(jīng)過(guò)檢查。 噴水球/360186。EDI 系統(tǒng)的特點(diǎn)是 脫鹽率高，樹(shù)脂無(wú)需使用酸堿再生，具有較高的產(chǎn)水質(zhì)量，水的電導(dǎo)率可達(dá)到 （25℃）以內(nèi)，水的利用率最高可達(dá) 95%，其最大特點(diǎn)是利用電能而不是酸堿化學(xué)對(duì)樹(shù)脂進(jìn)行再生處理。1 參考法規(guī)與文件 / DOCUMENT REFERENCES 2 職責(zé) / RESPONSIBILITIES 3 定義與縮寫 / DEFINITIONS AND ABBREVIATION4 系統(tǒng)描述 / SYSTEM DESCRIPTION南通海發(fā)水處理工程有限公司提供 3m3/h 一級(jí)反滲透+EDI 藥用純化水制取裝置。本公司反滲透膜選用國(guó)際最為先進(jìn)、回收率、脫鹽率最高的卷式復(fù)合膜作為組件材料。The acceptation of the IQ will allow the start of OQ... .. .. ..前提/ Prerequisite 完成 / Check1. 方案已經(jīng)通過(guò)This protocol has been approved2. 操作人經(jīng)過(guò)執(zhí)行驗(yàn)證的相關(guān)培訓(xùn)Operators are trained for process validation execution步驟No.驗(yàn)證項(xiàng)目Step description驗(yàn)證內(nèi)容Acceptance criteria驗(yàn)證標(biāo)準(zhǔn)Observed results合格與否C/NC偏差報(bào)告編號(hào)Anomaly reference功率 11KW電壓 380V（ 3 相 5 線）1供配電Electricity supply / consumption操作范圍是否合理、安裝是否符合要求Check the operative range is appropriate to the correct operation of the system and its installation is suitable for required use 頻率 50 Hz,水溫 830 186。 spraying ball液位控制器/Level controller空氣呼吸器/Spare nozzle on top儲(chǔ)水罐附件The storage tank is equiped with： 人孔/Man hole供應(yīng)商： Supplier 丹麥格蘭富類別： TypwCHI1225型號(hào)ModelD4F518025P10914材料： Material316揚(yáng)程： Head42m16純水泵02PC02Purified water pump流量大?。? flow10t/h17紫外 線殺菌燈 202UV01Flowing UV LAMP供應(yīng)商： Supplier 南通海發(fā)Nantong highfine.. .. .. ..步驟 No. 驗(yàn)證項(xiàng)日Step description驗(yàn)證內(nèi)容Acceptance criteria驗(yàn)證標(biāo)準(zhǔn)Observed results合格與否C/NC偏差報(bào)告編號(hào)Anomaly reference型號(hào)： model UV10數(shù)量： Quantity 1臺(tái)1set波長(zhǎng)： Wave length 254nm材料： Material： 316L紫外線系統(tǒng)附件 計(jì)時(shí)器供應(yīng)商Supplier 南通海發(fā)Nantong highfine型號(hào) ：Model： JMF407數(shù)量 ： Quantity：1臺(tái)1set結(jié)構(gòu)： 可自由更換濾芯外殼材質(zhì)material316L濾芯材質(zhì)materialPTEF1802JMF01 microhole filter過(guò)濾精度precision .. .. .. ..步驟 No. 驗(yàn)證項(xiàng)日Step description驗(yàn)證內(nèi)容Acceptance criteria驗(yàn)證標(biāo)準(zhǔn)Observed results合格與否C/NC偏差報(bào)告編號(hào)Anomaly reference濾芯規(guī)格數(shù)量Amount 40英寸*7根40ft*7pcs.. .. .. ..步驟/No. 備注/ Comments測(cè)試操作人/Test performed by: 簽名/Signature 日期/Date測(cè)試所用計(jì)量?jī)x器/List of equipments used : 附件列表 /List of attachments測(cè)試審核人/ Test reviewed by: 簽名/Signature 日期/Date合格 / Conform ? 不合格 / Non conform ?備注 / Comments :.. .. .. .... .. .. ..前提/ Prerequisite 完成 / Check2. 本方案已被批準(zhǔn)This protocol has been approved3. 操作人已接受執(zhí)行驗(yàn)證的培訓(xùn)Operators are trained for validation execution步驟 No. 驗(yàn)證項(xiàng)目與標(biāo)準(zhǔn)Step description驗(yàn)證內(nèi)容Acceptance criteria驗(yàn)證證明文件Observed results合格與否C/NC偏差報(bào)告編號(hào)Anomaly reference竣工圖(管道設(shè)施和安裝平面 圖Asbuilt drawings (Pamp。 Ids drawings used in installation verification are identified2 管道部件竣工管道設(shè)施圖中部件被確認(rèn)The ponents are identified in As Built Pamp。在這 % ，是符合FDA和GMP法規(guī)要求的。既糾結(jié)了自己，又打擾了別人。用一些事情，總會(huì)看清一些人。Join drawings to the test.儀表儀表安裝正確，容易讀出上面的數(shù)字The instruments are correctly installed , they are accessible and they can be easily read.. .. .. ..步驟 No. 測(cè)試步驟Step description驗(yàn)證項(xiàng)目Acceptance criteria驗(yàn)證標(biāo)準(zhǔn)Observed results合格與否C/NC偏差報(bào)告編號(hào)Anomaly reference5 操作各部件都可以順利地被操作，而且可以進(jìn)行維修工作The access to the different ponents of the system is easy so operation and maintenance works can be done步驟/No. 備注/ Comments測(cè)試操作人/Test performed by: 簽名/Signature 日期/Date測(cè)試所用計(jì)量?jī)x器/List of equipments used : 附件列表 /List of attachments測(cè)試審核人/ Test reviewed by: 簽名/Signature 日期/Date.. .. .. ..合格 / Conform ? 不合格 / Non conform ?備注 / Comments :.. .. .. ..前提/ Prerequisite 完成 / CheckN/A步驟 No. 驗(yàn)證項(xiàng)目Step description驗(yàn)證內(nèi)容Acceptance criteria驗(yàn)證標(biāo)準(zhǔn)Observed results合格與否C/NC偏差報(bào)告編號(hào)Anomaly reference1檢查所有的重要儀器的計(jì)量證書，保證計(jì)量范圍和精確度符合工作需求Check that calibration certificates are available when needede and that the calibration range and precision of the calibration are adequate for the instrument range of work and precision required見(jiàn)下表See table below見(jiàn)下表See table below標(biāo)簽tag描述description是否需要計(jì)量Need to be calibrated (YES/NO）檢查計(jì)量標(biāo)簽Conformity of certificate (yes or no)工作范圍Work scale測(cè)量范圍Measure scale精確度correctness合格與否（C/NC）備注remarksPHT0101原水 PH 變送器 是 yes58 014 TT0101原水溫度