VP纯化水系统验证方案.doc

PurifiedWaterSystemValidationProtocol纯化水系统验证方案纯化水系统验证方案ApprovalofthePurifiedWaterSystemValidationProtocol纯化水系统验证方案的审批纯化水系统验证方案的审批Title职务职务Name姓名姓名Signature签字签字Date日期日期WrittenBy起草人起草人ReviewedBy复核人复核人ApprovedBy批准人批准人TABLEOFCONTENTS1Summarize概述.32Purpose验证目的.43ValidationTeamandResponsibilities验证人员及职责.43.1ValidationTeamMember项目验证小组成员.43.2Responsibilities职责.44ContentandCriterion验证内容、方法及合格标准.54.1BeforehandQualification预确认（安装前确认）.54.2Installationqualification安装确认.74.3Operationqualification运行确认.114.4PeranceQualification性能确认.125Deviationanddealwith验证过程中的偏差及处理.146ValidationConclusion验证结果评定与结论.147.RidationPeriods再验证周期.158ValidationSchedule验证时间安排.159.Attachment附件.161Summarize概述概述ThecompanycommissionedtheJiaxingJiameWaterTreatmentEngineeringCo.Ltd.forthepurifiedwatersystemdesignandinstallationthesystemproductcapacityofwateris1.0m3husingoftwogradereverseosmosisprocesstoobtainpurifiedwater.Tapwaterafteraddingcoagulant(PAC)waspumpedbyoriginalwaterpumpthroughmultimediafiltersactivatedcarbonfilterforfiltrationandadsorptiontreatmenttoremoveparticulateimpuritiescolloidchlorineorganicmatteretc.Thefreechlorinecontentofthewaterislessthan0.1ppmSDI4.ThenViaprecisionfiltertoremoveparticlesgreaterthan5uenteredthetwogradereverseosmosissystemuseofmembraneseparationtechnologydesalinatethemajorityofionsinwaterSiO2organiccolloidsandotherimpuritieswaterproductionstoredinapurifiedwaterstoragetankbyultravioletsterilizerstokillbacteriathatmayexistintheterminalaftertheboosterpumpsandprecisionfiltersthroughthestainlesssteelpipetovariouspurifiedwaterusepointsusedforingredientsequipmentandcontainerscleaningwashingclothesandsoon.Partsofthepurifiedwaterthroughthecirculationpipebacktothepurifiedwaterstoragetank.Simpleprocessasfollows:rawwater(drinkingwater)originalwatertankflocculantdosingsystemmulti-mediumfilteractivatedcarbonfilterSoftWatersystemsFiltersahigh-pressurepumpreverseosmosisunitalkalidosingtwohigh-pressurepumpsystemreverseosmosisunitpurifiedwatertankandwaterpumpsultravioletdisinfectionTerminalfilterusepoint.公司纯化水系统为委托嘉兴嘉美水处理工程有限公司设计安装，制水能力为1.0m3h，利用二级反渗透工艺来制取纯化水。饮用水加入絮凝剂(PAC)后由原水泵增压后进多介质过滤器、活性炭过滤器的过滤和吸附处理，除去水中颗粒状杂质、胶体、余氯、有机物等，使出水游离氯含量小于0.1ppm，SDI4，再经精密过滤器除去水中大于5u的颗粒后进入二级反渗透系统，利用膜分离技术的高脱盐率，除去水中大部份离子、SiO2、有机物胶体等杂质，二级反渗透系统产水贮存于一只纯化水贮罐，经紫外线杀菌器杀死可能存在的细菌等后由终端水泵增压并经微孔过滤器过滤，通过不锈钢管道送至各纯化水用水点，用于配料用水、设备及容器具清洗、工作服清洗等。部份纯化水通过循环管道回至纯化水贮罐。简易流程为：原水（饮用水）原水箱絮凝剂加药系统多介质过滤器活性炭过滤器阻垢剂加药系统保安滤器一级高压泵一级反渗透装置碱加药系统二级高压泵二级反渗透装置纯化水箱送水泵紫外线杀菌装置终端微孔过滤器使用点。2Purpose验证目的验证目的Throughpurifiedwatersysteminstallationoperationandperancequalificationtoproveitsabilitytosteadyprovidedsupplyofqualityandquantityqualifiedwater.对纯化水系统的安装、运行和性能进行验证，以证明其有能力稳定地供应规定数量和质量的合格用水。3ValidationTeamandResponsibilities验证人员及职责验证人员及职责3.1ValidationTeamMember项目验证小组成员项目验证小组成员ProjectvalidationteamcomprisesofProductionManagementDepartmentQualityManagementDepartmentEquipmentEngineeringDivisionandtheoperatormaintenanceworkerQCpersonnel.Themanageroftheproductionmanagementdepartmentistheleaderofthisvalidationteam.Validationteammembersseeattachment2.项目验证小组由生产管理部、质量管理部、设备工程科和操作工、维修工、QA、QC组成，由生产管理部经理任项目验证组组长，验证小组成员见附件2。3.2Responsibilities职责职责EquipmentEngineeringDivision:DraftthidationprotocolTechnicaldocumentqualificationandimplementedthidationdraftthidationreport.ProductionManagementDepartment:ReviewthidationprotocolAssisttheengineeringDivisionimplementationthidationwork.QualityManagementDepartment:Reviewthidationprotocolfinishedtherelativeanalyticalwork.ValidationCommitteeDirector:Approvedthidationprotocolandthidationreport.设备工程科：负责设备验证方案的起草及验证工作的具体实施，起草验证报告。生产部：复核验证方案，协助设备工程科进行验证工作的实施。质量部：负责验证文件的审核，负责相关检验任务。验证委员会主任：负责设备及公用工程系统验证方案及报告的批准。Validationprocessshouldbestrictlyinaccordancewiththeapprovedvalidationprotocolifneedtochangeforspecialreasonstheyshouldfilloutthethidationprotocolchangeapplicationandapprovals(attachment1)accordingtotheoriginalreviewandapprovalproceduresfortheapprovalbeforethecutivethechange.验证过程应严格按照本方案规定的内容进行，若因特殊原因确需变更时，应填写验证方案变更申请及批准书(附件1)，按原审批程序批准后执行。4ContentandCriterion验证内容、方法及合格标准验证内容、方法及合格标准4.1BeforehandQualification预确认（安装前确认）预确认（安装前确认）4.1.1DocumentQualification资料确认Confirmedthattherelevantdocumenttosupporttheverificationiscompletefilloutconfirmrecordsinattachment3.确认支持本验证的相关资料是否齐全，确认记录填写于附件3Documentname资料名称Confirm确认方法Purifiedwatersystemthedetaileddesignrequirementsandtechnicalparametersofmajorequipment纯化水系统详细设计要求及主要设备技术参数Consultequipmentarchives查阅技术档案Orderingthecontractspecificationsandrelatedtechnicalination纯化水系统主要组成设备订货合同、说明书及相关技术资料Consultequipmentarchives查阅技术档案MainlyequipmentsCertificates各设备检验合格证Consultequipmentarchives查阅技术档案Purifiedwaterqualitystandards纯化水质量标准ConsultCP-2005查阅技术档案查阅药典2005版纯化水标准PurifiedWaterSystemFlowChart纯化水系统工艺流程图Consultequipmentarchivesandattachedattachment4.查阅技术档案查阅并附于附件4Purifiedwatersystemoperationandmaintenancestandardoperationprocedures纯化水系统操作和维护保养标准操作规程ConsulttherelativeSOP查阅技术档案Purifiedwatersystemsamplestandardoperatingprocedures纯化水取样标准操作规程ConsulttherelativeSOP查阅技术档案Purifiedwatersystemcleaningstandardoperatingprocedures纯化水系统清洁标准操作规程ConsulttherelativeSOP查阅技术档案Outoftheboxinspectionrecords开箱验收记录Consultequipmentarchives查阅技术档案Installationandcommissioningrecords安装调试记录Consultequipmentarchives查阅技术档案TestRunRecord试运行记录Consultequipmentarchives查阅技术档案PipelinePressureTestRecord管道试压记录Consultequipmentarchivesandattachedattachment5.查阅并附于附件5Pipecleaningrecordsbeforeuse管道使用前清洗记录Consultequipmentarchivesandattachedattachment6.查阅并附于附件6PipelinepassivationRecords管道钝化记录Consultequipmentarchivesandattachedattachment7.查阅并附于附件7Pipedisinfectionrecordbeforeuse管道使用前消毒记录Consultequipmentarchivesandattachedattachment8.查阅并附于附件8Waterpurificationwatersystemnetworkdiagram纯化水系统用水网络图Consultequipmentarchivesandattachedattachment9.查阅附于附件9Qualificationproofoftheequipmentsupplier各设备生产企业资质证明材料Consultequipmentarchivesandattachedattachment10.查阅附于附件10Theequipmentinspectionreports各设备检验报告Consultequipmentarchivesandattachedattachment11.查阅附于附件114.1.2Instrumentcalibrationverification仪器、仪表的检定或校验确认InstrumentsusedinSystemsuchasPressuregaugesconductivitymeteretc.shallbecalibratedandwithinthidityperiod.Theconfirmrecordsbefilledinattachment12.Instrumentsasfollowmustbecalibrated.系统所用的压力表等及检测所用的电导率仪等须经检定或检验合格，并在检定有效期内，确认记录填写于附件12。下列仪器仪表必须经过校验。InstrumentName名称Specification型号（规格）Count数量Pressuregauges耐振压力表0-2.5MPa4Pressuregauges耐振压力表0-1MPa7conductivitymeter电导率仪1PHmeterPH计14.1.3AfterserviceQualification售后服务确认Checkthepurifiedwatersystemsupplierafterserviceinationandassureitiscomplete.Theinationincludesuppliernameaddressphoneshouldfilledintheattachment13.检查各主要设备售后服务资料是否齐全。包括单位名称、地址、联系电话、保修及维修等详细资料，确认记录填写于附件13。4.2Installationqualification安装确认安装确认4.2.1PublicMediaConnectconfirmationrecordsfillinattachment14.公用介质连接确认，确认记录填写于附件14。PowerSupplyInstallationconfirmation电源安装确认Item项目Standard合格标准确认方法electricvoltage电压380V20VMultimetertest万用表检测Three-phasefive-wire三相五线On-siteinspection现场检查thelineofelectricitydemand进线要求YJV-42.5+BVR-12.5On-siteinspection现场检查GroundProtection接地保护Groundingresistanceislessthan4接地电阻小于4Ohmmetermeasurements欧姆表测量Watersupplyinstallationconfirmation进水安装确认Item项目Standard合格标准确认方法Waterqualityrequirements水质要求Shouldmeetdrinkingwaterhealthstandards(GB5749-2006)应符合生活饮用水卫生标准（GB5749-2006）SeeWaterQualityTestReport见水质检测报告Pressure压力0.4MpaMeasuredwithpressuregauge压力表测量Pipediameter管道管径DN32Measuredwithverniercaliper游标卡尺测量Pipematerial管道材质PPInspectionbyVisual目测4.2.2PurifiedwaterpipelineandValvesinstallationconfirmationtherecordsfillinattachment15.纯化水管道及阀门(3路)安装确认，确认记录填写于附件15.Item项目Standard合格标准确认方法Workpress操作压力0.4MpaMeasuredwithpressuregauge压力表测量Pipediameter管道管径DN322Measuredwithverniercaliper游标卡尺测量Pipematerial管道材质SS304Consultpipematerialcertificatedocumentandattachitinattachment16.检查材质证明并附于附件16Valvesmaterial阀门材质SS304Consultpipematerialcertificatedocumentandattachitinattachment16.检查材质证明并附于附件16Installationrequirement安装要求Usinghot-melt-typeweldingjointconnectingthehealth-quickcircularlayoutsmoothnodeadendseachwaterpointofuseofdiaphragmvalvesthewaterintakepointandtheoutletlayoutdrawingsbasedondesignrequirements.采用热熔式氩弧焊与卫生快装接头连接，循环布置，光滑、无死角；每个用水点采用隔膜阀，各取水点及出水口的布置依据图纸设计要求。InspectionbyVisualandchecktherelativerecords.目测及检查相关记录4.2.3purifiedwatertankinstallation(Atotalof1waterstoragecapacityof1m3)纯化水储罐安装确认(一只，贮水量为1m3):InspectionbyVisualMeasuredwithverniercaliperandConsultmaterialcertificatedocumentandattachitinattachment16recordsfillinattachment17.确认方法：目测、游标卡尺测量、检查材质证明(附于附件16)确认记录填写于附件17。Standards合格标准：（1）Tankinsideandoutsidesurfaceispolishedsmoothsurface.储罐内外表面经过抛光，表面光洁。（2）Insidesurfaceandsealedhead:MaterialSS304stainlesssteelthickness4mm内筒体及封头：材质SS304不锈钢，厚度4mm。（3）Connectorsandrelatedauxiliaryequipment连接口及相关配套设备：PurifiedwaterInlet(top)纯化水入口(顶部)：DN15PurifiedwaterOutlet(bottom)纯化水出口(底部)：DN20Limberhole(bottomofthelowest)排污口（底部最低位置）：DN15Cleanhole(atthetopofthemiddleposition):DN32With3600rotarycleaningballmaterialSS304.清洗口(顶部正中位置)：DN32，配3600旋转清洗球，材质SS304不锈钢。Breathhole(top)呼吸口(顶部)：DN154.2.4purifiedwaterstoragetankSCBAinstallation纯化水储罐空气呼吸器安装确认.Therecordfillinattachment18.确认记录填写于附件18。Item项目Standard合格标准确认方法Bodymaterial壳体材质SS304Consultmaterialcertificatedocumentandattachitinattachment16.检查材质证明并附于附件16Filtermaterial过滤材质Polypropylene聚丙烯Consultmaterialcertificatedocumentandattachitinattachment16.检查材质证明并附于附件16Seal密封方法Melttogether热熔合Consultcertificatedocumentandattachitinattachment16.检查证明并附于附件16HoleDiameter孔径0.22mConsultcertificatedocumentandattachitinattachment16.检查证明并附于附件164.2.5Criticalpartsmaterialqualification.关键部位材质确认.Therecordsfillinattachment19.确认记录填写于附件19。Requirement要求Partsname部件Bodymaterial壳体材质Mediaandrequirements介质及要求确认方法Originalwaterpump原水泵Stainlesssteel不锈钢Consultmaterialcertificatedocumentandattachitinattachment16.检查材质证明并附于附件16Multi-mediafilter多介质过滤器FRPQuartzsandanthracite石英砂、无烟煤Consultmaterialcertificatedocumentandattachitinattachment16.检查材质证明并附于附件16Activatedcarbonfilters活性炭过滤器FRPActivatedcarbon活性炭Consultmaterialcertificatedocumentandattachitinattachment16.检查材质证明并附于附件16Securityfilters保安滤器Stainlesssteel不锈钢Polyethylenefiber聚乙烯纤维Consultmaterialcertificatedocumentandattachitinattachment16.检查材质证明并附于附件16High-pressurepump高压泵Stainlesssteel不锈钢Consultmaterialcertificatedocumentandattachitinattachment16.检查材质证明并附于附件16CleaningPumps清洗泵Stainlesssteel不锈钢Consultmaterialcertificatedocumentandattachitinattachment16.检查材质证明并附于附件16reverseosmosissystemelement一、二级反渗透元件Stainlesssteel不锈钢TFCConsultmaterialcertificatedocumentandattachitinattachment16.检查材质证明并附于附件16UVsterilizers紫外线杀菌器Stainlesssteel不锈钢Consultmaterialcertificatedocumentandattachitinattachment16.检查材质证明并附于附件16Microporousfilter(thenumberis2)微孔过滤器(2个)Stainlesssteel不锈钢0.22mnylonfilter0.22m尼龙液体过滤芯Consultmaterialcertificatedocumentandattachitinattachment16.检查材质证明并附于附件16Terminalpump终端水泵Stainlesssteel不锈钢Consultmaterialcertificatedocumentandattachitinattachment16.检查材质证明并附于附件164.2.6Pipelinepressuretestcleanpassivationanddisinfectqualification.管道分配系统的试压、清洗、钝化、消毒确认Qualification确认方法Inspectthepipelinepressuretestrecord(attachment5)cleanrecordbeforeuse(attachment6)pipelinepassivationrecords(attachment7)andpipelinedisinfectrecords(attachment8).检查纯化水管路试压记录(附件5)、纯化水管道使用前清洗记录(附件6)、纯化水管道钝化记录(附件7)、纯化水管道使用前消毒记录(附件8)Standards合格标准（1）Pipelinepressuretest管路试压：PressuretestwithWaterexperimentalpressureis0.6Mpawhichis1.5timesworkingpressure(0.4MPa)thepipelineshouldbenoleakageunderthepressure.用水试压，实验压力为工作压力（0.4MPa）的1.5倍即0.6Mpa，整个管路在实验压力下应无渗漏发生。（2）Pipelinecleanpassivationanddisinfect管道清洗、钝化、消毒PurifiedwatercyclepipelinePre-washed:Thepurifiedwatertankpumpandpipelinetoconnectintoacyclepathaddsufficientamountofpurifiedwatertopurifiedtankopenthepumptocyclefor15minutesopenthedrainvalveandthencontinuecycle.纯化水循环预冲洗：将纯水罐、水泵与管路连接成一个循环通路，在纯水罐中注入足够量的纯化水，开启水泵进行循环，循环15分钟后，打开排水阀，边循环边排放。AlkalineCleaning:Thesodiumhydroxide(chemicallypureandabove)withhotwater(temperature90orabove)preparationof1%(wv)solution(500L)withthecirculationpumpmorethan30minutes(after30minutesopeningEachwaterpointofthvefor10secondstowashtheir)openthedrainvalvedischargelye.碱液清洗：将氢氧化钠（化学纯以上）用热水（温度90以上）配制成1%（wv）的溶液(500L)，用水泵循环30分钟以上（期间隔30分钟后开启每个用水点阀门10秒钟对其进行清洗），打开排水阀，排放碱液。Rinse:Addpurifiedwatertopurifiedwaterstoragetankstartthepumpopenthedrainvalverinsewhiledischargedischargetimeshouldbenolessthan30minutesuntiltheconductivityofthewaterinthetankandtheconductivityofoutletwateristhesame.冲洗：将纯化水加入纯水罐，启动水泵，打开排水阀，边冲洗边排放，排放时间应不少于30分钟，直至各出水口水的电导率与纯水罐中水的电导率一致。Passivation:Thenitricacid(chemicallypureandabove)preparationof5%oftheacid(500kg)injectionofpurewatertankrecycling120minutesusingsodiumhydroxideadjustPH=7anddischarge.钝化：将硝酸（化学纯以上）配制成5%的酸液(500kg)，注入纯水罐，循环120分钟，用氢氧化钠中和后排放。Rinse:Rinsewithpurifiedwaternolessthan30minutesuntiltheconductivityofimportandexportpurifiedwateristhesame.冲洗：用纯化水冲洗，时间不少于30分钟，直至进出口纯化水的电导率一致。Disinfection:preparationof3%hydrogenperoxidedisinfectingsolutionaddittothepurewatertankandstartthepumploopfor30minutes(every10minutesopeningdischargveforeachwaterpoint10secondsofitsdisinfection).消毒：配制3%的双氧水消毒液，注入纯水罐，启动水泵，循环30分钟（期间每隔10分钟开启每个用水点阀门排放10秒对其进行消毒）。Rinse:Rinsewithpurifiedwaternolessthan30minutesuntiltheconductivityofimportandexportpurifiedwateristhesame.冲洗：用纯化水冲洗，时间不少于30分钟，直至进出口纯化水的电导率值一致。4.3Operationqualification运行确认运行确认4.3.1Controlandsafetyprotectionperanceconfirmation控制及安全保护性能确认Recordsfillinattachment20.确认记录填写于附件Qualification确认方法Checkandassurethatthecontrolsystemandthecorrespondingdirectionisnormalover-voltageprotectionfunctionthewaterlevelautomaticcontrolfunctionsoverloadandshort-circuitprotectionfunctionSTOPfunctionisaccurateandeffective.检查控制系统运行及相应指示是否正常；过压保护功能、水位自动控制功能、过载及短路保护功能、“急停”功能是否准确有效。Standards合格标准Thecontrolsystemandthecorrespondingdirectionsisnormalover-voltageprotectionfunctionthewaterlevelautomaticcontrolfunctionsoverloadandshort-circuitprotectionfunctionE-STOPfunctionareaccuratelyandefficiently.控制系统运行及相应指示正常；过压保护功能、水位自动控制功能、过载及短路保护功能、“急停”功能准确有效。4.3.2Twogradereverseosmosislow-pressurecleaningqualification二级反渗透装置低压清洗确认Qualification确认方法Measuredwithstopwatchandinspectionbyvisual用秒表测量、目测Standard合格标准Everynormalrunautomaticlow-pressurewashingoriginalwaterpumpstartandlow-pressurewashingTwogradereverseosmosissystermthehigh-pressurepump3-minutedelaytostart.Therecordsfillinattachment21.每次正常开机，装置自动进行低压冲洗，原水泵开启对二级反渗透装置低压冲洗后，高压泵延时3分钟启动，确认记录填写于附件21。4.4PeranceQualification性能确认性能确认4.4.1Qualification确认方法（1）OperationaccordingtotheSOPNo.（HSSOP-CF-001）按纯化水系统操作、维护保养标准操作规程（HSSOP-CF-001）操作和清洗消毒。（2）Openthepurifiedwatersysteminoperationcontinuous3daysafterrunning1houreverydayeveryusepointopen10minutestherestpurifiedwaterreturnedtopurifiedwaterstoragetankforrecycling.Samplethepurifiedwaterofthepurifiedwaterstoragetankthetotaloutletthetotalreturnholeandtest.Allitemsshouldbequalifiedbeforestartthenextvalidationstep.开启纯化水系统连续运行3天，每天运行制水1小时后，各用水点依次放水10分钟，其余纯水分别回到纯化水贮罐进行循环，纯化水贮罐、总出水口、总回水口依次取样，检测全部合格后再进行下步验证。（3）Undernormalcircumstancestheverificationprocessshouldmonitorthewaterqualitycontinuedfor21daysrunningthesystem8hoursperdaysampleanddetectthepurifiedwatereverydayafterthesystemrunning1hourallwaterpointsopeninturnfor10minutestherestwerereturnedtowaterpurifiedstoragetanktocycle.正常情况下，验证过程的水质监控持续21天，每天运行8小时，每天运行制水1小时后，各用水点依次放水10分钟，其余纯水分别回到纯化水贮罐进行循环。（4）Thesamplingisasfollows(thedistributionofwaterpointsseewaterpurificationwatersystemnetworkdiagramsattachment10):具体取样方法如下（各取水点的分布见纯化水系统用水网络图附件10）：Samplethepurifiedstoragethetotaloutletthetotalreturnholeeverydayduringthidation.纯化水贮罐、总出水口，总回水口在确认的全过程中每天取样检测。Eachcyclethewatersamplingpointstotaketurnstoensurethatallwaterpointsroundstotakeatimeseachtimesamplesweremarkedandrecordedwaterintakenumbers每个周期，各用水点每天轮流取样，保证各用水点轮取1次，每次取样均注明取水口编号并记录。Ifduetosamplingtestingandotherfactorsresultingintheindividualwaterqualityfailurewemustconsiderre-samplingtest.There-sampleasfollows:由于取样，化验等因素，会出现个别水质不合格现象，必须考虑重新取样化验。方法如下：A.Intheunqualifieduseofpointandthentakeasub-sample.在不合格的使用点再取1次样。B.Retesttheunqualifieditem.重新化验不合格指标。C.Retestresultmustbequalified.重测这个指标必须合格。D.Iftheretestresultisfailurethidationisfailureandshoulddonewvalidationprocess.再次测定不合格，验证重新开始。Samplepointsasfollow各取水点编号如下：A1Samplinghole纯水取样口A2Purifiedwaterstoragetank纯化水贮A3Totaloutlet总出水口罐A4Totalreturnhole总回水口A5Purifiedroom提纯间A6Recrystallizationroom重结晶间A7Clotheswashingroom洗衣间A8Toolscleanroom器具洗涤间A9Cleantoolscleanroom洁具洗涤间Sample:AccordingtotheSOPNo.HSSOP-QC-079取样方法：按纯化水取样标准操作规程操作（HSSOP-QC-079）TestStandard:CP(2005)检验依据：按中华人民共和国药典2005年版二部纯化水质量标准确定。Acceptancelevel:CP(2005)合格标准：中华人民共和国药典2005年版二部纯化水标准项下。Accordingtotheabovesamplings，samplingpointsandsamplingfrequencytodoforthreecycleseachcycleof7daystheresultsofallsampleshouldbequalified.Theperancequalificationrecordattachedattachment23.按上述方案规定的取样方法及取样点按相应的取样频率对纯化水系统进行3个周期，每个周期7天的各项指标的检测，结果所有取样点的水质均合格。性能确认报告附于附件235Deviationanddeal