仪器确认-附件5-自动滴定仪确认-中英文

PA/PH/OMCL(07)1084R-OMCLGuidelineonautomatictitrators(Annex5)OMCLNetworkoftheCouncilofEuropeQUALITYMANAGEMENTDOCUMENT质量管理文件PA/PH/OMCL(07)1084RQUALIFICATIONOFEQUIPMENT仪器的确认ANNEX5:QUALIFICATIONOFAUTOMATICTITRATORS附件5：自动滴定仪的确认Fulldocumenttitleandreference文件全名和参考文献QualificationofEquipment仪器的确认Annex5:Qualificationofautomatictitrators附件5：自动滴定仪的确认PA/PH/OMCL(07)1084RDocumenttype文件类型Guideline指南Legislativebasis立法基础ThepreviousversionofthisdocumentwasalsoacceptedbyEAasrecommendationdocumenttobeusedinthecontextofQualityManagementSystemauditsofOMCLsDateoffirstadoption首次采用日期June2008Dateoforiginalentryintoforce初版生效日期August2008Dateofentryintoforceofreviseddocument修订本生效日期1stMay2012Previoustitles/otherReferences曾用名/其它参考文献ThisdocumentreplacesdocumentPA/PH/OMCL(07)1083R本文件替代文件PA/PH/OMCL(07)1083RCustodianOrganisation管理机构ThepresentdocumentwaselaboratedbytheOMCLNetwork/EDQMoftheCouncilofEuropeConcernedNetwork相关网络GEONANNEX5OFTHEOMCLNETWORKGUIDELINE“QUALIFICATIONOFEQUIPMENT”OMCL网络指南“仪器确认”附件5QUALIFICATIONOFAUTOMATICTITRATORS自动滴定仪的确认Introduction介绍Thepresentdocumentisthe5thAnnexofthecoredocument“QualificationofEquipment”,anditshouldbeusedincombinationwithitwhenplanning,performinganddocumentingthequalificationprocessofautomatictitrators.本文件为核心文件“仪器的确认”的第5个附件，在对计划、实施和记录自动滴定仪的确认过程中，应将本文件与核心文件一起使用。ThecoredocumentcontainstheIntroductionandgeneralformsforLevelIandIIofqualification,whicharecommontoalltypeofinstruments.核心文件包括第一级和第二级确认的介绍和通用表格，适用于所有类型的仪器。Itisrecommended,atLevelIIofqualificationoftheautomatictitrators(Installationandreleaseforuse),toperformagravimetrictestofthevolumes(10selectedvolumesinarandomwayfrom20to100%ofthecylindervolume).建议在自动滴定仪的第二级确认中（安装和使用放行），对体积进行重量检测（滴定管20%-100%体积随机选择10个）。Thepresentannexcontainsinstrument-relatedrecommendationsonparameterstobecheckedatLevelIIIandIVofqualificationandthecorrespondingtypicalacceptancelimits,aswellaspracticalexamplesonthemethodologythatcanbeusedtocarryoutthesechecks.所附文件包括与仪器相关的推荐，在第三级和第四级确认应检查何各参数，以及典型的可接受标准，还有可以用于实施这些检查的实践举例。TABLE表IIILevelIII.Periodicandmotivatedinstrumentchecks第三级周期性主动仪器检查Examplesofrequirementsforautomatictitrators自动滴定仪要求举例1.POTENTIOMETRICTITRATORS电位滴定仪(Ph.Eur.欧洲药典2.2.20)Parametertobechecked要检查的参数Typicaltolerancelimits典型可接受限度1.1.Precision精密度RSD≤0.2%1.2.Accuracy准确度drel≤±0.5%1.3.Linearity线性r2≥0.99902.KARLFISCHERVOLUMETRICTITRATORSusedforsemi-microdeterminationofwater卡尔费休容量法滴定仪，用于半微量水分测定(KarlFischerTitration,Ph.Eur.卡尔费休滴定，欧洲药典2.5.12)Parametertobechecked需要检查的参数Typicaltolerancelimits典型可接受限度2.1.Precision精密度RSD≤1.0%2.2.Linearity(optional)线性（可选项）r2≥0.99902.3.Recovery(optional)回收率（可选项）97.5%to102.5%TABLE表III(cont.续)LevelIII.Periodicandmotivatedinstrumentchecks第三级周期性仪器检查Examplesofrequirementsforautomatictitrators(cont.)自动滴定仪要求举例3.KARLFISCHERCOULOMETRICTITRATORSusedformicrodeterminationofwater卡尔费休库仑滴定仪，用于微量水分测定(CoulometricTitration,Ph.Eur.2.5.32)（库仑滴定法，欧洲药典2.5.32）Parametertobechecked需检查的参数Typicaltolerancelimits典型可接受限度3.1.Precision精密度Standard标准1000μg/gH2O:RSD≤2.0%Standard标准100μg/gH2O:RSD≤5.0%3.2.Recovery回收率Standard标准1000μg/gH2O:97.5%to102.5%Standard标准100μg/gH2O:90.0%to110.0%3.3.Linearity(optional)线性r2≥0.9904.KARLFISCHEROVENusedformicrodeterminationofwaterusinganevaporationtechnique(CoulometricTitration,Ph.Eur.2.5.32)卡尔费休炉，用于蒸发技术测定微量水，（库仑滴定，欧洲药典2.5.32）Parametertobechecked需要检查的参数Typicaltolerancelimits典型可接受限度温度准确性±5.0℃4.2.Temperaturestability温度稳定性±0.5℃4.3.Carriergasflowrate载气流速±10ml/minTABLEIVLevelIV.In-useinstrumentchecks第四层次在用仪器检查Examplesofrequirementsforautomatictitrators自动滴定仪要求举例1.POTENTIOMETRICTITRATORS自动电位滴定仪Parametertobechecked需要检查的参数Typicaltolerancelimits典型可接受标准1.1.Precision精密度RSD≤0.2%1.2.Accuracy准确度drel≤±2%2.KARLFISCHERVOLUMETRICTITRATORS卡尔费休容量法滴定仪Parametertobechecked需要检查的参数Typicaltolerancelimits典型可接受标准2.1.Precision精密度RSD≤1.5%2.2.Recovery准确度97.5%to102.5%3.KARLFISCHERCOULOMETRICTITRATORS卡尔费休库仑法滴定仪Parametertobechecked需要检查的参数Typicaltolerancelimits典型可接受标准3.1.Recovery回收率Standard标准1000μg/gH2O:97.5%to102.5%Standard标准100μg/gH2O:90.0%to110.0%ANNEX附件ILevelIII.Periodicandmotivatedinstrumentchecks第三级周期性主动仪器检查ThisAnnexcontainspracticalexamplesoftestsandtheirassociatedtolerancelimitsforseveralparametersrelatedtotheperformanceofautomatictitrators.本附件包括了检查的实践性例子，及其相关的几个与自动滴定仪性能相关的参数的可接受标准。TheseexamplescanbeconsideredbytheOMCLsaspossibleapproachestoperformtheLevelIIIoftheequipmentqualificationprocess:“Periodicandmotivatedinstrumentchecks”.这些例子可以被OMCL认为是仪器第三级别确认“周期性主动仪器检查”的方法。GENERALCONSIDERATIONS总体考虑—Duetothefactthataholisticapproachhasbeentaken,theverificationoftemperatureprobesandburettesisnotincludedinthisguideline,astheperformanceoftheseitemsisindirectlycheckedduringtheaccuracytest.—由于采用了整合功能的确认方法，本指南未包括温度探头和滴定管的确认，因为在准确度检查中，上述两项已经间接地被检查了。—Ifavailable,theinternalstart-uptestfunctionmaybeusedeachtimetheinstrumentisswitchedon.—如果可以的话，仪器内置开机检查功能在每次开机时可以使用。—Ifseveralexchangeunitsareusedfordifferenttitrants,allunitsshouldbetestedatLevelIII.—如果有几个滴定单元用于不同的滴定剂，所有单元在第III级均需要检测。—ThelimitsandspecificationsofthisguidelinehavebeensetaccordingtoMetrohmdocumentation.Forothermanufacturers(e.g.Mettler-