仪器确认-附件4-红外确认-中英文.doc

OMCLNetworkoftheCouncilofEuropeQUALITYASSURANCEDOCUMENT质量保证文件PA/PH/OMCL(07)12DEFCORRQUALIFICATIONOFEQUIPMENT仪器确认ANNEX4:QUALIFICATIONOFIRSPECTROPHOTOMETERS附件4红外分光光度计的确认Fulldocumenttitleandreference文件全名和索引号QualificationofEquipment仪器确认Annex4:QualificationofIRsepctrophotometers附件4：红外分光光度计确认PA/PH/OMCL(07)12DEFCORRDocumenttype文件类型GuidelineLegislativebasis立法基础ThepresentdocumentwasalsoacceptedbyEAasrecommendationdocumenttobeusedinthecontextofQualityManagementSystemauditsofOMCLsDateoffirstadoption首次采用日期May2007Dateoforiginalentryintoforce首次生效日期July2007Dateofentryintoforceofreviseddocument修订生效日期December2007Previoustitles/otherreferences曾用文件名/其它索引号ThisdocumentreplacesdocumentPA/PH/OMCL(07)12DEFCutodianorganisation管理机构ThepresentdocumentwaselaboratedbytheOMCLNetwork/EDQMoftheCouncilofEuropeConcernedNetwork相关网络GEONANNEX4OFTHEOMCLNETWORKGUIDELINE“QUALIFICATIONOFEQUIPMENT”OMCL网络指南“仪器确认”附件4QUALIFICATIONOFIRSPECTROPHOTOMETERS红外分光光度计的确认Introduction介绍ThepresentdocumentisthefourthAnnexofthecoredocument“QualificationofEquipment”,anditshouldbeusedincombinationwithitwhenplanning,performinganddocumentingtheIRspectrophotometerqualificationprocess.本文件为“仪器确认”核心文件的第四个附件，在对红外分光光度计确认过程进行计划、实施和记录时，应结合该核心文件一起使用。ThecoredocumentcontainstheIntroductionandgeneralformsforLevelIandIIofqualification,whicharecommontoalltypeofinstruments.核心文件包括了第一级和第二级确认的介绍和通用表格，该表格通用于各类型仪器。ForFTIRspectrometers,anexamplehasbeenaddedtogiveinstrument-specificproposalsthatmaybeusedincombinationwiththegeneralrequirementspresentedinthecoredocument“QualificationofEquipment”,whendrawingupaLevelIchecklist.对于傅立叶红外变换光度计，在本指南中给出一个仪器专用的方案，在起草第一级检查清单时，与“仪器确认”核心文件中的第一级通用表格一起使用。Thepresentannexcontainsinstrument-relatedrecommendationsonparameterstobecheckedatLevelIIIandIVofqualificationandthecorrespondingtypicalacceptancelimits,aswellaspracticalexamplesonthemethodologythatcanbeusedtocarryoutthesechecks.附件中包括了与仪器相关，在第三级和第四级确认中需要检查的参数，以及其相应的典型可接受限度，和用于实施这些检查的实用方法举例。TABLEI表一LevelI.Selectionofinstrumentsandsuppliers第一级仪器和供应商选择Exampleofcheck-list(non-exhaustive)检查清单举例（未尽列举）Manufacturer:生产商Provider/Distributor:分销商/供货商Nameofinstrumentandtype:仪器名称和型号Attribute特征(Thislistmaybeadaptedifnecessary)（本清单在需要时采用）Specification标准Benefits优点(Instrument/supplier)（仪器/供应商）Assessment评价Pass通过Fails不通过Spectrophotometer分光光度计Detectorrange检测器范围TheopticalbenchshallincludeaDTGSdetectorwithafrequencyrangeof7400to350cm-1光具座应包括一个DTGS检测器，其频率范围为7400至350cm-1Itshallincludeacompressedairinterferometer应包括一个压缩空气干涉仪Theinstrumentshallcomewithanair-cooledstandardinfraredsource仪器应具有气冷标准红外源Spectralresolution光谱分辨率Theinstrumentshallhaveaspectralresolutionnotexceeding1.0cm-1Wavenumberaccuracy波数准确度Wavenumberaccuracyshallbebetterthan±0.01cm-1Theinterferometershallhaveatleastfourbasicvelocitylevels;softwareshallpermittheselectionofagreaternumberofvelocitiesbetweenthebasiclevels.干涉仪应至少有四个基本速率水平；软件应允许在基本水平间选择较大值Themirror’sgreatestvelocityshallallowaspeedofatleastfivesweepspersecond.镜子最大速率应允许至少每秒5次清扫Thelaserandinfraredbeamsmustbecoaxialtoenablerapid,easyalignmentofthesystem,dependingonthesamplesoraccessories.激光和红外光束必须同轴，可以根据样品或附件情况，迅速容易地调整定位Theinstrumentshallhaveabeamsplitterwitharangeof7400to350cm-1仪器应具有分光器，其范围为7400至350cm-1Theopticalbenchshallhaveamainexperimentationmodulewithadevicetoallowpurgingwithnitrogen.光具座应具有主实验模具，允许用氮气吹扫净化Atpurchase,themainexperimentationmoduleshallbedesignedsoitcanreceive13and5mmpotassiumbromidepellets.采购时，主实验夹具应设计为可以接受13和5mm溴化钾丸Notes:注—Thischeck-list,containingexamplesoftechnicalattributesthatcanbetakenintoaccountintheselectionofaninstrumentandsupplier,canbeusedincombinationwiththegeneralcheck-listpresentedinLevelIinthecoredocument“QualificationofEquipment”.—本检查清单包括了技术特性举例，在选择仪器和生产商时可以进行考虑，可以与核心文件“仪器确认”中第一级通用检查清单结合使用。—ForTableII(LevelIIofEquipmentQualification:Installationandreleaseforuse)pleaserefertothecoredocument.—表二（第二级仪器确认安装和使用放行）参见核心文件TABLEIII表三LevelIII.Periodicandmotivatedinstrumentchecks第三级周期性主动仪器检查ExamplesofrequirementsforIRspectrophotometers红外分光光度仪的要求举例Parametertobechecked需要检查的参数Typicaltolerancelimits典型允许限度1.wave-numberscale波数刻度Seeannex1见附件12.Detectorenergyratio检测能量比Seemanufacturer’sspecification见生产商标准3.Signal/Noiseratio信噪比Seemanufacturer’sspecifications见生产商标准4.Resolution分辨率SeeAnnex1见附件15.Zerotest零点检测Seemanufacturer’sspecification见生产商标准6.Contaminationcheck(onlyforATRinstruments)污染检查（仅对ATR仪器）SeeAnnexI见附件17.Throughputcheck(onlyforATRinstruments)流量检查（仅对ATR仪器）80%8.Spectrallibrary图谱库SeeAnnexI见附件1TABLEIV表四LevelIV.In-useinstrumentchecks第四级在用仪器检查ExamplesofrequirementsforIRspectrophotometers红外分光光度计要求举例Parametertobechecked需要检查的参数Typicaltolerancelimits典型允许限度1.Systemsuitabilitycheck系统适用性检查AccordingtoPh.Eur.OrMAHdossierorvalidatedin-housemethod根据EP或MAH文件或验证过的内控方法ANNEXI附件1LevelIII.Periodicandmotivatedinstrumentchecks第三级周期性主动仪器检查ThisAnnexcontainspracticalexamplesoftestsandtheirassociatedtolerancelimitsforseveralparametersrelatedtotheperformanceofanIRspectrophotometer.本附件包括了红外分光光度计性能相关的几个参数的检查实例及其相关的允许限度TheseexamplescanbeconsideredbytheOMCLsaspossibleapproachestoperformtheLevelIIIoftheequipmentqualificationprocess: