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USP371251使用分析天平称量（中英文）(2014-06-0614:11:08)转载▼分类：食品药品1251WEIGHINGONANANALYTICALBALANCE使用分析天平称量（本文件来自USP37-NF32，目前尚未实施，信息仅供参考）INTRODUCTION介绍Weighingisafrequentstepinanalyticalprocedures,andthebalanceisanessentialpieceoflaboratoryequipment.Thegeneralinformationdescribedhereappliesdirectlytoelectronicbalancesusedinanalyticalprocedures.Althoughmanyportionsofthechapterareapplicabletoallbalances,someareapplicableonlytoanalyticalbalances.Thischaptershouldnotbeconsideredall-inclusive,andothersourcesofinformation(e.g.,theUSNationalInstituteforScienceandTechnologyandbalancemanufacturers)maybeusefulandapplicablewhenanalystsperformaweighingoperationorimplementaweighingprocedure[i][ii].Theinformationgiveninthischapterisapplicablenotonlytobalancesusedformaterialsthatmustbeaccuratelyweighed(seeBalances41)butalsotobalancesusedinallanalyticalprocedures.称重在分析程序中是一个很频繁的操作，天平是化验室的基本设备。这里的一般信息适用于在分析过程中使用的电子天平。尽管本章节的一部分也适用于所有天平，一些仅适用于分析天平。本章不应作为包括所有的文件，一些其它来源的信息（例如，美国国家科学技术研究所和天平生产商）可能也很有用，适用于化验员进行称量操作，或实施称重程序。本章中给出的信息不仅适用于必须精密称定的物质（参见/span天平41），同时也适用于所有分析过程中使用的天平。QUALIFICATION确认UsersshouldconsultAnalyticalInstrumentQualification1058,standardoperatingprocedures,andrecommendationsfrommanufacturerswhentheydevisequalificationplans.用户在设计其确认计划时，应参考/span分析仪器确认1058，标准操作规程，和生产商的推荐。Installation安装Thebalance'sperformancedependsontheconditionsofthefacilitywhereitisinstalled.Analystsshouldconsultinformationprovidedbythemanufacturerbeforetheyinstallabalance.天平的性能取决于其安装所处的环境。在安装天平前，化验员应参考供应商给出的信息。Supportsurface:Thebalanceshouldbeinstalledonasolid,level,nonmagneticsurfacethatminimizesthetransmissionofvibration(e.g.,afloor-mounted,graniteweighbench).Ifametallicsupportsurfaceisused,thesurfaceshouldbegroundedinordertopreventthebuildupofstaticelectricity.支持台面：天平应安装在坚固、水平、无磁场的平面，尽量减少震动传递（例如，安装在地板，花岗岩称重台）。如果采用了金属的支持台面，表面应接地，以避免静电聚积。Location:Ifpossible,thebalanceshouldbelocatedinaroomthatistemperatureandhumiditycontrolled.Thelocationshouldhaveaclean,consistentelectricalpowersupply.Thelocationshouldbefreeofdraftsandshouldnotbenearovens,furnaces,airconditionerducts,orcoolingfansfromequipmentorcomputers.位置：如果可能，天平应安装在一个温湿度可控的房间。位置应清洁，具有持续的电力供应。位置应不会产生波动，不靠近烘箱、马弗炉、空调送回风罩，或设备、空调的冷却风扇。Thebalanceshouldbepositionedawayfromoutsidewindowssothatdirectsunlightdoesnotstrikethebalance.Thebalanceshouldnotbeinstallednearsourcesofelectromagneticradiationsuchasradiofrequencygenerators,electricmotors,orhand-heldcommunicationdevices(includingcordlesstelephones,cellulartelephones,andwalkie-talkies).Thebalanceshouldnotbelocatednearmagneticfieldsinducedbylaboratoryinstrumentationorotherequipment.天平位置应远离窗户，以避免直接阳光照射。天平安装不应靠近电磁辐射源，如无线频率发向射源，电子马达，或手动通话设施（包括无绳电话、手机、手提无线电话机）。天平不应安装在化验室设备或其它设备产生的磁场区域附近。Theperformanceofthebalanceshouldbeassessedfollowinginstallationandbeforeuseinordertodemonstrateadequateperformance.Insomesituations,itmaynotbepossibletopositionthebalanceinanoptimumenvironment.Examplesofpotentialfacilityissuesincludethefollowing:天平的性能在安装后使用前应进行评估，以证明其性能符合要求。在某些情况下，可能无法将天平安装在一个理想的环境。潜在的设施问题包括以下：1.Aircurrentssometimesarepresentinthelaboratory.化验室中有时会有气流2.Temperaturesinthelaboratoryvaryexcessively(checkthemanufacturer'sliteratureabouttemperaturesensitivity).化验室温度有时会快速波动（检查供应商关于温度敏感性的说明）3.Humidityiseitherveryloworveryhigh.Eitherconditionmayincreasetherateatwhichthesampleweightvariesbecauseofpickuporlossofwater.Lowhumidityincreasesthebuildupofstaticelectricity.湿度可能会很低或很高。由于失水或吸水，太高或太低都会影响样品重量变动的速度。低湿度会增加静电积聚。4.Adjacentoperationsarecausingvibration.邻近操作产生震动5.Corrosivematerialsareusednearbyorareroutinelyweighed.附近使用腐蚀性材料，或常规称量腐蚀性物料6.Thebalanceislocatedwithinafumehoodbecauseitisusedtoweighcorrosiveorhazardousmaterials.由于天平用于称量腐蚀性或危险性物料，因此安装在排烟罩内7.Thebalanceisadjacenttoequipmentthatproducesamagneticfield(e.g.,amagneticstirrer).天平邻近产生磁场的设备（例如，电磁搅拌器）8.Directsunlightstrikesthebalance.天平有直接太阳光照Insituationswhenthebalanceislocatednearequipmentorsystemsthatinducevibration,drafts,electromagneticradiation,magneticfields,orchangesintemperatureorhumidity,theassessmentshouldbeconductedwiththosesystemsoperatinginordertoduplicateaworst-casescenario.如果天平位置接近产生震动、摆动、电磁辐射、磁场或温湿度变化的设备，则需要对这些系统在操作状态下进行评估，以重复最差情况环境。OperationalQualification运行确认Anoperationalqualificationshouldbeperformedeitherbytheuserorbyaqualifiedthird-partyvendoraftertheequipmenthasbeeninstalled.在天平安装后，应由用户或第三方供应商进行运行确认。Asaminimum,thepowershouldbeturnedonandthebalanceshouldbeallowedtoequilibrateaccordingtothemanufacturer'sinstructions(1–24h,dependingonthetypeofbalance)beforeuse.Dependingonthebalance,analystsshouldincludethefollowingproceduresintheoperationalqualification:最低要求，要打开电源，根据生产商的要求，在使用前让天平平衡（1-24小时，根据型号不同而不同）。根据天平型号，化验员应在运行确认中包括以下程序：1.Mechanicalmobilityofallmoveableparts所有可移动部件机械动态2.Controlofstableindication稳定指示的控制3.Manuallytriggeredorautomaticadjustmentbymeansofbuilt-inweights内置砝码的手动或自动调节4.Operationofancillaryequipment辅助设备的操作5.Tarefunction去皮功能6.Initialcalibration初始校正Severaltypesofelectronicanalyticalbalancesusebuilt-inweightsformanuallytriggeredorautomaticadjustment.Thisadjustmentusuallyisappliedtoreducet