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首页 sop - Administration of reagents

sop - Administration of reagents.doc

sop - Administration of reagen…

Brady内利
2019-06-17 0人阅读 举报 0 0 暂无简介

简介:本文档为《sop - Administration of reagentsdoc》,可适用于医药卫生领域

Title:AdministrationofReagentsThisSOPconsistsofpages本SOP共有页Attachments附件:标题:试剂的管理    Definitions 定义Reagent:discussedinthisSOPincludesgeneralreagentsandhazardouschemicals试剂:在本SOP中讨论的包括一般试剂和危险化学品。Generalreagents:refertothoseinorganicandorganicchemicals,withtheexceptionofhazardouschemicalsandalltheindicators一般试剂:指除化学危险品外的各种无机、有机试剂及各类指示剂。Hazardouschemicals:refertothetoxic,corrosive,flammableandexplosive(chemical)reagents化学危险品:指具有毒、腐蚀、易燃、易爆等危险特性的化学物品。Description 详述Classification分类 Upontherequirementofadministration,thechemicalreagentsareclassifiedintohazardouschemicalsandgeneralreagents依管理需要将实验室化学试剂分为化学危险品和一般试剂。  Procurement请购Upontheneedsofthetests,thedesigneeshouldapplyfortheprocurementofchemicalreagentsrequired,soastoensurethesmoothprogressofQCtasks根据需要及时请购相应规格的试剂保证工作的正常运行。Ifwithoutspecificdescription,analyticalorthehighergradereagentsshouldbeprocuredWhenpurchasingreagents,remarktheclassificationofreagentsinPR(includinggeneralreagents,toxicsubstance,drugmaterialetc)若无特殊说明一般应购买分析纯或以上级别试剂。请购时还应该备注该试剂的类别(如:一般试剂剧毒品试剂易制毒试剂等)Reagentshouldbepurchasedfromreliablesupplies,PurchaseDepartmentestablishcontactwiththereagentsuppliers,finishsupplierssurveychecklistCollecttheCertificateofthereagentsuppliersThereagentsuppliersshouldprovideBusinesslicense,Taxlicense,speciallicense(forexample:Hazardoushemicalslicense,DrugMateriallicense),qualitysystemCertificateandothersdemandsReagentSupplierSurveychecklistseeSOPWT试剂应当从可靠的供应商处采购采购部与试剂供应商建立联系采购部完成试剂供应商调查索取试剂供应商的资质证书供应商应提供营业执照、税务登记证、涉及特殊经营的还要有相应的许可证(如有毒、有害或易燃、易爆化学试剂的经营)、质量体系认证证书和其它特别技术上或商业上的要求。试剂供应商调查表见SOPWT。QCbuildupandapprove“ReagentSupplierlist”and“Reagentsupplierqualificationregistrationform”,andupdateitwhenanyinformationischanged,andapprovedbyQCmanager“Reagentsupplierqualificationregistrationform”shouldbestoredwithFandF,thecopiesshouldbedistributedtoPurchaseDepartmentandSCMlogisticReagentsupplierlistseeSOPWTReagentsupplierqualificationregistrationformseeSOPWTQC负责建立与批准试剂供应商名录和试剂供应商资质登记表当任一信息发生变化时须及时更新,并有QC经理批准。供应商资质登记表分别附在化学试剂库存和耗用一览表(F)和库房化学试剂库存和耗用一览表(F)之前并将复印件分发至采购部和供应链管理-物流部仓库。试剂供应商名录见SOPWT。试剂供应商资质登记表见SOPWT。Checking(includingcheckingsupplier,name,specification,label,andquantity,etc)shouldbemadeintimebytheQCdesigneeuponthearrivalofproducts货到时由QC人员及时清点核实(包括供应商试剂的名称、规格、标签及数量等)。ThedeliverysheetandreagentsshouldbesenttoSCMlogistictogetherifthereagentsneedtobestoredinSCMlogisticafterchecked检查后需要由供应链管理-物流部仓库保管的试剂应将送货清单和试剂一同送达供应链管理-物流部仓库。  Registration登记Getandconsumptionofreagentsshouldberegisteredinthechemicalreagentstorageandusagelist(F)withoutdelayforcheckinginthefuture领取和消耗的试剂及时登记在化学试剂库存和耗用一览表(F)以备查询。PreparetheMSDSfornewkindofreagentifnecessary如有必要需准备新品种试剂的物质安全数据表。  Storage存放Aftercheckingthemessagesofreagents,storetherelevantroomaccordingtostoragerequirementofreagentsGenerally,reagentroomkeepsconstantlowtemperatureThehighacidandcorrosivereagentsarestoredintheacidproofcabinets,flammableandexplosive(chemical)reagentsarestoredintheexplosionproofcabinetThestorageoftoxicsubstanceseeSOP试剂到货清点完毕后按照储存要求及时放入相应的试剂间保存。一般试剂间保持常年低温环境易燃易爆试剂放入防爆柜保存强酸强腐蚀试剂放入酸柜保存剧毒试剂保存参见SOP。Hazardouschemicals化学危险品Chemicalhazardousproductsmustbestoredinthehazardouswarehouse,andshouldbekeptaccordingtotheirclassificationsOnlythequantityofaboutoneweek’susageorausingpackagecanberemainedinthelabandshallbestoredinthesafetycupboard化学危险品须存放在危险品仓库分类贮存和保管实验室一般仅存放在用的或约一周的量并存放于相应的安全柜中。Generalreagents一般试剂GeneralreagentsshouldbestoredaccordingtothesequenceinthereagentsstorageroomSolidreagentsshouldbestoredseparatelyfromliquidreagentsSafetycountermeasuresshouldbetakenwhendealingwiththeleakageofliquidreagents此类试剂可存放在试剂贮存室中以一定顺序存放固体试剂和液体试剂分开存放泄漏的液体试剂要及时地安全处理。  Labelling标签Clearandintactlabelsshouldbefoundonthereagentbottlescontainingthereagent,indicatingthecharacteristicsofthereagent(includingbutnotlimitedtothedescription,grade,purityorconcentration,manufacturingdate,andtheinformationaboutthemanufacturer)试剂瓶上应有完整清晰的生产商的标签标明该试剂的特征(包括但不限于名称、级别、纯度或浓度、生产日期、生产商等信息)。TheoriginallabelonthebottleshouldbecarefullyprotectedIftheoriginallabel,especiallythesafetywarninglabelisfoundnotclearorincomplete,thenewlabelshallbeimmediatelystuckonthebottlecoveringtheoldone保护好试剂瓶原有的标签若原有标签不完整或不清晰须立即贴补尤其是安全警示标志。Uponthearrivalofpurchasedreagents,sticktheBISPLlabelandwritethename,batchNo,acceptedpersonandaccepteddateimmediatelybythedesigneeThefirstusershouldwritetherelevantinformationonthelabelsuchasthedateofopening,thepersonwhoopensandthevaliddateThereagentlabelformatseeattachment试剂到货时就贴上本公司标签写上名称批号接收日期接收人。首次开启时写上开瓶日期开瓶人和失效日期。试剂标签参见附件。  Validperiod有效期 Unlessotherwisespecified,thevalidperiodofthereagentissubjecttotheirdifferentqualitiesSoitcanbeclassifiedasacceptedvalidperiodandusedvalidperiodTheacceptedvalidperiodusuallywouldbeyearTheusedvalidperiodusuallywouldbe(afteropening)twoyearsfortheliquidreagent,fiveyearsforthesolidreagent,theusedvalidperiodiscalculatedfromtheopeningdateAndifthevaliddateprovidedbythemanufactureapplicable,theshorterisconsideredasthepracticalvaliddate试剂的有效期要按其性质进行规定分为接收有效期和使用有效期一般情况下接收有效期为年。使用有效期一般情况下液体试剂为年固体试剂为年有效期从开瓶之日起计算,另有规定除外。生产商提供的有效期和上述规定的有效期比较以短者为准。  Usage取用GetthereagentsfromSCMlogisticaccordingtotheconditionofconsumptionQC实验室根据消耗情况从供应链管理-物流部仓库领取试剂。Filltheoutsidestorerequisition(F)toSCMlogisticandcopyittokeepinQCchemicallaboratoryforregistrationFillinchemicalreagentstorageandusagelistinoutsidestore(F),copyFtokeepinSCMlogisticwhenupdateeverymonth领用时填写外部库房领料单(F)交给供应链管理-物流部仓库同时复印一份备实验室登记。填写库房化学试剂库存和耗用一览表(F),每月更新F时复印一份留存供应链管理-物流部仓库。TherequirementofreagentsvariesbydifferentanalyticalmethodsThereagentsofdifferentgradesshouldbechosenaccordingtotherequirementAnyexpiredreagentsorwithoutlabelareforbiddentouse不同分析方法对试剂有不同的要求因此要根据实际情况使用相应级别的试剂切勿使用无标签和过期失效的试剂。Solidreagentshouldbetakenfromthebottlebyusingtheplasticorstainlesssteellabspatulasthebiglumpscanbebrokenintosmallpieceswithacleanglassstickbeforeusing从固体试剂瓶中取试剂要用干净的牛角勺或不锈钢的小勺结块的试剂可用干净粗玻璃棒捣碎后取出。Liquidreagentcanbetakenbythecleanvolumetriccylinderortobepouredintothecleanbreaker液体试剂可用干净的量筒量取或倒在干净的烧杯中使用。VolatilereagentshouldbedisposedintheFumehood,theopeningofbottlemustnotbepointedtoyourselforanyothers挥发性的试剂要在通风橱中处理不要将瓶口对准自己或别人。Greatattentionmustbepaidandthesafetycountermeasuresshouldbetakenwhendealingwiththehazardousproductslikeconcacidoralkali,andtheinflammablesorexplosives取用浓酸、强碱或易燃易爆等危险品时注意安全并采取相应的安全防护措施。Protectionincludesbutnotlimitprotectiveglasses,glovesandfacemask防护包括但不限于防护眼镜手套和防护面罩。Thereagentoutofthebottleshouldnotbeputbackintotheoriginalbottleandtheplugshouldbefixedtightlytothebottleneckafterthetakingofthereagent取出的试剂不能再倒回原瓶取完试剂后原瓶须重新盖紧瓶盖。Thereagentjusttakenfromthelowtemperaturestorageareashouldnotbeusedonlyroomtemperatureinreached从低温储存区取出的试剂须待其恢复到室温后方可开启取用。  Disposal处理Chemicalreagent(organicsolvent,acid,alkalietc),separatingthereagentaccordingtoacidandalkali,collectingthereagentindesignated,labeledbinCollecttheneutroreagentincommonwastebinPutthereagentofsamecharactertogetherWhenthewasteisaccumulatedtocertainlevel,transfertoSCMlogisticfordisposal废化学试剂(有机溶剂酸碱等)根据其酸碱性分别倒入贴有恰当标签的酸碱容器和有机溶剂桶中中性试剂倒入一般废液桶中。可以将同类不发生相互作用的化学品混合在一起方便存储。当存储达到一定量后由实验室人员移交给供应链管理-物流部仓库进行处理。TheemptysolventbottlecanbestoredinwastebarrelWhenthewasteisaccumulatedtocertainlevel,thepersoninlabwillberesponsiblefordisposalThepackagesandcontainers,thesamplereserved(solid)aftertestingcanbestoredinsolidashbin,theliquidcanbestoredincommonwastebinWhenthewasteisaccumulatedtocertainlevel,transfertoSCMlogisticfordisposalDetailedcontentseeSOPNonpharmaceuticalwastedisposal试剂用完后空瓶存放于专用收集桶(大桶)中待一定量后由实验室人员负责处理。实验室检测完废弃包材和容器固体样品放入固体废物箱中液体样品倒入贴有恰当标签的有机溶剂桶中待一定量后由实验室人员移交给供应链管理-物流部仓库进行处理。具体参见SOP非制药垃圾的处理。  

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