ASMEBPE中英对照

生物加工设备GRGRGRGR部分一般要求GR-1GR-1GR-1GR-1简介简介简介简介INTRODUCTIONINTRODUCTIONINTRODUCTIONINTRODUCTION此标准所规定的要求，在生物处理﹑制药和个人保健品行业设备的设计非常实用，所涉及方面包括灭菌﹑清洁﹑材质﹑尺寸﹑公差﹑表面抛光﹑材料接合和密封等。主要应用于：ThisStandardprovidestherequirementsapplicabletothedesignofequipmentusedinthebioprocessing,pharmaceutical,andpersonalcareproductindustries,includingaspectsrelatedtosterilityandcleanability,materials,dimensionsandtolerances,surfacefinish,materialjoining,andseals.Theseapplyto:（a）在制造﹑改进和提高过程中与产品﹑原料﹑产品介质直接接触的关键部件;（b）产品制造中主要部件系统（如WFI，清洁蒸汽，过滤和半成品贮存等）(a)componentsthatareincontactwiththeproduct,rawmaterials,orproductintermediatesduringmanufacturing,development,orscale-up;(b)systemsthatareacriticalpartofproductmanufacture[e.g.,water-for-injection(WFI),cleansteam,filtration,andintermediateproductstorage].此标准不能应用于以下部分：不与成品或制造阶段介质部分直接接触的系统（如计算机系统，电气导管以及外部系统支撑结构）。ThisStandarddoesnotapplytothosecomponentsofthesystemthatarenotincontactwiththefinishedproductorareapartoftheintermediatemanufacturingstages(e.g.,computersystems,electricalconduits,andexternalsystemsupportstructures).蒸汽消毒系统通常要满足压力容器设计编码。其他的设备或系统在经过厂家和用户同意下，不需要遵循这些编码。Steamsterilizedsystemsnormallymeetpressurevesseldesigncodes.Otherequipmentorsystemsasagreedtobythemanufacturerandowner/usermaynotrequireadherencetothesecodes.在压力条件下操作时，系统的设计结构应分别符合ASME锅炉和压力容器编码，第VIII章节，第1部分和ASMEB31.3管道处理编码，用户能对说明和要求另行规定。当法律或强制机构（如市级，省级，州级或联邦）对此应用程序有明文规定时，最终的设计要求应符合这些法律规定。然而，一些标准虽然不符合现在BPE标准，以前所提到的构造编码也是满足的（如焊接接受标准，检察要求，压力测试等）。Whenoperatingunderpressureconditions,thesystemsshallbeconstructedinaccordancewiththeASMEBoilerandPressureVesselCode(BPVC),SectionVIII,Division1,andtheASMEB31.3,ProcessPipingCode,respectively.Theowner/usercanstipulateadditionalspecificationsandrequirements.WhenanapplicationiscoveredbylawsorregulationsissuedbyanEnforcementAuthority(e.g.,municipal,provincial,state,orfederal),thefinalconstructionrequirementsshallcomplywiththeselaws.However,allthepreviouslymentionedconstructioncodesshallbesatisfiedincludingthoseinstanceswherethesecodesarenotreferredtointhecurrentBPEStandard(e.g.,weldacceptancecriteria,inspectionrequirements,pressuretesting,etc.).GR-2GR-2GR-2GR-2范围SCOPESCOPESCOPESCOPE生物处理﹑制药﹑私人保健品行业的要求标准和其它相关的卫生高等级要求一样，覆盖物直接或间接的影响原料﹑设计﹑构造﹑压力系统（容器和管路）﹑检查﹑审核﹑测试和证明。此标准中没有明确规定的条款和要求并不意味着禁用，工程判断一定要符合此标准的基本原理准则，不能忽略强制规定规则或此标准明确的禁用条款。ThisStandarddealswiththerequirementsofthebioprocessing,pharmaceutical,andpersonalcareproductindustriesaswellasotherapplicationswithrelativelyhighlevelsofhygienicrequirements,coveringdirectlyorindirectlythesubjectsofmaterials,design,fabrication,pressuresystems(vesselsandpiping),examinations,inspections,testing,andcertifications.ItemsorrequirementsthatarenotspecificallyaddressedinthisStandardcannotbeconsideredprohibited.EngineeringjudgmentsmustbeconsistentwiththefundamentalprinciplesofthisStandard.SuchjudgmentsshallnotbeusedtooverrridemandatoryregulationsorspecificprohibitionsofthisStandard.GR-3GR-3GR-3GR-3检查INSPECTIONINSPECTIONINSPECTIONINSPECTION此标准的每一部分都有详细的检查要求。如果需要一个检查程序，在经过用户﹑订约人﹑检查订约人和工程师同意后要保证系统和部件满足此标准。TheinspectionrequirementsarespecifiedineachPartofthisStandard.Ifaninspectionorexaminationplanisrequired,itshallbedevelopedandagreedtobytheowner/user,contractor,inspectioncontractor,and/orengineerensuringthatthesystemsandcomponentsmeetthisStandard.GR-4GR-4GR-4GR-4检验员////检查员INSPECTOR/EXAMINERINSPECTOR/EXAMINERINSPECTOR/EXAMINERINSPECTOR/EXAMINER检验人员和试验人员在此标准应满足以下条件：InspectorandexaminerinthisStandardshallbedefinedfor:（a）压力容器，取得认证的检验人员应满足ASMEBPVCⅧ，第一部分，UG-91。（b）管道系统，管材和非标准容器，用户的检验员应遵照ASMEB31.3，340.4（a）。（c）管道系统和管材，试验员，作为生产厂家的员工进行质量控制试验要按照ASMEB30.3，341.1（a）要求。(a)PressureVessels.AnAuthorizedInspector,asdefinedinASMEBPVC,SectionVIII,Division1,para.UG-91;(b)Piping,Tubing,andNon-CodeVessels.Anowner/user’sinspector,asdefinedinASMEB31.3,para.340.4(a);and(c)PipingandTubing.Anexaminer,definedasapersonwhoperformsqualitycontrolexaminationsforamanufacturerasanemployeeofthemanufacturerasdefinedinASMEB31.3,para.341.1.当地方法规要求压力设备的设计和建造依据其他标准而非ASME规范时，则此标准的检验人员应为相关权威认可的合格人员。WhenlocalregulationsrequirethatpressureequipmentbedesignedandconstructedinaccordancewithstandardsotherthanASMEcodes/standards,theinspectorinthisStandardisdefinedasonewhoisacceptabletotherelevantregulatoryauthority.GR-5GR-5GR-5GR-5责任RESPONSIBILITIESRESPONSIBILITIESRESPONSIBILITIESRESPONSIBILITIES检查人员的职责包括以下部分：Theresponsibilitiesofinspectionpersonnelaredefinedasfollows.GR-5.1GR-5.1GR-5.1GR-5.1压力容器PressurePressurePressurePressureVesselsVesselsVesselsVessels用户检查员职责按照ASMEBPVC,VIII章节，第1部分，UG-91规定。Theresponsibilitiesoftheowner’sInspectorshallbethesameastheinspectorinASMEBPVC,SectionVIII,Division1,UG-91.GR-5.2GR-5.2GR-5.2GR-5.2管道，管子件和非标准容器Piping,Piping,Piping,Piping,Tubing,Tubing,Tubing,Tubing,andandandandNoncodeNoncodeNoncodeNoncodeVesselsVesselsVesselsVessels用户检查员职责按照ASMEB31.3340.2部分的规定。Theresponsibilitiesoftheowner/user’sinspectorshallbeinaccordancewithASMEB31.3,para.340.2.GR-6GR-6GR-6GR-6检验用人孔ACCESSACCESSACCESSACCESSFORFORFORFORINSPECTORSINSPECTORSINSPECTORSINSPECTORS生物处理设备和部件厂商应允许在设备和部件运作时，用户和授权人员自由进入，紧急检查通知应经过厂家和检查人员的互相同意。厂家设备的