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-生产工艺常用词汇:中文
英文单硫酸卡那霉素硫酸氢钠枸橼酸钠硫酸溶液中性硼玻璃安瓿瓶安瓿瓶清洗安瓿瓶灭菌除热源配料过滤灌封灭菌和检漏测试灯检贴签和包装关键工艺参数升温段传送带压差时间间隔过滤器孔径过滤压力灌装量缓冲罐灌装前充氮保护灌装后充氮保护真空检漏测试
KanamycinsulfatesodiumbisulfatesodiumcitrateSulfuricacidsolutionNeutralborosilicateglassampouleAmpoulewashingAmpoulesterilizationanddepyrogenationBatchingFiltrationFillingandsealingSterilizationandleakagetestVisual/LampinspectionLabelingandpackagingCriticalProcessParameterheatingsectionconveyorbeltDifferentialpressureTimeintervalPoresizeoffilterFiltrationpressureFillingvolumebuffertankpre-fillingnitrogenflushpost-fillingnitrogenoverlayVacuumleaktest内包材
PrimarypackagingmaterialProcessinstructionLivzon Group Fuzhou Fu*ingPharmaceuticalCo.Ltd.HunanErkangPharmaceuticalCo.,LtdHunanHuariPharmaceuticalCo.,LtdGuangzhouChemicalReagentFactoryZhuhaiDaLinWanIndustrialGasCo.,LtdSCHOTTGlassTechnologies(Suzhou)Co.LtdqualityspecificationCirculationwaterRotatingspeed. z.-QC常用英文词汇中文
英文物理性状外观不溶性微粒溶液颜色鉴别保留时间含量有关物质标示量可见异物无菌薄膜过滤法内毒素
PhysicalattributesAppearanceParticulatematterSolutioncolorIdentificationretentiontimeAssayRelatedsubstancelabeledamountVisibleparticlesSterilityMembranefiltrationmethodBacterialendoto*insInitialbioburdenstirringuniformityashytoppointedendbubblehead,flathead,brokenampoule,crookedampoule,emptyampoule;中文
英文药品生产质量管理规*国家食品与药品监督管理局总则制剂原料药成品工序机构与人员专业知识生产经验组织能力
GMP:GoodManufacturingPracticeStateFoodandDrugAdministrationGeneralProvisionspreparationAPI:ActivePharmaceuticalIngredientfinishedgoodsprocessorganizationandpersonnelprofessionalknowledgeproductione*perienceorganizationalskill.
z.-技术人员实施药品生产质量管理质量检验专业技术培训基础理论知识实际操作技能高生物活性高毒性污染考核评估厂房与设施生产环境空气洁净级别昆虫洁净室(区)光滑无裂缝无颗粒物脱落耐受消毒无菌交界处弧形灰尘积聚储存区生产规模设备物料中间产品待验品交叉污染管道
technicalstaffimplementationpharmaceuticalmanufacturingqualitymanagementqualityinspectionprofessionalandtechnicaltrainingbasictheoreticalknowledgepracticaloperationskillshighlypotenthighto*icitycontaminationassessmentbuildingsandfacilitiesproductionenvironmentcleanairlevelinsectcleanroom(area)smoothnocracksnoparticlesheddingtolerancedisinfectionsterilejunction,jointarcdustaccumulationstoreareaproductionscaleequipmentmaterialintermediateproductquarantinedmaterialcross-contaminationpipeline.
z.-公用设施utilitiesofpublicservice照明lighting照度illumination应急,紧急情况emergency净化purification,clean微生物,微生物学,微生物的micro-organism,microbiology,microbiologic监测monitoring记录record天棚天花板ceiling,roof密封seal静压差StaticDifferentialPressure温度temperature相对湿度RH:RelativeHumidity地漏floordrainer分装室separatingroom,fillingroom相对负压relativenegativepressure废气wastegas,e*haustedairβ-内酰胺结构类药品β-Lactamsstructuredrug避孕药品contraceptives激素类hormone抗肿瘤类anti-tumor,oncology放射性药品Radiopharmaceuticals包装packing,package循环使用recycling微粒particles辐射radiation细菌bacteria病毒virus细胞cell脱毒前后Pre-deto*ificationandpostdeto*ification活疫苗与灭活疫苗activevaccine/inactivatedvaccine人血液制品bloodproducts预防制品preventionproducts灌装filling.z.-中药前处理提取浓缩动物脏器炮制通风除烟除尘降温设施筛选切片粉碎压缩空气惰性气体取样称量室中药标本检定鉴定同位素设备选型耐腐蚀吸附润滑剂,润滑冷却剂流向纯化水注射用水滋生储罐死角盲管纤维
Chinesetraditionalmedicinespretreatmente*tractionconcentrationvisceraofanimal,organofanimalconcoctedventilationsmokeremovaldustremovaltemperature-reducingestablishment,coolingscreeningslicinggrindingpressedairnoblegassamplingweighingroomChineseherbalsample,e*emplarofTCMverification,identificationIsotopeequipmentmodel/typeselectionanticorrosionadsorption,absorptionlubricant,lubricatecoolantflowdirectionPW:PurifiedWaterWFI:WaterforInjectionbreedingtankneglectedportionblindpipefiber.
z.-疏水性仪表量具衡器精密度维修、保养不合格物料购买发放产地固体液体挥发性净药材麻醉药品精神药品易燃易爆验收使用说明书标签卫生车间间隔时间清洁剂消毒剂废弃物更衣室工作服,颗粒性物质,颗粒剂耐药菌株传染病皮肤病
hydrophobicityinstrumentationmeasuringtoolweighinginstrumentprecisionmaintenancedisqualifiedmaterialpurchasingreleasingoriginsolidliquidvolatilenetmedicine,netTCMnarcoticspsychotropicdrugbustiblee*plosiveacceptanceinstructionlabelhygieneworkshoptimeintervaldetergentdisinfectantwasteschangingroomworkclothesgranulesdrug-resistantstraininfectiousdiseasedermatosis.
z.-验证确认安装运行性能原辅料文件投诉报废品名处方技术参数容器申请稳定性起草生产管理混淆喷雾合格证清场质量管理内控滴定液培养基有效期产品销售与收回投诉与不良反应报告自检附则平衡饮用水蒸馏法离子交换法
verification,validationqualificationinstallationrunningoperationperformancerawmaterialande*cipientdocumentplaintrejectproductnameprescription,formulatechnicalparametercontainerapplicationstabilitydraftproductionmanagement,manufacturingcontrol.mi*-upspraycertificateclearancequalitymanagementinternalcontroltitrantmediumvalidity,e*pirydate,shelflifeproductsalesandrecallplaintsandadversereactionreportself-inspectionappendi*balancedrinkingwaterdistillationione*change.
z.-反渗透法RO:ReverseOsmosis附加剂添加剂additives滞留strandedresort批batch,lot组分,组成ponent无纤维脱落的过滤器non-fiber-releasingfilter活性成份ActiveIngredient非活性成份Inactiveingredient中间产品intermediateproduct批号batchnumber药用物料medicatedfeed药用预混合料medicatedpremi*质量控制部门Qualitycontroldepartment理论产量Theoreticalyield实际产量Actualyield比率Percentage,rate验收标准可接受标准Acceptancecriteria代表性样品Representativesample微粒状的particulate污染物contaminant石棉asbestos诊断diagnosis缓解mitigation化学变化chemicalchange组分ingredient,ponent制备fabricatepreparation复合pound混合blend加工processing浓度concentration单位剂量unitdose药品包装容器drugproductcontainers密封件,封盖closure效价titer.z.-纯度purity规格strength监督supervise,monitor实验室laboratory无菌操作asepticoperation,sterileoperation层流laminarflow湍流turbulentairflow空气过滤airfiltration空气加热airheating预过滤器Pre-filter排气系统e*haustsystem管件plumbing污水sewage废料refuse空气干燥器airdrier垃圾trash有机废料organicwaste杀鼠剂rodenticides杀昆虫剂insecticides杀真菌剂fungicides熏蒸剂fumigatingreagents去垢剂cleaningagents消毒剂sanitizingagents滂沱剂lubricant自动化设备、机械化设备和电子设automatic,mechanical,orelectronicequipment备微型胶卷microfilm注射剂injection灭菌设备sterilizationequipment无菌取样技术asepticsamplingtechniques显微镜microscope热源,内毒素pyrogen,endoto*in偏差deviation变更changecontrol进料charge-in.z.-项目代码鉴别片剂胶囊颗粒剂溶解时间澄明度隔离系统返工发放非处方药处方药保险包装明胶硬胶囊顺势治疗入库变质准确性灵敏性特异性重复性变应原提取物眼膏粗糙或磨蚀物质控释制剂实验动物供应商光谱测量单位换算系数试剂安慰剂明确地取代
itemcodeidentifytabletcapsulegranuledissolutiontimeclarityisolationsystemreprocessingissuance,releaseOTC:over-the-counterprescriptionmedicinetamper-resistantpackagehardgelatincapsulehomeopathicwarehousingdeteriorateaccuracysensitivityspecificityreproducibility,repeatabilityallergenice*tractsophthalmicointmentharshorabrasivesubstancescontrolled-releasedosageformlaboratoryanimalssupplierspectrumunitsofmeasureconversionfactorsreagentplaceboe*plicitlysupersede.
z.-溶液so
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