ampoule

生产工艺常用词汇：

中文英文

单硫酸卡那霉素

Kanamycinsulfate

硫酸氢钠sodiumbisulfate

枸橼酸钠sodiumcitrate

硫酸溶液Sulfuricacidsolution

中性硼玻璃安瓿瓶Neutralborosilicateglassampoule

安瓿瓶清洗Ampoulewashing

安瓿瓶灭菌除热源Ampoulesterilizationanddepyrogenation

配料Batching

过滤Filtration

灌封Fillingandaling

灭菌和检漏测试Sterilizationandleakagetest

灯检Visual/Lampinspection

贴签和包装Labelingandpackaging

关键工艺参数

CriticalProcessParameter

升温段heatingction

传送带conveyorbelt

压差Differentialpressure

时间间隔Timeinterval

过滤器孔径Poresizeoffilter

过滤压力Filtrationpressure

灌装量Fillingvolume

缓冲罐buffertank

灌装前充氮保护pre-fillingnitrogenflush

灌装后充氮保护post-fillingnitrogenoverlay

真空检漏测试Vacuumleaktest

内包材Primarypackagingmaterial

Processinstruction

LivzonGroupFuzhouFuxing

PharmaceuticalCo。Ltd.

HunanErkangPharmaceuticalCo.,Ltd

HunanHuariPharmaceuticalCo。,Ltd

GuangzhouChemicalReagentFactory

ZhuhaiDaLinWanIndustrialGasCo.,Ltd

SCHOTTGlassTechnologies（Suzhou）

qualityspecification

Circulationwater

Rotatingspeed

QC常用英文词汇

中文英文

物理性状Physicalattributes

外观Appearance

不溶性微粒Particulatematter

溶液颜色Solutioncolor

鉴别Identification

保留时间retentiontime

含量Assay

有关物质Relatedsubstance

标示量labeledamount

可见异物Visibleparticles

无菌Sterility

薄膜过滤法Membranefiltrationmethod

内毒素Bacterialendotoxins

Initialbioburden

stirringuniformity

ashytop

pointedend

bubblehead，flathead，brokenampoule，

crookedampoule,emptyampoule；

中文英文

药品生产质量管理规范GMP：GoodManufacturingPractice

国家食品与药品监督管理局StateFoodandDrugAdministration

总则GeneralProvisions

制剂preparation

原料药API：ActivePharmaceuticalIngredient

成品finishedgoods

工序process

机构与人员organizationandpersonnel

专业知识professionalknowledge

生产经验productionexperience

组织能力organizationalskill

技术人员technicalstaff

实施implementation

药品生产pharmaceuticalmanufacturing

质量管理qualitymanagement

质量检验qualityinspection

专业技术培训professionalandtechnicaltraining

基础理论知识basictheoreticalknowledge

实际操作技能practicaloperationskills

高生物活性highlypotent

高毒性hightoxicity

污染contamination

考核评估asssment

厂房与设施buildingsandfacilities

生产环境productionenvironment

空气洁净级别cleanairlevel

昆虫inct

洁净室（区）cleanroom（area)

光滑smooth

无裂缝nocracks

无颗粒物脱落noparticleshedding

耐受tolerance

消毒disinfection

无菌sterile

交界处junction,joint

弧形arc

灰尘积聚dustaccumulation

储存区storearea

生产规模productionscale

设备equipment

物料material

中间产品intermediateproduct

待验品quarantinedmaterial

交叉污染cross-contamination

管道pipeline

公用设施utilitiesofpublicrvice

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al

静压差StaticDifferentialPressure

温度temperature

相对湿度RH：RelativeHumidity

地漏floordrainer

分装室paratingroom,fillingroom

相对负压relativenegativepressure

废气wastegas,exhaustedair

β－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-detoxificationandpostdetoxification

活疫苗与灭活疫苗activevaccine/inactivatedvaccine

人血液制品bloodproducts

预防制品preventionproducts

灌装filling

中药Chinetraditionalmedicines

前处理pretreatment

提取extraction

浓缩concentration

动物脏器visceraofanimal,organofanimal

炮制concocted

通风ventilation

除烟smokeremoval

除尘dustremoval

降温设施temperature-reducingestablishment，cooling

筛选screening

切片slicing

粉碎grinding

压缩空气compresdair

惰性气体noblegas

取样sampling

称量室weighingroom

中药标本Chineherbalsample,exemplarofTCM

检定鉴定verification，identification

同位素Isotope

设备equipment

选型model/typelection

耐腐蚀anticorrosion

吸附adsorption，absorption

润滑剂,润滑lubricant，lubricate

冷却剂coolant

流向flowdirection

纯化水PW:PurifiedWater

注射用水WFI：WaterforInjection

滋生breeding

储罐tank

死角neglectedportion

盲管blindpipe

纤维fiber

疏水性hydrophobicity

仪表instrumentation

量具measuringtool

衡器weighinginstrument

精密度precision

维修、保养maintenance

不合格disqualified

物料material

购买purchasing

发放releasing

产地origin

固体solid

液体liquid

挥发性volatile

净药材netmedicine,netTCM

麻醉药品narcotics

精神药品psychotropicdrug

易燃combustible

易爆explosive

验收acceptance

使用说明书instruction

标签label

卫生hygiene

车间workshop

间隔时间timeinterval

清洁剂detergent

消毒剂disinfectant

废弃物wastes

更衣室changingroom

工作服,workclothes

颗粒性物质，颗粒剂granules

耐药菌株drug—resistantstrain

传染病infectiousdia

皮肤病dermatosis

验证verification，validation

确认qualification

安装installation

运行runningoperation

性能performance

原辅料rawmaterialandexcipient

文件document

投诉complaint

报废reject

品名productname

处方prescription,formula

技术参数technicalparameter

容器container

申请application

稳定性stability

起草draft

生产管理productionmanagement，manufacturingcontrol。

混淆mix—up

喷雾spray

合格证certificate

清场clearance

质量管理qualitymanagement

内控internalcontrol

滴定液titrant

培养基medium

有效期validity,expirydate，shelflife

产品销售与收回productsalesandrecall

投诉与不良反应报告complaintsandadverreactionreport

自检lf-inspection

附则appendix

平衡balance

饮用水drinkingwater

蒸馏法distillation

离子交换法ionexchange

反渗透法RO:ReverOsmosis

附加剂添加剂additives

滞留strandedresort

批batch，lot

组分,组成component

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medicatedpremix

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Reprentativesample

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，component

制备fabricatepreparation

复合compound

混合blend

加工processing

浓度concentration

单位剂量unitdo

药品包装容器drugproductcontainers

密封件，封盖closure

效价titer

纯度purity

规格strength

监督supervi,monitor

实验室laboratory

无菌操作apticoperation,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exhaustsystem

管件plumbing

污水wage

废料refu

空气干燥器airdrier

垃圾trash

有机废料organicwaste

杀鼠剂rodenticides

杀昆虫剂incticides

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

备

automatic，mechanical，orelectronicequipmen

t

微型胶卷microfilm

注射剂injection

灭菌设备sterilizationequipment

无菌取样技术apticsamplingtechniques

显微镜microscope

热源，内毒素pyrogen，endotoxin

偏差deviation

变更changecontrol

进料charge—in

项目代码itemcode

鉴别identify

片剂tablet

胶囊capsule

颗粒剂granule

溶解时间dissolutiontime

澄明度clarity

隔离系统isolationsystem

返工reprocessing

发放issuance，relea

非处方药OTC：over—the—counter

处方药prescriptionmedicine

保险包装tamper—resistantpackage

明胶硬胶囊hardgelatincapsule

顺势治疗homeopathic

入库warehousing

变质deteriorate

准确性accuracy

灵敏性nsitivity

特异性specificity

重复性reproducibility，repeatability

变应原提取物allergenicextracts

眼膏ophthalmicointment

粗糙或磨蚀物质harshorabrasivesubstances

控释制剂controlled-releadosageform

实验动物laboratoryanimals

供应商supplier

光谱spectrum

测量单位unitsofmeasure

换算系数conversionfactors

试剂reagent

安慰剂placebo

明确地explicitly

取代superde

溶液solution

批准approval

（美国）食品药品监督管理局FDA:FoodandDrugAdministration

标准操作程序SOP:StandardOperatingProcedure

质量保证QA：QualityAssurance

质量控制QC:QualityControl

批生产记录BPR:BatchProductionRecord

批检验记录BAR:BatchAnalysisRecord

工艺规程PP:ProcessProcedure

健康,安全,环保EHS：Environment，HealthandSafe

美国联邦法规CFR:CodeofFederalRegulation

美国药典USP：TheUnitedStatesPharmacopeia

欧洲药典EP:Europeanpharmacopeia

英国药典BP:Britishpharmacopeia

药物主文件DMF:DrugMasterFile

验证主计划VMP:ValidationMasterPlan

验证方案VP:ValidationProtocol

验证报告VR：ValidationReport

安装确认IQ：InstallationQualification

运行确认OQ:OperationQualification

性能确认PQ:PerformanceQualification

超出标准(限度)OOS：OutofSpecification

冻干产品freeze—dryproduct，lyophilizedproduct

工厂主述文件SMF：SiteMasterFile