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1、生产工艺常用词汇：中文英文学习文档 仅供参考单硫酸卡那霉素Kanamycin sulfate硫酸氢钠sodium bisulfate枸橼酸钠sodium citrate硫酸溶液Sulfuric acid solution中性硼玻璃安瓿瓶Neutral borosilicate glass ampoule安瓿瓶清洗Ampoule washing安瓿瓶灭菌除热源Ampoule sterilization and depyrogenation配料Batching过滤Filtration灌封Filling and sealing灭菌和检漏测试Sterilization and leakage test
2、灯检Visual / Lamp inspection贴签和包装Labeling and packaging关键工艺参数Critical Process Parameter升温段heating section传送带conveyor belt压差Differential pressure时间间隔Time interval过滤器孔径Pore size of filter过滤压力Filtration pressure灌装量Filling volume缓冲罐buffer tank灌装前充氮爱护pre-filling nitrogen flush灌装后充氮爱护post-filling nitrogen o
3、verlay真空检漏测试Vacuum leak test内包材Primary packaging materialProcess instructionLivzonGroupFuzhouFuxing Pharmaceutical Co. Ltd.Hunan Erkang Pharmaceutical Co., LtdHunan Huari Pharmaceutical Co., Ltd Guangzhou Chemical Reagent Factory Zhuhai Da Lin Wan Industrial Gas Co., LtdSCHOTTGlass TechnologiesSuzho
4、u Co.Ltdquality specification Circulation water Rotating speedQC常用英文词汇中文英文物理性状Physical attributes外观Appearance不溶性微粒Particulate matter溶液颜色Solution color鉴别Identification保留时间retention time含量Assay有关物质Related substance标示量labeled amount可见异物Visible particles无菌Sterility薄膜过滤法Membrane filtration method内毒素Bacte
5、rial endotoxinsInitial bioburden stirring uniformity ashy toppointed endbubblehead,flathead,brokenampoule, crooked ampoule, empty ampoule;中文英文药品生产质量治理标准GMP: Good Manufacturing Practice 国家食品与药品监督治理局State Food and Drug Administration 总就General Provisions制剂preparation原料药API: Active Pharmaceutical Ingre
6、dient成品finished goods工序process机构与人员organization andpersonnel专业学问professional knowledge生产体会production experience组织才能organizational skill技术人员technical staff实施implementation药品生产pharmaceutical manufacturing质量治理quality management质量检验quality inspection专业技术培训professional and technical training基础理论学问basic t
7、heoretical knowledge实际操作技能practical operation skills高生物活性highly potent高毒性high toxicity污染contamination考核评估assessment厂房与设施buildings andfacilities生产环境production environment空气干净级别clean air level昆虫insect干净室区clean roomarea光滑smooth无裂缝no cracks无颗粒物脱落no particle shedding耐受tolerance消毒disinfection无菌sterile交界处j
8、unction, joint弧形arc灰尘积聚dust accumulation储存区store area生产规模production scale设备equipment物料material中间产品intermediate product待验品quarantined material交叉污染cross-contamination管道pipeline公用设施utilities of public service照明lighting照度illumination应急 , 紧急情形emergency净化purification,clean微生物 ,微生物学 ,微生物的micro-organism,mic
9、robiology, microbiologic监测monitoring记录record天棚天花板ceiling, roof密封seal静压差Static Differential Pressure温度temperature相对湿度RH: RelativeHumidity地漏floor drainer分装室separating room,filling room相对负压relative negative pressure废气waste gas, exhausted air内酰胺结构类药品 -Lactamsstructure drug避孕药品contraceptives激素类hormone抗肿瘤
10、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-detoxification and postdetoxification活疫苗与灭活疫苗active vaccine/inactivated vaccine人血液制品blood products预防制品prevention products灌装filling中药Chinesetraditionalmedicines前处理pretreat
11、ment提取extraction浓缩concentration动物脏器viscera ofanimal, organ of animal炮制concocted通风ventilation除烟除尘smoke removaldust removal降温设施temperature-reducingestablishment, cooling挑选screening切片slicing粉碎grinding压缩空气compressed air惰性气体noble gas取样sampling称量室weighing room中药标本Chinese herbal sample, exemplar of TCM检定鉴定
12、verification,identification同位素Isotope设备equipment选型耐腐蚀model/typeselectionanticorrosion吸附adsorption, absorption润滑剂 ,润滑lubricant, lubricate冷却剂coolant流向flow direction纯化水PW: Purified Water注射用水WFI: Water forInjection滋生breeding储罐tank死角neglected portion盲管blind pipe纤维fiber疏水性hydrophobicity外表instrumentation量具
13、measuring tool衡器weighinginstrument精密度precision修理、保养maintenance不合格disqualified物料购买materialpurchasing发放releasing产地origin固体solid液体liquid挥发性volatile净药材net medicine, net TCM麻醉药品narcotics精神药品psychotropic drug易燃combustible易爆explosive验收acceptance使用说明书instruction标签卫生labelhygiene车间workshop间隔时间time interval清洁剂
14、detergent消毒剂disinfectant废弃物wastes更衣室changing room工作服 ,work clothes颗粒性物质,颗粒剂granules耐药菌株drug-resistant strain传染病infectious disease皮肤病dermatosis验证verification, validation确认qualification安装installation运行running operation性能performance原辅料raw material and excipient文件document投诉complaint报废reject品名product nam
15、e处方prescription,formula技术参数technical parameter容器container申请application稳固性stability起草draftproductionmanagement, manufacturing contro生产治理l.混淆mix-up喷雾spray合格证certificate清场clearance质量治理quality management内控internal control滴定液titrant培育基medium有效期validity, expiry date, shelf life产品销售与收回product salesand reca
16、ll投诉与不良反应报告complaints andadverse reaction report自检self-inspection附就appendix平稳balance饮用水drinking water蒸馏法distillation离子交换法ion exchange反渗透法RO: ReverseOsmosis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Active Ingredient非活性成份Inactiveingredient中间产品interm
17、ediate product批号batch number药用物料medicated feed药用预混合料medicated premix质量掌握部门Quality controldepartment理论产量Theoretical yield实际产量Actual yield比率Percentage, rate验收标准可接受标准Acceptance criteria代表性样品Representative sample微粒状的particulate污染物contaminant石棉asbestos诊断diagnosis缓解mitigation化学变化chemical change组分ingredien
18、t,component制备fabricatepreparation复合compound混合blend加工processing浓度concentration单位剂量unit dose药品包装容器drug product containers密封件 ,封盖closure效价titer纯度purity规格strength监督supervise,monitor试验室laboratory无菌操作asepticoperation, sterile operation层流laminar flow湍流turbulent airflow空气过滤air filtration空气加热air heating预过滤器P
19、re-filter排气系统exhaust system管件plumbing污水sewage废料refuse空气干燥器air drier垃圾trash有机废料organic waste杀鼠剂rodenticides杀昆虫剂insecticides杀真菌剂fungicides熏蒸剂fumigating reagents去垢剂cleaning agents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, or electronic equipmen t微型胶卷microfilm注射剂injection灭菌设备s
20、terilizationequipment无菌取样技术aseptic samplingtechniques显微镜microscope热源 ,内毒素pyrogen, endotoxin偏差deviation变更change control进料charge-in项目代码item code鉴别identify片剂tablet胶囊capsule颗粒剂granule溶解时间dissolution time澄明度clarity隔离系统isolationsystem返工reprocessing发放issuance,release非处方药OTC: over-the-counter处方药prescription
21、medicine保险包装tamper-resistant package明胶硬胶囊hard gelatin capsule顺势治疗homeopathic入库warehousing变质deteriorate精确性accuracy灵敏性sensitivity特异性specificity重复性reproducibility, repeatability变应原提取物allergenic extracts眼膏ophthalmic ointment粗糙或磨蚀物质harsh or abrasive substances控释制剂controlled-release dosage form试验动物laborat
22、ory animals供应商supplier光谱spectrum测量单位units of measure换算系数conversion factors试剂reagent抚慰剂placebo明确地explicitly取代supersede溶液solution批准 美国 食品药品监督治理局标准操作程序approvalFDA: Food and Drug AdministrationSOP: StandardOperating Procedure质量保证QA: Quality Assurance质量掌握QC: QualityControl批生产记录BPR: Batch Production Recor
23、d批检验记录工艺规程健康 , 安全 , 环保美国联邦法规BAR: Batch Analysis RecordPP:Process ProcedureEHS:Environment, Health and SafeCFR: Code ofFederal Regulation美国药典USP: The United States Pharmacopeia欧洲药典EP: Europeanpharmacopeia英国药典BP: Britishpharmacopeia药物主文件DMF: Drug MasterFile验证主方案VMP: Validation Master Plan验证方案VP:Validation Protocol验证报告VR:Validation Report安装确认IQ:Installation Qualification运行确认OQ:Operation Qualification性能确认超出标准 限度 冻干产品PQ:Performance QualificationOOS:Out of Specificationfreeze-dryproduct, lyophilized product工厂主述文件SMF: Site Master File