药品生产常用词汇中英文对照表.docVIP

药品生产常用词汇中英文对照表

环境，健康，安全environment，health,safety，EHS

质量风险管理qualityriskmanagement,QRM

风险评估riskassessment

风险控制riskcontrol

事先危害分析preliminaryhazardanalysis,PHA

失败模式效果分析failuremodeeffectsanalysis，FMEA

危害分析及主要控制点hazardanalysisandcriticalcontrolpoints,HACCP

过失树分析faulttreeanalysis,FTA

两次失败之间的平均时间meantimebetweenfailure,MTBF

主题事务专家subjectmatterexpert,SME

缎带式混合机ribbonblender

在线清洗cleaninplace，CIP

锥型混合机conicalscrewblender

辊压制粒rollercompaction

压片能力compressibility

导流管wurstercolumn

中间过程控制inprocesscontrol,IPC

物料桶intermediarybulkcontainers,IBCs

关键工艺参数criticalprocessparameters,CPP

工艺验证processvalidation

前验证/前瞻性验证prospectivevalidation

同步验证concurrentvalidation

回顾性验证retrospectivevalidation

个人防护设备personalprotectiveequipment,PPE

职业暴露限值occupationalexposurelimit,OEL

职业暴露等级occupationalexposurebands,OEB

口服固体制剂oralsoliddosage,OSD

人流/物流personflow/materialflow

药物活性成分activepharmaceuticalingredients，API

中间体intermediateproducts

需氧细菌aerobicbacteria

安瓿瓶ampoule

厌氧细菌anaerobicbacteria

空态洁净区as-bulitcleanroom

无菌生产asepticprocessing

静态at-rest

灭菌釜‘autoclave

微生物污染水平bioburden

生物指示剂biologicalindicators

吹灌封blow/fill/seal

玻璃瓶bottle

轧盖capping

洁净区cleanarea

洁净级别cleanlinesslevel

在线清洗cleaninplace,CIP

洁净室cleanroom

菌落数colonyformingunit,CFU

组分component

压缩气体compressedgas

污染contaminant

关键区域criticalareas

关键表面criticalsurfaces

菌种保藏culturepreservation

脱水培养基dehydratedmedia

隧道烘箱depyrogenatingtunnel

消毒disinfection

直接接种法directinoculationmethod

干热灭菌法dryheatsterilization

染色浴dyebath

混悬剂emulsion

内毒素endotoxin

环氧乙烷ethyleneoxide

面罩facemask

灌装filling

硫乙醇酸盐流体培养基fluidthioglycollatemedium

词汇表

脆碎性friability

真菌fungi

着装gowning

热分布heatdistribution

热穿透heatpenetration

供热通风与空气调节heating,ventilationandairconditioning,HVAC

高效空气过滤器highefficiencyparticulateairfilter,HEPA

高压电检漏highfrequencycracktest

高风险操作highriskoperations

疏水性hydrophobicbehaviour

卫生hygiene

完整性integrity

干预intervention

辐射irradiation

隔离器isolato