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1、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
2、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criticalprocessparam
3、eters,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/materialfl
4、ow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
5、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dry
6、heatsterilization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highefficiencyparticul
7、ateairfilter,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isolator层流laminarflow缓冲容器levelvessel培养基灌装mediafilling微生物学microbiology微生物microorganism含多种溶剂的混合溶剂mixturesofvarioussolvents改良马丁培养基mo
8、difiedMartinmedium监测计划monitoringprogram阴性对照negativecontrol软膏剂ointments眼用制剂ophthalmicpreparation参数放行parametricr
