藥品生產(chǎn)常用詞匯中英文對(duì)照表

藥品生產(chǎn)常用詞匯中英文對(duì)照表環(huán)境，健康，安全environment，health,safety，EHS質(zhì)量風(fēng)險(xiǎn)管理qualityriskmanagement,QRM風(fēng)險(xiǎn)評(píng)估riskassessment風(fēng)險(xiǎn)控制riskcontrol事先危害分析preliminaryhazardanalysis,PHA失敗模式效果分析failuremodeeffectsanalysis，F(xiàn)MEA危害分析及主要控制點(diǎn)hazardanalysisandcriticalcontrolpoints,HACCP過(guò)失樹(shù)分析faulttreeanalysis,FTA兩次失敗之間的平均時(shí)間meantimebetweenfailure,MTBF主題事務(wù)專家subjectmatterexpert,SME緞帶式混合機(jī)ribbonblender在線清洗cleaninplace，CIP錐型混合機(jī)conicalscrewblender輥壓制粒rollercompaction壓片能力compressibility導(dǎo)流管wurstercolumn中間過(guò)程控制inprocesscontrol,IPC物料桶intermediarybulkcontainers,IBCs關(guān)鍵工藝參數(shù)criticalprocessparameters,CPP工藝驗(yàn)證processvalidation前驗(yàn)證/前瞻性驗(yàn)證prospectivevalidation同步驗(yàn)證concurrentvalidation回顧性驗(yàn)證retrospectivevalidation個(gè)人防護(hù)設(shè)備personalprotectiveequipment,PPE職業(yè)暴露限值occupationalexposurelimit,OEL職業(yè)暴露等級(jí)occupationalexposurebands,OEB口服固體制劑oralsoliddosage,OSD人流/物流personflow/materialflow藥物活性成分activepharmaceuticalingredients，API中間體intermediateproducts需氧細(xì)菌aerobicbacteria安瓿瓶ampoule厭氧細(xì)菌anaerobicbacteria空態(tài)潔凈區(qū)as-bulitcleanroom無(wú)菌生產(chǎn)asepticprocessing靜態(tài)at-rest滅菌釜‘a(chǎn)utoclave微生物污染水平bioburden生物指示劑biologicalindicators吹灌封blow/fill/seal玻璃瓶bottle軋蓋capping潔凈區(qū)cleanarea潔凈級(jí)別cleanlinesslevel在線清洗cleaninplace,CIP潔凈室cleanroom菌落數(shù)colonyformingunit,CFU組分component壓縮氣體compressedgas污染contaminant關(guān)鍵區(qū)域criticalareas關(guān)鍵表面criticalsurfaces菌種保藏culturepreservation脫水培養(yǎng)基dehydratedmedia隧道烘箱depyrogenatingtunnel消毒disinfection直接接種法directinoculationmethod干熱滅菌法dryheatsterilization染色浴dyebath混懸劑emulsion內(nèi)毒素endotoxin環(huán)氧乙烷ethyleneoxide面罩facemask灌裝filling硫乙醇酸鹽流體培養(yǎng)基fluidthioglycollatemedium詞匯表脆碎性friability真菌fungi著裝gowning熱分布heatdistribution熱穿透heatpenetration供熱通風(fēng)與空氣調(diào)節(jié)heating,ventilationandairconditioning,HVAC高效空氣過(guò)濾器highefficiencyparticulateairfilter,HEPA高壓電檢漏highfrequencycracktest高風(fēng)險(xiǎn)操作highriskoperations疏水性hydrophobicbehaviour衛(wèi)生hygiene完整性integrity干預(yù)intervention輻射irradiation隔離器isolator層流laminarflow緩沖容器levelvessel培養(yǎng)基灌裝mediafilling微生物學(xué)microbiology微生物microorganism運(yùn)行確認(rèn)operationqualification,OQ原料藥續(xù)表超標(biāo)outofspecification,OOS性能確認(rèn)performancequalification,PQ原始細(xì)胞庫(kù)preliminarycellbank，PCB質(zhì)量協(xié).qualityagreement質(zhì)量審核qualityreview快速傳遞接口rapidtransferport，RTP物料