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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，E H S质量风险管理quality risk management, Q R M风险评估risk assessment风险控制risk control事先危害分析preliminary hazard analysis, P H A失败模式效果分析failure mode effects analysis，F M E A危害分析及主要控制点hazard analysis and critical control points, H A C C P过失树分析fault tree analysis,
2、FTA两次失败之间的平均时间mean time between failure, M T B F主题事务专家subject matter expert, S M E缎带式混合机ribbon blender在线清洗clean in place，CIP锥型混合机conical screw blender辊压制粒roller compaction压片能力compressibility导流管wurster column中间过程控制in process control, IPC物料桶intermediary bulk containers, IBCs关键工艺参数critical process para
3、meters, CPP工艺验证process validation前验证/前瞻性验证prospective validation同步验证concurrent validation回顾性验证retrospective validation个人防护设备personal protective equipment, PPE职业暴露限值occupational exposure limit, O E L职业暴露等级occupational exposure bands, O E B口服固体制剂oral solid dosage, OSD人流/物流person flow / material flow药物
4、活性成分active pharmaceutical ingredients，API中间体 intermediate products需氧细菌aerobic bacteria安瓿瓶ampoule厌氧细菌anaerobic bacteria空态洁净区as - bulit clean room无菌生产aseptic processing静态at - rest灭菌釜 autoclave微生物污染水平bioburden生物指示剂biological indicators吹灌封blow/fill/seal玻璃瓶bottle轧盖capping洁净区clean area洁净级别cleanliness leve
5、l在线清洗clean in place, CIP洁净室clean room菌落数colony forming unit, C F U组分component压缩气体compressed gas污染contaminant关键区域critical areas关键表面critical surfaces菌种保藏culture preservation脱水培养基dehydrated media隧道烘箱depyrogenating tunnel消毒disinfection直接接种法direct inoculation method干热灭菌法dry heat sterilization染色浴dye bath混
6、悬剂emulsion内毒素endotoxin环氧乙烷ethylene oxide面罩face mask灌装filling硫乙醇酸盐流体培养基fluid thioglycollate medium词汇表脆碎性friability真菌fungi着装gowning热分布heat distribution热穿透heat penetration供热通风与空气调节heating, ventilation and air conditioning, H V A C高效空气过滤器high efficiency particulate air filter, H E P A高压电检漏high frequency
7、 crack test高风险操作high risk operations疏水性hydrophobic behaviour卫生hygiene完整性integrity干预intervention辐射irradiation隔离器isolator层流laminar flow缓冲容器level vessel培养基灌装media filling微生物学microbiology微生物microorganism含多种溶剂的混合溶剂mixtures of various solvents改良马丁培养基modified Martin medium监测计划monitoring program阴性对照negative
8、 control软膏剂ointments眼用制剂ophthalmic preparation参数放行parametric release未完全密封状态partially closed state微粒particulate悬浮粒子particle增塑剂plasticizer日允许接触剂量permitted daily exposure, PDE极化过滤器polarisation filter阳性对照positive control内包装材料primary package materials非无菌单元的概率probability of non - sterile unit, PNSU无菌工艺模拟试
9、验process stimulation test保护性眼罩protective goggle热原pyrogen无菌药品Aseptic drug快速传递口rapid transfer ports, RTPs即灭菌胶塞ready for sterilization stoppers，RFS即用胶塞ready for use stoppers, R F U回收测试recovery test冗余过滤redundant filtration储料罐reservoir限制进出隔离系统restricted access barrier system, R A RS清洁sanitization沉降碟法sett
10、le plates区域隔离sit - over大豆胰蛋白胨培养基soybean - casein digest medium质量标准specifications孢子spore杀孢子剂sporicidal标准操作规程standard operation procedure, SOP无菌保证水平sterility assurance level, SAL无菌检査sterility test无菌药品sterile pharmaceutical products灭菌sterilization在线灭菌sterilization in place, SIP储液罐storage vessel表面取样法sur
11、face sampling最终灭菌terminal sterilization总有机碳total organic carbon, T O C透明度transparency紊流turbulence单向流unidirectional airflow用户需求标准user requirement specifications，URS西林瓶vial目检visual inspection定量空气法volumetric air称量箱weighing boxes最差条件 worst case基本设计basic design按批次生产batch - based production混合blending混批ble
12、nding batches阶段性生产campaign - based production清场cleanance or site cleaning在线清洗clean in place, CIP概念设计concept design连续生产continuous production委托生产contract manufacture委托检验contract analysis关键偏差critical deviation关键工艺参数critical process parameter, CPP关键操作步骤critical processing step交叉污染cross contamination设计确认
13、design qualification， DQ详细设计detailed design设备使用日志equipment logbook预期收率expected yield有效期expiry date良好工程实践good engineering practice, GEPC 存期holding time杂质档案impurity profile过程控制in _ process control过程取样in _ process sampling安装确认installation qualification, IQ中间体intermediate维护基本实践maintenance basic practice
14、维护最佳实践maintenance best practice,维护良好实践maintenance good practice维护计划maintenance plan维护管理程序maintenance program主细胞库master cell b a n k ，MCB主生产和控制记录master production and control record, MP&CR不合格non - conformance运行确认operation qualification, OQ原料药续表超标out of specification , OOS性能确认performance qualification, PQ原始细胞库preliminary cell b a n k ， PCB质量协.quality agreement质量审核quality review快速传递接口rapid transfer port， RTP物料平衡reconciliation拒收reject复验期retest date环境、健康及安全safety, environment, health, EHS半连续生产semi - continuous production质量标准
