药品生产常用词汇中英文对照表

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 controlpoints, H A C C P过失树分析fault tree analy

2、sis, 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 proce

3、ss parameters, 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 / mat

4、erial flow药物活性成分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洁净区 clean area洁净级别cleanlines

5、s level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dy

6、e bath混悬剂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 PA高压电检漏high freq

7、uency 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neg

8、ative 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positivecontrol内包装材料primary package materials非无菌单元的概率probability of non - sterile unit, PNSU无

9、菌工艺模拟试验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sanitizati

10、on沉降碟法settle 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无菌检查 sterility test无菌药品sterile pharmaceutical products灭菌 sterilization在线灭菌sterilization in place, SIP储液罐 storage

11、vessel表面取样法surface 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 airflowURS用户需求标准user requirement specifications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 productio

12、n混合blending混批blending 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 co

13、ntamination设计确认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maintenanc

14、e basic practice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