药品生产常用词汇中英文对照表

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, 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 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 / material 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

轧盖capping

洁净区clean area

洁净级别cleanliness 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dye 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 P A

高压电检漏high frequency 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 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surface sampling

最终灭菌terminal sterilization

总有机碳total organic carbon, T O C