药品生产常用词汇中英文对照表.doc

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isolato