药品生产常用词汇中英文对照表.pdfVIP

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 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 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 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 hea