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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危害分析与主要控制点 hazard analysis and critical control points, H A C C P过失树分析 fault tree
2、 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i ntermediary bulk containers, IBCs 关键工
3、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c oncurrent validation回顾性验证 retrospective validation个人防护设备 personal protective equipment, PPE 职业暴露限值o ccupational exposure limit, O E L 职业暴露等级o ccupational exposure bands, O E B 口服固体制剂 oral solid dosage, O
4、SD 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2七-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
5、bottle 轧盖c apping洁净区cl ean area洁净级别 cleanliness level在线清洗 clean in place, CIP洁净室clean room菌洛数co lony forming unit, C F U组分 component压缩气体compressed gas污染c ontaminant关键区域critical areas关键外表 critical surfaces菌种保臧c ulture preservation脱水培养基dehydrated media隧道烘箱 depyrogenating tunnel消毒 disinfection直接接种法 dir
6、ect inoculation method干热灭菌法 dry heat sterilization染色浴dye bath混悬剂emulsion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
7、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i ntervention辐射 irradiation隔离器isolator层流l aminar 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
8、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参数放彳丁 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 con
9、trol包装材料 primary package materials非无菌单兀的概率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艮口灭菌胶塞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 redundan
10、t 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无菌检查sterility test无菌药品 st
11、erile pharmaceutical products灭菌sterilizationSIP在线灭菌 sterilization in place,储液罐 storage vessel外表取样法surface sampling最终灭菌terminal sterilization总有机碳 total organic carbon, T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v isual inspection定量空气法v o
12、lumetric air称量箱 weighing boxes最差条件worst case根本设计basic design按批次生产 batch - based production混合 blending混批 blending batches阶段性生产 c ampaign - based production清场。leanance or site cleaning在线清洗 c lean in place, CIP概念设计 c oncept design连续生产 c ontinuous production委托生产 c ontract manufacture委托检验 c ontract analy
13、sis关键偏差 c ritical deviation关键工艺参数 critical process parameter, CPP关键操作步骤 c ritical processing step交叉污染 cross contamination设计确认 design qualification， DQ详细设计 detailed design设备使用日志e quipment 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 i mpurity prof
14、ile过程控制 in _ process control过程取样 in _ process sampling安装确认 i nstallation qualification, IQ中间体i ntermediate维护根本实 践maintenance basic practice维护最正确实 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 prod
15、uction and control record, MP&CR 不合格 non - conformance运行确认 o peration qualification, OQ原料药续表超标。诞 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、健康与安全 safety, environment, health, EHS半连续生产 semi - continuous production质量标准
