System系统 | | | |
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FACILITY AND FACILITY SYSTEMS厂房设施系统 | | | |
Architectural Finishes (Classified Spaces) 建筑装修(洁净区域) | | | | | | | | |
Door Interlocking System (Classified Spaces)门互锁系统(洁净区域) | | | | | | | | |
Data and Communication Systems (non GMP data)数据及信息系统(非 GMP数据) | | | | | | | | |
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LAF Modular System for Local Area Protection局部区域保护的层流模块系统 | | | | | | | | |
Exhaust Fans / Systems 排气扇/排气系统 | | | | | | | | |
HVAC Systems (Support, Admin, etc.) 空调系统(支持、管理等) | | | | | | | | |
Building Automation System 楼宇自动化系统 | | | | | | | | |
Environmental Monitoring Program环境监控方案 | | | | | | | | |
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Plant Steam and Condensate Systems 工业蒸汽及冷凝水系统 | | | | | | | | |
Heating Hot Water System热水系统 | | | | | | | | |
Domestic Hot & Cold Water Systems车间内热 /冷水系统 | | | | | | | | |
Non-Potable Make-up Water 非饮用水 | | | | | | | | |
Sanitary Waste & Vent System清洁用水及下水系统 | | | | | | | | |
Process Waste & Vent System生产废水及下水系统 | | | | | | | | |
Waste Deactivation & Neutralization System废水灭活及中和系统 | | | | | | | | |
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Fire Protection System防火系统 | | | | | | | | |
Electrical Power (Normal) 电力系统(正常用电) | | | | | | | | |
Emergency Power Generation System紧急用电系统 | | | | | | | | |
Uninterruptible Power System不断电系统 | | | | | | | | |
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Clean Compressed Air System / Air Filters 洁净压缩空气系统 /空气过滤器 | | | | | | | | |
Clean Nitrogen System / Nitrogen Filters 清洁氮气系统 /氮气过滤器 | | | | | | | | |
USP Purified Water Generation System 纯水制备系统 | | | | | | | | |
USP Purified Water Storage and Distribution System纯水储存及分配系统 | | | | | | | | |
USP Purified Water System (Pre-treatment) 纯水系统(预处理) | | | | | | | | |
WFI Generation System注射用水制备系统 | | | | | | | | |
WFI Storage and Distribution System 注射用水储存及分配系统 | | | | | | | | |
Clean Steam Generator 洁净蒸汽制备系统 | | | | | | | | |
Clean Steam Distribution System 洁净蒸汽分配系统 | | | | | | | | |
SIP/CIP System在线灭菌 /在线清洗系统 | | | | | | | | |
SIP/CIP Distribution System 在线灭菌 /在线清洗分配系统 | | | | | | | | |
PRODUCTION SUPPORT SYSTEMS 生产支持系统 | | | |
Downflow Containment Booth 降尘操作间 | | | | | | | | |
Tank Wash Control System罐清洗控制系统 | | | | | | | | |
Ultrasonic Parts Washer超声清洗器 | | | | | | | | |
Cabinet Components Washer部件清洗机 | | | | | | | | |
Component Autoclave 部件灭菌柜 | | | | | | | | |
Dry Heat Oven干热灭菌柜 | | | | | | | | |
Filter Integrity Tester(s)过滤膜完整性测试仪 | | | | | | | | |
Glove Integrity Tester(s) 手套完整性测试仪 | | | | | | | | |
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Floor and Bench Scales 地秤及台秤 | | | | | | | | |
Sampling/Dispensing Isolator取样/配料隔离器 | | | | | | | | |
Post Filter Isolator 过滤后隔离器 | | | | | | | | |
Compounding Tanks, Portable, Jacketed配料罐,可移动,带夹套 | | | | | | | | |
Formulation (Charging) Containment Isolator配料(投料)密闭隔离器 | | | | | | | | |
Temperature Control Unit 温控单元 | | | | | | | | |
Terminal Sterile Filters 终端无菌过滤器 | | | | | | | | |
Isolated Filling Line including: 隔离灌装线包括: ? Interior Vial Washer洗瓶机 ? Depyrogenation Tunnel除热原隧道烘箱 ? Isolated Accumulation Table 隔离器内的转盘 ? Isolated Filling Machine隔离器内的灌装机 ? Isolators隔离器 | | | | | | | | |
Isolator VHP System隔离器 VHP系统 | | | | | | | | |
Isolated Lyophilizer Auto Loader隔离器内冻干自动装卸料机 | | | | | | | | |
Isolated Lyophilizers 隔离器内的冻干机 | | | | | | | | |
Lyophilized Vial Capper冻干加塞机 | | | | | | | | |
Lyophilized Exterior Vial Washer / Trayer冻干瓶外壁清洗机 /托盘 | | | | | | | | |
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Liquid Vial Capper 液体制剂瓶加塞机 | | | | | | | | |
Liquid Exterior Vial Washer / Trayer液体制剂瓶外壁清洗机 /托盘 | | | | | | | | |