移动式智能无菌培养工作站
智能化移动式细胞培养工作站是一种通用性比较强的移动净化系统。
Flexible cleanroom platform is a general air cleaning equipment, provide a cleanroom environment on the go.
对安装环境没有特殊要求 （层高大于2.6m，面积 > 45 m2 的空间均可安装）
No special requirement on installation area ( Floor height > 2.6 m, installation area > 45 m2)
安装只需要5天
5 day installation
可拆卸重装，移动性强
Flexible, module design, easy install, dismount, and re-install
配备远程环境检测报警及设备控制系统
Remote monitoring and control system
可用为临床试验、检验、或细胞生产，提供所需洁净操作环境
Can be used for clinical trials, examination, and cell production required clean room environment
Product Parameter
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RM-CellCUBE-100 |
RM-CellCUBE-10000 |
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箱体结构 |
不锈钢结合双层玻璃抽真空设计 |
全彩钢板结构 |
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工作区尺寸(W×D×H) |
2500×4300×55000px |
2500×4300×55000px |
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外形尺寸(W×D×H) |
4400×4675×65000px |
4400×4675×65000px |
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洁净等级及规格和数量 |
主要操作区域各项指标达到GMP的B标准（静态百级动态万级），辅助区域达到GMP的C级标准 |
主要操作区域达到GMP的C标准，辅助区域达到GMP的C级标准，具体参照国家标准规定 |
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高效过滤器数量 |
12 |
≥8 |
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荧光/紫外灯规格及数量 |
30W×12 / 30W×12 |
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适用人数 |
2人 |
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空气流动方向 |
垂直单向流 |
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物料进出 |
内外物品传递通过洁净传递窗，污物和净物传递分离，进向出向传递分离 |
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人员进出 |
人员进出分离 |
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操作区域参数 |
温度 ℃ |
18 ~ 26 |
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相对湿 ％ |
45 ~ 65 |
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噪声dB[A] |
≤65 |
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压差 Pa |
≥15相对于室外大气,≥5相对于洁净等级不同的区域 |
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照度 Lx |
≥300 |
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沉降菌 cfu/皿，0.5hr计 |
B级 |
≤3 |
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C级 |
≤25 |
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浮游菌 cfu/m3 |
B级 |
≤5 |
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C级 |
≤100 |
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悬浮粒子 粒/m3 |
B级 |
≥0.5μm颗粒数≤3520 ≥5μm颗粒数≤29 |
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C级 |
≥0.5μm颗粒数≤352000 ≥5μm颗粒数≤2900 |
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监控及数据记录系统 |
组成模块 |
接收器、监控模块、转发器、软件、报警模块 |
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无线电传输方式 |
434MHz，室内400m，室外 700m |
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合规能力 |
FDA 21 CFR Part 11，ISO 17025，cGxP等 可进行IQ/OQ认证服务 |
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接收器 |
USB、RS232和TCP/IP 三种接口供选择 最多支持200个监控模块 |
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监控模块 |
温度、湿度、CO2浓度、压差、4-20mA输出 （可选配） 最多串联3台转发器 延伸传输≥400m 带液晶屏显示 |
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传感器 |
数据同步至软件 自带内存记录 ≥3000点 |
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转发器 |
配备锂电池，寿命约1年 可配备多个转发器增强信号 |
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报警模块 |
现场实时声光报警； 微信，短消息，电话语音，email， 传真以及打印报告等实时远程报警 |
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搭载软件 |
MySQL专业数据分析系统 |
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远程操控 |
远程控制设备的空调，照明，臭氧，紫外的开启及关闭 |
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RM-CellCUBE-100 |
RM-CellCUBE-10000 |
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Materials |
Stainless steel, double layer vacuumed glass |
Color steel plate |
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Working area (W×D×H) |
2500×4300×55000px |
2500×4300×55000px |
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Equipment size (W×D×H) |
4400×4675×65000px |
4400×4675×65000px |
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Cleanness |
l Operation area meet GMP B grade standard l Preparation area meet GMP C grade standard |
l Operation area meet GMP B grade standard l Preparation area meet GMP C grade standard |
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HEPA filter |
12 |
≥8 |
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UV & Fluorescence Lamp |
30W×12 / 30W×12 |
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# People |
2 |
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Air flow direction |
Perpendicular uni-direction flow |
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Material in/out |
Material in/out through passing box, clean material in/out and waste out is separated |
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People in/out |
Separated |
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Operation area parameter |
Temperature℃ |
18 ~ 26 |
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RH％ |
45 ~ 65 |
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Noise dB[A] |
≤65 |
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PressurePa |
≥15相对于室外大气,≥5相对于洁净等级不同的区域 |
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Light intensityLx |
≥300 |
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Settlement bacteria cfu/dish，0.5hr |
B grade |
≤3 |
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Cgrade |
≤25 |
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Suspended bacteria cfu/m3 |
Bgrade |
≤5 |
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Cgrade |
≤100 |
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Suspended particles /m3 |
B grade |
≥0.5μmparticles ≤3520 ≥5μm particles ≤29 |
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Cgrade |
≥0.5μm颗粒数≤352000 ≥5μm颗粒数≤2900 |
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Monitoring and Data Recording |
Modules |
Receiver, monitoring, senor, software, alarm |
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Wireless |
434MHz, in door: 400m，out door:700m |
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Compatibility |
FDA 21 CFR Part 11，ISO 17025，cGxPetc. IQ/OQ Qualification |
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Receiver |
USB、RS232和TCP/IP connector Support max 200monitor module |
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Monitor modules |
Temperature, humidity, CO2, Pressure, 4-20mA output (optional) Max connect 3 sensor through series connection Extended transport≥400m LEDdisplay |
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Sensor |
Data synchronized to software Internal memory≥3000 data |
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Forwarder |
Li Battery Can connect multiple forwarder to amplify signal |
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Alarm |
Real-time alarm Wechat, message, phone, email, fax remote alarm system
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Software |
MySQL data analysis system |
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Remote control |
Air conditioning, lighting, ozone, UV |
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