TSI公司介绍和客户.docx

一、公司介绍1、TSI公司介绍 美国TSI公司是一家设计并制造流体测量、环境颗粒物及其它环境参数实时监测等高精密仪器的高科技跨国公司，产品涉及基础研究、环境监测、劳动保护、生物医药及工业生产等诸多领域，能满足工业企业、政府部门、大学及研究机构等不同层次的需求 50年粒子计数器的研究和开发历史 世界第一台气溶胶分析仪的发明者 产品覆盖了0.003微米-20微米粒径范围内的纳米颗粒、亚微米及微米颗粒、超微米粉尘等 在中国的年销售额在2000万美元，为2008年奥运会，2010年亚运会提供环境监测产品 与中国环境科学研究院、药物制剂国家工程研究中心、同济大学等合建了国家重点实验室。 为许多粒子计数器厂家提供生产标定和校验的仪器 是许多标准的制定者（如套帽式风量罩、风速仪、流量表） 尘埃粒子在线系统软件、验证文件编写者是美国EU GMP的编写者之一 在中国北京、上海设立了办事处和技术服务中心，保证售后服务的及时可靠 在中国建立了校验实验室，提供精确便宜的校验服务 粒子计数器技术先进，提供5年的保修服务，融合了许多专利技术2、北京国瑞泰介绍 北京国瑞泰公司是一家致力于为制药企业、生物工程和生命科学领域提供综合性服务和整体解决方案的高科技企业。公司拥有经验丰富的专业设计、施工、验证团队。为制药企业提供流体工艺设计施工、制药设备代理、验证检测服务、环境监测等业务。是美国TSI产品在中国制药行业的总代理具有10年以上制药企业水系统、洁净室的设计施工经验方案设计、验证人员具有药监局颁发的GMP培训讲师资格已与兰州生物制品研究所、石药集团、华药集团、哈药集团、武汉福星、广东瑞昇等制药企业成功合作 配备有30人的安装、售后服务队伍在北京、石家庄、深圳、上海建立了分支机构粒子计数器备有充足的货源，保证施工周期和售后服务24小时服务保证，响应时间不超过1小时建有计数器校验实验室，提供最优惠的校验价格计数器5年保修，系统真空泵3年保修软件终身免费升级随时提供免费人员培训二、典型工程石药集团中润制药有限公司(3套在线系统)石药集团中奇制药（1套在线系统）兰州生物研究所（3套在线系统）广东瑞昇生物（1套在线系统）武汉福星生物（1套在线系统）成都生物所（1套在线系统）华兰生物重庆公司（3套在线系统）上海中信国建（1套系统） 重庆庆余堂（1套系统）重庆莱美（1套系统） 北京博康健生物（1套系统）辽宁诺维诺（1套系统）烟台百克生物（1 套系统）烟台绿叶制药（2 套系统）已通过EU GMP 认证的欧洲客户EU TSI FMS Customer Reference List (Partial)1、 Astra Zeneca Location: Maccelsfield UKProcess: Aseptic Processing Regulatory framework: FDA and EU GMP Annex1 3 Systems (now 2) Originally 165 remote particle counters in 3 separate buildings and 3 separate systems. With FMS, FMS Buddy and FMS Mirror database. One of the buildings has ceased production so now they are collecting data from 120 particle counters. 2、Pfizer Location: Sandwich Kent UK Process: Aseptic Processing Regulatory Framework: FDA and EU GMP Annex 1 Building 510 34 Remote particle counters 83 differential pressures 7 temperature and humidity probes FMS, FMS Buddy, FMS Mirror Building 518 29 Pressure sensors 10 Temperature and Humidity probes FMS software, FMS Buddy 3、Baxter Healthcare Location: Thetford UK Process: Aseptic Processing Regulatory framework: EU GMP Annex 1 Two systems System 1 Manifold (16 port used) 9 Pressures 3 temperatures FMS Software System 2 3 Remotes VHP sampling 11 Pressures 3 Temperature and relative humidity sensors FMS Software 4、Bourn Hall Location: Bourn Cambridge UK Process: Embryology (IVF), Aseptic processing, Clinical trials Regulatory Framework: EU Tissue and Cells directive (EU GMP Annex 1) Two systems System 1 +2 91 Temperatures (Freezer fridges and stores) 62 Fridge/Freezer or storage room door contacts 16 Temp/Relative Humidity 8 Carbon Dioxide Monitoring points 9 pressure sensors 12 Liquid Nitrogen Level sensors FMS software, FMS Buddy, Mirror Database 5、Braun Location: Sheffield UK Process: Aseptic processing, Hospital Pharmacy services Regulatory framework: EU GMP Annex 1 5 Remote Particle Counters 23 differential pressure sensors 20 Temperature and relative humidity sensors FMS Software 6、Hospira Location: London UK Process: Aseptic processing, Hospital Pharmacy services Regulatory framework: EU GMP Annex 1 26 Room pressure sensors 17 Room temperature Sensors 9 Incubator temperature sensors 7 Volt free contact inputs 2 Auto dialers for alarming 2 Fridges 2 FMS software, 2 database mirrors 7、Calea Location: Runcorn UK Process: Aseptic Processing Regulatory Framework: EU GMP Annex 1 12 Remote Particle counters 20 Differential Pressures 10 temperature probes FMS Software, Mirror database 8、Schering Plough(Merck) Location: Brinny Ireland Process: Aseptic processing Regulatory Framework: EU GMP Annex 1 and FDA cGMP 53 remote particle counters FMS software, FMS Buddy 9、UK National Health Service (NHS)- (4thlargest company in the world!) Individual systems are detailed below Burton Hospital Location: Burton UK Process: Aseptic Processing Regulatory Framework: EU GMP Annex 1 8 Remote Particle counters 8 Fridge Freezer temps 21 Differential Pressures 4 T/RH probes Oxygen Depletion 3 Incubator temperatures FMS Software 10、University Hospital Coventry and Warwick Location: Coventry UK Process: Embryology, Andrology and Research Regulatory Framework: EU Tissue and Cells directive (EU GMP Annex 1) 14 Remote counters 50 Liquid Nitrogen level and temperature sensors 6 CO2 Incubator sensors 26 Temperature probes 8 Door contact sensors FMS software 11、GCRM Location: Glasgow UK Process: Embryology/IVF Regulatory Framework: EU Tissue and Cells directive (EU GMP Annex1) 1 Remote particle Counter 4 Liquid Nitrogen level and temperature sensors 2 CO2 Sensors 2 Incubator temperature sensors Oxygen Depletion Sensors 2 Fridge/Freezer temperature Sensors FMS software 12、Guys Radio Pharmacy Location: Central London UK Process: Hospital Radiopharmacy Regulatory Framework: EU GMP Annex 1 4 Differential pressures 2 temperatures 4 Remote particle counters FMS software Mirror database 13、Portsmouth Hospital Pharmacy Location: Portsmouth UK Process: Hospital Pharmacy Regulatory Framework: EU GMP Annex 1 8 Remote particle counters 12 Differential Pressure sensors 12 Cold store/room temperature sensors 11 Incubator temperature sensors 8 Fridge temperature sensors FMS software 14、Intercell Biomedical Location: Livingstone, Scotland UK Process: Pharmaceutical manufacturing Regulatory Framework: EU GMP Annex 1 and FDA cGMP 4 Remote particle counters 8 Pressure sensors 40-50 temperatures sensors (fridges/Freezers and incubators) 3 FMS Software Nodes FMS Buddy 15、ITH Pharma Location: London UK Process: Aseptic processing and Pharmacy services Regulatory Framework: EU GMP Annex 1 8 Remote particle counters 9 Differential Pressure Sensors 5 Room Temperature and Humidity Sensors 11 Fridge/Freezer/Warehouse temperature sensors FMS software Mirror Database 16、London Fertility Center Location: London UKProcess: Embryology IVF Regulatory Framework: EU Tissue and cells directive (EU GMP Annex 1) 1 portable particle counter with 8 real time intelligent wall plate connectivity 3 Fridge Temp sensors 4 Room Temp relative humidity sensors 5 Incubator temp and humidity sensors 9 Incubator humidity sensors 4 Surface temperature sensors 9 CO2 Incubator sensors FMS software Alarm Auto dialer 17、Loughborough University Location: Loughborough UK Process: Biotechnology Lab and cGMP cell processing facility Regulatory Framework: EU Tissue and cells directive (EU GMP Annex 1) 4 Remote Particle Counters 7 Differential pressure sensors 7 Fridge/Freezer temperature sensors 2 incubator Temperature sensors 2 Incubator CO2 sens