世界知名放射性药物防护解决方案提供者-TEMA介绍

CompanyPresentationTEMA介绍天津，May19，2013TEMASinergie特玛斯尼尔吉Aworldleadingcompanyforradioprotectionsystemsandhealthcareequipments世界领先的医学核防护系统和医疗设备供应商ISOcertifiedsince2000ISO认证企业PROFILE公司介绍TEMACHINAPROFILE公司简介ProductionPLANTinHouzhousince20092009年成立特玛中国，落户浙江湖州TEMASinergieOurmainactivites:主要业务领域PROFILENuclearMedicine核医学Radiotherapy放射治疗Radiodiagnostics放射诊断IndustrialApplications工业应用Ourcustomerbasecountsover1500hospitals,radiopharmaciesandresearchcentersallovertheworld.全球范围内1500个医院和科研机构使我们的忠诚客户TEMASinergieOurmainactivites:PROFILE公司介绍Sincetheyearofourfoundation,1985thatis,wehavebeenfocusingondesigning,manufacturingandsellingourownlinesofradioprotectionsystemsandhealthcareequipments.自从1985年，我们一直专注于设计，制造和销售我们自己的核防护系统，以及医疗设备。TEMASinergiehasbeenshowinganexponentialgrowthsinceitsbirth、从诞生到现在，特玛的业务一直保持稳健增长GROWTH公司业务额增长迅速0481216202428200620072008200920102011TurnoverMillionsEurosTEMASinergiehasbeenshowinganexponentialgrowthsinceitsbirth强劲的增长源于研发的投入Team优秀的团队0204060801002006200820102012EmployeesAlmost100employeestodate,andcounting.35%ofouremployeeshaveaPhD–theyarebiotechnologists,engineers,bioengineers,physicistsetcetera.全球约100名员工，35%拥有博士学位，他们的专业重要为生物技术，工程，生物工艺或者物理我们的产品–GMPPETCyclotronCenters回旋中心FranceTours法国ItalyRome意大利USASterlingVA美国产品–派特中心防护热室PETCLINICALCENTERSNMCDSI分装热室Flex分装热室NMCGa-68鎵68分装热室产品–分装和注射系统DispensersandInjectorsCRP瓶剂自动分装仪µDDS-A自动分装仪KARL100自动分装自动注射一体化系统RAD-Inject自动注射器OURPRODUCTS–Monitoring核辐射监控产品ENVIRO环境监护仪定制化产品–GMPCustomizedProjectsU.S.A.SomersetIBAMolecularFRANCESaclayCISBIO–IBAGroupGERMANYBerlinEckert&ZieglerTEMASINERGIE特玛斯尼尔吉WHYISIMPORTANTTOHAVEGOODQUALITYHOTCELLs?高品质的热室为什么如此重要RADIOPROTECTIONfortheOperators(doseratefortheoperator)对医生和护士提供良好辐射防护STERILITYoftheproductsforthesafetyofthepatients无菌保证患者安全（无血液传染，无肝炎病毒传染）(i.e.Nobloodinfection,noHepatitis)TEMASINERGIERADIOPROTECTION核辐射防护原理Particleα粒子Particleβ粒子Rayγ射线RayX射线Papersheet纸板Aluminiumsheet铝板Lead铅板TEMASINERGIEAIRCONTAMINATION气密性的重要性A)AIRCONTAMINATION空气污染RADIOPROTECTION核辐射防护不应忽视空气污染TEMASINERGIELEADPROTECTIONB)DIRECTRADIATION直接辐射的危害RADIOPROTECTIONTEMASINERGIEHowweCANASSURERadioprotectionfromAIRCONTAMINATION?特玛如何防止空气污染带来的辐射危害BOXwithAIRTIGHTNESSClassIIaccordingtoISO10648Containmentenclosures我们的热室能够实现气密性二级水平，依据：ISO10648密封度环绕INFLATINGSEALS充气式密封TEMASINERGIEHowweASSURERadioprotectionfromDIRECTCONTAMINATION?我们如何保证直接辐射带来的危害NoleakeageandOverlappingshielding无泄漏，并且重叠的防护结构RADIOPROTECTIONonallsidesoftheHOTCells,notonlyonthefrontDOOR核防护环绕整个热室，不只是正面有铅防护TEMASINERGIESTERILITY无菌环境TOASSURETHESTERILITYofTHEPRODUCTandTHESAFETYofTHEPATIENTS特玛始终重视产品的无菌性，以及重视病人的安全。TEMASINERGIESTERILITY根据报道，药物容器被怀疑为肝炎的传染源TEMASINERGIESTERILITY洁净无菌ISOLATIONClassIIaccordingtoISO10648ContainmentenclosuresINFLATINGGASKET膨胀垫圈YOURFDGPRODUCTHOTCELL热室TEMASINERGIESTERILITY洁净无菌ISOLATIONClassIIaccordingtoISO10648Containmentenclosures密封等级IITEMASINERGIESTERILITY洁净无菌STERILITYaccordingtoEECGMPIIIED.Class“A”(airparticlecontamination)特玛产品的洁净无菌符合EECGMPIIIEDA级标准（空气粒子污染）TEMASINERGIESTERILITY洁净无菌STERILITYaccordingtoEECGMPIIIED.Class“A”(airparticlecontamination)洁净无菌符合EECGMPIIIEDA级标准（空气粒子污染）ClassAAtrest非运行状态3.520part/m3forparticleØ0.5µm20part/m3forparticleØ5.0µmInoperation运行状态3.520part/m3forparticleØ0.5µm20part/m3forparticleØ5.0µmTEMASINERGIEHOWWECANASSURESTERILITY?我们如何保证洁净无菌WITHLAMINARFLOWandFILTERULPAU15forGMPClassA符合GMPA级标准超高效空气过滤器，以及特别设计的垂直单向层流系统OnthecompletesurfaceoftheboxfordispensingRADIOPHARMACEUTICALSintosyringes更高标准的表面钢材，更洁净，边角弧形设计，更加容易清洗。LAMINARFLOWTEMASINERGIEHOWWECANASSURESTERILITY?我们如何保证洁净无菌INFLATINGGASKETForINSULATIONAlsoinPRE-CHAMBER充气式密封垫圈保证内部空气洁净，也防止辐射空气散出。TEMASINERGIEGMPCOMPLIANCEGMPcompliantoperatorpaneltouchscreenPCforhotcellfunctionsmanagement符合GMP标准的操作面板和触摸屏，界面友好操控4passwordaccesslevel-Absolutecontrol密码控制，符合安全要求TEMASINERGIEanISO9001:2008CertifiedCompanyREG.N.1248UNIENISO9001:2008ProducedandDevelopedby:谢谢