世界知名放射性药物防护解决方案提供者TEMA-介绍课件

CompanyPresentationTEMA介绍

天津，May19，2013CompanyPresentation天津，May11TEMASinergie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ISOcertifiedsince2000

ISO认证企业PROFILE公司介绍TEMASinergie特玛斯尼尔吉PROFILE公司2TEMACHINAPROFILE公司简介ProductionPLANTinHouzhousince20092009年成立特玛中国，落户浙江湖州TEMACHINAPROFILE公司简介Producti3TEMASinergieOurmainactivites: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,radiopharmaciesandresearchcenters

allovertheworld.全球范围内1500个医院和科研机构使我们的忠诚客户TEMASinergiePROFILENuclearMe4TEMASinergieOurmainactivites:PROFILE公司介绍Sincetheyearofourfoundation,

1985thatis,wehavebeenfocusingondesigning,manufacturingandsellingourownlinesofradioprotectionsystems

andhealthcareequipments.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。TEMASinergiePROFILE公司介绍Since5TEMASinergiehasbeenshowing

anexponentialgrowthsinceitsbirth、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TEMASinergiehasbeenshowing6TEMASinergiehasbeenshowing

anexponentialgrowthsinceitsbirth强劲的增长源于研发的投入Team

优秀的团队Almost100employeestodate,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TEMASinergiehasbeenshowing7我们的产品–GMPPETCyclotronCenters回旋中心FranceTours法国ItalyRome意大利USASterlingVA美国我们的产品–GMPPETCyclotronCente8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–派特中心防护热室PETCLINICALCENT9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自动注射器产品–分装和注射系统DispensersandInj10OURPRODUCTS–Monitoring核辐射监控产品ENVIRO环境监护仪OURPRODUCTS–Monitoring核辐射监11定制化产品–GMPCustomizedProjectsU.S.A.SomersetIBAMolecularFRANCESaclayCISBIO–IBAGroupGERMANYBerlinEckert&Ziegler定制化产品–GMPCustomizedProjects12TEMASINERGIE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)TEMASINERGIE特玛斯尼尔吉WHYISIMP13TEMASINERGIERADIOPROTECTION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TEMASINERGIERADIOPROTECTION核14TEMASINERGIEAIRCONTAMINATION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TEMASINERGIEAIRCONTAMINATION15TEMASINERGIELEADPROTECTIONB)DIRECTRADIATION直接辐射的危害RADIOPROTECTIONTEMASINERGIELEADPROTECTIONB)16TEMASINERGIEHowweCANASSURERadioprotectionfromAIRCONTAMINATION?特玛如何防止空气污染带来的辐射危害BOXwithAIRTIGHTNESSClassIIaccordingto

ISO10648Containmentenclosures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TEMASINERGIEHowweCANASSURE17TEMASINERGIEHowweASSURERadioprotectionfromDIRECTCONTAMINATION?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TEMASINERGIEHowweASSURERad18TEMASINERGIESTERILITY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无菌环境TO19TEMASINERGIESTERILITY根据报道，药物容器被怀疑为肝炎的传染源TEMASINERGIESTERILITY根据报道，药物20TEMASINERGIESTERILITY洁净无菌ISOLATIONClassIIaccordingto

ISO10648ContainmentenclosuresINFLATINGGASKET膨胀垫圈YOURFDGPRODUCTHOTCELL热室TEMASINERGIESTERILITY洁净无菌ISO21TEMASINERGIESTERILITY洁净无菌ISOLATIONClassIIaccordingto

ISO10648Containmentenclosures密封等级IITEMASINERGIESTERILITY洁净无菌ISO22TEMASINERGIESTERILITY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STE23TEMASINERGIESTERILITY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/m3forparticleØ0.5µm<20part/m3forparticleØ5.0µmInoperation运行状态<3.520part/m3forparticleØ0.5µm<20part/m3forparticleØ5.0µmTEMASINERGIESTERILITY洁净无菌ST24TEMASINERGIEHOWWECANASSURESTERILITY?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。LAMINARFLOWTEMASINERGIEHOWWECANASSURE25TEMASINERGIEHOWWECANASSURESTERILITY?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。TEMASINERGIEHOWWECANASSURE26TEMASINERGIEGMPCOMPLIANCEGMPcompliantoperatorpaneltouchscreenPCforhotcellfunctionsmanageme