世界知名放射性藥物防護解決方案提供者TEMA-介紹課件

CompanyPresentationTEMA介紹

天津，May19，2013CompanyPresentation天津，May11TEMASinergie特瑪斯尼爾吉Aworldleadingcompanyforradioprotectionsystemsandhealthcareequipments世界領(lǐng)先的醫(yī)學核防護系統(tǒng)和醫(yī)療設(shè)備供應商ISOcertifiedsince2000

ISO認證企業(yè)PROFILE公司介紹TEMASinergie特瑪斯尼爾吉PROFILE公司2TEMACHINAPROFILE公司簡介ProductionPLANTinHouzhousince20092009年成立特瑪中國，落戶浙江湖州TEMACHINAPROFILE公司簡介Producti3TEMASinergieOurmainactivites:主要業(yè)務領(lǐng)域PROFILENuclearMedicine核醫(yī)學Radiotherapy放射治療Radiodiagnostics放射診斷IndustrialApplications工業(yè)應用Ourcustomerbasecountsover1500hospitals,radiopharmaciesandresearchcenters

allovertheworld.全球范圍內(nèi)1500個醫(yī)院和科研機構(gòu)使我們的忠誠客戶TEMASinergiePROFILENuclearMe4TEMASinergieOurmainactivites:PROFILE公司介紹Sincetheyearofourfoundation,

1985thatis,wehavebeenfocusingondesigning,manufacturingandsellingourownlinesofradioprotectionsystems

andhealthcareequipments.自從1985年，我們一直專注于設(shè)計，制造和銷售我們自己的核防護系統(tǒng)，以及醫(yī)療設(shè)備。TEMASinergiePROFILE公司介紹Since5TEMASinergiehasbeenshowing

anexponentialgrowthsinceitsbirth、從誕生到現(xiàn)在，特瑪?shù)臉I(yè)務一直保持穩(wěn)健增長GROWTH公司業(yè)務額增長迅速TEMASinergiehasbeenshowing6TEMASinergiehasbeenshowing

anexponentialgrowthsinceitsbirth強勁的增長源于研發(fā)的投入Team

優(yōu)秀的團隊Almost100employeestodate,andcounting.35%ofouremployeeshaveaPhD–theyarebiotechnologists,engineers,bioengineers,physicistsetcetera.全球約100名員工，35%擁有博士學位，他們的專業(yè)重要為生物技術(shù)，工程，生物工藝或者物理TEMASinergiehasbeenshowing7我們的產(chǎn)品–GMPPETCyclotronCenters回旋中心FranceTours法國ItalyRome意大利USASterlingVA美國我們的產(chǎn)品–GMPPETCyclotronCente8產(chǎn)品–派特中心防護熱室PETCLINICALCENTERSNMCDSI分裝熱室Flex分裝熱室NMCGa-68鎵68分裝熱室產(chǎn)品–派特中心防護熱室PETCLINICALCENT9產(chǎn)品–分裝和注射系統(tǒng)DispensersandInjectorsCRP瓶劑自動分裝儀μDDS-A自動分裝儀KARL100自動分裝自動注射一體化系統(tǒng)RAD-Inject自動注射器產(chǎn)品–分裝和注射系統(tǒng)DispensersandInj10OURPRODUCTS–Monitoring核輻射監(jiān)控產(chǎn)品ENVIRO環(huán)境監(jiān)護儀OURPRODUCTS–Monitoring核輻射監(jiān)11定制化產(chǎn)品–GMPCustomizedProjectsU.S.A.SomersetIBAMolecularFRANCESaclayCISBIO–IBAGroupGERMANYBerlinEckert&Ziegler定制化產(chǎn)品–GMPCustomizedProjects12TEMASINERGIE特瑪斯尼爾吉WHYISIMPORTANTTOHAVEGOODQUALITYHOTCELLs?高品質(zhì)的熱室為什么如此重要RADIOPROTECTIONfortheOperators

(doseratefortheoperator)

對醫(yī)生和護士提供良好輻射防護STERILITYoftheproductsforthesafetyofthepatients

無菌保證患者安全（無血液傳染，無肝炎病毒傳染）(i.e.Nobloodinfection,noHepatitis)TEMASINERGIE特瑪斯尼爾吉WHYISIMP13TEMASINERGIERADIOPROTECTION核輻射防護原理Particleα

粒子Particleβ

粒子Rayγ

射線RayX射線Papersheet紙板Aluminiumsheet鋁板Lead鉛板TEMASINERGIERADIOPROTECTION核14TEMASINERGIEAIRCONTAMINATION氣密性的重要性A)AIRCONTAMINATION空氣污染RADIOPROTECTION核輻射防護不應忽視空氣污染TEMASINERGIEAIRCONTAMINATION15TEMASINERGIELEADPROTECTIONB)DIRECTRADIATION直接輻射的危害RADIOPROTECTIONTEMASINERGIELEADPROTECTIONB)16TEMASINERGIEHowweCANASSURERadioprotectionfromAIRCONTAMINATION?特瑪如何防止空氣污染帶來的輻射危害BOXwithAIRTIGHTNESSClassIIaccordingto

ISO10648Containmentenclosures我們的熱室能夠?qū)崿F(xiàn)氣密性二級水平，依據(jù)：ISO10648密封度環(huán)繞INFLATINGSEALS充氣式密封TEMASINERGIEHowweCANASSURE17TEMASINERGIEHowweASSURERadioprotectionfromDIRECTCONTAMINATION?我們?nèi)绾伪ＷC直接輻射帶來的危害NoleakeageandOverlappingshielding無泄漏，并且重疊的防護結(jié)構(gòu)RADIOPROTECTIONonallsidesoftheHOTCells,notonlyonthefrontDOOR核防護環(huán)繞整個熱室，不只是正面有鉛防護TEMASINERGIEHowweASSURERad18TEMASINERGIESTERILITY無菌環(huán)境TOASSURETHESTERILITYofTHEPRODUCTandTHESAFETYofTHEPATIENTS特瑪始終重視產(chǎn)品的無菌性，以及重視病人的安全。TEMASINERGIESTERILITY無菌環(huán)境TO19TEMASINERGIESTERILITY根據(jù)報道，藥物容器被懷疑為肝炎的傳染源TEMASINERGIESTERILITY根據(jù)報道，藥物20TEMASINERGIESTERILITY潔凈無菌ISOLATIONClassIIaccordingto

ISO10648ContainmentenclosuresINFLATINGGASKET膨脹墊圈YOURFDGPRODUCTHOTCELL熱室TEMASINERGIESTERILITY潔凈無菌ISO21TEMASINERGIESTERILITY潔凈無菌ISOLATIONClassIIaccordingto

ISO10648Containmentenclosures密封等級IITEMASINERGIESTERILITY潔凈無菌ISO22TEMASINERGIESTERILITY潔凈無菌STERILITYaccordingtoEECGMPIIIED.Class“A”(airparticlecontamination)特瑪產(chǎn)品的潔凈無菌符合EECGMPIIIEDA級標準（空氣粒子污染）TEMASINERGIESTERILITY潔凈無菌STE23TEMASINERGIESTERILITY潔凈無菌STERILITYaccordingtoEECGMPIIIED.Class“A”(airparticlecontamination)潔凈無菌符合EECGMPIIIEDA級標準（空氣粒子污染）ClassAAtrest非運行狀態(tài)<3.520part/m3forparticle?0.5μm<20part/m3forparticle?5.0μmInoperation運行狀態(tài)<3.520part/m3forparticle?0.5μm<20part/m3forparticle?5.0μmTEMASINERGIESTERILITY潔凈無菌ST24TEMASINERGIEHOWWECANASSURESTERILITY?我們?nèi)绾伪ＷC潔凈無菌WITHLAMINARFLOWandFILTERULPAU15forGMPClassA符合GMPA級標準超高效空氣過濾器，以及特別設(shè)計的垂直單向?qū)恿飨到y(tǒng)OnthecompletesurfaceoftheboxfordispensingRADIOPHARMACEUTICALSintosyringes更高標準的表面鋼材，更潔凈，邊角弧形設(shè)計，更加容易清洗。LAMINARFLOWTEMASINERGIEHOWWECANASSURE25TEMASINERGIEHOWWECANASSURESTERILITY?我們?nèi)绾伪ＷC潔凈無菌INFLATINGGASKETForINSULATIONAlsoinPRE-CHAMBER充氣式密封墊圈保證內(nèi)部空氣潔凈，也防止輻射空氣散出。TEMASINERGIEHOWWECANASSURE26TEMASINERGIEGMPCOMPLIANCEGMPcompliantoperatorpaneltouchscreenPCforhotcellfunctionsmanageme