Tsis ntev los no, TÜV SÜD Tuam Tshoj Group (tom qab no hu ua "TÜV SÜD") tau lees paub cov ntaub ntawv hluav taws xob thiab kos npe hluav taws xob ntawm Haier Biomedical's kua nitrogen tswj system raws li qhov yuav tsum tau ua ntawm FDA 21 CFR Part 11. Kaum rau kev daws teeb meem khoom, nws tus kheej tsim los ntawm Haier Biomedical, tau txais txiaj ntsig TÜV SÜD daim ntawv tshaj tawm, suav nrog Smartand Biobank series.
Tau txais FDA 21 CFR Part 11 daim ntawv pov thawj txhais tau hais tias cov ntaub ntawv hluav taws xob thiab kos npe ntawm LN₂ kev tswj hwm ntawm Haier Biomedical ua tau raws li cov qauv kev ntseeg siab, kev ncaj ncees, tsis pub lwm tus paub thiab traceability, yog li ua kom cov ntaub ntawv zoo thiab kev nyab xeeb.Qhov no yuav ua kom ceev cov kev siv cov kua nitrogen cia cov kev daws teeb meem hauv kev lag luam xws li Asmeskas thiab Europe, txhawb kev nthuav dav thoob ntiaj teb ntawm Haier Biomedical.
Tau txais FDA daim ntawv pov thawj, HB's kua nitrogen tswj qhov system tau pib rau txoj kev tshiab ntawm kev ua haujlwm thoob ntiaj teb.
TÜV SÜD, tus thawj coj thoob ntiaj teb hauv kev sim thib peb thiab ntawv pov thawj, tsis tu ncua tsom mus rau kev txhawb nqa kev ua raws cai thoob plaws kev lag luam, pab cov lag luam nyob twj ywm rau cov kev cai hloov zuj zus.Tus txheej txheem FDA 21 CFR Part 11 tau muab los ntawm US Food and Drug Administration (FDA), muab cov ntaub ntawv hluav taws xob zoo tib yam raws li kev cai lij choj uas muaj cov ntaub ntawv sau thiab kos npe, kom ntseeg tau tias siv tau thiab kev ntseeg siab ntawm cov ntaub ntawv hluav taws xob.Cov qauv no siv tau rau cov koom haum uas siv cov ntaub ntawv hluav taws xob thiab kos npe hauv biopharmaceuticals, khoom siv kho mob, thiab kev lag luam zaub mov.
Txij li thaum nws tshaj tawm, tus qauv tau txais kev pom zoo thoob ntiaj teb, tsis yog los ntawm Asmeskas cov tuam txhab biopharmaceutical, tsev kho mob, cov chaw tshawb fawb, thiab cov chaw soj nstuam, tab sis kuj los ntawm Tebchaws Europe thiab Asia.Rau cov tuam txhab uas tso siab rau cov ntaub ntawv hluav taws xob thiab kos npe, ua raws li cov cai ntawm FDA 21 CFR Part 11 cov cai yog qhov tseem ceeb rau kev nthuav dav thoob ntiaj teb ruaj khov, kom ntseeg tau tias ua raws li FDA cov cai thiab cov qauv kev noj qab haus huv thiab kev nyab xeeb.
Haier Biomedical's CryoBio kua nitrogen tswj system yog qhov tseem ceeb ntawm "lub hlwb ntse" rau cov kua nitrogen ntim.Nws hloov pauv cov peev txheej piv txwv rau hauv cov ntaub ntawv cov ntaub ntawv, nrog ntau cov ntaub ntawv raug saib xyuas, kaw, thiab khaws cia hauv lub sijhawm tiag tiag, ceeb toom rau txhua qhov tsis txaus ntseeg.Nws tseem muaj kev ywj pheej dual ntsuas ntawm qhov kub thiab txias, nrog rau kev tswj hwm hierarchical ntawm cov neeg ua haujlwm.Tsis tas li ntawd, nws tseem muab kev tswj qhov muag pom ntawm cov qauv rau kev nkag tau sai.Cov neeg siv tuaj yeem hloov pauv ntawm phau ntawv, roj-theem, thiab kua-theem hom nrog ib zaug nias, txhim kho kev ua haujlwm.Tsis tas li ntawd, lub kaw lus ua ke nrog IoT thiab BIMS cov ntaub ntawv piv txwv platform, ua kom muaj kev sib txuas ntawm cov neeg ua haujlwm, khoom siv, thiab cov qauv.Qhov no muab kev tshawb fawb, tsim qauv, muaj kev nyab xeeb, thiab muaj txiaj ntsig ultra-low kub cia kev paub.
Haier Biomedical tau tsim ib qho kev ua tiav ib-nres kua nitrogen cia tshuaj haum rau txhua qhov chaw thiab ntim ntu, tsom mus rau ntau qhov kev xav tau ntawm cov qauv cryogenic cia tswj.Cov kev daws teeb meem suav nrog ntau yam xwm txheej, suav nrog kev kho mob, chaw kuaj mob, qhov ntsuas kub qis, cov khoom siv roj ntsha, thiab kev thauj mus los lom neeg, thiab muab cov neeg siv nrog cov txheej txheem tag nrho suav nrog kev tsim qauv engineering, qauv khaws cia, coj mus kuaj, qauv kev thauj mus los, thiab kev tswj cov qauv.
Los ntawm kev ua raws li FDA 21 CFR Tshooj 11 cov qauv, Haier Biomedical's CryoBio kua nitrogen tswj qhov system tau ntawv pov thawj rau kev siv tau ntawm peb cov ntawv kos npe hluav taws xob thiab kev ncaj ncees ntawm peb cov ntaub ntawv hluav taws xob.Daim ntawv pov thawj kev ua raws cai no tau ntxiv dag zog rau Haier Biomedical qhov kev sib tw tseem ceeb hauv thaj chaw ntawm cov kua nitrogen cia cov kev daws teeb meem, ua kom lub hom phiaj nthuav dav hauv kev lag luam thoob ntiaj teb.
Txhawb kev hloov pauv thoob ntiaj teb kom nyiam cov neeg siv khoom, thiab txhim kho kev sib tw ntawm kev lag luam thoob ntiaj teb
Haier Biomedical yeej ib txwm ua raws li lub tswv yim thoob ntiaj teb, txuas ntxiv txhawb "kev sib koom ua ke + thaj chaw" dual system.Nyob rau tib lub sijhawm, peb txuas ntxiv ntxiv dag zog rau kev txhim kho kev lag luam kom ntsib cov neeg siv khoom, txhim kho peb cov kev daws teeb meem hauv kev sib cuam tshuam, kev hloov kho, thiab kev xa khoom.
Tsom ntsoov rau kev tsim cov neeg siv kev paub zoo tshaj plaws, Haier Biomedical ntxiv dag zog rau hauv cheeb tsam los ntawm kev tsim cov pab pawg hauv zos thiab cov tshuab kom sai sai rau cov neeg siv xav tau.Thaum kawg ntawm 2023, Haier Biomedical tau muaj kev faib tawm txawv teb chaws ntawm ntau dua 800 tus neeg koom tes, koom tes nrog ntau dua 500 tus neeg muab kev pabcuam tomqab muag.Lub caij no, peb tau tsim ib qho kev paub dhau los thiab kev cob qhia qhov system, nyob hauv United Arab Emirates, Nigeria thiab United Kingdom, thiab lub chaw khaws khoom thiab chaw xa khoom nyob hauv Netherlands thiab Tebchaws Meskas.Peb tau tob zuj zus peb qhov chaw nyob hauv UK thiab maj mam hloov cov qauv no thoob ntiaj teb, tas li ntxiv dag zog rau peb cov kev lag luam txawv teb chaws.
Haier Biomedical tseem tab tom ua kom nthuav dav ntawm cov khoom tshiab, suav nrog cov cuab yeej kuaj, cov khoom siv, thiab cov chaw muag tshuaj ntse, txhim kho kev sib tw ntawm peb cov kev daws teeb meem scenario.Rau cov neeg siv kev tshawb fawb txog lub neej, peb cov centrifuges tau ua tiav hauv Tebchaws Europe thiab Amelikas, peb lub tshuab ziab khaub ncaws khov tau txais thawj qhov kev txiav txim hauv Asia, thiab peb cov khoom siv biosafety tau nkag mus rau sab hnub tuaj Europe ua lag luam.Lub caij no, peb cov khoom siv kuaj tau ua tiav thiab rov ua dua hauv Asia, North America, thiab Europe.Rau cov tsev kho mob, ntxiv rau cov tshuaj tiv thaiv hnub ci, cov tshuaj tub yees txias, chav ntim ntshav, thiab cov khoom siv kuj tseem txhim kho sai.Los ntawm kev sib tham txuas ntxiv nrog cov koom haum thoob ntiaj teb, Haier Biomedical muab cov kev pabcuam suav nrog kev tsim kho hauv chav kuaj, kuaj ib puag ncig thiab ua kom tsis muaj menyuam, tsim kom muaj txoj hauv kev loj hlob tshiab.
Thaum kawg ntawm 2023, ntau tshaj 400 tus qauv ntawm Haier Biomedical tau raug lees paub rau txawv teb chaws, thiab xa mus rau ntau qhov haujlwm loj hauv Zimbabwe, Democratic Republic of Congo, Ethiopia, thiab Liberia, nrog rau Tuam Tshoj-Africa Union Chaw Tswj Kab Mob. (CDC) qhov project, qhia txog kev txhim kho kev xa khoom.Peb cov khoom thiab cov kev daws teeb meem tau siv dav hauv ntau dua 150 lub teb chaws thiab cheeb tsam.Tib lub sijhawm, peb tau tuav kev koom tes ntev nrog ntau dua 60 lub koom haum thoob ntiaj teb, suav nrog World Health Organization (WHO) thiab UNICEF.
Tau txais FDA 21 CFR Tshooj 11 daim ntawv pov thawj yog qhov tseem ceeb rau Haier Biomedical thaum peb tsom mus rau kev tsim kho tshiab hauv peb txoj kev nthuav dav thoob ntiaj teb.Nws kuj qhia peb txoj kev cog lus kom ua tau raws li cov neeg siv xav tau los ntawm kev tsim kho tshiab.Saib ua ntej, Haier Biomedical yuav txuas ntxiv rau peb cov neeg siv-centric innovation txoj hauv kev, ua kom peb lub ntiaj teb kev siv tswv yim thoob plaws hauv cheeb tsam, cov channel, thiab cov khoom lag luam.Los ntawm kev hais txog kev tsim kho tshiab hauv zos, peb tsom mus tshawb txog kev lag luam thoob ntiaj teb los ntawm kev txawj ntse.
Post lub sij hawm: Lub Xya hli ntuj-15-2024
