nplooj ntawv_banner

Xov xwm

Haier Biomedical's LN₂Management System Tau Txais Daim Ntawv Pov Thawj FDA

1 (1)

Tsis ntev los no, TÜV SÜD Tuam Tshoj Pawg (txij no mus hu ua "TÜV SÜD") tau lees paub cov ntaub ntawv hluav taws xob thiab cov kos npe hluav taws xob ntawm Haier Biomedical lub kaw lus tswj cov kua nitrogen raws li cov kev cai ntawm FDA 21 CFR Ntu 11. Kaum rau cov khoom daws teeb meem, tsim los ntawm Haier Biomedical, tau txais daim ntawv qhia kev ua raws li TÜV SÜD, suav nrog Smartand Biobank series.

Tau txais daim ntawv pov thawj FDA 21 CFR Ntu 11 txhais tau tias cov ntaub ntawv hluav taws xob thiab kos npe ntawm LN₂ kev tswj hwm system ntawm Haier Biomedical ua tau raws li cov qauv ntawm kev ntseeg siab, kev ncaj ncees, kev ceev ntiag tug thiab kev taug qab, yog li ua kom cov ntaub ntawv zoo thiab kev ruaj ntseg. Qhov no yuav ua kom nrawm dua kev siv cov kua nitrogen cia cov kev daws teeb meem hauv kev lag luam xws li Asmeskas thiab Tebchaws Europe, txhawb nqa kev nthuav dav thoob ntiaj teb ntawm Haier Biomedical.

1 (2)

Tau txais daim ntawv pov thawj FDA, HB lub tshuab tswj cov kua nitrogen tau pib txoj kev tshiab ntawm kev lag luam thoob ntiaj teb

TÜV SÜD, tus thawj coj thoob ntiaj teb hauv kev kuaj thiab ntawv pov thawj sab nraud, ib txwm tsom mus rau kev muab kev txhawb nqa kev ua raws li kev tshaj lij thoob plaws hauv kev lag luam, pab cov tuam txhab lag luam kom paub txog cov cai tswjfwm uas hloov pauv. Tus qauv FDA 21 CFR Ntu 11 uas tau muab los ntawm US Food and Drug Administration (FDA), muab cov ntaub ntawv hluav taws xob tib yam li cov ntaub ntawv sau thiab kos npe, kom ntseeg tau tias cov ntaub ntawv hluav taws xob muaj tseeb thiab ntseeg tau. Tus qauv no siv tau rau cov koom haum uas siv cov ntaub ntawv hluav taws xob thiab kos npe hauv biopharmaceuticals, cov khoom siv kho mob, thiab kev lag luam zaub mov.

Txij li thaum nws tshaj tawm, tus qauv no tau txais kev pom zoo thoob ntiaj teb, tsis yog los ntawm cov tuam txhab tshuaj biopharmaceutical Asmeskas, tsev kho mob, cov tsev tshawb fawb, thiab cov chaw soj nstuam xwb, tab sis kuj los ntawm Tebchaws Europe thiab Asia. Rau cov tuam txhab uas vam khom cov ntaub ntawv hluav taws xob thiab kos npe, kev ua raws li cov kev cai ntawm FDA 21 CFR Ntu 11 yog qhov tseem ceeb rau kev nthuav dav thoob ntiaj teb ruaj khov, xyuas kom 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 ib qho "lub hlwb ntse" rau cov kua nitrogen. Nws hloov cov ntaub ntawv piv txwv mus rau hauv cov ntaub ntawv, nrog ntau cov ntaub ntawv raug saib xyuas, sau tseg, thiab khaws cia rau lub sijhawm tiag tiag, ceeb toom rau txhua qhov tsis zoo. Nws kuj muaj kev ntsuas ob qho tib si ntawm qhov kub thiab qib kua, nrog rau kev tswj hwm hierarchical ntawm cov neeg ua haujlwm ua haujlwm. Tsis tas li ntawd, nws kuj muab kev tswj hwm pom ntawm cov qauv rau kev nkag mus sai. Cov neeg siv tuaj yeem hloov ntawm phau ntawv, roj-theem, thiab kua-theem hom nrog ib qho nias, txhim kho kev ua haujlwm zoo. Tsis tas li ntawd, lub kaw lus sib koom ua ke nrog IoT thiab BIMS qauv cov ntaub ntawv platform, ua rau muaj kev sib txuas tsis muaj kev sib txuas ntawm cov neeg ua haujlwm, cov khoom siv, thiab cov qauv. Qhov no muab kev paub txog kev khaws cia kub qis heev, kev tshawb fawb, kev nyab xeeb, thiab ua haujlwm tau zoo.

Haier Biomedical tau tsim ib qho kev daws teeb meem cia cov kua nitrogen uas ua haujlwm tau zoo rau txhua qhov chaw thiab txhua qhov ntim, tsom mus rau ntau yam kev xav tau ntawm kev tswj hwm kev khaws cia cov qauv cryogenic. Cov kev daws teeb meem no suav nrog ntau yam xwm txheej, suav nrog kev kho mob, chaw kuaj mob, kev khaws cia kub qis, cov koob tshuaj lom neeg, thiab cov koob tshuaj thauj mus los, thiab muab rau cov neeg siv nrog kev paub txog kev ua haujlwm tag nrho suav nrog kev tsim qauv engineering, kev khaws cia cov qauv, kev nrhiav cov qauv, kev thauj mus los cov qauv, thiab kev tswj hwm cov qauv.

1 (5)

Los ntawm kev ua raws li FDA 21 CFR Ntu 11 cov qauv, Haier Biomedical's CryoBio kua nitrogen tswj system tau txais daim ntawv pov thawj rau qhov tseeb ntawm peb cov kos npe hluav taws xob thiab kev ncaj ncees ntawm peb cov ntaub ntawv hluav taws xob. Daim ntawv pov thawj ua raws li txoj cai no tau txhim kho Haier Biomedical qhov kev sib tw tseem ceeb hauv kev daws teeb meem cia kua nitrogen, ua kom lub hom lag luam nthuav dav hauv kev lag luam thoob ntiaj teb.

Ua kom kev hloov pauv thoob ntiaj teb sai dua los nyiam cov neeg siv, thiab txhim kho kev sib tw ntawm cov lag luam thoob ntiaj teb

Haier Biomedical yeej ib txwm ua raws li lub tswv yim thoob ntiaj teb, txuas ntxiv txhawb nqa "network + localization" dual system. Tib lub sijhawm, peb txuas ntxiv txhawb nqa kev tsim kho ntawm cov txheej txheem kev lag luam kom ntsib cov neeg siv, txhim kho peb cov kev daws teeb meem hauv kev sib cuam tshuam, kev hloov kho, thiab kev xa khoom.

Ua kom pom tseeb rau kev tsim kom muaj kev paub zoo tshaj plaws rau cov neeg siv khoom, Haier Biomedical txhawb kom muaj kev lag luam hauv zos los ntawm kev tsim cov pab pawg hauv zos thiab cov txheej txheem kom teb sai rau cov neeg siv khoom xav tau. Thaum kawg ntawm xyoo 2023, Haier Biomedical tau muaj lub network faib khoom txawv teb chaws ntawm ntau dua 800 tus khub, koom tes nrog ntau dua 500 tus neeg muab kev pabcuam tom qab muag. Lub caij no, peb tau tsim kom muaj kev paub thiab chaw cob qhia, uas yog nyob rau hauv United Arab Emirates, Nigeria thiab United Kingdom, thiab lub chaw khaws khoom thiab chaw logistics nyob hauv Netherlands thiab Tebchaws Meskas. Peb tau ua kom peb qhov chaw lag luam tob dua hauv UK thiab maj mam rov ua qhov qauv no thoob ntiaj teb, thiab txhim kho peb lub lag luam txawv teb chaws tas li.

Haier Biomedical kuj tseem tab tom ua kom nrawm dua kev nthuav dav ntawm cov khoom tshiab, suav nrog cov cuab yeej siv hauv chaw kuaj mob, cov khoom siv tau, thiab cov khw muag tshuaj ntse, txhim kho kev sib tw ntawm peb cov kev daws teeb meem. Rau cov neeg siv kev tshawb fawb txog lub neej, peb cov centrifuges tau ua tiav hauv Tebchaws Europe thiab Asmeskas, peb cov tshuab ziab khov tau txais thawj qhov kev txiav txim hauv Asia, thiab peb cov txee biosafety tau nkag mus rau sab hnub tuaj Europe kev ua lag luam. Lub caij no, peb cov khoom siv hauv chaw kuaj mob tau ua tiav thiab rov ua dua hauv Asia, North America, thiab Europe. Rau cov tsev kho mob, ntxiv rau cov kev daws teeb meem tshuaj tiv thaiv hnub ci, cov tub yees tshuaj, cov chaw khaws ntshav, thiab cov khoom siv tau kuj tseem tab tom txhim kho sai. Los ntawm kev sib cuag tas mus li nrog cov koom haum thoob ntiaj teb, Haier Biomedical muab cov kev pabcuam suav nrog kev tsim kho chaw kuaj mob, kev sim ib puag ncig thiab kev ua kom tsis muaj menyuam, tsim cov cib fim tshiab rau kev loj hlob.

Txog thaum kawg ntawm xyoo 2023, ntau tshaj 400 tus qauv ntawm Haier Biomedical tau txais daim ntawv pov thawj txawv teb chaws, thiab xa mus rau ntau qhov project loj hauv Zimbabwe, Democratic Republic of Congo, Ethiopia, thiab Liberia, nrog rau China-Africa Union Centers of Disease Control (CDC) project, qhia txog kev txhim kho ntawm kev ua tau zoo. Peb cov khoom thiab cov kev daws teeb meem tau txais kev pom zoo dav dav hauv ntau tshaj 150 lub teb chaws thiab thaj chaw. Tib lub sijhawm, peb tau tswj hwm kev koom tes ntev nrog ntau tshaj 60 lub koom haum thoob ntiaj teb, suav nrog World Health Organization (WHO) thiab UNICEF.

Tau txais daim ntawv pov thawj FDA 21 CFR Ntu 11 yog ib qho 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 txog peb txoj kev cog lus los ua kom tau raws li cov neeg siv xav tau los ntawm kev tsim kho tshiab. Saib rau pem hauv ntej, Haier Biomedical yuav txuas ntxiv peb txoj hauv kev tsim kho tshiab uas tsom mus rau cov neeg siv, txhim kho peb txoj kev xa mus thoob ntiaj teb thoob plaws thaj chaw, cov channel, thiab cov khoom lag luam. Los ntawm kev hais txog kev tsim kho tshiab hauv zos, peb lub hom phiaj yog tshawb nrhiav cov lag luam thoob ntiaj teb los ntawm kev txawj ntse.


Lub sijhawm tshaj tawm: Lub Xya Hli-15-2024