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Haier Biomedical's LN₂Management System Imapeza Chitsimikizo cha FDA

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Posachedwapa, TÜV SÜD China Group (yotchedwa "TÜV SÜD") idatsimikizira zolemba zamagetsi ndi siginecha zamagetsi za Haier Biomedical's liquid nitrogen management system molingana ndi zofunikira za FDA 21 CFR Part 11. Mayankho azinthu khumi ndi asanu ndi limodzi, opangidwa paokha ndi Haier Biomedical, adapatsidwa lipoti lotsatira la TÜV SÜD, kuphatikiza mndandanda wa Smartand Biobank.

Kupeza chiphaso cha FDA 21 CFR Gawo 11 kumatanthauza kuti zolembedwa pakompyuta ndi siginecha za LN₂ management system ya Haier Biomedical zimakwaniritsa miyezo yodalirika, kukhulupirika, chinsinsi komanso kutsatiridwa, potero zimatsimikizira mtundu wa data ndi chitetezo.Izi zithandizira kukhazikitsidwa kwa njira zosungiramo nayitrogeni wamadzimadzi m'misika monga US ndi Europe, kuthandizira kukulitsa kwapadziko lonse kwa Haier Biomedical.

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Kupeza certification ya FDA, HB's liquid nitrogen management system yayamba ulendo watsopano wakumayiko ena.

TÜV SÜD, mtsogoleri wapadziko lonse lapansi pakuyesa ndi ziphaso za chipani chachitatu, nthawi zonse amayang'ana kwambiri pakupereka chithandizo chaukadaulo m'mafakitale onse, kuthandiza mabizinesi kuti azitsatira malamulo omwe akusintha.Muyezo wa FDA 21 CFR Gawo 11 loperekedwa ndi US Food and Drug Administration (FDA), limapereka zolemba zamagetsi zamalamulo zofanana ndi zolemba zolembedwa ndi siginecha, kuwonetsetsa kutsimikizika ndi kudalirika kwa data yamagetsi.Mulingo uwu umagwira ntchito m'mabungwe omwe amagwiritsa ntchito ma rekodi amagetsi ndi siginecha mu biopharmaceuticals, zida zamankhwala, ndi mafakitale azakudya.

Kuyambira pomwe idalengezedwa, mulingowu walandiridwa padziko lonse lapansi, osati kokha ndi makampani aku America biopharmaceutical, zipatala, mabungwe ofufuza, ndi ma laboratories, komanso ndi Europe ndi Asia.Kwa makampani omwe amadalira zolemba ndi siginecha zamagetsi, kutsata zofunikira za FDA 21 CFR Gawo 11 ndikofunikira pakukulitsa kokhazikika kwapadziko lonse lapansi, kuwonetsetsa kuti zikutsatira malamulo a FDA komanso miyezo yoyenera yaumoyo ndi chitetezo.

Haier Biomedical's CryoBio liquid nitrogen management system kwenikweni ndi "ubongo wanzeru" wazotengera za nayitrogeni zamadzimadzi.Imasintha zinthu zachitsanzo kukhala zida za data, ndikuwunika zambiri, kujambulidwa, ndikusungidwa munthawi yeniyeni, kuchenjeza za zolakwika zilizonse.Imakhalanso ndi kuyeza kodziyimira pawiri kwa kutentha ndi kuchuluka kwamadzimadzi, komanso kasamalidwe ka kayendetsedwe ka ogwira ntchito.Kuphatikiza apo, imaperekanso kasamalidwe kowoneka bwino kwa zitsanzo zofikira mwachangu.Ogwiritsa ntchito amatha kusinthana pakati pa ma manual, gas-phase, and liquid-gawo modes ndikudina kamodzi, kuwongolera bwino.Kuphatikiza apo, dongosololi limaphatikizana ndi nsanja yazidziwitso ya IoT ndi BIMS, zomwe zimathandizira kulumikizana kosasunthika pakati pa ogwira ntchito, zida, ndi zitsanzo.Izi zimapereka chidziwitso chasayansi, chokhazikika, chotetezeka, komanso chothandiza kwambiri pakusungirako kutentha kwambiri.

Haier Biomedical yapanga njira yosungiramo madzi a nayitrogeni yokhala ndi malo amodzi oyenera mawonekedwe onse ndi magawo a voliyumu, poyang'ana zofunikira zosiyanasiyana za kasamalidwe kosungirako cryogenic.Njira yothetsera vutoli imaphatikizapo zochitika zosiyanasiyana, kuphatikizapo zachipatala, labotale, kusungirako kutentha pang'ono, mndandanda wa zamoyo, ndi mndandanda wa zoyendera zamoyo, ndipo zimapereka ogwiritsa ntchito zochitika zonse kuphatikizapo mapangidwe a uinjiniya, kusungirako zitsanzo, kubweza zitsanzo, zoyendera zitsanzo, ndi kasamalidwe ka zitsanzo.

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Potsatira miyezo ya FDA 21 CFR Part 11, Haier Biomedical's CryoBio liquid nitrogen management system yatsimikiziridwa kuti ndi yowona kwa siginecha zathu zamagetsi komanso kukhulupirika kwa zolemba zathu zamagetsi.Chitsimikizo chotsatirachi chapititsa patsogolo mpikisano wa Haier Biomedical pazankho zosungiramo nayitrogeni wamadzimadzi, ndikufulumizitsa kukula kwa mtunduwo m'misika yapadziko lonse lapansi.

Limbikitsani kusintha kwapadziko lonse kuti mukope ogwiritsa ntchito, ndikukweza mpikisano wamisika yapadziko lonse lapansi

Haier Biomedical yakhala ikutsatira njira zapadziko lonse lapansi, kulimbikitsa mosalekeza "network + localization" yapawiri.Panthawi imodzimodziyo, tikupitiriza kulimbikitsa chitukuko cha machitidwe a msika kuti tiyang'ane ndi ogwiritsa ntchito, kupititsa patsogolo mayankho athu pazochitika, kusintha, ndi kutumiza.

Poyang'ana pakupanga chidziwitso chabwino kwambiri cha ogwiritsa ntchito, Haier Biomedical imalimbitsa malo mwa kukhazikitsa magulu am'deralo ndi machitidwe kuti ayankhe mwachangu zosowa za ogwiritsa ntchito.Pofika kumapeto kwa chaka cha 2023, Haier Biomedical ili ndi gulu logawa zakunja kwa anzawo opitilira 800, ogwirizana ndi opitilira 500 opereka chithandizo pambuyo pogulitsa.Pakadali pano, takhazikitsa njira yophunzitsira komanso yophunzitsira, yokhazikika ku United Arab Emirates, Nigeria ndi United Kingdom, komanso malo osungiramo zinthu komanso malo opangira zinthu omwe ali ku Netherlands ndi United States.Takulitsa kukhazikika kwathu ku UK ndikufanizira pang'onopang'ono chitsanzochi padziko lonse lapansi, kulimbitsa nthawi zonse msika wathu wakunja.

Haier Biomedical ikufulumizitsanso kukulitsa kwazinthu zatsopano, kuphatikiza zida za labotale, zogula, ndi ma pharmacies anzeru, kupititsa patsogolo mpikisano wamayankho athu.Kwa ogwiritsa ntchito sayansi ya moyo, ma centrifuge athu apita patsogolo ku Europe ndi America, zowumitsira zowuma mufiriji zapeza maoda oyamba ku Asia, ndipo makabati athu oteteza zachilengedwe alowa kumsika wakum'mawa kwa Europe.Pakadali pano, zogwiritsidwa ntchito mu labotale yathu zakwaniritsidwa ndikubwerezedwanso ku Asia, North America, ndi Europe.Kwa zipatala, kuwonjezera pa mankhwala opangira katemera wa solar, mafiriji opangira mankhwala, malo osungiramo magazi, ndi zinthu zomwe zimagwiritsidwa ntchito pogula zikukulanso mwachangu.Kupyolera mu kuyanjana kosalekeza ndi mabungwe apadziko lonse lapansi, Haier Biomedical imapereka ntchito kuphatikizapo kumanga ma labotale, kuyesa zachilengedwe ndi kulera, kupanga mipata yatsopano yakukula.

Pofika kumapeto kwa chaka cha 2023, mitundu yopitilira 400 ya Haier Biomedical idatsimikiziridwa kunja, ndipo idaperekedwa bwino kuzinthu zazikulu zingapo ku Zimbabwe, Democratic Republic of Congo, Ethiopia, ndi Liberia, komanso China-Africa Union Centers of Disease Control. (CDC) pulojekiti, kuwonetsa kusintha kwa magwiridwe antchito.Zogulitsa zathu ndi mayankho akhala akuvomerezedwa kwambiri m'maiko ndi zigawo zopitilira 150.Nthawi yomweyo, takhala tikugwirizana kwanthawi yayitali ndi mabungwe opitilira 60 apadziko lonse lapansi, kuphatikiza World Health Organisation (WHO) ndi UNICEF.

Kupeza satifiketi ya FDA 21 CFR Gawo 11 ndichinthu chofunikira kwambiri ku Haier Biomedical pamene timayang'ana kwambiri zaukadaulo paulendo wathu wotukuka padziko lonse lapansi.Zikuwonetsanso kudzipereka kwathu kukwaniritsa zosowa za ogwiritsa ntchito kudzera mwaukadaulo.Kuyang'ana m'tsogolo, Haier Biomedical ipitiliza njira yathu yopangira zinthu zatsopano, kupititsa patsogolo njira zathu zapadziko lonse lapansi kumadera, mayendedwe, ndi magulu azogulitsa.Pogogomezera luso lamakono, tikufuna kufufuza misika yapadziko lonse ndi nzeru.


Nthawi yotumiza: Jul-15-2024