Posachedwapa, TÜV SÜD China Group (yomwe pano ikutchedwa "TÜV SÜD") yatsimikizira zolemba zamagetsi ndi ma siginecha amagetsi a makina oyendetsera nayitrogeni yamadzimadzi a Haier Biomedical motsatira zofunikira za FDA 21 CFR Part 11. Mayankho khumi ndi asanu ndi limodzi azinthu, omwe adapangidwa pawokha ndi Haier Biomedical, adapatsidwa lipoti lotsatira malamulo a TÜV SÜD, kuphatikiza mndandanda wa Smartand Biobank.
Kupeza satifiketi ya FDA 21 CFR Gawo 11 kumatanthauza kuti zolemba zamagetsi ndi ma siginecha a dongosolo loyang'anira LN₂ la Haier Biomedical zikukwaniritsa miyezo yodalirika, yodalirika, yachinsinsi komanso yolondola, motero kuonetsetsa kuti deta ndi yabwino komanso yotetezeka. Izi zithandizira kukhazikitsidwa kwa njira zosungira nayitrogeni yamadzimadzi m'misika monga US ndi Europe, kuthandizira kufalikira kwa Haier Biomedical padziko lonse lapansi.
Atalandira satifiketi ya FDA, dongosolo la HB loyang'anira nayitrogeni wamadzimadzi layamba ulendo watsopano wolumikizana ndi mayiko ena
TÜV SÜD, mtsogoleri wapadziko lonse lapansi pa mayeso ndi ziphaso za anthu ena, nthawi zonse imayang'ana kwambiri pakupereka chithandizo chaukadaulo pakutsatira malamulo m'mafakitale onse, kuthandiza mabizinesi kuti azitsatira malamulo omwe akusintha. Muyezo wa FDA 21 CFR Part 11 woperekedwa ndi US Food and Drug Administration (FDA), umapereka zolemba zamagetsi zotsatira zalamulo zomwezo monga zolemba zolembedwa ndi masainidwe, kuonetsetsa kuti deta yamagetsi ndi yodalirika. Muyezo uwu umagwira ntchito ku mabungwe omwe amagwiritsa ntchito zolemba zamagetsi ndi masainidwe mu mankhwala a biopharmaceuticals, zida zamankhwala, ndi mafakitale azakudya.
Kuyambira pomwe idakhazikitsidwa, muyezowu wagwiritsidwa ntchito kwambiri padziko lonse lapansi, osati ndi makampani aku America okha omwe amagwiritsa ntchito mankhwala a biopharmaceutical, zipatala, mabungwe ofufuza, ndi ma laboratories, komanso ndi Europe ndi Asia. Kwa makampani omwe amadalira zolemba zamagetsi ndi ma siginecha, kutsatira zofunikira za FDA 21 CFR Part 11 ndikofunikira kuti pakhale kukula kokhazikika padziko lonse lapansi, kuonetsetsa kuti malamulo a FDA ndi miyezo yoyenera yazaumoyo ndi chitetezo atsatiridwa.
Dongosolo loyang'anira nayitrogeni yamadzimadzi la Haier Biomedical la CryoBio kwenikweni ndi "ubongo wanzeru" wa zotengera za nayitrogeni yamadzimadzi. Limasintha zinthu za zitsanzo kukhala zinthu za deta, ndi deta yambiri ikuyang'aniridwa, kulembedwa, ndikusungidwa nthawi yeniyeni, kuchenjeza za zolakwika zilizonse. Lilinso ndi muyeso wodziyimira pawokha wa kutentha ndi kuchuluka kwa madzi, komanso kayendetsedwe ka kayendetsedwe ka ntchito za ogwira ntchito. Kuphatikiza apo, limaperekanso kuyang'anira kowoneka bwino kwa zitsanzo kuti zipezeke mwachangu. Ogwiritsa ntchito amatha kusinthana pakati pa njira zamanja, za gasi, ndi zamadzimadzi podina kamodzi, zomwe zimapangitsa kuti magwiridwe antchito azigwira ntchito bwino. Kuphatikiza apo, dongosololi limalumikizana ndi nsanja yodziwitsa zitsanzo za IoT ndi BIMS, zomwe zimathandiza kulumikizana bwino pakati pa ogwira ntchito, zida, ndi zitsanzo. Izi zimapereka chidziwitso chasayansi, chokhazikika, chotetezeka, komanso chogwira ntchito bwino chosungira kutentha kochepa kwambiri.
Haier Biomedical yapanga njira yosungiramo nayitrogeni yamadzimadzi yokwanira magawo onse ndi kuchuluka, ikuyang'ana kwambiri zofunikira zosiyanasiyana pakusamalira zosungiramo zitsanzo za cryogenic. Yankholi limakhudza zochitika zosiyanasiyana, kuphatikizapo zachipatala, labotale, zosungiramo kutentha kochepa, zosungiramo zachilengedwe, ndi zoyendera zachilengedwe, ndipo imapatsa ogwiritsa ntchito chidziwitso chathunthu kuphatikiza kapangidwe ka uinjiniya, kusungirako zitsanzo, kutengera zitsanzo, kunyamula zitsanzo, ndi kuyang'anira zitsanzo.
Potsatira miyezo ya FDA 21 CFR Gawo 11, njira yoyendetsera nayitrogeni ya Haier Biomedical ya CryoBio yatsimikiziridwa kuti ndi yolondola pa siginecha zathu zamagetsi komanso kuti zolemba zathu zamagetsi ndi zolondola. Chitsimikizochi chawonjezera mpikisano waukulu wa Haier Biomedical pankhani yosungira nayitrogeni yamadzimadzi, zomwe zathandizira kukula kwa kampaniyi m'misika yapadziko lonse.
Kufulumizitsa kusintha kwa mayiko kuti akope ogwiritsa ntchito, ndikukweza mpikisano wamisika yapadziko lonse
Haier Biomedical nthawi zonse yakhala ikutsatira njira yapadziko lonse lapansi, ikulimbikitsa nthawi zonse njira ziwiri za "network + localization". Nthawi yomweyo, tikupitilizabe kulimbitsa chitukuko cha machitidwe amsika kuti agwirizane ndi ogwiritsa ntchito, kukulitsa mayankho athu pazochitika zosiyanasiyana polumikizana, kusintha, komanso kupereka.
Poganizira kwambiri pakupanga njira yabwino kwambiri yogwiritsira ntchito, Haier Biomedical imalimbitsa kufalikira kwa malo mwa kukhazikitsa magulu am'deralo ndi machitidwe kuti ayankhe mwachangu zosowa za ogwiritsa ntchito. Pofika kumapeto kwa chaka cha 2023, Haier Biomedical yakhala ndi netiweki yogawa zinthu kunja kwa dziko ya ogwirizana nawo oposa 800, ndipo yagwirizana ndi opereka chithandizo cha pambuyo pa malonda oposa 500. Pakadali pano, takhazikitsa njira yophunzitsira ndi yophunzitsira, yomwe imayang'ana kwambiri United Arab Emirates, Nigeria ndi United Kingdom, komanso njira yosungiramo zinthu ndi malo osungiramo katundu omwe ali ku Netherlands ndi United States. Takulitsa kufalikira kwa malo athu ku UK ndipo pang'onopang'ono tabwereza chitsanzochi padziko lonse lapansi, nthawi zonse tikulimbitsa njira yathu ya msika wakunja.
Haier Biomedical ikuthandizanso kukulitsa zinthu zatsopano, kuphatikizapo zida za labotale, zogwiritsidwa ntchito, ndi mankhwala anzeru, ndikuwonjezera mpikisano wa mayankho athu. Kwa ogwiritsa ntchito sayansi ya moyo, ma centrifuge athu apita patsogolo ku Europe ndi America, makina athu owumitsa oundana apeza maoda oyamba ku Asia, ndipo makabati athu oteteza zachilengedwe alowa pamsika wa kum'mawa kwa Europe. Pakadali pano, zogwiritsidwa ntchito za labotale zathu zakwaniritsidwa ndikubwerezedwanso ku Asia, North America, ndi Europe. Kwa mabungwe azachipatala, kupatula mayankho a katemera wa dzuwa, mafiriji a mankhwala, malo osungira magazi, ndi zogwiritsidwa ntchito zikukula mwachangu. Mwa kulumikizana kosalekeza ndi mabungwe apadziko lonse lapansi, Haier Biomedical imapereka ntchito kuphatikiza kumanga ma labotale, kuyesa zachilengedwe ndi kuyeretsa, ndikupanga mwayi watsopano wokulira.
Pofika kumapeto kwa chaka cha 2023, mitundu yoposa 400 ya Haier Biomedical yavomerezedwa kumayiko ena, ndipo yaperekedwa bwino ku mapulojekiti akuluakulu angapo ku Zimbabwe, Democratic Republic of Congo, Ethiopia, ndi Liberia, komanso pulojekiti ya China-Africa Union Centers of Disease Control (CDC), zomwe zikusonyeza kusintha kwa magwiridwe antchito. Zogulitsa zathu ndi mayankho athu zagwiritsidwa ntchito kwambiri m'maiko ndi madera opitilira 150. Nthawi yomweyo, tasunga mgwirizano wa nthawi yayitali ndi mabungwe opitilira 60 apadziko lonse lapansi, kuphatikiza World Health Organization (WHO) ndi UNICEF.
Kupeza satifiketi ya FDA 21 CFR Gawo 11 ndi gawo lofunika kwambiri kwa Haier Biomedical pamene tikuyang'ana kwambiri pa luso pa ulendo wathu wopita patsogolo padziko lonse lapansi. Zimasonyezanso kudzipereka kwathu kukwaniritsa zosowa za ogwiritsa ntchito kudzera mu luso. Poyang'ana patsogolo, Haier Biomedical ipitiliza njira yathu yopangira luso yoyang'ana kwambiri ogwiritsa ntchito, kupititsa patsogolo kufalikira kwathu kwa njira zapadziko lonse lapansi m'madera, njira, ndi magulu azinthu. Mwa kutsindika luso lapadziko lonse lapansi, cholinga chathu ndi kufufuza misika yapadziko lonse pogwiritsa ntchito luntha.
Nthawi yotumizira: Julayi-15-2024
