Muva nje, i-TÜV SÜD China Group (ebizwa ngokuthi "i-TÜV SÜD" lapha) iqinisekisile amarekhodi kagesi kanye nokusayina kwe-elekthronikhi kohlelo lokuphathwa kwe-nitrogen oluketshezi lwe-Haier Biomedical ngokuhambisana nezidingo ze-FDA 21 CFR Ingxenye 11. Izixazululo zemikhiqizo eziyishumi nesithupha, ezakhiwe ngokuzimela yi-Haier Biomedical, zanikezwa umbiko wokuthobela imithetho ye-TÜV SÜD, okuhlanganisa nochungechunge lwe-Smartand Biobank.
Ukuthola isitifiketi se-FDA 21 CFR Ingxenye 11 kusho ukuthi amarekhodi e-elekthronikhi kanye nokusayina kohlelo lokuphatha lwe-LN₂ lwe-Haier Biomedical kuhlangabezana nezindinganiso zokwethembeka, ubuqotho, ubumfihlo kanye nokulandelelwa, ngaleyo ndlela kuqinisekiswe ikhwalithi yedatha kanye nokuphepha. Lokhu kuzosheshisa ukwamukelwa kwezixazululo zesistimu yokugcina i-nitrogen ewuketshezi ezimakethe ezifana ne-US ne-Europe, kusekela ukwanda komhlaba wonke kwe-Haier Biomedical.
Ngokuthola isitifiketi se-FDA, uhlelo lokuphathwa kwe-nitrogen oluwuketshezi lwe-HB luqale uhambo olusha lokuhwebelana ngamazwe ngamazwe
I-TÜV SÜD, umholi womhlaba wonke ekuhlolweni nasekuqinisekisweni yizinkampani zangaphandle, igxila njalo ekuhlinzekeni ukwesekwa kokuhambisana kobungcweti kuzo zonke izimboni, isiza amabhizinisi ukuthi ahlale ehambisana nemithethonqubo eshintshayo. I-FDA 21 CFR Ingxenye 11 ejwayelekile ekhishwe yi-US Food and Drug Administration (FDA), inikeza amarekhodi kagesi umphumela ofanayo wezomthetho njengamarekhodi abhaliwe kanye nokusayina, okuqinisekisa ukufaneleka nokuthembeka kwedatha kagesi. Le nqubo iyasebenza ezinhlanganweni ezisebenzisa amarekhodi kagesi kanye nokusayina kumithi ye-biopharmaceuticals, kumadivayisi ezokwelapha, kanye nasezimbonini zokudla.
Kusukela ekumenyezelweni kwayo, le ndinganiso iye yamukelwa kabanzi emhlabeni wonke, hhayi kuphela yizinkampani zaseMelika zemithi ye-biopharmaceutical, izibhedlela, izikhungo zocwaningo, kanye nama-laboratory, kodwa futhi yiYurophu ne-Asia. Ezinkampanini ezithembele kumarekhodi e-elekthronikhi kanye nokusayina, ukuhambisana nezidingo ze-FDA 21 CFR Ingxenye 11 kubalulekile ekukhuleni okuzinzile kwamazwe ngamazwe, ukuqinisekisa ukuhambisana nemithethonqubo ye-FDA kanye nezindinganiso ezifanele zezempilo nokuphepha.
Uhlelo lokuphathwa kwe-CryoBio oluyi-liquid nitrogen lwe-Haier Biomedical empeleni "luyingqondo ehlakaniphile" yezitsha ze-liquid nitrogen. Luguqula izinsiza zesampula zibe izinsiza zedatha, idatha eminingi iqashwa, irekhodwe, futhi igcinwe ngesikhathi sangempela, ixwayisa nganoma yikuphi ukungalingani. Luphinde lube nokulinganisa okubili okuzimele kwamazinga okushisa kanye noketshezi, kanye nokuphathwa kwemisebenzi yabasebenzi ngokwezinga eliphezulu. Ngaphezu kwalokho, luphinde lunikeze ukuphathwa okubonakalayo kwamasampula ukuze kufinyeleleke ngokushesha. Abasebenzisi bangashintsha phakathi kwezindlela zesandla, zesigaba segesi, kanye nesigaba se-liquid ngokuchofoza okukodwa, okuthuthukisa ukusebenza kahle. Ngaphezu kwalokho, uhlelo luhlangana nepulatifomu yolwazi lwesampula ye-IoT kanye ne-BIMS, okuvumela ukuxhumana okungenamthungo phakathi kwabasebenzi, imishini, kanye namasampula. Lokhu kunikeza ulwazi lwesayensi, olujwayelekile, oluphephile, nolusebenza kahle lokugcina izinga lokushisa eliphansi kakhulu.
I-Haier Biomedical ithuthukise isisombululo sokugcina i-nitrogen ewuketshezi esiphelele esilungele zonke izigcawu kanye nezingxenye zomthamo, igxile ezidingweni ezahlukahlukene zokuphathwa kwesitoreji samasampula esi-cryogenic. Isixazululo sihlanganisa izimo ezahlukahlukene, kufaka phakathi ezokwelapha, elebhu, isitoreji esisezingeni eliphansi lokushisa, uchungechunge lwezinto eziphilayo, kanye nochungechunge lokuthuthwa kwezinto eziphilayo, futhi sinikeza abasebenzisi ulwazi oluphelele oluhlanganisa ukuklama kobunjiniyela, ukugcinwa kwamasampula, ukutholwa kwamasampula, ukuthuthwa kwamasampula, kanye nokuphathwa kwamasampula.
Ngokuhambisana nezindinganiso ze-FDA 21 CFR Ingxenye 11, uhlelo lokuphatha i-nitrogen oluyi-CryoBio lwe-Haier Biomedical luqinisekiswe ukuthi lusebenza kahle yini uphawu lwethu lwe-elekthronikhi kanye nobuqotho bamarekhodi ethu e-elekthronikhi. Lesi sitifiketi sokuthobela imithetho sithuthukise kakhulu ukuncintisana okuyinhloko kwe-Haier Biomedical emkhakheni wezixazululo zokugcina i-nitrogen oluyi-liquid, okusheshisa ukwanda komkhiqizo ezimakethe zomhlaba wonke.
Sheshisa uguquko lwamazwe ngamazwe ukuze udonse abasebenzisi, futhi uthuthukise ukuncintisana kwezimakethe zomhlaba wonke
I-Haier Biomedical ibilokhu inamathela esu lamazwe ngamazwe, ikhuthaza njalo uhlelo oluphindwe kabili "lwenethiwekhi + lwendawo". Ngesikhathi esifanayo, siyaqhubeka nokuqinisa ukuthuthukiswa kwezinhlelo zemakethe ukubhekana nabasebenzisi, sithuthukisa izixazululo zethu zesimo ekusebenzisaneni, ukwenza ngokwezifiso, kanye nokulethwa.
Igxile ekudaleni ulwazi olungcono kakhulu lomsebenzisi, i-Haier Biomedical iqinisa ukwenziwa kwendawo ngokusungula amaqembu endawo nezinhlelo ukuze ziphendule ngokushesha ezidingweni zomsebenzisi. Ekupheleni kuka-2023, i-Haier Biomedical ibilokhu inenethiwekhi yokusabalalisa kwamanye amazwe enabalingani abangaphezu kuka-800, ibambisene nabahlinzeki bezinsizakalo zokuthengisa abangaphezu kuka-500. Okwamanje, sesisungule uhlelo lwesikhungo solwazi nesipiliyoni, olugxile e-United Arab Emirates, eNigeria nase-United Kingdom, kanye nohlelo lwesikhungo sokugcina impahla kanye nesezokuthutha oluseNetherlands nase-United States. Sijulise ukwenziwa kwendawo yethu e-UK futhi kancane kancane saphinda lo modeli emhlabeni jikelele, siqinisa njalo uhlelo lwethu lwemakethe lwaphesheya kwezilwandle.
I-Haier Biomedical nayo isheshisa ukwanda kwemikhiqizo emisha, okuhlanganisa amathuluzi elebhu, izinto ezisetshenziswayo, kanye namakhemisi ahlakaniphile, okuthuthukisa ukuncintisana kwezixazululo zethu zesimo. Kubasebenzisi besayensi yokuphila, ama-centrifuge ethu enze intuthuko eYurophu naseMelika, ama-dryer ethu aqandisiwe athole ama-oda okuqala e-Asia, futhi amakhabethe ethu okuphepha kwe-bio angene emakethe yasempumalanga yeYurophu. Okwamanje, izinto zethu ezisetshenziswayo elebhu zifeziwe futhi zaphindaphindwa e-Asia, eNyakatho Melika, naseYurophu. Ezikhungweni zezokwelapha, ngaphandle kwezixazululo zokugomela ilanga, amafriji emithi, amayunithi okugcina igazi, kanye nezinto ezisetshenziswayo nazo zithuthuka ngokushesha. Ngokusebenzisana okuqhubekayo nezinhlangano zomhlaba wonke, i-Haier Biomedical inikeza izinsizakalo okuhlanganisa ukwakhiwa kwelebhu, ukuhlolwa kwemvelo kanye nokubulala amagciwane, okudala amathuba amasha okukhula.
Ekupheleni kuka-2023, amamodeli angaphezu kuka-400 e-Haier Biomedical aseqinisekiswe phesheya kwezilwandle, futhi alethwe ngempumelelo kumaphrojekthi amaningana amakhulu eZimbabwe, eDemocratic Republic of Congo, e-Ethiopia naseLiberia, kanye nephrojekthi ye-China-Africa Union Centers of Disease Control (CDC), okubonisa ukuthuthuka kokusebenza kokulethwa. Imikhiqizo nezixazululo zethu sezamukelwe kabanzi emazweni nasezifundeni ezingaphezu kuka-150. Ngesikhathi esifanayo, sigcine ukubambisana kwesikhathi eside nezinhlangano zomhlaba wonke ezingaphezu kuka-60, okuhlanganisa ne-World Health Organization (WHO) kanye ne-UNICEF.
Ukuthola isitifiketi se-FDA 21 CFR Ingxenye 11 kuyingqophamlando ebalulekile ye-Haier Biomedical njengoba sigxila ekusunguleni izinto ezintsha ohambweni lwethu lokukhula komhlaba wonke. Kuphinde kubonise ukuzibophezela kwethu ekuhlangabezaneni nezidingo zabasebenzisi ngokusebenzisa izinto ezintsha. Uma sibheka phambili, i-Haier Biomedical izoqhubeka nendlela yethu yokusungula izinto ezintsha egxile kubasebenzisi, ithuthukise ukuthunyelwa kwethu kwamasu emhlabeni wonke kuzo zonke izifunda, iziteshi, kanye nezigaba zemikhiqizo. Ngokugcizelela ukusungula izinto ezintsha endaweni, sihlose ukuhlola izimakethe zomhlaba wonke ngokusebenzisa ubuhlakani.
Isikhathi sokuthunyelwe: Julayi-15-2024
