Muva nje, i-TÜV SÜD China Group (ngemuva kwalokhu ebizwa ngokuthi "TÜV SÜD") iqinisekise amarekhodi e-elekthronikhi namasiginesha ka-elekthronikhi ohlelo lokuphathwa kwenitrogen eliwuketshezi lwe-Haier Biomedical ngokuvumelana nezidingo ze-FDA 21 CFR Ingxenye 11. Izixazululo zemikhiqizo eziyishumi nesithupha, ezithuthukiswe ngokuzimele ngabakwa-Haier I-Biomedical, baklonyeliswe ngombiko wokuthobela we-TÜV SÜD, okuhlanganisa nochungechunge lwe-Smartand Biobank.
Ukuthola isitifiketi se-FDA 21 CFR Ingxenye 11 kusho ukuthi amarekhodi e-elekthronikhi namasiginesha ohlelo lokuphatha lwe-LN₂ lwe-Haier Biomedical ahlangabezana namazinga okuthembeka, ubuqotho, ubumfihlo nokulandelelwa, ngaleyo ndlela kuqinisekisa ikhwalithi nokuphepha kwedatha.Lokhu kuzosheshisa ukwamukelwa kwezixazululo zesistimu yokugcina i-nitrogen ewuketshezi ezimakethe ezifana ne-US ne-Europe, ukusekela ukwanda kwamazwe ngamazwe kwe-Haier Biomedical.
Ukuthola isitifiketi se-FDA, uhlelo lwe-HB lokulawula i-nitrogen ewuketshezi seluqale uhambo olusha lokuya kwamanye amazwe.
U-TÜV SÜD, umholi womhlaba wonke ekuhlolweni nasekutholeni izitifiketi zenkampani yangaphandle, uhlale egxile ekuhlinzekeni ukwesekwa kokuhambisana nobuchwepheshe kuzo zonke izimboni, esiza amabhizinisi ukuthi ahlale ehambisana nemithetho eguqukayo.I-FDA 21 CFR ejwayelekile Ingxenye 11 ekhishwe yi-US Food and Drug Administration (FDA), inikeza amarekhodi e-electronic imiphumela yomthetho efanayo namarekhodi abhaliwe namasiginesha, iqinisekisa ukufaneleka nokuthembeka kwedatha ye-elekthronikhi.Leli zinga lisebenza ezinhlanganweni ezisebenzisa amarekhodi namasiginesha ka-elekthronikhi kuma-biopharmaceuticals, kumadivayisi ezokwelapha, nasezimbonini zokudla.
Selokhu lamenyezelwa, izinga liye lamukelwa kabanzi emhlabeni wonke, hhayi kuphela izinkampani zaseMelika ze-biopharmaceutical, izibhedlela, izikhungo zocwaningo, kanye nezindawo zokucwaninga, kodwa naseYurophu nase-Asia.Ezinkampanini ezithembele kumarekhodi namasignesha e-elekthronikhi, ukuthobelana nezidingo ze-FDA 21 CFR Ingxenye 11 kubalulekile ekwandeni okuzinzile kwamazwe ngamazwe, ukuqinisekisa ukuthotshelwa kwemithetho ye-FDA kanye namazinga ezempilo nokuphepha afanelekile.
Uhlelo lokuphathwa kwenitrogen ye-Haier Biomedical lwe-Haier Biomedical empeleni "luwubuchopho obuhlakaniphile" beziqukathi ze-nitrogen eziwuketshezi.Iguqula izinsiza zesampula zibe izinsiza zedatha, ngedatha eminingi eqashweyo, eqoshiwe, futhi egcinwe ngesikhathi sangempela, ixwayisa nganoma yikuphi okudidayo.Iphinde ibe nokulinganisa okukabili okuzimele kwezinga lokushisa namazinga oketshezi, kanye nokuphathwa kwezigaba zokusebenza kwabasebenzi.Ngaphezu kwalokho, iphinde inikeze ukuphathwa okubonakalayo kwamasampuli ukuze kufinyeleleke ngokushesha.Abasebenzisi bangashintsha phakathi kwezindlela zemanuwali, ze-gas-phase, kanye nesigaba se-liquid ngokuchofoza okukodwa, ukuthuthukisa ukusebenza kahle.Ngaphezu kwalokho, uhlelo luhlanganisa ne-IoT kanye ne-BIMS yesikhulumi solwazi lwesampula, olwenza ukuxhumana okungenamthungo phakathi kwabasebenzi, okokusebenza, namasampula.Lokhu kunikeza ulwazi lwesitoreji lwesayensi, olujwayelekile, oluphephile, futhi olusebenzayo lwe-ultra-low.
I-Haier Biomedical isungule isisombululo sokugcina i-nitrogen ewuketshezi esine-stop esisodwa esifanele zonke izigcawu namasegimenti evolumu, egxile ezidingweni ezihlukene zokuphathwa kwesampula ye-cryogenic storage.Isixazululo sihlanganisa izimo ezihlukahlukene, kuhlanganise nezokwelapha, ilabhorethri, isitoreji sezinga lokushisa eliphansi, uchungechunge lwebhayoloji, nochungechunge lwezokuthutha zebhayoloji, futhi sinikeza abasebenzisi ulwazi olugcwele lwenqubo oluhlanganisa ukuklama kobunjiniyela, ukugcinwa kwesampula, ukubuyisa isampula, ukuthutha isampula, nokuphathwa kwesampula.
Ngokuthobelana namazinga e-FDA 21 CFR Ingxenye 11, isistimu yokulawula i-nitrogen liquid ye-Haier Biomedical ye-CryoBio iqinisekiswe ukufaneleka kwamasiginesha ethu kagesi kanye nobuqotho bamarekhodi ethu kagesi.Lesi sitifiketi sokuthobela sithuthukise futhi ukuncintisana okuyinhloko kwe-Haier Biomedical emkhakheni wezixazululo ze-nitrogen eziwuketshezi, okusheshisa ukwanda komkhiqizo ezimakethe zomhlaba.
Sheshisa uguquko lwamazwe ngamazwe ukuze uhehe abasebenzisi, futhi uthuthukise ukuncintisana kwezimakethe zomhlaba
I-Haier Biomedical ibilokhu ibambelele esu lamazwe ngamazwe, ngokuqhubekayo iphromotha isistimu ekabili "inethiwekhi + yendawo".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 kwasendaweni ngokusungula amaqembu endawo namasistimu ukuze aphendule ngokushesha kuzidingo zabasebenzisi.Ekupheleni kuka-2023, i-Haier Biomedical isiphethe inethiwekhi yokusabalalisa phesheya kwezilwandle yozakwethu abangaphezu kuka-800, ihlanganyele nabahlinzeki besevisi bangemva kokuthengisa abangaphezu kuka-500.Khonamanjalo, sisungule uhlelo lwesikhungo sokuhlangenwe nakho nokuqeqeshwa, olugxile e-United Arab Emirates, e-Nigeria nase-United Kingdom, kanye nohlelo lwesikhungo sokugcinwa kwempahla nelokuhlela esise-Netherlands nase-United States.Siye sajulisa ukwenziwa kwethu kwasendaweni e-UK futhi kancane kancane salingisa le modeli emhlabeni wonke, siqinisa njalo uhlelo lwethu lwemakethe yaphesheya.
I-Haier Biomedical futhi isheshisa ukunwetshwa kwemikhiqizo emisha, okuhlanganisa amathuluzi aselabhorethri, okudlekayo, namakhemisi ahlakaniphile, okuthuthukisa ukuncintisana kwezixazululo zethu zesimo.Kubasebenzisi besayensi yezempilo, ama-centrifuges ethu enze impumelelo eYurophu naseMelika, okomisa iqhwa kwethu kuthola ama-oda okuqala e-Asia, futhi amakhabethe ethu e-biosafety angenile emakethe yasempumalanga ye-Europe.Ngaleso sikhathi, izinto ezisetshenziswayo zaselabhorethri zethu ziye zazuzwa futhi zaphindwa e-Asia, eNyakatho Melika naseYurophu.Ezikhungweni zezokwelapha, ngaphandle kwezixazululo zomgomo welanga, iziqandisi zemithi, izindawo zokugcina igazi, nezinto ezisetshenziswayo nakho kukhula ngokushesha.Ngokusebenzelana okuqhubekayo nezinhlangano zamazwe ngamazwe, i-Haier Biomedical inikeza izinsizakalo ezihlanganisa ukwakhiwa kwelabhorethri, ukuhlolwa kwemvelo kanye nokuvala inzalo, ukudala amathuba amasha okukhula.
Ekupheleni kuka-2023, amamodeli angaphezu kuka-400 e-Haier Biomedical asegunyazwe phesheya kwezilwandle, futhi alethwa ngempumelelo kumaphrojekthi ambalwa amakhulu eZimbabwe, Democratic Republic of Congo, Ethiopia, naseLiberia, kanye ne-China-Africa Union Centers of Disease Control. (CDC) iphrojekthi, ekhombisa ukuthuthukiswa kokusebenza kokulethwa.Imikhiqizo yethu nezisombululo ziye zamukelwa kabanzi emazweni nasezifundeni ezingaphezu kuka-150.Ngesikhathi esifanayo, siye salondoloza ukubambisana kwesikhathi eside nezinhlangano zamazwe ngamazwe ezingaphezu kuka-60, okuhlanganisa ne-World Health Organization (WHO) kanye ne-UNICEF.
Ukuthola isitifiketi se-FDA 21 CFR Ingxenye 11 kuyingqopha-mlando ephawulekayo ku-Haier Biomedical njengoba sigxila ekusungulweni okusha ohambweni lwethu lokunwetshwa komhlaba wonke.Kuphinde kubonise ukuzibophezela kwethu ekuhlangabezaneni nezidingo zabasebenzisi ngokusungula izinto ezintsha.Uma sibheka phambili, i-Haier Biomedical izoqhubeka nendlela yethu yokusungula egxile kubasebenzisi, ithuthukise ukuthunyelwa kwethu kwamasu omhlaba kuzo zonke izifunda, iziteshi, nezigaba zemikhiqizo.Ngokugcizelela ukusungulwa kwasekhaya, sihlose ukuhlola izimakethe zamazwe ngamazwe ngobuhlakani.
Isikhathi sokuthumela: Jul-15-2024
