Kutshanje, i-TÜV SÜD Iqela laseTshayina (emva koko libizwa ngokuba yi "TÜV SÜD") liqinisekise iirekhodi zombane kunye nezisayino zombane ze-Haier Biomedical's liquid nitrogen management system ngokuhambelana neemfuno ze-FDA 21 CFR Icandelo 11. Izisombululo zemveliso ezilishumi elinesithandathu, eziphuhliswe ngokuzimeleyo nguHaier I-Biomedical, bawongwa ngengxelo yokuthotyelwa ye-TÜV SÜD, kuquka nochungechunge lwe-Smartand Biobank.
Ukufumana isiqinisekiso se-FDA 21 CFR Icandelo le-11 lithetha ukuba iirekhodi ze-elektroniki kunye neesignesha zenkqubo yolawulo lwe-LN₂ ye-Haier Biomedical iyahlangabezana nemigangatho yokuthembeka, imfezeko, imfihlo kunye nokulandelelwa, ngaloo ndlela iqinisekisa umgangatho wedatha kunye nokhuseleko.Oku kuya kukhawulezisa ukwamkelwa kwezisombululo zenkqubo yokugcina initrogen engamanzi kwiimarike ezifana ne-US kunye neYurophu, ukuxhasa ukwandiswa kwamazwe ngamazwe kwe-Haier Biomedical.
Ukufumana isatifikethi se-FDA, inkqubo yolawulo lwenitrogen ye-HB iqalise uhambo olutsha lokuya kumazwe ngamazwe.
TÜV SÜD, inkokeli yehlabathi kuvavanyo lomntu wesithathu kunye nesatifikethi, ihlala igxile ekuboneleleni ngenkxaso yobuchwephesha yokuthotyelwa kuwo wonke amashishini, inceda amashishini ukuba ahlale ehambelana nemigaqo eguqukayo.Umgangatho we-FDA 21 CFR iSigaba se-11 esikhutshwe yi-US Food and Drug Administration (FDA), inika iirekhodi zombane iziphumo ezifanayo zomthetho njengeerekhodi ezibhaliweyo kunye nemisayino, iqinisekisa ukunyaniseka kunye nokuthembeka kwedatha ye-elektroniki.Lo mgangatho usebenza kwimibutho esebenzisa iirekhodi ze-elektroniki kunye nokutyikitya kwi-biopharmaceuticals, izixhobo zonyango, kunye namashishini okutya.
Ukusukela oko wabhengezwa, umgangatho wamkelwe ngokubanzi kwihlabathi liphela, kungekuphela nje ziinkampani zaseMelika, izibhedlele, amaziko ophando, kunye neelebhu, kodwa nayiYurophu neAsia.Kwiinkampani ezithembele kwiirekhodi zombane kunye notyikityo, ukuthobela iimfuno ze-FDA 21 CFR Icandelo le-11 liyimfuneko kulwando oluzinzileyo lwamazwe ngamazwe, ukuqinisekisa ukuthotyelwa kwemigaqo ye-FDA kunye nemigangatho efanelekileyo yezempilo nokhuseleko.
Inkqubo yolawulo lwenitrogen yeHaier Biomedical yeHaier Biomedical yeyona "ingqondo ekrelekrele" kwizikhongozeli zenitrogen ezingamanzi.Iguqula izixhobo zesampulu zibe yimithombo yedatha, kunye nedatha eninzi ebekwe iliso, irekhodwe, kwaye igcinwe ngexesha lokwenyani, ilumkisa nakuphi na ukungahambi kakuhle.Ikwabonisa imilinganiselo emibini ezimeleyo yobushushu kunye namanqanaba olwelo, kunye nolawulo lwemigangatho yemisebenzi yabasebenzi.Ukongeza, ikwabonelela ngolawulo olubonakalayo lweesampulu zokufikelela ngokukhawuleza.Abasebenzisi banokutshintsha phakathi kweendlela ze-manual, i-gas-phase, kunye nesigaba se-liquid ngokuchofoza kanye, ukuphucula ukusebenza kakuhle.Ngaphaya koko, inkqubo idibanisa ne-IoT kunye ne-BIMS iqonga lolwazi lwesampulu, eyenza unxibelelwano olungenamthungo phakathi kwabasebenzi, izixhobo kunye neesampulu.Oku kubonelela ngenzululwazi, esemgangathweni, ekhuselekileyo, kunye namava okugcina ubushushu obuphantsi kakhulu.
I-Haier Biomedical iphuhlise isisombululo sokugcina ulwelo lwe-nitrogen olubanzi olupheleleyo olufanelekileyo kuzo zonke izigcawu kunye namacandelo omthamo, ugxininise kwiimfuno ezihlukeneyo zolawulo lokugcina isampuli cryogenic.Isisombululo sibandakanya iimeko ezahlukeneyo, kubandakanywa unyango, i-laboratory, ukugcinwa kobushushu obuphantsi, uchungechunge lwebhayoloji, kunye nochungechunge lwezothutho lwebhayoloji, kwaye lubonelela abasebenzisi ngamava enkqubo epheleleyo kubandakanya uyilo lobunjineli, ukugcinwa kwesampulu, ukubuyiswa kwesampuli, ukuthuthwa kwesampulu, kunye nolawulo lwesampulu.
Ngokuthobela imigangatho ye-FDA 21 CFR Icandelo le-11, inkqubo yolawulo lwe-nitrogen ye-Haier Biomedical ye-CryoBio iye yaqinisekiswa ngokusemthethweni kweesignesha zethu ze-elektroniki kunye nokuthembeka kweerekhodi zethu ze-elektroniki.Esi satifikethi sokuthotyelwa siphucule ngakumbi ukhuphiswano olungundoqo lwe-Haier Biomedical kummandla wezisombululo zokugcina initrogen elulwelo, kukhawulezisa ukwanda kwebhrendi kwiimarike zehlabathi.
Ukukhawulezisa inguqu yamazwe ngamazwe ukutsala abasebenzisi, kunye nokuphucula ukukhuphisana kweemarike zehlabathi
I-Haier Biomedical isoloko ibambelele kwisicwangciso samazwe ngamazwe, ngokuqhubekayo ikhuthaza "inethiwekhi + yendawo yokuhlala" inkqubo emibini.Kwangaxeshanye, siyaqhubeka ukomeleza uphuhliso lweenkqubo zentengiso ukujongana nabasebenzisi, siphucula izisombululo zethu zemeko ekusebenzisaneni, ukwenza ngokwezifiso, kunye nokuhanjiswa.
Ukugxininisa ekudaleni amava angcono kakhulu omsebenzisi, i-Haier Biomedical iqinisa indawo yokuhlala ngokuseka amaqela asekuhlaleni kunye neenkqubo zokuphendula ngokukhawuleza kwiimfuno zabasebenzisi.Ekupheleni kuka-2023, i-Haier Biomedical inenethiwekhi yokusasaza phesheya yamaqabane angaphezu kwama-800, isebenzisana nababoneleli benkonzo abangaphezulu kwe-500 emva kokuthengisa.Okwangoku, siye saseka amava kunye nenkqubo yeziko loqeqesho, egxile kwi-United Arab Emirates, eNigeria nase-United Kingdom, kunye nenkqubo yeziko lokugcina impahla kunye nelothutho eliseNetherlands nase-United States.Siye sazinzisa ukusebenzelana kwethu e-UK kwaye ngokuthe ngcembe siphindaphinda le modeli kwihlabathi liphela, sisomeleza rhoqo inkqubo yethu yentengiso yaphesheya.
IHaier Biomedical ikwanyusa isantya sokwanda kweemveliso ezintsha, kubandakanywa izixhobo zaselabhoratri, izinto ezisetyenziswayo, kunye neekhemesti ezikrelekrele, ziphucula ukukhuphisana kwezisombululo zethu zemeko.Kubasebenzisi besayensi yobomi, ii-centrifuges zethu zenze impumelelo eYurophu naseMelika, izomisi zethu zomkhenkce zifumene iiodolo zokuqala e-Asiya, kwaye iikhabhathi zethu zokhuseleko lwebhayoloji zingene kwimakethi esempuma Yurophu.Ngeli xesha, izinto ezisetyenziswa kwilabhoratri yethu ziye zaphunyezwa kwaye zaphindwa e-Asia, kuMntla Melika naseYurophu.Kumaziko ezonyango, ngaphandle kwezicombululo zezitofu zelanga, iifriji zamayeza, iiyunithi zokugcina igazi, nezinto ezisetyenziswayo zikhula ngokukhawuleza.Ngonxibelelwano oluqhubekayo nemibutho yamazwe ngamazwe, i-Haier Biomedical ibonelela ngeenkonzo ezibandakanya ukwakhiwa kwelabhoratri, uvavanyo lokusingqongileyo kunye nokuvala inzala, ukudala amathuba amatsha okukhula.
Ekupheleni kuka-2023, ngaphezulu kweemodeli ezingama-400 zeHaier Biomedical ziye zaqinisekiswa phesheya, kwaye zaziswa ngempumelelo kwiiprojekthi ezininzi eZimbabwe, iDemocratic Republic of Congo, Ethiopia, naseLiberia, kunye neChina-Africa Union Centres of Disease Control. (CDC) iprojekthi, ebonisa ukuphuculwa komsebenzi wokuhanjiswa.Iimveliso zethu kunye nezisombululo ziye zamkelwa ngokubanzi kumazwe angaphezu kwama-150 kunye nemimandla.Kwangaxeshanye, siye sagcina intsebenziswano yexesha elide kunye nemibutho yamazwe ngamazwe engaphezulu kwama-60, kubandakanywa noMbutho wezeMpilo weHlabathi (i-WHO) kunye ne-UNICEF.
Ukufumana isatifikethi se-FDA 21 CFR Icandelo le-11 linyathelo elibalulekileyo kwi-Haier Biomedical njengoko sigxile ekuqaliseni izinto ezintsha kuhambo lwethu lolwando lwehlabathi.Ikwabonisa ukuzinikela kwethu ekuhlangabezaneni neemfuno zabasebenzisi ngokusungula izinto ezintsha.Ukujonga phambili, i-Haier Biomedical iya kuqhubeka nendlela yethu yokuvelisa izinto ezintsha, siqhubela phambili ukusasazwa kwesicwangciso-qhinga sehlabathi kuyo yonke imimandla, amajelo, kunye neendidi zeemveliso.Ngokugxininisa ukuveliswa kwasekhaya, sijonge ukuhlola iimarike zamazwe ngamazwe ngobukrelekrele.
Ixesha lokuposa: Jul-15-2024
