Kutshanje, i-TÜV SÜD China Group (ebizwa ngokuba yi-"TÜV SÜD") iqinisekisile iirekhodi ze-elektroniki kunye notyikityo lwe-elektroniki lwenkqubo yolawulo lwe-nitrogen engamanzi ye-Haier Biomedical ngokuhambelana neemfuno ze-FDA 21 CFR Part 11. Izisombululo zemveliso ezilishumi elinesithandathu, eziphuhliswe ngokuzimeleyo yi-Haier Biomedical, zinikwe ingxelo yokuthobela i-TÜV SÜD, kuquka uthotho lwe-Smartand Biobank.
Ukufumana isiqinisekiso se-FDA 21 CFR Icandelo 11 kuthetha ukuba iirekhodi ze-elektroniki kunye notyikityo lwenkqubo yolawulo lwe-LN₂ yeHaier Biomedical ziyahlangabezana nemigangatho yokuthembeka, ukuthembeka, ubumfihlo kunye nokulandeleka, ngaloo ndlela kuqinisekiswa umgangatho wedatha kunye nokhuseleko. Oku kuya kukhawulezisa ukwamkelwa kwezisombululo zenkqubo yokugcina i-nitrogen engamanzi kwiimarike ezifana ne-US neYurophu, kuxhasa ukwanda kwe-Haier Biomedical kwihlabathi liphela.
Ngokufumana isiqinisekiso se-FDA, inkqubo yolawulo lwe-HB ye-nitrogen engamanzi iqalise uhambo olutsha lokudibana namazwe ngamazwe
I-TÜV SÜD, inkokheli yehlabathi kuvavanyo lwesithathu kunye nesatifikethi, igxila rhoqo ekuboneleleni ngenkxaso yobuchwephesha yokuthobela imithetho kuzo zonke iifektri, inceda amashishini ukuba ahlale elandela imithetho eguqukayo. I-FDA 21 CFR Part 11 esemgangathweni ekhutshwe yi-US Food and Drug Administration (FDA), inika iirekhodi ze-elektroniki impembelelo efanayo yezomthetho njengeerekhodi ezibhaliweyo kunye nezityikityo, iqinisekisa ukufaneleka kunye nokuthembeka kwedatha ye-elektroniki. Lo mgangatho usebenza kwimibutho esebenzisa iirekhodi ze-elektroniki kunye nezityikityo kwi-biopharmaceuticals, izixhobo zonyango, kunye nemizi-mveliso yokutya.
Ukususela oko yapapashwa, lo mgangatho uye wamkelwa ngokubanzi kwihlabathi liphela, kungekuphela nje ziinkampani zaseMelika ze-biopharmaceutical, izibhedlele, amaziko ophando, kunye neelabhoratri, kodwa nakwiYurophu nase-Asia. Kwiinkampani ezixhomekeke kwiirekhodi ze-elektroniki kunye notyikityo, ukuthobela iimfuno ze-FDA 21 CFR Part 11 kubalulekile ekwandiseni okuzinzileyo kwamazwe ngamazwe, ukuqinisekisa ukuthotyelwa kwemigaqo ye-FDA kunye nemigangatho efanelekileyo yezempilo nokhuseleko.
Inkqubo yolawulo lwe-CryoBio ye-liquid nitrogen yeHaier Biomedical ngokusisiseko "yingqondo ekrelekrele" kwizikhongozeli ze-liquid nitrogen. Iguqula izixhobo zesampulu zibe zizixhobo zedatha, kunye nedatha ezininzi ezijongwayo, zirekhodwe, kwaye zigcinwe ngexesha langempela, zilumkisa naziphi na izinto ezingaqhelekanga. Ikwabonelela ngokulinganisa okuzimeleyo okuphindwe kabini kwamanqanaba obushushu kunye nolwelo, kunye nolawulo oluhambelanayo lwemisebenzi yabasebenzi. Ukongeza, ikwabonelela ngolawulo olubonakalayo lweesampulu ukuze zifikeleleke ngokukhawuleza. Abasebenzisi banokutshintsha phakathi kweendlela zesandla, zesigaba segesi, kunye nesigaba se-liquid ngokucofa kanye, nto leyo ephucula ukusebenza kakuhle. Ngaphezu koko, inkqubo idityaniswa neqonga lolwazi lweesampulu ze-IoT kunye ne-BIMS, okuvumela unxibelelwano olungenamthungo phakathi kwabasebenzi, izixhobo, kunye neesampulu. Oku kubonelela ngamava okugcina ubushushu obuphantsi kakhulu ngokwesayensi, obuqhelekileyo, obukhuselekileyo, nobusebenzayo.
I-Haier Biomedical iphuhlise isisombululo sokugcina i-nitrogen engamanzi esipheleleyo esifanelekileyo kuzo zonke izigcawu kunye namacandelo omthamo, igxile kwiimfuno ezahlukeneyo zolawulo lokugcina iisampulu ze-cryogenic. Isisombululo sigubungela iimeko ezahlukeneyo, kubandakanya ezonyango, elebhu, indawo yokugcina eshushu kakhulu, uthotho lwebhayoloji, kunye nothotho lokuthuthwa kwezinto eziphilayo, kwaye inika abasebenzisi amava apheleleyo aquka uyilo lobunjineli, ukugcina iisampulu, ukufunyanwa kwesampulu, ukuthuthwa kwesampulu, kunye nolawulo lweesampulu.
Ngokuthobela imigangatho ye-FDA 21 CFR Part 11, inkqubo yolawulo lwe-CryoBio lwe-liquid nitrogen ye-Haier Biomedical iqinisekisiwe ukuba isemthethweni isayinwe zethu ze-elektroniki kunye nokuthembeka kweerekhodi zethu ze-elektroniki. Esi siqinisekiso sokuthobela imithetho siphucule ngakumbi ukhuphiswano oluphambili lwe-Haier Biomedical kwicandelo lezisombululo zokugcina i-liquid nitrogen, oku kukhawulezisa ukwanda kophawu kwiimarike zehlabathi.
Ukukhawulezisa utshintsho lwamazwe ngamazwe ukutsala abasebenzisi, kunye nokuphucula ukukhuphisana kweemarike zehlabathi
I-Haier Biomedical ibisoloko ibambelele kwisicwangciso samazwe ngamazwe, ikhuthaza ngokuqhubekayo inkqubo "yenethiwekhi + yendawo". Kwangaxeshanye, siyaqhubeka nokuqinisa uphuhliso lweenkqubo zemarike ukuze zijongane nabasebenzisi, siphucula izisombululo zethu zeemeko ekusebenzisaneni, ukwenza ngokwezifiso, kunye nokuhambisa.
Igxile ekudaleni amava angcono omsebenzisi, iHaier Biomedical yomeleza ukwenziwa kwendawo ngokuseka amaqela asekuhlaleni kunye neenkqubo ukuze ziphendule ngokukhawuleza kwiimfuno zomsebenzisi. Ekupheleni kuka-2023, iHaier Biomedical ibinenethiwekhi yokusasaza kwamanye amazwe enamaqabane angaphezu kwama-800, isebenzisana nababoneleli beenkonzo zokuthengisa abangaphezu kwama-500. Okwangoku, simisele inkqubo yamava kunye neziko loqeqesho, egxile kwi-United Arab Emirates, eNigeria nase-United Kingdom, kunye nenkqubo yeziko lokugcina impahla kunye nelogistics eNetherlands nase-United States. Siye sazinzisa ukwenziwa kwendawo yethu e-UK kwaye siphinda kancinci le modeli kwihlabathi liphela, siqinisa rhoqo inkqubo yethu yemarike yaphesheya.
IHaier Biomedical ikwakhawulezisa ukwandiswa kweemveliso ezintsha, kuquka izixhobo zelebhu, izinto ezisetyenziswayo, kunye neekhemesti ezikrelekrele, iphucula ukhuphiswano lwezisombululo zethu zeemeko. Kubasebenzisi besayensi yobomi, ii-centrifuge zethu zenze inkqubela phambili eYurophu naseMelika, ii-freezer dryers zethu zifumene ii-odolo zokuqala e-Asia, kwaye iikhabhathi zethu zokhuseleko lwebhayoloji zingene kwimarike yasempuma Yurophu. Okwangoku, izinto zethu ezisetyenziswayo zelebhu zifezekisiwe kwaye zaphindaphindwa e-Asia, eMntla Melika, naseYurophu. Kumaziko ezonyango, ngaphandle kwezisombululo zokugonya ngelanga, iifriji zamayeza, iiyunithi zokugcina igazi, kunye nezinto ezisetyenziswayo nazo zikhula ngokukhawuleza. Ngokusebenzisana rhoqo nemibutho yamazwe ngamazwe, iHaier Biomedical ibonelela ngeenkonzo kubandakanya ukwakhiwa kwelebhu, uvavanyo lokusingqongileyo kunye nokubulala iintsholongwane, ukudala amathuba amatsha okukhula.
Ekupheleni kuka-2023, iimodeli ezingaphezu kwama-400 zeHaier Biomedical sele ziqinisekisiwe phesheya, kwaye zihanjiswe ngempumelelo kwiiprojekthi ezininzi ezinkulu eZimbabwe, kwiDemocratic Republic of Congo, e-Ethiopia, naseLiberia, kunye neprojekthi ye-China-Africa Union Centers of Disease Control (CDC), ebonisa ukuphuculwa kokusebenza kokuhanjiswa. Iimveliso zethu kunye nezisombululo zethu zamkelwe ngokubanzi kumazwe nakwimimandla engaphezu kwe-150. Kwangaxeshanye, sigcine intsebenziswano yexesha elide nemibutho yamazwe ngamazwe engaphezu kwama-60, kuquka iWorld Health Organisation (WHO) kunye ne-UNICEF.
Ukufumana isatifikethi se-FDA 21 CFR Part 11 sisiganeko esibalulekileyo kwiHaier Biomedical njengoko sigxila ekuveliseni izinto ezintsha kuhambo lwethu lokwanda kwehlabathi. Kwakhona kubonisa ukuzinikela kwethu ekuhlangabezaneni neemfuno zabasebenzisi ngokusebenzisa izinto ezintsha. Ukujonga phambili, iHaier Biomedical iza kuqhubeka nendlela yethu yokuvelisa izinto ezintsha egxile kubasebenzisi, iqhubela phambili ukusasazwa kwethu kweqhinga lehlabathi kwiindawo ezahlukeneyo, kwiindlela, nakwiindidi zeemveliso. Ngokugxininisa ekuveliseni izinto ezintsha zasekuhlaleni, sijolise ekuhloleni iimarike zamazwe ngamazwe ngokusebenzisa ulwazi.
Ixesha leposi: Julayi-15-2024
