Kwanan nan, TÜV SÜD China Group (wanda ake kira "TÜV SÜD") ya ba da takaddun bayanan lantarki da sa hannun lantarki na tsarin sarrafa nitrogen na ruwa na Haier Biomedical daidai da buƙatun FDA 21 CFR Sashe na 11. Maganin samfuri goma sha shida, wanda Haier ya haɓaka da kansa. Biomedical, an ba su rahoton yarda da TÜV SÜD, gami da jerin Smartand Biobank.
Samun takaddun shaida na FDA 21 CFR Sashe na 11 yana nufin cewa bayanan lantarki da sa hannu na tsarin gudanarwa na LN₂ na Haier Biomedical sun cika ka'idojin aminci, mutunci, sirri da ganowa, ta haka ne ke tabbatar da ingancin bayanai da tsaro.Wannan zai hanzarta ɗaukar tsarin tsarin ajiyar ruwa na nitrogen a cikin kasuwanni kamar Amurka da Turai, yana tallafawa haɓaka haɓakar Haier Biomedical na duniya.
Samun takaddun shaida na FDA, tsarin sarrafa ruwa na HB na nitrogen ya fara sabuwar tafiya ta duniya
TÜV SÜD, jagora na duniya a gwaji da takaddun shaida na ɓangare na uku, koyaushe yana mai da hankali kan ba da tallafin ƙwararrun ƙwararrun masana'antu, yana taimaka wa kamfanoni su kasance masu dacewa da ƙa'idodi masu tasowa.Daidaitaccen FDA 21 CFR Sashe na 11 wanda Hukumar Abinci da Magunguna ta Amurka (FDA) ta bayar, tana ba da bayanan lantarki iri ɗaya tasirin doka kamar rubuce-rubuce da sa hannu, yana tabbatar da inganci da amincin bayanan lantarki.Wannan ma'auni yana aiki ga ƙungiyoyi waɗanda ke amfani da bayanan lantarki da sa hannu a cikin kayan aikin biopharmaceutical, na'urorin likitanci, da masana'antar abinci.
Tun lokacin da aka fitar da shi, mizanin ya sami karbuwa sosai a duk duniya, ba kawai ta kamfanonin Amurkan biopharmaceutical, asibitoci, cibiyoyin bincike, da dakunan gwaje-gwaje ba, har ma ta Turai da Asiya.Ga kamfanonin da suka dogara da bayanan lantarki da sa hannu, bin ka'idodin FDA 21 CFR Sashe na 11 buƙatun yana da mahimmanci don haɓakar faɗaɗawar ƙasa da ƙasa, tabbatar da bin ƙa'idodin FDA da ƙa'idodin lafiya da aminci.
Haier Biomedical's CryoBio tsarin sarrafa nitrogen ruwa shine ainihin "kwakwalwa mai hankali" don kwantena nitrogen ruwa.Yana canza albarkatun samfuri zuwa albarkatun bayanai, tare da kulawa da yawa, yin rikodi, da adana su a cikin ainihin lokaci, faɗakarwa ga duk wani rashin daidaituwa.Hakanan yana fasalta ma'aunin ma'auni biyu masu zaman kansu na zazzabi da matakan ruwa, da kuma tsarin sarrafa ayyukan ma'aikata.Bugu da kari, yana kuma bayar da kulawar gani na samfuran samfuri don shiga cikin sauri.Masu amfani za su iya canzawa tsakanin manual, gas-phase, da yanayin ruwa-lokaci tare da dannawa ɗaya, inganta inganci.Bugu da ƙari kuma, tsarin yana haɗawa tare da dandamali na samfurin IoT da BIMS, yana ba da damar haɗin kai tsakanin ma'aikata, kayan aiki, da samfurori.Wannan yana ba da ingantaccen ilimin kimiyya, daidaitaccen, aminci, da ingantaccen ƙwarewar ajiya mai ƙarancin zafi.
Haier Biomedical ya ɓullo da wani m daya-tsaya ruwa nitrogen ajiya bayani dace da duk al'amuran da girma segments, mayar da hankali a kan bambancin bukatun na samfurin cryogenic ajiya management.Maganinta ya ƙunshi yanayi daban-daban, ciki har da likita, dakin gwaje-gwaje, ajiyar ƙananan zafin jiki, jerin kwayoyin halitta, da jerin jigilar kwayoyin halitta, kuma yana ba masu amfani da cikakkiyar kwarewa ciki har da zane-zane na injiniya, ajiyar samfurin, samfurin samfurin, sufurin samfurin, da kuma sarrafa samfurin.
Ta hanyar bin ka'idodin FDA 21 CFR Sashe na 11, Haier Biomedical's CryoBio tsarin sarrafa ruwa nitrogen an ba da izini don ingancin sa hannun mu na lantarki da amincin bayanan mu na lantarki.Wannan takardar shedar yarda ta ƙara haɓaka ainihin gasa na Haier Biomedical a fagen samar da hanyoyin adana ruwa na nitrogen, yana haɓaka haɓakar alamar a kasuwannin duniya.
Haɓaka sauyi na ƙasa da ƙasa don jawo hankalin masu amfani, da haɓaka gasa na kasuwannin duniya
Haier Biomedical ya kasance koyaushe yana bin dabarun ƙasa da ƙasa, yana ci gaba da haɓaka tsarin “cibiyar sadarwa + yanki” biyu.A lokaci guda, muna ci gaba da ƙarfafa ci gaban tsarin kasuwa don fuskantar masu amfani, haɓaka hanyoyin magance mu a cikin hulɗa, gyare-gyare, da bayarwa.
Mayar da hankali kan ƙirƙirar mafi kyawun ƙwarewar mai amfani, Haier Biomedical yana ƙarfafa haɓakawa ta hanyar kafa ƙungiyoyin gida da tsarin don amsa buƙatun mai amfani da sauri.Ya zuwa ƙarshen 2023, Haier Biomedical ya mallaki hanyar sadarwar rarraba ta ketare sama da abokan haɗin gwiwa 800, tare da haɗin gwiwar sama da masu ba da sabis na bayan-tallace 500.A halin yanzu, mun kafa tsarin kwarewa da cibiyar horarwa, wanda ya shafi Hadaddiyar Daular Larabawa, Najeriya da Ingila, da tsarin cibiyar adana kayayyaki da kayan aiki da ke cikin Netherlands da Amurka.Mun zurfafa wurin zama a cikin Burtaniya kuma a hankali muna yin wannan samfurin a duniya, muna ƙarfafa tsarin kasuwancin mu na ketare koyaushe.
Haier Biomedical kuma yana haɓaka haɓaka sabbin samfura, gami da kayan aikin dakin gwaje-gwaje, kayan masarufi, da kantin magani masu wayo, yana haɓaka gasa na mafita na yanayin mu.Ga masu amfani da ilimin kimiyyar rayuwa, centrifuges ɗinmu sun sami ci gaba a Turai da Amurka, masu bushewar mu sun sami umarni na farko a Asiya, kuma kabad ɗin mu na biosafety sun shiga kasuwar gabashin Turai.A halin yanzu, an cimma abubuwan da muke amfani da su na dakin gwaje-gwaje kuma an sake yin su a Asiya, Arewacin Amurka, da Turai.Ga cibiyoyin kiwon lafiya, baya ga maganin rigakafin hasken rana, firji na magunguna, rukunin ajiyar jini, da kayan masarufi kuma suna haɓaka cikin sauri.Ta hanyar ci gaba da hulɗa tare da ƙungiyoyin ƙasa da ƙasa, Haier Biomedical yana ba da sabis waɗanda suka haɗa da ginin dakin gwaje-gwaje, gwajin muhalli da haifuwa, ƙirƙirar sabbin damar haɓaka.
Ya zuwa karshen shekarar 2023, sama da nau'ikan Haier Biomedical sama da 400 ne aka ba da takardar shedar zuwa kasashen waje, kuma an samu nasarar isar da su ga manyan ayyuka da dama a Zimbabwe, da Jamhuriyar Dimokaradiyyar Kwango, da Habasha, da Laberiya, da kuma Cibiyar Yaki da Cututtuka ta Sin da Afirka. (CDC) aikin, yana nuna haɓaka aikin bayarwa.An karɓe samfuranmu da mafita a cikin ƙasashe da yankuna sama da 150.A sa'i daya kuma, mun kiyaye hadin gwiwa na dogon lokaci tare da kungiyoyin kasa da kasa sama da 60, ciki har da Hukumar Lafiya ta Duniya (WHO) da UNICEF.
Samun FDA 21 CFR Sashe na 11 takaddun shaida muhimmin ci gaba ne ga Haier Biomedical yayin da muke mai da hankali kan ƙirƙira a cikin tafiyarmu ta faɗaɗa duniya.Hakanan yana nuna sadaukarwar mu don biyan buƙatun mai amfani ta hanyar ƙirƙira.Ana sa ran gaba, Haier Biomedical zai ci gaba da tsarin sabuntar mai amfani da mu, yana haɓaka dabarun tura dabarun mu na duniya a cikin yankuna, tashoshi, da nau'ikan samfura.Ta hanyar jaddada ƙirƙira na gida, muna nufin bincika kasuwannin duniya ta hanyar hankali.
Lokacin aikawa: Yuli-15-2024
