Munguva pfupi yapfuura, TÜV SÜD China Group (inozivikanwa pano se "TÜV SÜD") yakasimbisa zvinyorwa zvemagetsi uye masiginecha emagetsi eHaier Biomedical's liquid nitrogen management system zvichienderana nezvinodiwa neFDA 21 CFR Chikamu 11. Zvigadzirwa gumi nematanhatu, zvakagadzirwa zvakazvimiririra neHaier Biomedical, zvakapihwa mushumo wekutevedzera TÜV SÜD, kusanganisira Smartand Biobank series.
Kuwana chitupa cheFDA 21 CFR Chikamu 11 zvinoreva kuti zvinyorwa zvemagetsi nemasaini ehurongwa hwekutarisira hweLN₂ hweHaier Biomedical zvinosangana nezvinodiwa zvekuvimbika, kuvimbika, kuvanzika uye kuteverwa, nokudaro zvichivimbisa kunaka kwedata uye kuchengetedzeka. Izvi zvichakurumidzisa kugamuchirwa kwemhinduro dzekuchengetedza nitrogen yemvura mumisika yakaita seUS neEurope, zvichitsigira kuwedzera kweHaier Biomedical pasi rose.
Nekuwana chitupa cheFDA, sisitimu yeHB yekutarisira nitrogen yemvura yakatanga rwendo rutsva rwekudyidzana nedzimwe nyika
TÜV SÜD, mutungamiri wepasi rose mukuyedza nekupa zvitupa kune vechitatu, inogara ichitarisa pakupa rutsigiro rwehunyanzvi mukutevedzera mitemo mumaindasitiri ese, ichibatsira mabhizinesi kuti arambe achiziva mitemo iri kuchinja. Standard FDA 21 CFR Part 11 yakaburitswa neUS Food and Drug Administration (FDA), inopa zvinyorwa zvemagetsi simba rakafanana repamutemo sezvinyorwa zvakanyorwa nemasaini, ichivimbisa kushanda uye kuvimbika kwedata remagetsi. Standard iyi inoshanda kumasangano anoshandisa zvinyorwa zvemagetsi nemasaini mumishonga yemishonga, zvishandiso zvekurapa, uye maindasitiri ezvekudya.
Kubva pakatanga kushandiswa, mwero uyu wave uchishandiswa zvakanyanya pasi rose, kwete chete nemakambani ekuAmerica emishonga yekurapa, zvipatara, masangano ekutsvagisa, uye marabhoritari, asiwo neEurope neAsia. Kune makambani anovimba nezvinyorwa zvemagetsi nemasaini, kutevedzera zvinodiwa neFDA 21 CFR Chikamu 11 kwakakosha kuti pave nekuwedzera kwakasimba kwenyika dzese, kuve nechokwadi chekutevedzera mitemo yeFDA uye mitemo yehutano nekuchengetedzeka yakakodzera.
Sisitimu yekutarisira nitrogen yemvura yeHaier Biomedical inonzi CryoBio inonyanya kushandiswa nepfungwa dzakangwara dzemidziyo yenitrogen yemvura. Inoshandura zviwanikwa zvesample kuita zviwanikwa zvedata, nedata rakawanda richitariswa, richirekodhwa, uye richichengetwa munguva chaiyo, zvichizivisa chero zvisina kunaka. Inewo nzira mbiri dzekuenzanisa tembiricha nemazinga emvura, pamwe nekutonga kwemabasa evashandi. Pamusoro pezvo, inopawo manejimendi yekuona yemasample kuti asvike nekukurumidza. Vashandisi vanogona kuchinja pakati pemamodhi emaoko, egasi, uye echikamu chemvura nekudzvanya kamwe chete, zvichivandudza kushanda zvakanaka. Uyezve, sisitimu iyi inobatanidzwa nepuratifomu yeruzivo rwesample yeIoT neBIMS, zvichigonesa kubatana pakati pevashandi, michina, uye masampuli. Izvi zvinopa ruzivo rwesainzi, rwakajairika, rwakachengeteka, uye runoshanda rwekuchengetedza tembiricha yakaderera zvakanyanya.
Haier Biomedical yakagadzira mhinduro yakakwana yekuchengetera nitrogen yemvura yakakodzera zvikamu zvese zvezviitiko uye huwandu, ichitarisa pane zvinodiwa zvakasiyana-siyana zvekutarisira kuchengetwa kwesample cryogenic. Mhinduro iyi inosanganisira zviitiko zvakasiyana-siyana, zvinosanganisira zvekurapa, zverabhoritari, zvekuchengetera tembiricha yakaderera, zvebiological series, uye zvebiological transportation series, uye inopa vashandisi ruzivo rwakazara rwunosanganisira dhizaini yeinjiniya, kuchengetedza sampuro, kutora sampuro, kutakurwa kwesampuro, uye kutarisira sampuro.
Nekutevedzera mitemo yeFDA 21 CFR Chikamu 11, sisitimu yeHaier Biomedical yeCryoBio liquid nitrogen management system yakapihwa chitupa chekuti masaini edu emagetsi anoshanda uye kuti zvinyorwa zvedu zvemagetsi ndezvechokwadi. Chitupa ichi chekutevedzera mitemo chakawedzera kukwikwidzana kweHaier Biomedical mumunda wekugadzirisa nitrogen yemvura, zvichikurumidzisa kukura kwechiratidzo ichi mumisika yepasi rose.
Kurumidza kushandura nyika kuti ukoshe vashandisi, uye kuvandudza kukwikwidzana kwemisika yepasi rose
Haier Biomedical yagara ichitevedzera hurongwa hwepasi rose, ichiramba ichikurudzira sisitimu ye "network + localization". Panguva imwe chete, tinoramba tichisimbisa kuvandudzwa kwemasisitimu emusika anotarisana nevashandisi, tichivandudza mhinduro dzedu dzemamiriro ezvinhu mukudyidzana, kugadzirisa, uye kupa.
Ichinyanya kutarisa pakugadzira ruzivo rwakanakisisa rwemushandisi, Haier Biomedical inosimbisa kugona kwedu kwenzvimbo nekugadza mapoka emunharaunda nemasisitimu kuti akurumidze kupindura zvinodiwa nevashandisi. Pakupera kwa2023, Haier Biomedical yave ne network yekugovera kunze kwenyika ine vanobatana vanopfuura 800, yakabatana nevanopfuura 500 vanopa masevhisi ekutengesa mushure mekutengesa. Panguva iyi, takagadzira sisitimu yeruzivo nenzvimbo yekudzidzira, yakatarisana neUnited Arab Emirates, Nigeria neUnited Kingdom, uye sisitimu yekuchengetedza nekuchengetedza zvinhu iri muNetherlands neUnited States. Takawedzera kugona kwedu kwenzvimbo muUK uye tichidzokorora zvishoma nezvishoma modhi iyi pasi rose, tichigara tichisimbisa sisitimu yedu yemusika wekunze kwenyika.
Haier Biomedical iri kuwedzerawo kukura kwezvigadzirwa zvitsva, kusanganisira zvishandiso zvemarabhoritari, zvinodyiwa, uye ma pharmacy akangwara, zvichiwedzera kukwikwidzana kwemhinduro dzedu dzemamiriro ezvinhu. Kune vashandisi vesainzi yehupenyu, ma centrifuge edu abudirira muEurope neAmerica, ma freezer dryers edu awana maodha ekutanga muAsia, uye makabati edu ekuchengetedza biosafety apinda mumusika wekumabvazuva kweEurope. Panguva iyi, ma laboratory edu anoshandiswa uye akadzokororwa muAsia, North America, neEurope. Kune masangano ekurapa, kunze kwemhinduro dzekudzivirira zuva, mafiriji emishonga, mayuniti ekuchengetera ropa, uye zvinodyiwa zviri kukurawo nekukurumidza. Kuburikidza nekudyidzana nguva dzose nemasangano epasi rose, Haier Biomedical inopa masevhisi anosanganisira kuvaka marabhoritari, kuongororwa kwezvakatipoteredza uye kuuraya utachiona, zvichigadzira mikana mitsva yekukura.
Pakupera kwegore ra2023, mhando dzinopfuura mazana mana dzeHaier Biomedical dzave nemagwaro ekupa zvitupa kunze kwenyika, uye dzakabudirira kumabasa makuru akati wandei muZimbabwe, Democratic Republic of Congo, Ethiopia, neLiberia, pamwe nechirongwa cheChina-Africa Union Centers of Disease Control (CDC), zvichiratidza kuvandudzwa kwekushanda kwemishonga. Zvigadzirwa zvedu nemhinduro zvave zvichishandiswa zvakanyanya munyika dzinopfuura zana nemakumi mashanu nenzvimbo. Panguva imwe chete, takaramba tichishanda pamwe chete kwenguva refu nemasangano epasi rose anopfuura makumi matanhatu, kusanganisira World Health Organization (WHO) neUNICEF.
Kuwana chitupa cheFDA 21 CFR Chikamu 11 chiitiko chakakosha kuHaier Biomedical sezvatinotarisa pakugadzira zvinhu zvitsva murwendo rwedu rwekukura kwepasi rose. Izvi zvinoratidzawo kuzvipira kwedu kusangana nezvinodiwa nevashandisi kuburikidza nekugadzira zvinhu zvitsva. Tichitarisa mberi, Haier Biomedical icharamba ichiita kuti zvinhu zvitsva zvionekwe nevashandisi, ichisimudzira kushandiswa kwedu kwehurongwa hwepasi rose munzvimbo dzakasiyana-siyana, nzira, uye zvigadzirwa. Nekusimbisa hunyanzvi hwemuno, chinangwa chedu ndechekuongorora misika yepasi rose kuburikidza nehunyanzvi.
Nguva yekutumira: Chikunguru-15-2024
