Vuba aha, TÜV SÜD Itsinda ryUbushinwa (nyuma yiswe "TÜV SÜD") ryemeje inyandiko za elegitoronike n’umukono wa elegitoronike wa sisitemu yo gucunga azote ya Haier Biomedical ikurikije ibisabwa na FDA 21 CFR Igice cya 11. Ibisubizo 16 byibicuruzwa, byakozwe na Haier byigenga. Biomedical, bahawe raporo ya TÜV SÜD yubahiriza, harimo na Smartand Biobank.
Kubona FDA 21 CFR Igice cya 11 Icyemezo bivuze ko inyandiko za elegitoronike n'umukono wa sisitemu yo gucunga LN₂ ya Haier Biomedical yujuje ubuziranenge, ubunyangamugayo, ibanga no gukurikiranwa, bityo bigatuma amakuru meza n'umutekano.Ibi bizihutisha iyemezwa rya sisitemu yo kubika azote yuzuye mu masoko nka Amerika n'Uburayi, ishyigikira kwaguka mpuzamahanga kwa Haier Biomedical.
Kubona ibyemezo bya FDA, sisitemu yo gucunga azote ya HB yatangiye urugendo rushya rwo kumenyekanisha mpuzamahanga
TÜV SÜD, umuyobozi wisi yose mugupima no gutanga ibyemezo byabandi, ahora yibanda mugutanga inkunga yubahirizwa ryumwuga mu nganda, ifasha ibigo gukomeza kubahiriza amabwiriza agenda ahinduka.Igipimo gisanzwe FDA 21 CFR Igice cya 11 cyatanzwe n’ikigo cy’Amerika gishinzwe ibiryo n’ibiyobyabwenge (FDA), gitanga inyandiko za elegitoronike kimwe n’amategeko yemewe n’inyandiko zashyizweho umukono, byemeza ko amakuru ya elegitoroniki afite ishingiro kandi yizewe.Ibipimo ngenderwaho bikurikizwa mumashyirahamwe akoresha inyandiko za elegitoronike n'umukono muri biofarmaceuticals, ibikoresho byubuvuzi, ninganda zibiribwa.
Kuva yatangazwa, amahame yemejwe ku isi hose, atari amasosiyete y’ibinyabuzima yo muri Amerika gusa, ibitaro, ibigo by’ubushakashatsi, na laboratoire, ariko no mu Burayi na Aziya.Ku masosiyete yishingikiriza ku nyandiko za elegitoroniki n'umukono, kubahiriza ibisabwa na FDA 21 CFR Igice cya 11 ni ngombwa mu kwaguka mpuzamahanga mu buryo bunoze, byemeza kubahiriza amabwiriza ya FDA hamwe n’ubuziranenge bw’ubuzima n’umutekano.
Haryo Biomedical's CryoBio sisitemu yo gucunga azote ni "ubwonko bwubwenge" kubintu bya azote yuzuye.Ihindura ibyitegererezo mubikoresho byamakuru, hamwe namakuru menshi akurikiranwa, akandikwa, kandi akabikwa mugihe nyacyo, akamenyesha ibintu byose bidasanzwe.Iragaragaza kandi ibipimo byigenga bipima ubushyuhe nubushyuhe bwamazi, hamwe nubuyobozi bukurikirana ibikorwa byabakozi.Mubyongeyeho, itanga kandi imiyoborere igaragara yicyitegererezo kugirango igerweho vuba.Abakoresha barashobora guhinduranya hagati yintoki, gazi-fase, nuburyo bwamazi-feri hamwe gukanda rimwe, kuzamura imikorere.Byongeye kandi, sisitemu ihuza na IoT na BIMS icyitegererezo cyamakuru yamakuru, igafasha guhuza abakozi, ibikoresho, hamwe nicyitegererezo.Ibi bitanga ubumenyi, busanzwe, umutekano, kandi bunoze bwo kubika ubushyuhe bukabije.
Haier Biomedical yateje imbere uburyo bumwe bwo kubika amazi ya azote ikwiranye nuburyo bwose hamwe nibice byijwi, yibanda kubisabwa bitandukanye byo gucunga neza ububiko bwa cryogenic.Igisubizo gikubiyemo ibintu bitandukanye, birimo ubuvuzi, laboratoire, kubika ubushyuhe buke, urukurikirane rw'ibinyabuzima, hamwe no gutwara ibinyabuzima, kandi bigaha abayikoresha uburambe bwuzuye burimo igishushanyo mbonera, ububiko bw'icyitegererezo, kugarura icyitegererezo, ubwikorezi bw'icyitegererezo, hamwe no gucunga icyitegererezo.
Mugukurikiza ibipimo bya FDA 21 CFR Igice cya 11, Sisitemu yo gucunga azote ya CryoBio ya Haier Biomedical yemejwe ko umukono wa elegitoroniki ufite agaciro hamwe nubunyangamugayo bwibikoresho bya elegitoroniki.Iki cyemezo cyo kubahiriza cyarushijeho kongera ingufu za Haier Biomedical mu guhatanira amasoko mu bijyanye no kubika amazi ya azote, byihutisha kwamamara ku masoko y’isi.
Kwihutisha impinduka mpuzamahanga gukurura abakoresha, no kuzamura ubushobozi bwamasoko yisi
Haier Biomedical yamye yubahiriza ingamba mpuzamahanga, ikomeza guteza imbere "umuyoboro + waho" sisitemu ebyiri.Mugihe kimwe, dukomeje gushimangira iterambere rya sisitemu yisoko kugirango duhure nabakoresha, tunoza ibisubizo byacu muburyo bwo gukorana, kugena ibintu, no gutanga.
Kwibanda mugukora ubunararibonye bwabakoresha, Haier Biomedical ishimangira aho ushyiraho amatsinda na sisitemu yo gusubiza vuba ibyo abakoresha bakeneye.Mu mpera za 2023, Haier Biomedical ifite umuyoboro wo gukwirakwiza mu mahanga w’abafatanyabikorwa barenga 800, ukorana n’abatanga serivisi zirenga 500 nyuma yo kugurisha.Hagati aho, twashyizeho uburyo bwo guhugura no guhugura ikigo, gishingiye kuri Leta zunze ubumwe z'Abarabu, Nijeriya n'Ubwongereza, hamwe na sisitemu yo kubika no gutanga ibikoresho iherereye mu Buholandi no muri Amerika.Twakomeje kwimakaza aho mu Bwongereza kandi twigana buhoro buhoro iyi moderi ku isi, duhora dushimangira gahunda y’isoko ryo hanze.
Haier Biomedical nayo yihutisha kwagura ibicuruzwa bishya ， harimo ibikoresho bya laboratoire, ibikoreshwa, na farumasi zifite ubwenge, byongera ubushobozi bwo guhangana n’ibisubizo byacu.Kubakoresha siyanse yubuzima, centrifuges yacu imaze gutera intambwe muburayi no muri Amerika, ibyuma byumye byabonye ibicuruzwa byambere muri Aziya, kandi akabati kacu ka biosafeti kinjiye mumasoko yuburayi bwiburasirazuba.Hagati aho, ibyo dukoresha muri laboratoire byagezweho kandi byigana muri Aziya, Amerika y'Amajyaruguru, n'Uburayi.Ku bigo nderabuzima, usibye ibisubizo by'inkingo zikomoka ku zuba, firigo zikoreshwa mu bya farumasi, ibikoresho bibika amaraso, n’ibikoreshwa nabyo biratera imbere byihuse.Binyuze mu mikoranire ikomeje n’imiryango mpuzamahanga, Haier Biomedical itanga serivisi zirimo kubaka laboratoire, gupima ibidukikije no kuboneza urubyaro, bigatanga amahirwe mashya yo gukura.
Mu mpera z'umwaka wa 2023, imideli irenga 400 ya Haier Biomedical yahawe impamyabumenyi mu mahanga, kandi igezwa ku mishinga myinshi ikomeye muri Zimbabwe, Repubulika Iharanira Demokarasi ya Kongo, Etiyopiya, na Liberiya, ndetse n'Ikigo cy’Ubumwe n'Ubushinwa gishinzwe kurwanya indwara. (CDC) umushinga, werekana kunoza imikorere yo gutanga.Ibicuruzwa byacu nibisubizo byemewe cyane mubihugu n'uturere birenga 150.Muri icyo gihe, twakomeje ubufatanye burambye n’imiryango mpuzamahanga 60 - harimo n’umuryango w’ubuzima ku isi (OMS) na UNICEF.
Kubona FDA 21 CFR Igice cya 11 Icyemezo ni intambwe ikomeye kuri Haier Biomedical mugihe twibanze ku guhanga udushya murugendo rwacu rwo kwaguka kwisi.Irerekana kandi ko twiyemeje guhaza ibyo abakoresha bakeneye binyuze mu guhanga udushya.Urebye imbere, Haier Biomedical izakomeza uburyo bushya bwo guhanga udushya, dutezimbere gahunda yacu yisi yose mukarere, imiyoboro, nibyiciro byibicuruzwa.Mugushimangira udushya twaho, tugamije gushakisha amasoko mpuzamahanga dukoresheje ubwenge.
Igihe cyo kohereza: Nyakanga-15-2024
