N'oge na-adịbeghị anya, TÜV SÜD China Group (nke a na-akpọ "TÜV SÜD") kwadoro ndekọ eletrọniki na mbinye aka eletrọniki nke sistemụ njikwa nitrogen mmiri nke Haier Biomedical dịka iwu FDA 21 CFR Nkebi nke 11 siri dị. Ngwọta ngwaahịa iri na isii, nke Haier Biomedical mepụtara n'onwe ya, natara akụkọ nnabata TÜV SÜD, gụnyere usoro Smartand Biobank.
Inweta asambodo FDA 21 CFR Nkebi nke 11 pụtara na ndekọ eletrọniki na mbinye aka nke sistemụ njikwa LN₂ nke Haier Biomedical na-emezu ụkpụrụ nke ntụkwasị obi, iguzosi ike n'ezi ihe, nzuzo na nchụso, si otú a na-ahụ na data dị mma na nchekwa. Nke a ga-eme ka nnabata nke ngwọta sistemụ nchekwa nitrogen mmiri dị ngwa ngwa n'ahịa dịka US na Europe, na-akwado mgbasawanye mba ụwa nke Haier Biomedical.
Site n'inweta asambodo FDA, sistemụ njikwa nitrogen mmiri nke HB amalitela njem ọhụrụ nke mba ụwa.
TÜV SÜD, onye ndu zuru ụwa ọnụ n'ule na asambodo nke ndị ọzọ, na-elekwasị anya mgbe niile n'inye nkwado nrubeisi ọkachamara n'ofe ụlọ ọrụ, na-enyere ụlọ ọrụ aka ịnọgide na-agbaso iwu ndị na-agbanwe agbanwe. Ụkpụrụ FDA 21 CFR Nkebi nke 11 nke US Food and Drug Administration (FDA) nyere, na-enye ndekọ eletrọniki otu mmetụta iwu dị ka ndekọ ederede na mbinye aka, na-ahụ na data eletrọniki ziri ezi na ntụkwasị obi. Ụkpụrụ a metụtara òtù ndị na-eji ndekọ eletrọniki na mbinye aka na biopharmaceuticals, ngwaọrụ ahụike, na ụlọ ọrụ nri.
Kemgbe e weputara ya, a nabatala ọkọlọtọ a n'ụwa niile, ọ bụghị naanị site n'aka ụlọ ọrụ ọgwụ biopharmaceutical nke America, ụlọ ọgwụ, ụlọ ọrụ nyocha, na ụlọ nyocha, kamakwa site na Europe na Eshia. Maka ụlọ ọrụ ndị na-adabere na ndekọ eletrọnịkị na mbinye aka, irube isi na ihe achọrọ nke FDA 21 CFR Part 11 dị mkpa maka mgbasawanye mba ụwa kwụsiri ike, na-ahụ na nrubeisi na iwu FDA na ụkpụrụ ahụike na nchekwa dị mkpa.
Sistemụ njikwa nitrogen mmiri CryoBio nke Haier Biomedical bụ "ụbụrụ nwere ọgụgụ isi" maka akpa nitrogen mmiri. Ọ na-agbanwe akụrụngwa ihe atụ ka ọ bụrụ akụrụngwa data, yana ọtụtụ data a na-enyocha, dekọọ, ma chekwaa n'oge, na-adọ aka ná ntị maka ihe ọ bụla na-adịghị mma. Ọ na-egosipụtakwa nha abụọ nke okpomọkụ na ọkwa mmiri mmiri n'onwe ya, yana njikwa nhazi nke ọrụ ndị ọrụ. Na mgbakwunye, ọ na-enyekwa njikwa anya nke ihe nlele maka ịnweta ngwa ngwa. Ndị ọrụ nwere ike ịgbanwe n'etiti ụdị aka, usoro gas, na usoro mmiri mmiri na otu pịa, na-eme ka arụmọrụ ka mma. Ọzọkwa, sistemụ ahụ na-ejikọta na ikpo okwu ozi ihe atụ IoT na BIMS, na-eme ka njikọ dị n'etiti ndị ọrụ, akụrụngwa, na ihe nlele dị mfe. Nke a na-enye ahụmịhe nchekwa okpomọkụ dị ala nke sayensị, nke a haziri ahazi, nke dị nchebe, na nke dị irè.
Haier Biomedical emepụtala ngwọta nchekwa nitrogen mmiri zuru oke nke dabara adaba maka ihe nkiri na akụkụ olu niile, na-elekwasị anya na ihe dị iche iche achọrọ maka njikwa nchekwa cryogenic sample. Ngwọta a na-ekpuchi ọnọdụ dị iche iche, gụnyere ahụike, ụlọ nyocha, nchekwa okpomọkụ dị ala, usoro bayoloji, na usoro njem bayoloji, ma na-enye ndị ọrụ ahụmịhe usoro zuru oke gụnyere imewe injinia, nchekwa ihe nlele, mwepụta ihe nlele, njem ihe nlele, na njikwa ihe nlele.
Site n'ịgbaso ụkpụrụ FDA 21 CFR Nkebi nke 11, a na-enye asambodo sistemụ njikwa nitrogen mmiri nke Haier Biomedical CryoBio maka ịdị irè nke mbinye aka eletrọniki anyị na iguzosi ike n'ezi ihe nke ndekọ eletrọniki anyị. Asambodo nnabata a emeela ka asọmpi isi nke Haier Biomedical dịkwuo mma n'ọhịa nke ngwọta nchekwa nitrogen mmiri, na-eme ka mgbasawanye nke akara ahụ dịkwuo ngwa ngwa n'ahịa ụwa.
Mee ngwa ngwa mgbanwe mba ụwa iji dọta ndị ọrụ, ma melite asọmpi nke ahịa ụwa niile
Haier Biomedical na-agbaso atụmatụ mba ụwa mgbe niile, na-akwalite usoro abụọ nke "netwọk + localization". N'otu oge ahụ, anyị na-aga n'ihu na-eme ka mmepe nke sistemụ ahịa sie ike iji chee ndị ọrụ ihu, na-eme ka ngwọta ọnọdụ anyị dịkwuo mma na mmekọrịta, nhazi, na nnyefe.
N'ilekwasị anya n'ịmepụta ahụmịhe onye ọrụ kacha mma, Haier Biomedical na-eme ka ebe obibi sie ike site n'ịhazi otu na sistemụ mpaghara iji meghachi omume ngwa ngwa maka mkpa onye ọrụ. Ka ọ na-erule ngwụcha afọ 2023, Haier Biomedical nwere netwọk nkesa mba ofesi nke ihe karịrị ndị mmekọ 800, soro ihe karịrị ndị na-enye ọrụ mgbe erechara ahịa 500 rụkọọ ọrụ. Ka ọ dị ugbu a, anyị eguzobela usoro ebe ahụmịhe na ọzụzụ, nke lekwasịrị anya na United Arab Emirates, Nigeria na United Kingdom, yana sistemụ ebe a na-echekwa ihe na nhazi nke dị na Netherlands na United States. Anyị emeela ka ebe obibi anyị dịkwuo omimi na UK ma jiri nwayọọ nwayọọ na-emegharị ụdị a n'ụwa niile, na-eme ka usoro ahịa mba ofesi anyị sikwuo ike mgbe niile.
Haier Biomedical na-emekwa ka mgbasawanye nke ngwaahịa ọhụrụ dịkwuo ngwa ngwa, gụnyere ngwa ụlọ nyocha, ihe oriri, na ụlọ ahịa ọgwụ mara mma, na-eme ka asọmpi nke ngwọta ọnọdụ anyị dịkwuo elu. Maka ndị na-eji sayensị ndụ, centrifuges anyị emeela ihe ọhụrụ na Europe na America, igwe nkụ oyi anyị enwetala iwu mbụ na Eshia, kabinet biosafety anyị abanyela n'ahịa ọwụwa anyanwụ Europe. Ka ọ dị ugbu a, a rụpụtala ma mepụta ihe oriri ụlọ nyocha anyị na Eshia, North America, na Europe. Maka ụlọ ọgwụ, ewezuga ngwọta ọgwụ mgbochi anyanwụ, friji ọgwụ, nkeji nchekwa ọbara, na ihe oriri na-etolitekwa ngwa ngwa. Site na mmekọrịta na-aga n'ihu na òtù mba ụwa, Haier Biomedical na-enye ọrụ gụnyere owuwu ụlọ nyocha, nnwale gburugburu ebe obibi na ime ka ọ dị ọcha, na-emepụta ohere uto ọhụrụ.
Ka ọ na-erule ngwụcha afọ 2023, e nyela ihe karịrị ụdị Haier Biomedical 400 asambodo na mba ofesi, ma nye ha nke ọma n'ọtụtụ ọrụ dị mkpa na Zimbabwe, Democratic Republic of Congo, Ethiopia, na Liberia, yana ọrụ China-Africa Union Centers of Disease Control (CDC), nke na-egosi mmụba nke arụmọrụ nnyefe. A nabatala ngwaahịa na ngwọta anyị n'ọtụtụ mba na mpaghara karịrị 150. N'otu oge ahụ, anyị anọgidewo na-arụkọ ọrụ ogologo oge na ihe karịrị òtù mba ụwa 60, gụnyere World Health Organisation (WHO) na UNICEF.
Inweta asambodo FDA 21 CFR Nkebi nke 11 bụ ihe dị mkpa maka Haier Biomedical ka anyị na-elekwasị anya na ihe ọhụrụ na njem anyị nke mgbasawanye ụwa. Ọ na-egosikwa nkwa anyị imezu mkpa ndị ọrụ site na ihe ọhụrụ. Na-ele anya n'ihu, Haier Biomedical ga-aga n'ihu n'ụzọ ihe ọhụrụ anyị si elebara anya na onye ọrụ, na-akwalite ntinye atụmatụ anyị zuru ụwa ọnụ n'ofe mpaghara, ọwa, na ụdị ngwaahịa. Site n'ịkwado ihe ọhụrụ mpaghara, anyị na-achọ inyocha ahịa mba ụwa site na ọgụgụ isi.
Oge ozi: Julaị-15-2024
