N'oge na-adịbeghị anya, TÜV SÜD China Group (nke a na-akpọ "TÜV SÜD") kwadoro ndekọ eletrọnịkị na mbinye aka electronic nke Haier Biomedical's liquid nitrogen management system dị ka achọrọ FDA 21 CFR Nkebi 11. Ihe ngwọta ngwaahịa iri na isii, nke Haier mepụtara n'onwe ya. Biomedical, ka enyere ya akụkọ nnabata TÜV SÜD, gụnyere usoro Smartand Biobank.
Inweta asambodo FDA 21 CFR Nkebi 11 pụtara na ndekọ eletrọnịkị na mbinye aka nke sistemu njikwa LN₂ nke Haier Biomedical na-ezute ụkpụrụ nke ntụkwasị obi, iguzosi ike n'ezi ihe, nzuzo na traceability, si otú ahụ na-ahụ maka ịdịmma data na nchekwa.Nke a ga-eme ka nnabata nke usoro nchekwa mmiri nitrogen dị na ahịa dị ka US na Europe, na-akwado mgbasawanye mba ụwa nke Haier Biomedical.
Inweta asambodo FDA, sistemu njikwa mmiri nitrogen HB amalitela njem ọhụrụ nke mba ụwa
TÜV SÜD, onye ndu ụwa zuru ụwa ọnụ na nnwale na asambodo nke ndị ọzọ, na-elekwasị anya mgbe niile n'inye nkwado nnabata ọkachamara n'ofe ụlọ ọrụ, na-enyere ụlọ ọrụ aka ịnọgide na-agbaso ụkpụrụ iwu.Ọkọlọtọ FDA 21 CFR Nkebi 11 nke US Food and Drug Administration (FDA) nyere, na-enye ndekọ eletrọnịkị otu mmetụta iwu dị na ndekọ na mbinye aka, na-ahụ maka izi ezi na ntụkwasị obi nke data eletrọnịkị.Ụkpụrụ a na-adabara ndị otu na-eji ndekọ eletrọnịkị na mbinye aka na biopharmaceuticals, ngwaọrụ ahụike na ụlọ ọrụ nri.
Kemgbe mgbasa ozi ya, ọkọlọtọ anabatala ụwa niile, ọ bụghị naanị site na ụlọ ọrụ biopharmaceutical 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 FDA 21 CFR Nkebi 11 chọrọ dị mkpa maka mgbasawanye mba ụwa kwụsiri ike, na-ahụ na nnabata na ụkpụrụ FDA na ụkpụrụ ahụike na nchekwa dị mkpa.
Haier Biomedical's CryoBio mmiri mmiri nitrogen sistemu bụ n'ezie "ụbụrụ nwere ọgụgụ isi" maka mmiri mmiri nitrogen arịa.Ọ na-agbanwe akụrụngwa nlele ka ọ bụrụ akụrụngwa data, yana ọtụtụ data a na-enyocha, dekọọ ma chekwaa ya ozugbo, na-amata ihe adịghị mma ọ bụla.Ọ na-egosipụtakwa nleba anya ọnụọgụ abụọ nke ọnọdụ okpomọkụ na ọkwa mmiri mmiri, yana njikwa nhazi nke ọrụ ndị ọrụ.Na mgbakwunye, ọ na-enyekwa njikwa anya nke sampels maka ịnweta ngwa ngwa.Ndị ọrụ nwere ike ịgbanwe n'etiti akwụkwọ ntuziaka, gas-phase, na ụdị mmiri mmiri na otu ọpịpị, na-emeziwanye arụmọrụ.Ọzọkwa, sistemụ ahụ na-ejikọta na ikpo okwu ozi IoT na BIMS, na-eme ka njikọ na-enweghị ntụpọ n'etiti ndị ọrụ, akụrụngwa na ihe nlele.Nke a na-enye ahụmịhe nchekwa sayensị, ahaziri ahazi, nchekwa yana arụ ọrụ nke ọma.
Haier Biomedical ewepụtala ngwọta nchekwa mmiri nitrogen na-akwụsị otu nkwụsị kwesịrị ekwesị maka ihe nkiri niile na akụkụ olu, na-elekwasị anya na ihe dị iche iche chọrọ nke njikwa nchekwa nchekwa cryogenic.Ngwọta ahụ na-ekpuchi ọnọdụ dị iche iche, gụnyere ọgwụ, ụlọ nyocha, nchekwa okpomọkụ dị ala, usoro ndu, na usoro njem ndu, ma na-enye ndị ọrụ ahụmahụ zuru oke gụnyere nhazi injinia, nchekwa ihe nlele, iweghachite ihe nlele, njem nlele, na njikwa nlele.
Site n'ịgbaso ụkpụrụ FDA 21 CFR Nkebi 11, Haier Biomedical's CryoBio mmiri mmiri nitrogen usoro akwadoro maka izi ezi nke mbinye aka eletrọnịkị anyị yana iguzosi ike n'ezi ihe nke ndekọ eletrọnị anyị.Asambodo nnabata a akwalitela asọmpi isi nke Haier Biomedical n'ọhịa nke ngwọta nchekwa mmiri nitrogen, na-eme ka mgbasawanye nke ika ahụ dị n'ahịa zuru ụwa ọnụ.
Mee ngwa ngwa mgbanwe mba ụwa iji dọta ndị ọrụ, ma kwalite asọmpi nke ahịa ụwa
Haier Biomedical na-agbaso usoro mba ụwa mgbe niile, na-aga n'ihu na-akwalite sistemụ abụọ "netwọk + localization".N'otu oge ahụ, anyị na-aga n'ihu na-ewusi mmepe nke usoro ahịa ike iji chee ndị ọrụ ihu, na-eme ka ngwọta ọnọdụ anyị dị na mmekọrịta, nhazi, na nnyefe.
Na-elekwasị anya n'ịmepụta ahụmịhe onye ọrụ kachasị mma, Haier Biomedical na-ewusi obodo ike site n'ịmepụta otu na usoro mpaghara iji zaghachi ngwa ngwa maka mkpa onye ọrụ.Ka ọ na-erule njedebe nke 2023, Haier Biomedical enweela netwọkụ nkesa esenidụt nke ihe karịrị ndị mmekọ 800, jikọtara ya na ihe karịrị ndị na-eweta ọrụ ahịa mgbe 500 gasịrị.Ka ọ dị ugbu a, anyị eguzobela usoro ahụmahụ na ụlọ ọrụ ọzụzụ, gbadoro ụkwụ na United Arab Emirates, Nigeria na United Kingdom, yana usoro ụlọ nkwakọba ihe na ngwa ngwa dị na Netherlands na United States.Anyị emeela ka mpaghara anyị dị na UK wee jiri nwayọọ nwayọọ na-emegharị ihe nlereanya a n'ụwa niile, na-ewusi usoro ahịa anyị na mba ofesi ike mgbe niile.
Haier Biomedical na-emekwa ka mgbasawanye nke ngwaahịa ọhụrụ, gụnyere ngwa ụlọ nyocha, ihe oriri, na ụlọ ahịa ọgwụ mara mma, na-eme ka asọmpi nke ngwọta ọnọdụ anyị dị.Maka ndị ọrụ sayensị ndụ, centrifuges anyị emeela ihe ịga nke ọma na Europe na America, igwe nkụ anyị enwetala iwu mbụ na Eshia, ebe nchekwa biosafety anyị abanyela n'ahịa ọwụwa anyanwụ Europe.Ka ọ dị ugbu a, a rụpụtala ma megharịa ihe oriri ụlọ nyocha anyị na Eshia, North America, na Europe.Maka ụlọ ọrụ ahụike, ewezuga ihe ngwọta ọgwụ mgbochi anwụ, friji ọgwụ, ngalaba nchekwa ọbara, na ihe oriri na-etolitekwa ngwa ngwa.Site na mmekorita ya na ndị otu mba ụwa na-aga n'ihu, Haier Biomedical na-enye ọrụ gụnyere owuwu ụlọ nyocha, nnwale gburugburu ebe obibi na ịmụ nwa, na-eke ohere uto ọhụrụ.
Ka ọ na-erule njedebe nke 2023, ihe karịrị ụdị 400 nke Haier Biomedical ka enwetara asambodo na mba ofesi ma nyefee ya nke ọma n'ọtụtụ nnukwu ọrụ na Zimbabwe, Democratic Republic of Congo, Ethiopia na Liberia, yana China-Africa Union Centre of Disease Control. (CDC), na-egosipụta nkwalite arụmọrụ nnyefe.A nabatala ngwaahịa anyị na ngwọta anyị n'ọtụtụ mba na mpaghara 150.N'otu oge ahụ, anyị na ihe karịrị òtù mba ụwa 60, gụnyere World Health Organisation (WHO) na UNICEF nọgidere na-arụkọ ọrụ ogologo oge.
Inweta asambodo FDA 21 CFR Nkebi 11 bụ ihe dị ịrịba ama maka Haier Biomedical ka anyị na-elekwasị anya na ihe ọhụrụ na njem anyị nke mgbasawanye ụwa.Ọ na-egosipụtakwa nkwa anyị na-egbo mkpa onye ọrụ site na ọhụrụ.N'ile anya n'ihu, Haier Biomedical ga-aga n'ihu na usoro mmepụta ihe ọhụrụ dabere na onye ọrụ, na-aga n'ihu n'ịkwalite atụmatụ anyị zuru ụwa ọnụ n'ofe mpaghara, ọwa, na ụdị ngwaahịa.Site n'imesi ihe ọhụrụ ime obodo ike, anyị bu n'obi iji ọgụgụ isi nyochaa ahịa mba ụwa.
Oge nzipu: Jul-15-2024
