Hauv kev lag luam kws tshuaj, txhua cov txheej txheem ntau lawm yog cuam tshuam nrog kev nyab xeeb ntawm cov neeg mob lub neej. Los ntawm RAW cov khoom siv xaiv cov txheej txheem ntau lawm, los ntawm cov cuab yeej tu mus rau ib puag ncig tswj, muaj cov pa phem me me tuaj yeem ua rau cov tshuaj muaj kev pheej hmoo. Ntawm cov ntsiab lus txuas tseem ceeb, tusKws Tshuaj Kho Cov Tshuaj NtshiabTau dhau los ua ib qho ntawm cov khoom tseem ceeb rau kev siv tshuaj rau kev nyab xeeb rau kev nyab xeeb rau kev nyab xeeb rau kev nyab xeeb. Nws tsis yog muab kev ntseeg tau lees paub rau cov neeg ua haujlwm tau txais txiaj ntsig zoo, tab sis kuj ua haujlwm ua ke yog rau kev lag luam tseem ceeb rau kev ua lag luam kom nyob ntawm cov txheej txheem siab thiab cov khoom lag luam zoo.
Ntshiab Chav: Lub neej ntawm cov khoom lag luam
Cov tseev kom muaj rau kev huv huv ntawm kws tshuaj yuav luag nruj. Seb nws yog kev txhaj tshuaj, tshuaj tiv thaiv kab mob, tshuaj tiv thaiv, lossis cov tshuaj siv, cov khoom siv, ib puag ncig, thiab txawm tias muaj zog ua kom tiav hauv lawv cov txheej txheem ntau ntxiv. Cov pa ntshiab (tseem hu ua "Cov Tub Tsev Tshuaj Qib Chav") tau dhau los ua qhov tsis muaj kev lag luam tsis ntev los ntawm cov tshuaj muaj zog vim nws qhov kev kub siab thiab tsis muaj tshuaj lom neeg.
Cov cab kuj tseem ceeb ntawm cov tsis muaj menyuam
Cov ntshiab ntshiab tuaj yeem nkag mus rau cov kab mob hlwb thiab tua cov kab mob, thiab cov noob kab mob siab (feem ntau yog siab dua 121 ℃) thiab siab siab. Piv nrog cov tshuaj tua kab mob tshuaj, cov tshuaj ntshiab kom tsis muaj sij hawm tsis muaj kev pheej hmoo, tshwj xeeb yog tsim nyog rau cov cuab yeej thiab cov thawv ntim uas nkag mus rau kev sib chwv nrog yeeb tshuaj. Piv txwv li, kev tsis huv ntawm cov khoom siv tseem ceeb xws li txhaj tshuaj puv kab, khov-kom qhuav cov cav tov, thiab bioreactors ntawm cov ntshiab huv.
Cov nruj me ntsis ntawm cov qauv zoo
Raws li GMP cov kev xav tau, Cov Tshuaj Ntshiab Cov Tshuaj Ntshiab yuav tsum tau ua raws li peb cov cim tseem ceeb:
Tsis muaj qhov kub kub: qhov chaw cua sov yog qhov muaj kuab paug uas muaj peev xwm ua rau pom cov neeg mob thiab yuav tsum tau muab tshem tawm kiag li.
Condensed dej sib ntsib tus txheej txheem: cov dej ua tau zoo tom qab cov dej ntshiab yuav tsum tau ua kom tau raws li cov dej kom txhaj tshuaj (≤ 1.3 μ S / cm.
Tsim nyog cov khoom siv dryness: lub ncos dryness yuav tsum yog ≥ 95% kom tsis txhob muaj cov dej ua kom tsis muaj txiaj ntsig.
Daim Ntawv Thov Kev Pab Puv Cov Txheej Txheem
Los ntawm kev kawm tsis muaj menyuam hauv online (SIP) ntawm cov khaub ncaws cua kom huv, los ntawm kev ntxuav cov txheej txheem ua kom tsis muaj zog los ntawm tag nrho cov chaw ntawm cov tshuaj ntawm cov tshuaj. Tshwj xeeb tshaj yog nyob rau hauv aseptic npaj rov taws yog lub tshuab hluav taws xob zoo "uas tau khiav yuav luag 24 teev nyob rau ib hnub yam tsis muaj kev cuam tshuam
Kev tsim kho thev naus laus zis tshiab ntawm cov tshuaj ntshiab ncu hluav taws xob
Nrog rau kev siv nce ntxiv rau qhov ua tau zoo, thiab ib puag ncig kev tiv thaiv hauv kev lag luam kws tshuaj, thev naus laus zis ntawm cov tshuab hluav taws xob ntshiab kuj tseem niaj hnub ua txhaum. Cov cuab yeej niaj hnub tau ua tiav cov kev ruaj ntseg ntau dua thiab lub zog txuag los ntawm kev txawj ntse thiab cov qauv tsim.
Kev tawg hauv cov ntsiab lus thev naus laus zis
Ntau cov nyhuv distillation Technology: los ntawm ntau-theem lub zog rov qab, cov dej nyoos (feem ntau yog hloov pauv hluav taws xob los ntawm cov khoom siv ntshiab lossis ntau dua 30% piv rau cov khoom siv ib txwm muaj.
Kev tswj kom txawj ntse: Nruab nrog ib qho kev soj ntsuam tsis siv neeg, kev siv sijhawm tiag tiag ntawm cov hluav taws xob qhuav, siv hluav taws xob thiab txuag rau kev ua haujlwm tsis raug.
Tsawg tus qauv tsim: Adopting pov tseg cov khib nyiab kom txo cov khoom siv hluav taws xob kom txo cov hluav taws xob, hauv kev hloov pauv ntsuab ntawm cov kev lag luam ntsuab.
Qhov 'Dual Kev Pov Hwm' ntawm Kev Tsim Kho Kom Zoo
Niaj hnub nimno ntshiab cov chav tsim hluav taws xob feem ntau tau nruab nrog cov txheej txheem zoo ntawm cov txheej txheem:
Kev soj xyuas online soj ntsuam: Lub sijhawm saib xyuas tiag tiag ntawm cov nplaum purity los ntawm cov cuab yeej xws li ua haujlwm metres thiab TC analyzers.
Kev Tsim Kho Dua (Dual Twj Backup, Ntau-theem pom thiab lwm yam qauv tsim kom ntseeg tau tias ua haujlwm ruaj khov ntawm cov cuab yeej ua tsis tau.
Yooj taus rau hauv teb rau cov nyom
Cov tshuab hluav taws xob ntshiab tuaj yeem kho rau cov teb no xws li biopharmaceuticals thiab kev kho mob cell. Piv txwv li, cov khoom siv tau siv rau MRP cov tshuaj tiv thaiv kev tsim khoom yuav tsum tau ua kom tau raws li cov khoom siv endotoxin hauv cov dej ntshiab hauv qab 0.001 EU / ML.
Nrog rau kev loj hlob sai ntawm biopharraceuticals, cov yuav tsum tau muaj dua tau muab tso rau pem hauv ntej rau qhov zoo ntawm cov ntshiab huv si. Kev tsim cov tshuaj tshiab xws li cov tshuaj gene thiab monoclonal Antibodies yuav tsum muaj Chav Purer Ib puag ncig. Qhov no nthuav qhia txoj kev sib tw thev naus laus zis tshiab rau cov roj av ntshiab.
Lub tswv yim ntawm cov khoom lag luam ntsuab tau hloov pauv tus qauv tsim ntawm cov ntshiab ua chav tsim hluav taws xob. Daim ntawv thov ntawm cov khoom txuag hluav taws xob, cov khoom siv ib puag ncig, thiab kev txhim kho kev tswj hwm kev txawj ntse yog txhua tsav tsheb rau kev coj ua kom muaj kev ruaj ntseg.
Daim ntawv thov ntawm cov thev naus laus zis ntse tau rov kho dua cov kev ua haujlwm ntawm hom kev ua haujlwm ntawm cov khoom ntshiab. Kev siv cov chaw saib xyuas cov chaw taws teeb, kev ua tiav kev sib kho, kev kho kom zoo dua thiab muaj lwm yam haujlwm tsis yog siv ntau yam kev ua haujlwm zoo rau kev tsim tshuaj.
Niaj hnub no, raws li kev nyab xeeb tshuaj muaj txiaj ntsig zoo heev, qhov tseem ceeb ntawmKws tsim hluav taws xob ntshiabYog ua ntau yam tseem ceeb. Nws tsis yog tsuas yog cov khoom tseem ceeb rau kev siv tshuaj yeeb, tab sis kuj muaj qhov tseem ceeb rau pej xeem kev nyab xeeb. Nrog kev nce qib nruam ntawm thev naus laus zis, cov chav tsim hluav taws xob ntshiab yuav undoubtedly ua kev lag luam ntau ntxiv rau tib neeg kev noj qab haus huv.
Lub sijhawm Post: Feb-07-2025