Nyob rau hauv kev lag luam kws tshuaj, sterile filtration yog ib qho tseem ceeb txuas los xyuas kom meej cov khoom muaj kev ruaj ntseg, purity thiab ntev txee lub neej. Raws li cov neeg siv khoom xav tau rau kev noj qab haus huv thiab kev ua tau zoo txuas ntxiv mus ntxiv, kev tsim tshuaj yeeb tau teeb tsa cov qauv siab heev rau cov dej zoo, cov khoom siv purity thiab microbial tswj. Txhua yam kab mob me me tuaj yeem cuam tshuam qhov saj, kev ruaj ntseg thiab txawm tias kev nyab xeeb ntawm cov khoom, yog li cov kev xav tau nruj dua tau muab tso rau ntawm qhov kev ua tau zoo ntawm qhov pom.
Raws li ib qho tseem ceeb ntawm cov davhlau ya nyob twg pom, PES cov ntsiab lus lim tau dhau los ua cov kev daws teeb meem zoo tshaj plaws rau kev ua kom tsis muaj menyuam hauv kev lag luam kws tshuaj nrog lawv cov peev xwm khaws cia microbial zoo, muaj peev xwm ua tau zoo thiab muaj tshuaj lom neeg zoo. Nws cov kev ua tau zoo tsis tsuas yog ua tau raws li qhov xav tau ntawm kev tsim khoom niaj hnub no kom muaj kev nyab xeeb thiab ua haujlwm tau zoo, tab sis kuj muab cov khoom lav rau cov lag luam kom ua tiav cov txheej txheem aseptic ruaj khov thiab ua haujlwm tau zoo.
Cov ntsiab lus
1. Core technical zoo ntawm PES lim caij
2. Cov xwm txheej ntawm daim ntawv thov nyob rau hauv kev lag luam kws tshuaj
3. Kev lag luam tiam sis thiab kev lag luam tsav tsheb
4. Cov kev sib tw thiab cov lus qhia kev txhim kho yav tom ntej
1. Core technical zoo ntawm PES lim caij
Raws li cov khoom tseem ceeb hauv kev ua kom tsis muaj menyuam, qhov laj thawj yog vim li cas PES lim cov ntsiab lus tau siv dav hauv kev lag luam dej haus yog vim lawv cov khoom zoo heev thiab cov qauv tsim. Ua ntej tshaj plaws, PES lim membrane muaj hydrophilicity zoo, ua ke nrog cov qauv asymmetric siab heev, nws tuaj yeem ua tiav siab flux thiab tsis tshua muaj siab sib txawv ua haujlwm. Ntawm qhov tseeb ntawm 0.22μm, nws tuaj yeem cuam tshuam cov kab mob zoo thiab ua tau raws li cov qauv kev lim dej nruj.
Nyob rau hauv ib puag ncig kev tshaj tawm, PES lim cov ntsiab lus qhia cov tshuaj tiv thaiv corrosion zoo heev thiab tuaj yeem tiv taus cov kua qaub thiab alkali ntxuav. Lawv tsim nyog rau cov khoom siv dej haus uas yooj yim kis los yog muaj corrosive heev, xws li qab zib thiab cawv. Tsis tas li ntawd, nws cov qauv folded tsis tsuas yog nce qhov pom ntawm thaj chaw, tab sis kuj tseem txhim kho cov neeg kho tshuab lub zog. Nws tuaj yeem tiv taus qhov sib txawv siab txog li 0.42MPa, txuas ntxiv lub neej kev pabcuam ntawm lub lim dej thiab txhim kho kev ua haujlwm ruaj khov.
Piv nrog rau lwm cov ntaub ntawv lim dej xws li PP thiab PTFE, PES muaj qhov zoo tshaj plaws hauv cov protein tsawg adsorption thiab tiv thaiv - muaj peev xwm ua paug. Qhov no txhais tau hais tias muaj kev pheej hmoo ntawm kev kis kab mob tsawg dua thiab muaj kev ntseeg siab dua pom, uas yog qhov tshwj xeeb tshaj yog tsim rau cov xwm txheej ntawm cov dej haus uas tsis tshua muaj siab rau kev nyiam huv thiab zoo. Yog li ntawd, PES lim cov ntsiab lus ua kom pom qhov tsis muaj txiaj ntsig kev hloov pauv hauv kev ua tiav cov txiaj ntsig zoo, muaj kev nyab xeeb thiab ruaj khov kom tsis muaj menyuam.
2. Cov xwm txheej ntawm daim ntawv thov nyob rau hauv kev lag luam kws tshuaj
Hauv kev lag luam kws tshuaj, PES lim cov ntsiab lus tau siv dav hauv cov kev sib txuas tseem ceeb xws li sterile filtration thiab terminal fine filtration vim lawv cov hydrophilicity zoo heev, tsis tshua muaj protein ntau adsorption thiab cov yam ntxwv flux siab. Ua ntej sau cov tshuaj ua kua xws li txhaj tshuaj, tshuaj pleev qhov muag, thiab cov khoom siv lom neeg, PES lim cov ntsiab lus tuaj yeem ua tiav cov khoom khaws cia ntawm cov kab mob thiab cov khoom kom ntseeg tau tias tsis muaj menyuam thiab pom tseeb ntawm cov khoom kawg. Nws cov qauv membrane pore muaj qhov ruaj khov pom kev ua tau zoo rau 0.1μm-0.45μm hais, thiab muaj ob qho tib si kub tsis kam thiab tshuaj lom neeg sib raug zoo, uas yog tsim rau ntau yam kev tu, tshuaj tua kab mob thiab ua kom tsis muaj menyuam. Piv nrog rau lwm cov ntaub ntawv lim, PES lim membranes ruaj khov nyob rau hauv siab -flux thiab tsawg sib txawv siab ua hauj lwm, zoo txo batch sib txawv thiab zog noj, thiab xyuas kom meej lub continuation thiab zoo sib xws ntawm cov tshuaj ntau lawm.
Tsis tas li ntawd, PES lim cov ntsiab lus tseem ua lub luag haujlwm tseem ceeb hauv kev npaj cov tshuaj, kev kho dej thiab kev tsis pom kev. Hauv cov dej huv huv (PW), dej rau kev txhaj tshuaj (WFI) lossis CIP / SIP cov tshuab, PES lim cov ntsiab lus feem ntau yog siv rau qhov ntsuas qhov ntsuas qhov tseeb, uas tuaj yeem tshem tawm cov kab mob thiab cov teeb meem zoo thiab tiv thaiv kev sib kis los ntawm kev sib kis mus rau hauv cov dej ntws. Nyob rau hauv kev npaj cov tshuaj tiv thaiv, recombinant proteins, thiab cell kab lis kev cai kua, nws cov yam ntxwv uas tsis muaj protein binding muaj peev xwm txo qhov poob ntawm lub hom phiaj cov khoom thiab txhim kho kev rov qab thiab cov txheej txheem yield. Nrog rau kev txhim kho txuas ntxiv ntawm GMP cov lus qhia tshwj xeeb thiab kev saib xyuas tshuaj nruj dua, cov tuam txhab tshuaj tau vam khom rau siab -kev ua haujlwm lim cov ntsiab lus los ua kom tiav- cov txheej txheem tswj kom zoo, thiab PES cov ntsiab lus lim tau dhau los ua qhov kev xaiv tseem ceeb rau kev ua tiav qib siab pom kev nyab xeeb thiab kev ua haujlwm zoo nrog lawv cov khoom zoo heev thiab cov ntaub ntawv pov thawj.
3. Kev lag luam tiam sis thiab kev lag luam tsav tsheb
Kev lag luam kev lag luam thiab kev ua lag luam tsav tsheb ntawm PES lim cov ntsiab lus tau txuas ntxiv los ntawm kev txhim kho sai ntawm cov txheej txheem tshuaj siab -kawg xws li biopharmaceuticals, tshuaj tiv thaiv, thiab kev kho ntawm tes, thiab tag nrho cov qauv yog kev ua haujlwm siab, kev tswj hwm - taw qhia, thiab ruaj khov.
Ntawm qhov tod tes, thoob ntiaj teb GMP cov qauv thiab kev tswj hwm kev hloov kho tshiab yog tsav cov tuam txhab tshuaj kom nce lawv cov peev hauv cov kev sib txuas tseem ceeb, tshwj xeeb tshaj yog qhov kev thov loj hlob rau cov protein tsawg adsorption, tsis yog -pyrogen, thiab cov ntaub ntawv pov thawj. PES lim ntsiab yog nyiam nyob rau hauv aseptic pom, davhlau ya nyob twg filling, thiab cov txheej txheem ua kua kom meej vim lawv zoo heev tshuaj stability thiab biocompatibility. Kev nce siab ntawm biopharmaceuticals tau ua rau muaj kev thov loj rau siab -throughput, low-inactivation filter element, tshwj xeeb tshaj yog nyob rau hauv cov khoom xws li tshuaj tiv thaiv, monoclonal antibodies, thiab noob therapy.
Ntawm qhov tod tes, kev txhim kho kom ruaj khov thiab kev lag luam ntsuab tau dhau los ua tus tsav tsheb tshiab. Cov neeg siv khoom muaj kev txhawj xeeb ntau ntxiv txog kev ua kom tsis muaj menyuam thiab rov siv dua, kev pabcuam lub neej, thiab kev rov ua dua tshiab ntawm cov lim dej, nrog rau cov pa roj carbon hneev taw thiab cov khoom siv kev nyab xeeb ntawm cov khoom lim lim. Qhov no tau ua rau PES lim cov khoom lag luam kom txuas ntxiv tsim cov qauv tsim qauv tsim, ua kom zoo dua cov khoom siv hauv tsev, thiab ntxiv dag zog rau lawv cov kev pabcuam kev pov thawj uas muaj peev xwm sib piv nrog cov tuam txhab sab saud thiab hauv qab kom hloov mus rau cov kev cai nce ntxiv thiab kev cia siab ntawm kev lag luam. Zuag qhia tag nrho, PES lim cov ntsiab lus tau hloov pauv los ntawm "cov khoom siv tau zoo" mus rau "kev pov thawj- theem tseem ceeb."
4. Cov kev sib tw thiab cov lus qhia kev txhim kho yav tom ntej
Txawm hais tias PES lim cov ntsiab lus muaj txiaj ntsig zoo hauv kev lag luam tshuaj, lawv daim ntawv thov tseem ntsib qee qhov kev sib tw. Ntawm lawv, tus nqi siab yog ib qho teeb meem tseem ceeb rau kev nce qib thiab kev thov tam sim no. Tshwj xeeb tshaj yog nyob rau hauv lub siab -kawg lag luam, ntau siab -PES daim nyias nyias cia siab rau ntshuam, thiab lawv cov nqi feem ntau yog 2 mus rau 3 npaug ntawm cov ntaub ntawv lim hauv tsev, uas ua rau kom cov khoom thiab kev ua haujlwm siab ntawm cov lag luam me thiab nruab nrab- loj. Tsis tas li ntawd, thaum cuam tshuam nrog cov kua dej uas muaj viscosity siab lossis siab impurity cov ntsiab lus, cov ntsiab lus lim yog nquag ua rau txhaws, ua rau muaj kev hloov pauv ntau zaus thiab ua haujlwm luv luv, ntxiv kev ua haujlwm thiab kev saib xyuas cov nqi ntxiv.
Hauv kev teb rau cov teeb meem saum toj no, kev txhim kho yav tom ntej ntawm PES lim ntsiab yog txav mus rau kev tsim kho thev naus laus zis thiab kev ua kom zoo dua qub. Ntawm qhov tod tes, los ntawm cov cuab yeej sib xyaw ua ke, kev sib txuas ntawm PES nrog cov khoom siv nano tuaj yeem txhim kho kev tiv thaiv - pa phem thiab flux stability ntawm lub lim dej, txuas nws lub neej kev pab cuam, thiab hloov mus rau ntau qhov chaw pom kev nyuaj. Ntawm qhov tod tes, cov qauv tsim tau maj mam dhau los ua qauv, txhawb kev hloov pauv hloov pauv ntawm cov khoom pom raws li cov kab ntau lawm sib txawv, uas tsis tsuas yog txhim kho kev sib koom ua ke, tab sis kuj pab txo cov nqi kho thiab hloov cov nqi. Cov kev tsim kho tshiab no yuav txhawb nqa qhov nrov ntawm PES lim cov ntsiab lus hauv kev lag luam haus dej haus thiab muab kev txhawb nqa rau kev ua kom muaj txiaj ntsig zoo, qis -kev siv, thiab kev tsim khoom ruaj khov.