Isizinda Socwaningo Nokubaluleka Kwalo
Ekukhiqizweni kwemithi yokugomela i-FMD, izinto ezivikela amangqamuzana ziqukethe inani elikhulu lemfucumfucu yamangqamuzana. Uma zihlungwa ngokuqondile ku-0.2 μm sterilizing filtration, ama-filter membranes athambekele ekungcoleni okusheshayo, okunciphisa ukusebenza kahle futhi okungenzeka kuthinte ukungena kanye nokukhiqizwa kwe-antigen eqondiwe (izinhlayiya zegciwane ezingu-146S).
Lolu cwaningo lugxile emibuzweni emithathu ebalulekile:
Ukuqhathanisa ukusebenza kokuhlunga ubuso kanye nokuhlunga ukujula ngokwezinga lokukhipha, ukunciphisa ukungcoliswa kwamanzi, kanye nokuvikelwa kwezihlungi zokuhlanza ezingezansi.
Ukuqinisekisa inzuzo eyingqayizivele yezihlungi zokujula eziqinile ezishajelwe kahle ekususweni kwemfucumfucu yamaseli.
Ukusungula izinhlelo zokuhlunga ezingandiswa ngokwezidingo zokukhiqiza ezihambisana noketshezi olusetshenziswayo olunezinga elihlukene lokungcoliswa kwamanzi, ukuze kuhlangatshezwane nezidingo zokukhiqiza zezimboni.
Ukuhlolwa Okuyinhloko kanye Nemiphumela
Ukuhlunga Okungaphezulu vs. Ukuhlunga Okujulile
Ukuhlolwa:Uketshezi lomjovo we-FMD olungasebenzi luhlungiwe kusetshenziswa ulwelwesi olungaphezulu lwe-polypropylene oluyi-0.45 μm kanye namaphepha okuhlunga okujulile, kulandelwe ukuhlunga okuhlanzisisa okungu-0.2 μm.
Okutholakele:
Ukuqala kokungcoliswa: 77 NTU.
Ukuhlunga ukujula:umthamo wokuphuma 641 L/m²; ukukhukhumala kuncishisiwe kwaba yi-9.65 NTU (kucacile futhi kukhanya).
Ukuhlunga okungaphezulu:amandla okukhipha angu-46 L/m² kuphela; ukudungeka kwahlala kungu-41 NTU.
Ukuhlunga okuhlanzisisa phansi:Ngemva kokuhlunga okujulile, izihlungi ezingu-0.2 μm zazinomthamo wokuphuma ongu-655 L/m², uma kuqhathaniswa no-91 L/m² kuphela ngemva kokuhlunga ubuso—ukuthuthuka okungu-7.2 ×.
Inzuzo ye-146S:Ukuhlunga okujulile kuphakeme kakhulu kunokuhlunga okungaphezulu.
Isiphetho:Ububanzi bokuhlunga obujulile babuphakeme ngo-13.9× kunokuhlunga okungaphezulu, ukuthuthumela kokuhlunga kwakuphansi ngo-76.5%, kanti impilo yokuhlunga yokuhlanza yandiswa ngaphezu kuka-7×. Kusukela kokubili ekuboneni izindleko kanye nokuvuna, ukuhlunga okujulile kungcono kakhulu.
Ukushaja Okuhle Kakhulu vs. Ukuhluzwa Kokujula Okushaja Okuhle Kakhulu
Ukuhlolwa:Izinhlobo ezimbili zamashidi okuhlunga okujulile anosayizi ofanayo wembobo kodwa ubuningi bokushaja obuhlukile (okuvamile okuhle vs. okunamandla okuhle) ahlolwe eziphuzweni ze-FMD ezingasebenzi.
Okutholakele:
Amaphrofayili okusebenza kanye nokucindezela ayefana.
Ukujula okuhle okuvamileisihlungi:ukungcola kokuhlunga 25 NTU.
Ukujula okuhle okuqinileisihlungi:i-filtrate turbidity engu-9.65 NTU (ngu-38.6% kuphela wejwayelekile).
Umthamo wokushaja oqinile uvela kuma-ligand e-resin akhethekile athuthukisa ukumuncwa kwe-electrostatic.
Imibiko yezincwadi iqinisekisa ukuthi izihlungi ezijulile eziqinile zingasusa namaprotheni eseli lomnikazi (i-HCP) kanye ne-DNA.
Isiphetho:Izihlungi zokujula eziqinile ziletha ukunciphisa okungcono kakhulu kokungcola (<10 NTU), zivikela ukuhlunga okuhlanzwayo/ukuhlanza okungaphansi komfula, futhi zisuse ukungcola okwengeziwe okuhlobene nenqubo.
1. Izimiso Zobuchwepheshe kanye Nezinzuzo Zokuhlunga Okujulile
Ukuhlunga okungaphezulu:Ibamba izinhlayiya kuphela ebusweni be-membrane; ikakhulukazi ukuvinjelwa okusekelwe ngobukhulu.
Ukuhlunga ukujula:Isusa izinhlayiya kulo lonke i-matrix ngokufaka i-entrapment kanye ne-electrostatic adsorption.
Izinzuzo ezibalulekile:
Ayikho i-asbestos (ngokungafani nemidiya yokuhlunga yasekuqaleni).
Kwenziwe ngemicu ye-cellulose emsulwa kakhulu, izinsiza zokuhlunga, kanye nama-resin e-polymeric.
Amaqembu asebenzayo aneshaja enhle ahlinzeka ngokumuncwa okunamandla kwezinhlayiya ezincane kanye nokungcola.
Ihambisana ngokugcwele nezidingo zomthetho ze-biopharmaceutical.
2. Izinhlelo Zokuhlunga Ezingakhula Zamazinga Ahlukene Okukhukhula
Ngokusekelwe ezifundweni zokuqhathanisa:
Phansiukudungekauketshezi:ukuhlunga okulula ngaphambi kokusebenzisa.
Okuphakathi nendawoukudungekauketshezi:Kunconywa ukuhlunga ukujula okunezingqimba ezimbili.
Phezuluukudungekauketshezi:Kudingeka ukuhlunga okujulile okuhle ukuze kuncishiswe ukungcoliswa kwamanzi ngaphansi kwe-NTU engu-10, kuqinisekiswe ukucubungula okusebenzayo kanye nokukhiqizwa okuphezulu kwe-antigen.
3. Ukusetshenziswa Komkhiqizo: Izihlungi Zokujula Kokuhlunga Okukhulu Kodonga
I-Great Wall Filtration inikeza izinhlelo zokuhlunga okujulile ezenzelwe izinqubo ze-biopharmaceutical.
Izici ezibalulekile:
Amashidi okuhlunga anamandla aphezulu okususa amaseli, udoti, kanye nezinto ezinkulu eziqinile.
Kusebenza kumasiko amangqamuzana ezilwane ezincelisayo, ama-bacterial/yeast lysates.
Iyakwazi ukususa i-HCP, i-DNA, amagciwane, ama-endotoxin, kanye nama-antifoaming agents.
Idizayini encane, ingandiswa ngendlela eqondile, ifanele ukusetshenziswa emgqeni noma ngokulingana.
Amazinga okugeleza azinzile, impilo yesevisi ende, kanye nezindleko zokusebenza eziphansi.
Isiphetho
Ubuchwepheshe bokuhlunga ukujula okushajwe kahle buthuthukisa kakhulu ukusebenza kahle kokucacisa kanye nokululama kwe-antigen ekukhiqizweni kwemithi yokugomela i-FMD. Ngaphandle kwemithi yokugomela i-FMD, inikeza indlela ethembekile yokuhlanzwa kwezinye izinto eziphilayo. Njengoba ukulungiswa kwe-bioprocess kuqhubeka, ubuchwepheshe bokuhlunga obuthuthukisiwe buzohlala bubalulekile ekukhiqizweni kwemithi yokugomela ephephile nephumelelayo.
Lesi sihloko sisekelwe kudatha yangempela yokuhlola ukuze kubhekwe kuphela.Ukuqinisekiswangaphansi kwezimo zokukhiqiza zangempela kuyanconywa.
