Validation Study on the Cleaning Lifetime of Ultrafiltration Cassettes
Validation Study on the Cleaning Lifetime of Ultrafiltration Cassettes
"Kev Tu Lub Neej Ua Haujlwm ntawm Ultrafiltration (UF) Cassettes" yog thaj chaw tseem ceeb thiab kev siv tau zoo hauv kev tsim tshuaj biopharmaceutical. Nws lub hom phiaj tseem ceeb yog txiav txim siab seb lub cassette tuaj yeem tswj hwm nws qhov kev xav tau thiab cov khoom lag luam zoo tom qab siv ntau lub voj voog thiab ntxuav.
Rau kev tu kom zoo thiab kev siv lub neej siv tau ntawm ultrafiltration cassettes, ob qho tib si US FDA thiab Tuam Tshoj National Medical Products Administration (NMPA) muaj cov cai nruj heev. Cov koom haum tswj hwm thoob plaws ntau lub teb chaws muab cov kev cia siab ua raws li kev cia siab txog kev tshawb fawb lub neej (nrog rau kev tu lub neej thiab kev ua haujlwm lub neej). Txawm hais tias cov lus hais yuav txawv ntawm GMP cov cai tswj hwm thoob ntiaj teb, lawv cov kev txhawj xeeb tau zoo ib yam - tsom rau seb qhov kev siv cov khoom siv rov ua rau muaj kev pheej hmoo rau cov khoom zoo.
Kev ntxuav ntawm ultrafiltration cassettes lub hom phiaj los tsim kom muaj txheej txheem rov ua dua thiab muaj zog. Nws qhov tseem ceeb yog nyob rau hauv kev tshem tawm cov kab mob thiab tiv thaiv kev sib kis -kev kis kab mob, tswj cov flux thiab tawm los, thiab tiv thaiv cov kab mob microbiological. Los ntawm cov kev ntsuas no, kev tu lub cassette yuav pab xyuas kom cov khoom zoo thiab cov txheej txheem ua tau zoo thaum ua kom cov cassette ntau tshaj plaws.
Txhawm rau ua kom muaj txiaj ntsig zoo ntawm kev ntxuav cov cassette, plaub txheej txheej txheej txheem yuav tsum ua raws li plaub-:
Tsim ib tug scientific suab tu txoj kev.
Tsim kom muaj cov txheej txheem tu kom ntxaws thiab cov txheej txheem kev ua haujlwm raws li tus qauv.
Txheeb xyuas qhov ua tau thiab rov tsim dua ntawm cov txheej txheem thiab txheej txheem los ntawm kev ua haujlwm raug cai.
Tsis tu ncua ua raws li cov txheej txheem uas tau lees paub hauv kev tsim khoom, thaum saib xyuas thiab tshuaj xyuas cov kev ntsuas tseem ceeb kom ntseeg tau tias cov txheej txheem ntxuav tseem nyob hauv kev tswj hwm.
Cov txheej txheem tu tus txheej txheem rau TFF cassettes tuaj yeem ua tiav raws li:
buffer yaug → dej yaug → ntxuav tus neeg saib xyuas kev kho → dej yaug.
Hauv cov khoom siv bioprocess tu, cov tshuaj ntxuav feem ntau siv xws li sodium hydroxide (NaOH), sodium hypochlorite (NaClO), thiab cov kua qaub (xws li phosphoric acid, nitric acid, thiab hydrochloric acid).
Sodium hydroxide (NaOH) ntawm 0.1–0.5 N, 30–50 degree, rau 30–60 feeb, zoo hydrolyzes proteins thiab saponifies lipids, tab sis tsis tshua muaj txiaj ntsig ntawm polysaccharides thiab cell debris. Nws cov txiaj ntsig tu tuaj yeem tshawb xyuas tau yooj yim los ntawm kev saib xyuas pH.
Sodium hypochlorite (NaClO) ntawm pH 9–10, dawb chlorine 250–500 ppm lossis 0.1 N, 30–50 degree, rau tib lub sijhawm, tuaj yeem oxidize ze li ntawm tag nrho cov organic tebchaw thiab cov khib nyiab ntawm tes. Kev tu kom zoo tuaj yeem txheeb xyuas tau siv cov tshuaj ntsuam xyuas colorimetric lossis cov txheej txheem zoo sib xws.
Acid cleaners ntawm 0.1 N, 30-50 degree, rau 30-60 feeb, feem ntau yog siv los hydrolyze nucleic acids thiab yaj inorganic ntsev. Cov tshuaj lom lom yuav tsum tau muab tshem tawm ua ntej cov kua qaub ntxuav. Lawv cov txiaj ntsig tseem tuaj yeem txheeb xyuas tau yooj yim los ntawm kev ntsuas pH.
Raws li tsab ntawv tshaj tawm - siv cov kev ntsuam xyuas tu, cov dej permeability (NWP) ntawm daim nyias nyias lossis qhov system yuav tsum tau muab piv ua ntej thiab tom qab siv. Yog tias NWP tom qab siv txo qis dua ntau dua20%piv nrog qhov pib NWP (piv txwv li, qhov rov qab yog hauv qab no80%, thaum lub hom phiaj yuav tsumntau dua 90%), kev ntxuav ntxiv yuav tsum tau txiav txim siab. Kev ntsuas yuav suav nrog kev ua kom huv huv- tus neeg sawv cev kom muaj zog, txuas ntxiv lub sijhawm ntxuav, nce qhov kub thiab txias, lossis hloov cov tshuaj ntxuav.
Tom qab ntxuav, cov qauv yuav tsum tau sau los ntawm ob qho tib si retentate thiab permeate sab thiab sim rau ntau yam tsis muaj, suav nrogTag nrho cov organic carbon (TOC), endotoxin, microbial txwv, tag nrho cov protein, Cov khoom seem (ELISA), Kev tshuaj xyuas HPLC, zoo liconductivitythiabpH. Cov kev ntsuam xyuas no muab kev ntsuam xyuas tag nrho ntawm kev ua haujlwm huv thiab kev ua haujlwm ntawm lub cev. TOC thiab NWP yog cov cuab yeej siv tau zoo tshaj plaws rau kev ntsuas kev ua haujlwm tu.
Piv txwv ntawm Kev Saib Xyuas Kev Ntsuas thiab Kev Pom Zoo rau TFF Cassette Cleaning Validation thiab Routine Cleaning Effectiveness Assessment
Txhawm rau ua kom tau raws li kev cai tswj hwm thiab ua kom muaj kev ruaj ntseg ntawm TFF cassettes hauv cov txheej txheem tiag tiag, tuam txhab lag luam yuav tsum tsim kom muaj cov ntaub ntawv tsim nyog thiab tsim kom muaj kev tshawb fawb zoo thiab ua tiav txoj kev npaj ua tiav lub neej.
Cov ntaub ntawv System:
Cassette Lifetime Study Protocol:Xws li kev tsim qauv, kev siv ntau tshaj plaws, thiab cov txheej txheem kev ntsuas cuam tshuam.
Ntxuav -Cycle Simulation Records:Qhov tseeb flux thiab cov ntaub ntawv kev ua tau zoo tau sau los ntawm kev rov ua dua tshiab.
Cleaning Validation Report:Cov txiaj ntsig ntawm TOC, conductivity, residual cleaning agents, thiab lwm yam kev ntsuam xyuas.
Daim Ntawv Qhia Txog Cov Khoom Siv Compatibility:Kev ruaj ntseg ntawm cov ntaub ntawv cassette nyob rau hauv tej yam kev mob xws li NaOH raug, siab kub, thiab lwm yam.
Kev siv lub log:Traceable cov ntaub ntawv ntawm kev siv cov cassette, suav nrog tus lej ntawm lub voj voog.
Txoj Cai Nyiaj Laus:Qhia meej meej txog qhov kev ua tau zoo uas lub cassette yuav tsum raug tshem tawm.
Kev Npaj Ua Haujlwm Hauv Lub Neej:
Txhais qhov siab tshaj plaws ntawm kev siv lub voj voog, feem ntau txiav txim siab raws li cov txheej txheem xav tau lossis cov lus pom zoo ntawm tus neeg muag khoom, thiab txhawb nqa los ntawm kev kwv yees thiab cov ntaub ntawv pov thawj txaus.
Qhia cov txheej txheem ntxuav, nrog rau cov hom thiab concentration ntawm cov tshuaj ntxuav tu, ntxuav qhov kub thiab txias thiab lub sij hawm, ntxuav ib ntus thiab yaug cov kauj ruam, nrog rau lub caij nyoog ntawm kev tu lub voj voog.
Tsim kom muaj qhov tseem ceeb saib xyuas kev ua haujlwm, xws li normalized water permeability (NWP), protein retention rate, transmembrane pressure (TMP), integrity testing, and microbial/endotoxin residuals.
Kev ntsuas tshuaj lom neeg tsis tu ncua, saib xyuas cov ntaub ntawv cassette rau cov cim qhia ntawm degradation. Cov txheej txheem xws li FTIR lossis SEM tuaj yeem siv los ntsuas cov ntaub ntawv hloov pauv, nrog rau kev ntsuas kev rho tawm thiab cov ntaub ntawv pov thawj thaum tsim nyog.
Xyuas cov residuals, suav nrog kev sim qhov kawg yaug rau pH, conductivity, thiab tag nrho cov organic carbon (TOC) kom ntseeg tau tias kev tshem tawm tag nrho cov tshuaj ntxuav, nrog rau kev kuaj microbial thiab endotoxin.
Cov ntsiab lus tseem ceeb rau Ultrafiltration Cassette Lifetime Validation:
