Txhaj dej ntau lawm txheej txheem nrog tshav kub Exchanger
Khoom piav qhia
Kev txhaj tshuaj dej yog qhov kev siv ntau tshaj plaws uas tsis muaj tshuaj lom hauv kev tsim cov tshuaj tsis muaj menyuam.Cov kev cai zoo rau kev txhaj tshuaj dej tau raug tswj hwm nruj me ntsis hauv cov tshuaj pharmacopoeias.Ntxiv rau cov khoom tshuaj xyuas ib txwm muaj rau cov dej distilled, xws li acidity, chloride, sulfate, calcium, ammonium, carbon dioxide, yooj yim oxidizable tshuaj, tsis-volatile tshuaj, thiab hnyav hlau, nws kuj yuav tsum xeem dhau qhov kev kuaj pyrogen.GMP qhia meej meej tias kev npaj, khaws cia, thiab faib cov dej huv thiab cov dej txhaj tshuaj yuav tsum tiv thaiv kom tsis txhob muaj kev loj hlob thiab kis kab mob.Cov ntaub ntawv siv rau lub tank thiab cov kav dej yuav tsum tsis muaj tshuaj lom thiab corrosion-resistant.
Cov kev xav tau zoo rau cov khoom siv tshuaj tua dej yog raws li hauv qab no:
Cov dej txhaj tshuaj yog siv los ua cov kuab tshuaj rau kev npaj cov tshuaj tua kab mob thiab cov tshuaj tua kab mob kom tsis muaj menyuam, lossis rau kev ntxuav cov vials (kev ntxuav huv), kev ntxuav zaum kawg ntawm cov roj hmab stoppers, cov dej ntshiab huv, thiab kev kho mob cov dej-soluble hmoov cov kuab tshuaj rau sterile hmoov txhaj tshuaj, infusions, Kev txhaj tshuaj dej, thiab lwm yam. Vim tias cov tshuaj npaj tau ncaj qha rau hauv lub cev los ntawm cov leeg nqaij lossis cov hlab ntsha, cov kev xav tau zoo yog qhov tshwj xeeb thiab yuav tsum ua kom tau raws li cov kev cai ntawm ntau yam kev txhaj tshuaj, tsis muaj pyrogens, clarity, hluav taws xob conductivity yuav tsum tau. > 1MΩ/cm, kab mob endotoxin <0.25EU/ml, thiab microbial index <50CFU/ml.
Lwm cov qauv dej zoo yuav tsum ua tau raws li cov ntsuas tshuaj ntawm cov dej huv huv thiab muaj cov organic carbon concentration tsawg heev (ppb qib).Qhov no tuaj yeem raug saib xyuas ncaj qha los ntawm kev siv tshwj xeeb tag nrho cov organic carbon analyzer, uas tuaj yeem muab tso rau hauv cov dej txhaj tshuaj lossis xa rov qab mus rau ib txhij saib xyuas hluav taws xob conductivity thiab qhov kub thiab txias.Ntxiv rau kev ua kom tau raws li qhov yuav tsum tau ua ntawm cov dej huv huv, cov dej txhaj tshuaj yuav tsum muaj cov kab mob suav nrog <50CFU / ml thiab dhau qhov kev kuaj pyrogen.
Raws li GMP cov cai, cov dej huv huv thiab cov dej txhaj tshuaj yuav tsum tau txais kev lees paub GMP ua ntej lawv tuaj yeem siv tau.Yog tias cov khoom yuav tsum tau xa tawm, nws yuav tsum tau ua raws li cov kev cai sib xws ntawm USP, FDA, cGMP, thiab lwm yam. Rau kev siv yooj yim thiab ntau yam kev kho mob kom tshem tawm impurities hauv dej, Table 1 teev cov dej zoo ntawm USP GMP thiab cov teebmeem ntawm ntau yam kev kho mob rau kev tshem tawm impurities hauv dej raws li suav nrog hauv Suav GMP cov lus qhia.Kev npaj, khaws cia, thiab faib cov dej txhaj tshuaj yuav tsum tiv thaiv kev loj hlob thiab kis kab mob ntawm cov kab mob.Cov ntaub ntawv siv rau lub tank thiab cov kav dej yuav tsum tsis muaj tshuaj lom thiab corrosion-resistant.Kev tsim thiab kev teeb tsa cov kav dej yuav tsum tsis txhob muaj qhov kawg tuag thiab qhov muag tsis pom cov kav dej.Kev tu thiab ua kom tsis muaj menyuam yuav tsum tsim kom muaj lub tank cia thiab cov kav dej.Qhov chaw nres nkoj ntawm qhov tso dej tso dej yuav tsum tau nruab nrog lub lim dej hydrophobic bactericidal uas tsis tso cov fibers.Cov dej txhaj tshuaj tuaj yeem khaws cia los ntawm kev siv cov rwb thaiv tsev kub siab tshaj 80 ℃, qhov kub ntawm qhov kub siab tshaj 65 ℃, lossis cia hauv qab 4 ℃.
Cov kav dej siv rau cov khoom siv ua ntej rau kev txhaj tshuaj dej feem ntau siv ABS engineering yas lossis PVC, PPR, lossis lwm yam khoom tsim nyog.Txawm li cas los xij, kev faib cov dej huv thiab cov dej txhaj tshuaj yuav tsum siv cov khoom siv sib txuas rau cov tshuaj tua kab mob, pasteurization, cua sov kom tsis muaj menyuam, thiab lwm yam, xws li PVDF, ABS, PPR, thiab nyiam dua stainless hlau, tshwj xeeb tshaj yog hom 316L.Stainless hlau yog ib lo lus dav dav, nruj me ntsis hais lus, nws muab faib ua stainless hlau thiab acid-resistant steel.Stainless hlau yog ib hom hlau uas tiv taus corrosion los ntawm cov xov xwm tsis muaj zog xws li huab cua, chav, thiab dej, tab sis tsis tiv taus corrosion los ntawm cov tshuaj lom neeg xws li acids, alkalis, thiab ntsev, thiab muaj cov khoom tsis muaj zog.
(I) Cov yam ntxwv ntawm kev txhaj tshuaj dej Tsis tas li ntawd, kev cuam tshuam ntawm kev khiav ceev ntawm kev loj hlob ntawm cov kab mob hauv cov yeeb nkab yuav tsum raug txiav txim siab.Thaum Reynolds tus naj npawb Re nce mus txog 10,000 thiab tsim kom muaj kev ruaj khov, nws tuaj yeem tsim cov xwm txheej tsis zoo rau kev loj hlob ntawm cov kab mob.Ntawm qhov tsis sib xws, yog tias cov ntsiab lus ntawm cov txheej txheem dej tsim thiab kev tsim khoom tsis tau them nyiaj rau, ua rau qis qis qis, cov yeeb nkab phab ntsa, lossis cov kav dej tsis pom kev hauv cov kav dej, lossis siv cov khoom siv tsis zoo, thiab lwm yam, cov kab mob tuaj yeem ua tiav. cia siab rau lub hom phiaj xwm txheej tshwm sim los ntawm qhov no los tsim lawv tus kheej qhov chaw yug me nyuam - biofilm, uas ua rau muaj kev pheej hmoo thiab teeb meem rau kev ua haujlwm thiab kev tswj hwm txhua hnub ntawm cov dej lim dej thiab cov dej txhaj tshuaj.
(II) Cov kev cai tseem ceeb rau kev txhaj tshuaj dej
Cov dej txhaj tshuaj yog tsim los ntawm cov khoom siv kho dej, cov khoom siv cia, cov twj tso kua mis, thiab cov kav dej.Kev kho dej yuav raug cuam tshuam rau sab nraud los ntawm cov dej nyoos thiab lwm yam.Cov dej tsis huv yog qhov tseem ceeb sab nraud ntawm cov pa phem rau kev kho dej.Teb Chaws Asmeskas Pharmacopeia, European Pharmacopeia, thiab Suav Pharmacopeia txhua tus kom meej meej tias cov dej nyoos rau cov dej tshuaj yuav tsum ua kom tau raws li cov qauv zoo rau cov dej haus.Yog tias tsis tau raws li tus qauv dej haus, kev ntsuas ua ntej yuav tsum tau ua.Txij li thaum Escherichia coli yog ib qho cim ntawm kev sib kis hauv dej, muaj cov kev cai meej rau Escherichia coli hauv cov dej haus thoob ntiaj teb.Lwm cov kab mob kis tsis tau raug cais tawm thiab tau sawv cev hauv cov qauv raws li "tag nrho cov kab mob suav".Tuam Tshoj qhia txog kev txwv ntawm 100 kab mob / ml rau tag nrho cov kab mob suav, qhia tias muaj cov kab mob microbial nyob rau hauv cov dej nyoos uas ua tau raws li tus qauv dej haus, thiab cov kab mob tseem ceeb uas ua rau muaj kev phom sij rau kev kho dej yog cov kab mob Gram-negative.Lwm yam xws li cov chaw nres nkoj tsis muaj kev tiv thaiv ntawm lub tso tsheb hlau luam lossis kev siv cov roj lim tsis zoo, lossis cov dej rov qab los ntawm cov qhov hluav taws xob tsis huv, tuaj yeem ua rau muaj kev sib kis sab nraud.
Tsis tas li ntawd, muaj kev sib kis sab hauv thaum lub sijhawm npaj thiab ua haujlwm ntawm kev kho dej.Kev sib kis sab hauv yog ze ze rau kev tsim, xaiv cov khoom siv, kev ua haujlwm, kev tu, kev khaws cia, thiab kev siv cov tshuab kho dej.Ntau yam khoom siv kho dej tuaj yeem dhau los ua qhov chaw sab hauv ntawm cov kab mob microbial, xws li cov kab mob hauv cov dej nyoos raug adsorbed rau ntawm qhov chaw ntawm cov pa roj carbon activated, ion exchange resins, ultrafiltration membranes, thiab lwm yam khoom siv, tsim biofilms.Cov kab mob nyob hauv biofilms raug tiv thaiv los ntawm biofilms thiab feem ntau tsis cuam tshuam los ntawm cov tshuaj tua kab mob.Lwm qhov chaw ntawm kev sib kis muaj nyob rau hauv qhov system faib.Cov kab mob tuaj yeem tsim cov kab mob ntawm cov kav dej, cov kav dej, thiab lwm qhov chaw thiab muab faib rau hauv, tsim biofilms, yog li ua qhov chaw tsis tu ncua ntawm kev sib kis.Yog li ntawd, qee lub tuam txhab txawv teb chaws muaj cov qauv nruj dua rau kev tsim cov tshuab kho dej.
(III) Kev khiav hauj lwm hom kev txhaj tshuaj dej
Xav txog kev tu thiab tshuaj tua kab mob tsis tu ncua ntawm cov kav dej xa dej, feem ntau muaj ob txoj haujlwm ua haujlwm rau cov dej lim dej thiab cov dej txhaj tshuaj.Ib qho yog batch lag luam, qhov twg cov dej yog tsim nyob rau hauv batch, zoo ib yam li cov khoom.Kev ua haujlwm "batch" feem ntau yog rau kev txiav txim siab txog kev nyab xeeb, vim tias txoj kev no tuaj yeem cais qee qhov dej thaum lub sijhawm sim mus txog thaum qhov kev xeem tiav.Lwm qhov yog kev tsim khoom tas mus li, hu ua "nruam", uas cov dej tuaj yeem tsim tau thaum siv.
IV) Kev tswj hwm txhua hnub ntawm cov dej txhaj tshuaj Kev tswj hwm txhua hnub ntawm cov dej hauv dej, suav nrog kev ua haujlwm thiab kev saib xyuas, yog qhov tseem ceeb rau kev siv tau thiab kev siv ib txwm muaj.Yog li ntawd, yuav tsum tau tsim kom muaj kev saib xyuas thiab kev tiv thaiv kev tiv thaiv kev tiv thaiv kom ntseeg tau tias cov dej hauv lub cev yeej ib txwm tswj tau.Cov ntsiab lus no suav nrog:
Kev khiav hauj lwm thiab kev saib xyuas cov txheej txheem rau cov dej system;
Kev soj ntsuam txoj kev npaj rau qhov tseem ceeb ntawm cov dej tsis zoo thiab kev ua haujlwm tsis zoo, suav nrog kev ntsuas cov cuab yeej tseem ceeb;
Kev npaj tshuaj tua kab mob/sterilization;
Kev tiv thaiv kev saib xyuas cov khoom siv kho dej;
Kev tswj cov txheej txheem rau cov khoom siv kho dej tseem ceeb (nrog rau cov khoom tseem ceeb), cov kav dej xa dej, thiab cov kev ua haujlwm.
Cov kev xav tau rau cov khoom siv kho mob ua ntej:
Cov khoom siv kho mob ua ntej rau cov dej lim dej yuav tsum tau nruab raws li cov dej tsis zoo ntawm cov dej nyoos, thiab qhov yuav tsum tau ua ntej ua kom tau raws li tus qauv dej haus.
Multi-media filters thiab water softeners yuav tsum muaj peev xwm ua tsis siv neeg rov qab ntxuav, rov tsim dua tshiab, thiab tso tawm.
Activated carbon lim yog qhov chaw uas cov organic teeb meem accumulates.Txhawm rau tiv thaiv cov kab mob thiab cov kab mob endotoxin paug, ntxiv rau qhov yuav tsum tau siv rov qab tsis siv neeg, cov tshuaj tua kab mob tuaj yeem siv tau.
Txij li qhov kev siv ntawm 255 nm wavelength ntawm UV teeb raug cuam tshuam los ntawm UV yog qhov sib npaug ntawm lub sijhawm, cov cuab yeej siv nrog lub sijhawm kaw thiab siv ntsuas ntsuas yuav tsum tau ua.Lub immersed ib feem yuav tsum siv 316L stainless hlau, thiab lub quartz teeb npog yuav tsum tau detachable.
Cov dej huv tom qab dhau los ntawm kev sib xyaw-txaj deionizer yuav tsum tau nthuav tawm kom ruaj khov cov dej zoo.Txawm li cas los xij, lub txaj sib xyaw deionizer tuaj yeem tshem tawm cov cations thiab anions los ntawm dej, thiab nws tsis zoo rau kev tshem tawm endotoxins.
Cov kev xav tau rau kev tsim cov dej txhaj tshuaj (ntsev huv) los ntawm cov khoom siv kho dej: Cov dej txhaj tshuaj tuaj yeem tau txais los ntawm distillation, thim rov qab osmosis, ultrafiltration, thiab lwm yam. Ntau lub teb chaws tau teev meej txoj hauv kev rau kev tsim cov dej txhaj tshuaj, xws li:
Tebchaws Asmeskas Pharmacopeia (24th tsab) hais tias "cov dej txhaj tshuaj yuav tsum tau txais los ntawm kev siv tshuaj tua kab lossis rov qab osmosis purification ntawm cov dej uas ua tau raws li cov cai ntawm American Water and Environmental Protection Association, European Union, lossis Japanese txoj cai lij choj."
Cov European Pharmacopeia (1997 tsab) hais tias "cov dej txhaj yog tau los ntawm kev tsim cov dej distillation uas ua tau raws li kev cai lij choj rau cov dej haus lossis dej huv."
Suav Pharmacopeia (2000 tsab) qhia meej tias "cov khoom no (cov dej txhaj tshuaj) yog dej tau los ntawm distillation ntawm cov dej huv."Nws tuaj yeem pom tau tias cov dej huv uas tau txais los ntawm distillation yog qhov kev lees paub thoob ntiaj teb kev nyiam rau kev tsim cov dej txhaj tshuaj, thaum lub tshuab nqus dej huv tuaj yeem tau txais los ntawm tib lub tshuab dej distillation lossis lub tshuab hluav taws xob sib cais.
Distillation muaj txiaj ntsig zoo rau kev tshem tawm cov khoom tsis-volatile organic thiab inorganic, suav nrog cov khib nyiab pov tseg, colloids, kab mob, kab mob, endotoxins, thiab lwm yam impurities hauv dej nyoos.Cov qauv, kev ua tau zoo, cov khoom siv hlau, cov txheej txheem ua haujlwm, thiab cov dej tsis zoo ntawm lub tshuab dej distillation yuav cuam tshuam rau qhov zoo ntawm cov dej txhaj tshuaj.Lub "multi-effect" ntawm lub tshuab dej distillation multi-effect feem ntau yog hais txog kev txuag hluav taws xob, qhov twg thermal zog siv tau ntau zaus.Lub ntsiab tseem ceeb ntawm kev tshem tawm cov tshuaj endotoxins hauv lub tshuab dej distillation yog cov chav dej sib cais.
