Kev lag luam kws tshuaj tau qiv cov thev naus laus zis los ntawm kev sib xyaw yas los ua ib qho kev sib xyaw tshuaj tshwj xeeb. Ntawm qhov tod tes, peb tuaj yeem kawm ntau yam los ntawm cov neeg qiv nyiaj. Interestingly, cov kawm yuav twv yuav raug hu tsim yav dhau los technologies los ntawm txawv foundations, uas nyob rau hauv lem yuav tsim kev tshoov siab tshiab rau cov kawm. Piv txwv li:
1. Pharmaceutical TSE them ntau xim rau cov kev cai thiab cov ntaub ntawv qhia, tshwj xeeb tshaj yog cov dynamic pharmaceutical manufacturing xyaum (cGMP) siv nyob rau hauv kev lag luam kev lag luam, uas yuav ua rau manufacturing ntau ruaj khov, reproducing, thiab ntau npaum. Nyob rau niaj hnub no nrhiav kev txawj ntse tsim, cov kev ntsuas no muaj txiaj ntsig zoo heev, vim tias kev ua haujlwm tau zoo yog lub hauv paus thiab qhov chaw ntawm kev txawj ntse.
2. Qhov kev nyiam rau qee yam ntawm TSE, xws li kev nyiam rau counter-rotating intermeshing ntxaib-ntsia hlau extruders, yog ib qho nthuav tshwm sim uas tsim nyog rau kev tsom xam.
3. Nws yog tsim nyog sau cia qhov tseem ceeb ntawm tej yam yas TSE technologies. Piv txwv li, los ntawm kev rov tshuaj xyuas qhov kev ua haujlwm ntawm kev tshaib plab noj, peb tuaj yeem kawm tau los ntawm PP volatilization thiab txo cov ntxhiab tsw, thiab kev paub txog kev zam kom tsis txhob muaj shearing ntau dhau ntawm kev noj qab haus huv ntawm qhov chaw ua haujlwm yog qhov txhawb nqa rau lub teeb-diffusing plastics. .
Twin-ntsia hlau extrusion tau ua tus txheej txheem rau plastics compounding rau xyoo lawm, tab sis nws tsuas yog tau txais los ntawm kev lag luam tshuaj nyob rau hauv xyoo tas los no. Nov yog yam uas cov yas compounders tuaj yeem kawm tau los ntawm peb cov kwv tij, tus kws tsim tshuaj, los pab peb ua cov khoom lag luam zoo dua thiab zoo ib yam.
Lub kaw lus siv lub ntxaib-ntsia hlau extruder los tsim cov khoom xa tshuaj. Qhov ntxaib-ntsia hlau extrusion granulation system nta cov cua txias conveyor siv thiab hauv-kab tuab txiav txim siab los tsim microparticles ntawm kwv yees li 0.8 hli rau microcapsule filling.
Rau ntau tshaj 50 xyoo, ntxaib-ntsia hlau extrusion yog ib tug zoo-tsim technology rau manufacturing yas blends. Ua ntej ntxaib-ntsia hlau extruders (TSE) tau txais, mixers thiab ib leeg-ntsia hlau extruders feem ntau yog cov khoom siv sib xyaw ntawm kev xaiv rau cov khoom sib xyaw. Tab sis niaj hnub no, TSE yog qhov kev xaiv zoo tshaj plaws rau cov yas sib xyaw vim qhov ruaj khov ntawm ntau cov qauv sib txawv ntawm tib lub extruder thiab nws cov khoom siv tu tus kheej.
Ob peb lub xyoo dhau los, kev lag luam kws tshuaj kuj tau txais cov ntxaib-ntsia hlau extruders rau kev tsim ntau yam ntawm cov tshuaj thiab cov khoom siv kho mob ntau yam. TSE tam sim no feem ntau siv los ua cov khoom xyaw tshuaj nquag ua ke nrog cov khoom siv polymers thiab cov khoom siv ntxiv, qhov twg cov khoom siv polymers thiab cov khoom siv ua cov khoom sib txuas. Raws li nyob rau hauv daim ntawv thov masterbatch, TSE yog siv los ua ib qho kev sib xyaw ua ke los tsim cov khoom zoo, cov ntaub ntawv zoo sib xws rau kev xa tshuaj, suav nrog cov ntsiav tshuaj, cov khoom siv cog qoob loo, kev kho mob thiab ntau lwm yam khoom. Cov ntawv thov muaj xws li los ntawm cov tswj kev tso tawm mus rau qhov ncauj bioavailability txhim kho.
Tsis muaj qhov tsis ntseeg tias cov tuam txhab tshuaj tau sau cov txiaj ntsig ntawm 100 xyoo ntawm TSE kev tsim kho thev naus laus zis thiab kev ua kom zoo dua qub, suav nrog kev ua tiav kev lag luam thiab kev tshawb fawb hauv plastics. Tab sis tam sim no yog lub sijhawm rau cov tuam txhab plastics ua raws li cov kauj ruam ntawm cov tuam txhab tshuaj thiab - tsawg kawg yog qee lub sijhawm - siv cov kev coj ua zoo tsim khoom (cGMP) siv hauv kev lag luam tshuaj kom ntseeg tau tias kev tsim khoom muaj txiaj ntsig thiab tsim cov khoom zoo dua.
Kev txhim kho kev ua haujlwm nyob rau xyoo 1980s thiab 1990s tau ua rau muaj ntau yam kev lag luam xa tshuaj uas vam khom rau TSEs. Tsav los ntawm FDA's Process Analytical Technology kev ua ub no, kev siv cov ntxaib-ntsia hlau extruders txij li thaum tau txais los ntawm tiag tiag feem ntau ntawm cov tuam txhab tshuaj hauv ntiaj teb.
Keeb kwm, feem ntau cov qauv xa tshuaj tau tsim los ntawm kev sib xyaw ua ke. FDA's 2004 PAT kev ua ub no muab cov tuam txhab tshuaj nrog lub hauv paus los qhia kev txhim kho tshuaj, tsim khoom, thiab kev ruaj ntseg zoo los ntawm kev saib xyuas online. Hauv luv luv, PAT cov dej num txhawb kom cov neeg ua haujlwm tshiab yuav tsum tau tsim thiab tsim los ntawm kev ua haujlwm tas mus li nrog kev saib xyuas hauv online ntawm cov ntsiab lus tseem ceeb. Cov ntaub ntawv no tuaj yeem tsuas yog sau los ntawm tus neeg xa khoom extruder.
Twin-screw extruders txheej txheem cov khoom siv nyob rau hauv ib qho channel uas txuas nrog ib sab ntawm cov ntsia hlau thiab lub thoob phab ntsa, yog li nws yog hu ua me me-batch nruam tov khoom. Lub cev muaj zog inputs lub zog rau hauv cov txheej txheem, thiab kev sib tov yog nqa tawm los ntawm rotating cov ntsia hlau. Cov txheej txheem tswj tsis muaj xws li cov ntsia hlau ceev (rpm), pub tus nqi, qhov kub thiab txias raws lub thoob rau qhov tuag, thiab lub tshuab nqus tsev. Cov kev ntsuas tsis zoo uas tau saib xyuas rau hauv-kab kev ntsuas zoo suav nrog yaj siab, yaj kub, lub cev muaj zog tam sim no thiab hauv kab IR sensors. Programmable logic controllers (PLCs) thiab touchscreen human-machine interfaces (HMIs) yog tam sim no cov cuab yeej siv tau zoo piv rau cov laus dua kev tswj hwm thiab cov cuab yeej nyeem ntawv.
Lub hauv paus tsim ntawm TSE rau cov yas lossis cov tshuaj yog tib yam. Lub hauv paus ntsiab lus sib xyaw thiab chav ua haujlwm segmentation yog qhov tseem ceeb tib yam. TSE cov thev naus laus zis ua pov thawj hauv cov chaw ua lag luam feem ntau tuaj yeem siv sai sai hauv cov txheej txheem tshuaj-TSE ua tiav yog qhov tseeb.
TSE siv segmented threads sib sau ua ke ntawm siab torque ntsia hlau shafts. Lub chim kuj yog modular thiab kev koom ua ke nrog cov bores sab hauv rau chim txias. Lub segmented ntsia hlau thiab chim, ua ke nrog cov tswj twj tso kua mis thiab nws tus kheej-tu khoom ntawm cov co-rotating screws, cia cov ntsia hlau / chim geometry yuav tsum matched rau cov ua hauj lwm. Lub counter-rotating intermeshing ntxaib-ntsia hlau qauv kuj yog siv rau kev ua PVC, masterbatches thiab tshuaj compounding daim ntaub ntawv.
Piv nrog rau cov khoom siv sib xyaw ua ke loj, TSE qhov kev sib xyaw ua ke siab thiab lub sij hawm luv luv ntawm cov khoom sib pauv ntawm cov ntsia hlau yog qhov tsim nyog rau kev sib xyaw ua haujlwm zoo. Cov huab cua, cov dej noo thiab cov volatiles raug tshem tawm los ntawm lub tshuab nqus tsev thaum lub sij hawm extrusion txheej txheem. Lub sijhawm nyob luv luv (1 thib ob mus rau 2 feeb) hauv TSE yog qhov zoo rau ntau cov ntaub ntawv kub thiab shear rhiab heev, vim tias TSE tuaj yeem tsim los txwv nws qhov kub thiab txias rau ob peb feeb xwb.
TSE siv kev tshaib kev nqhis, thiab tus nqi ntau lawm yog txiav txim siab los ntawm lub feeder, uas ntsuas pellets, kua, hmoov thiab fibers mus rau seem ua. TSE ntsia hlau ceev tsis nyob ntawm tus nqi pub, vim kev pom kev sib xyaw ua haujlwm zoo. Zoo li pigments, qee cov APIs (cov khoom xyaw tshuaj nquag) xav tau kev sib xyaw ua ke hauv TSE, thaum lwm tus tau txais txiaj ntsig los ntawm kev faib khoom sib xyaw. Piv txwv li, ib qho shear-sensitive API los yog pigment tuaj yeem ntsuas nyob rau tom qab kawg ntawm qhov kev ua haujlwm kom tsis txhob muaj zog shear siab nyob rau hauv cov txheej txheem yaj.
Co-rotating TSE tam sim no sawv cev rau 90 feem pua ntawm TSE siv los tsim cov khoom lag luam masterbatch. Interestingly, ib tug loj feem ntawm counter-rotating intermeshing TSEs yog siv los ntawm cov kws manufacturers, tej zaum vim hais tias lawv tsis muaj preset preset rau co-rotating twin-screws.
Ib qho piv txwv ntawm cov txheej txheem tseem ceeb uas tau saib xyuas (nyob ntawm seb nws puas yog cov khoom siv yas, masterbatch lossis formulation) yog lub zog tshwj xeeb (SE), uas txhais tau tias yog lub zog nkag rau ib chav tsev ntawm cov khoom siv ua tiav. Yog tias muaj kev hloov pauv sai sai hauv SE, nws txhais tau tias, cov khoom siv, cov txheej txheem txheej txheem lossis cov khoom siv raw tau hloov pauv, thiab cov khoom kawg yuav txawv.
SE yog xam raws li nram no:
KW (lub sijhawm tiag tiag)=kW (lub cev muaj zog) X feem pua torque XRPM (khiav) / siab tshaj RPMX0.97 (gearbox efficiency)
yog li:
Lub zog tshwj xeeb=kW (lub sijhawm tiag) / ((kg / hr))
chav tsev:
SE yog cim raws li kW ib kg/hr
KW{{0}}kilowatt (lub cev muaj zog hauv kW=HPX0.746)
feem pua Torque=Feem pua ntawm kev siv lub zog siab tshaj plaws
RPM =Screw rotation speed/feeb
Nws tseem tuaj yeem ua ib lub thawv khoom uas saib xyuas thiab sau cov SE ntawm cov txheej txheem extrusion, txawm li cas los xij, feem ntau txaus nws tsis saib xyuas thiab nws tsim nyog nug vim li cas nws tsis raug saib xyuas.
Rau kev siv tshuaj, cov kab ke hauv qab kuj zoo ib yam li cov yas. Strand thiab tuag ntsej muag pellets yog siv rau cov dej soluble tshuaj cov khoom. Ntxiv nrog rau cov dej, cov khoom kuj tseem raug muab tso rau ntawm txoj siv conveyor, lossis thauj thiab txias hauv huab cua kom yooj yim granulation. Cov khoom me me tuaj yeem siv tau ncaj qha microencapsulation filling, thaum cov khoom loj dua feem ntau hauv av thiab compressed rau hauv cov ntsiav tshuaj. Laminated systems yog siv rau subcutaneous thiab insoluble film daim ntaub ntawv. Tubing systems tsim cov qauv tshuaj tiv thaiv kab mob, thaum coextruded rods tau muab tso rau hauv cov khoom siv tiv thaiv kab mob (xws li cov nplhaib ntawm qhov chaw mos). Xws li daim ntawv thov yog infinite.
TSEs siv nyob rau hauv ib puag ncig cGMP feem ntau ua raws FDA Tshooj 11 ntawm Title 21 ntawm Txoj Cai Tswjfwm Ntiag Tug (CFR) ntawm Cov Ntaub Ntawv Hluav Taws Xob thiab Cov Ntawv Sau Npe Hluav Taws Xob, uas teev cov qauv uas cov ntaub ntawv hluav taws xob yuav tsum ncaj ncees thiab ntseeg tau. Hauv kev xyaum, Tshooj 11 xav kom cov tuam txhab tshuaj siv los tswj, kev tshuaj xyuas, thiab kev siv cov software thiab cov tshuab koom nrog hauv kev ua cov ntaub ntawv hluav taws xob. Cov kev ntsuas uas raug saib xyuas yuav tsum raug txheeb xyuas thiab ntsuas raws sij hawm - qhov kev coj ua zoo rau kev teeb tsa extrusion.
Cov txheej txheem yuav tsum tau ua raws li txwv tsis pub nkag mus rau lub kaw lus los ntawm cov neeg tau txais kev tso cai thiab ua cov ntawv pov thawj kev ua haujlwm, kev txheeb xyuas cov cuab yeej siv, kev tswj cov ntaub ntawv kaw lus thiab lwm cov ntaub ntawv qhia. Kev ua raws li txoj hauv kev rau kev luam thiab khaws cov ntaub ntawv yog ib feem ntawm daim ntawv qhia.
Cov ntaub ntawv tsim nyog ntawm cov cuab yeej cuam tshuam nrog kev teeb tsa hauv thaj chaw tshuaj-qib ib puag ncig yuav tsum tau nthuav dav dua li ntawm cov khoom siv yas. Pharmaceutical grade installations siv sijhawm ntau lub hlis thiab ua haujlwm kom tiav kev teeb tsa thiab kev teeb tsa ntawm cov cuab yeej siv, xav tau cov ncauj lus kom ntxaws txog cov ntaub ntawv tshwj xeeb (FAT), kev tsim nyog (IQ) thiab kev ua haujlwm tsim nyog (OQ).
Kuj tseem muaj cov lus qhia cGMP rau kev tu tshuaj qib TSE tshuab. Piv txwv li, cov cuab yeej siv yuav tsum tau muab ntxuav ntawm lub sijhawm tsim nyog raws li cov txheej txheem sau tseg uas tau hais meej thiab meej. Tom qab ntxuav, cov cuab yeej tiv thaiv los ntawm kev kis kab mob mus txog thaum nws siv, thiab nws qhov kev huv huv yog kuaj ua ntej siv. Cov ntaub ntawv thiab cov cuab yeej teev tseg ntawm tag nrho cov kev tu thiab kev tshuaj xyuas yuav tsum tau khaws cia thiab lub sijhawm ntawm kev ua tiav thiab kev ntxuav tawm yuav tsum tau sau tseg. Cov txheej txheem zoo sib xws yuav muaj txiaj ntsig zoo rau kev ua haujlwm ntawm cov yas.
Raws li cov kev cai tswj hwm uas muaj nyob rau hauv kev tsim cov tshuaj, txhua yam uas muaj feem xyuam rau TSE manufacturing unit yuav tsum tau nruj me ntsis tswj thiab cov ntaub ntawv mus kom ze tshaj cov txheej txheem kev ua ub no ntawm cov plastics kev lag luam.
Peb cov lus qhia ntawm no tsis yog tias FDA cov lus qhia thiab cov kev cai rau cov khoom siv tshuaj tuaj yeem siv nruj me ntsis rau kev tsim cov yas sib xyaw, tab sis nws yuav muaj txiaj ntsig zoo los tshuaj xyuas cov haujlwm ntawm cov tuam txhab tsim tshuaj thiab xaiv cov khoom siv uas siv tau thiab siv tau. cov khoom, uas pab ua kom cov khoom ruaj khov thiab rov ua dua.
