Muab ob npaug rau Tube Cua Txias: Ib qho Kev Tiv Thaiv Kev Nyab Xeeb Kev Tiv Thaiv Kev Tiv Thaiv Kab Mob hauv Kev Lag Luam Pharmaceutical
Kev nkag siab tseem ceeb: Lub hauv paus ntsiab lus ntawm kev tiv thaiv kev sib kis kab mob thiab kev cais ob lub yeeb nkab
1. Cov kev pheej hmoo tseem ceeb ntawm cov tshuaj muaj kab mob sib kis
Hauv kev tsim tshuaj, kev khiav ntawm cov khoom sib txawv ntawm cov khoom, cov khoom siv, thiab cov khoom siv hluav taws xob (xws li dej txias thiab chav dej) yog qhov tseem ceeb ntawm kev sib kis. Tshwj xeeb tshaj yog nyob rau hauv cov tshuaj ua haujlwm siab, sterile formulations, thiab biopharmaceutical scenarios, trace contamination tuaj yeem ua rau cov khoom seem ntawm tag nrho cov khoom thiab ua rau muaj kev nyab xeeb. Nyob rau theem kev tswj hwm, Tshooj 197 ntawm Tuam Tshoj GMP (hloov kho hauv 2010) qhia meej tias yuav tsum tau ntsuas ntau li ntau tau los tiv thaiv kev ua qias tuaj thiab hla kev sib kis thaum lub sijhawm tsim khoom, suav nrog kev tsim khoom hauv thaj chaw sib txawv, kev tswj hwm qhov sib txawv, cov cuab yeej tshwj xeeb, thiab lwm yam kev ntsuas los ntawm tsoomfwv Suav; Pharmacopoeia Committee's "Cov Lus Qhia rau Kev Siv Tau thiab Kev Siv Cov Txheej Txheem Kev Txiav Txim Rau Kev Tshuaj Ntsuam Xyuas Aseptic" (9206) tau piav qhia ntxiv txog qhov yuav tsum tau ua rau kev sib khi, ua kom tsis muaj menyuam, thiab saib xyuas cov txheej txheem cais tawm.
2.Qhov tseem ceeb ntawm kev sib cais ntawm ob lub raj: dual barrier + lus ceeb toom tawm
Ob chav raj cais tawm (nrog ob lub raj phaj kub exchanger raws li cov tub ntxhais cov cab kuj) yog cov txheej txheem kev daws teeb meem rau kev siv tshuaj tua kab mob, thiab nws cov tshuaj tiv thaiv kev ua qias tuaj nyob rau hauv cov nyhuv synergistic ntawm ob lub sealing teeb meem thiab xau ceeb toom raws:
Kev tsim qauv: Ob lub raj xaim hluav taws xob tau nruab rau ntawm txhua qhov kawg ntawm lub raj xa hluav taws xob sib txuas, txuas lub raj sab (khoom / txheej txheem nruab nrab) thiab lub plhaub sab (qhov nruab nrab siv hluav taws xob) raws li, tsim ib qho nruab nrab cais chamber ntawm ob lub raj phaj; Cov raj xa hluav taws xob hla dhau los ntawm ob lub raj xaim ib txhij thiab raug kho los ntawm kev nthuav dav / vuam, tsim ob txoj kab sib khi ywj pheej.
Kev tiv thaiv kev ua qias tuaj: Yog tias ib lub raj xa hluav taws xob los yog lub raj phaj txuas txuas, qhov nruab nrab yuav tsis ncaj qha mus rau sab nraud ntawm cov dej ntws, tab sis yuav raug coj mus rau qhov nruab nrab ntawm kev sib cais chamber thiab tso tawm los ntawm qhov chaw nres nkoj tawm / saib xyuas chaw nres nkoj, ua tiav kev tiv thaiv kev nyab xeeb ntawm "controlled to → ceeb toom ntxov →".
Kev ua raws li tus nqi: Kev tshuaj xyuas FDA tau teev npe ob lub raj phaj tsim raws li cov kev xav tau rau kev siv tshuaj dej (cov dej huv, dej txhaj tshuaj). Ib lub phaj tsim yuav tsum tau ntsuas kev ntsuas ntxiv, txwv tsis pub nws yuav raug suav nrog hauv 483 daim ntawv teev kev soj ntsuam xyuas.
Kev lees paub ua raws: tag nrho lub voj voog tswj los ntawm kev tsim mus rau kev ua haujlwm
Kev ua tau zoo ntawm ob lub raj sib cais yuav tsum tau kuaj xyuas los ntawm DQ / IQ / OQ / PQ tag nrho lub voj voog pov thawj kom ua raws li cov kev cai tswj hwm. Cov txheej txheem tshwj xeeb yog raws li hauv qab no:
1.Design Confirmation (DQ)
Cov ntsiab lus tseem ceeb: Sib piv URS (Cov Neeg Siv Cov Lus Qhia Tshwj Xeeb) kom paub meej tias cov qauv, cov khoom siv, kev tsim channel ntws, thiab kev saib xyuas cov dej xau ntawm ob lub raj phaj ua raws li cov txiaj ntsig ntawm kev ntsuas kev pheej hmoo ntawm kev sib kis; Qhia meej meej txog qib kev huv, qhov sib txawv ntawm qhov sib txawv, thiab txoj kev ua kom tsis muaj menyuam (xws li vaporized hydrogen peroxide VHP) ntawm lub tshuab cais tawm thiab RABS ( txwv tsis pub nkag mus rau hauv lub cev).
Cov ntaub ntawv tso tawm: tsim cov duab kos, daim ntawv qhia txog kev pheej hmoo (FMEA), cov ntaub ntawv pov thawj, URS daim ntawv lees paub ua raws.
2. Kev lees paub kev teeb tsa (IQ)
Cov ntsiab lus tseem ceeb: Txheeb xyuas cov ntaub ntawv pov thawj cov khoom siv, cov ntaub ntawv txheeb xyuas vuam (kev nkag mus / kuaj hluav taws xob), thiab cov ntawv qhia ob lub raj phaj hydrostatic test; Paub meej tias qhov kev huv huv ntawm qhov chaw teeb tsa tsis yog qis dua qib D, thiab siv cov flanges tshwj xeeb thiab cov sealant los kaw cov phab ntsa kom tsis txhob muaj qhov khoob.
Kev tshuaj ntsuam xyuas tseem ceeb: kev ncaj ncees ntawm cov dej xau nrhiav kom pom chamber sealing, tsis muaj cov kab tuag / qhov muag tsis pom cov kav dej hauv cov kav dej, hloov pauv lub valve qhib thiab kaw, thiab ntsuas qhov ntsuas qhov sib txawv ntawm cov khoom sib txawv.
3.Operational Qualification (OQ)
Cov ntsiab lus tseem ceeb: Kev ntsuas kub hloov pauv kev ua haujlwm, kev poob siab, thiab kev tswj qhov kub thiab txias; Txheeb xyuas qhov kev saib xyuas cov dej xau (simulate to, paub meej tias lub chamber cais tau sai sai thiab tswb); Paub meej tias cov txheej txheem CIP (online tu) / SIP (online sterilization) txheej txheem tuaj yeem npog tag nrho cov kev khiav dej num, thiab cov nyhuv tu raws li tus qauv (qhov seem tsawg dua lossis sib npaug li 10ppm).
Cov ntaub ntawv tso zis: Khiav cov ntaub ntawv xeem, ceeb toom muaj nuj nqi pov thawj, CIP / SIP txheej txheem kev lees paub daim ntawv tshaj tawm.
4. Kev Kawm Txuj Ci (PQ)
Cov ntsiab lus tseem ceeb: Lub kaw lus ua haujlwm tsis tu ncua rau 21 hnub, saib xyuas cov ntsuas microbial thiab endotoxin ntawm cov khoom sab yam tsis muaj qhov txawv txav; Ib puag ncig sab hauv ntawm lub tshuab cais tawm mus txog Chav Kawm A (ib qho- kev txheeb xyuas qhov ntws); Tus nqi xau tseem ua tau raws li cov qauv thiab tsis muaj qhov xwm txheej ntawm kev sib kis.
Cov ntaub ntawv tso tawm: Daim Ntawv Pom Zoo Ua Haujlwm, Cov Ntaub Ntawv Saib Xyuas Ib Cheeb Tsam, Cov Ntaub Ntawv Deviation.
Daim ntawv thov Scenario: Dual tube rho tawm tswv yim rau cov kws tshuaj sib txawv
1. Kev tsim cov tshuaj ua kom tsis muaj menyuam (txhaj tshuaj, qhov muag tee)
Cov ntsiab lus tseem ceeb: Tshem tawm cov xov xwm streaming, tswj kom muaj chav kawm A huv si, thiab tsis txhob muaj kab mob microbial.
Cov ntsiab lus tseem ceeb ntawm txoj kev npaj: Cov dej txhaj tshuaj tau txais ob lub raj phaj kub hloov pauv (Sub Loop thib ob ncig tsim) kom ua tiav cov dej txias ntawm 80℃mus rau 25℃(hauv qab tus nqi ntws ntawm 6T / h, ib qho 1-meter-ntev ob lub raj phaj tuaj yeem ua tau raws li qhov yuav tsum tau ua, thiab kev teeb tsa yooj yim); Qhov chaw ua haujlwm tseem ceeb tau txais kev sib cais / RABS, nrog unidirectional ntws tshuab sab hauv. Cov ntaub ntawv nkag thiab tawm los ntawm ob lub qhov rooj sib cuam tshuam hloov qhov rais, thiab lub qhov rooj thaiv qhov rooj tiv thaiv kev qhib ib txhij.
2. Biopharmaceuticals (monoclonal antibodies, tshuaj tiv thaiv, tshuaj peptide)
Cov ntsiab lus tseem ceeb: Txhawm rau tiv thaiv kev sib kis ntawm cov protein ntau / cov kab mob thiab tsis txhob muaj roj ntsha ntau dhau.
Cov ntsiab lus tseem ceeb ntawm txoj kev npaj: ob lub raj phaj kub exchanger yog siv rau kev tswj kub ntawm kab lis kev cai nruab nrab thiab kev sib kis ntawm tus kab mob inactivation tov; Tsim cov kev cob qhia ua haujlwm ywj pheej rau siab - cov tshuaj peptide pheej hmoo, nruab nrog kev hloov pauv ywj pheej, hloov khoom siv, thiab cov chaw pov tseg pov tseg; Lub hauv paus ntawm phab ntsa siv cov khoom siv pov tseg (lub tes tsho, daim phiaj dig muag) kom tsis txhob muaj kab mob sib kis.
3. Pharmaceutical utility system (purified water, pure steam)
Cov ntsiab lus tseem ceeb: Ua kom huv huv ntawm kev tshaj tawm pej xeem thiab tsis txhob muaj cov txheej txheem dej paug.
Cov ntsiab lus tseem ceeb ntawm txoj kev npaj: Cov txheej txheem dej huv / tshuaj txhaj tshuaj tau txais ob lub raj phaj hluav taws xob hloov pauv, uas yog cais tawm tag nrho los ntawm cov dej nruab nrab ntawm cov dej kub kub los ntawm boiler; Lub tshuab hluav taws xob ntshiab huv yog nruab nrog ob lub raj phaj qauv, thiab cov dej nyoos thiab chav dej yog kaw thiab cais tawm kom tsis txhob muaj cov kab mob endotoxin.
Summary thiab Prospect
Lub hauv paus ntawm kev tiv thaiv kev sib kis kab mob yog nyob rau hauv kev sib cais ntawm qhov chaw, thiab dual tube cais tshuab muab ib qho kev nyab xeeb kev daws teeb meem rau kev siv tshuaj tua kab mob los ntawm "dual barriers + leak ceeb toom". Hauv kev siv cov tswv yim, nws yog ib qho tsim nyog yuav tsum sib koom ua ke cov cuab yeej siv ob lub raj nrog kev sib cais, kev tswj cov txheej txheem, thiab cov txheej txheem pov thawj txhawm rau txhawm rau tsim kom muaj kev tiv thaiv kev tiv thaiv kev tiv thaiv kab mob.
Nyob rau hauv lub neej yav tom ntej, raws li kev lag luam kev lag luam hloov mus rau automation thiab kev txawj ntse, dual tube kev rho tawm thev naus laus zis yuav txuas ntxiv nrog kev saib xyuas hauv online (xws li -lub sij hawm xau sensors thiab microbial online soj ntsuam) thiab ntse tswj (tsis siv neeg siab sib txawv hloov kho, CIP / SIP ntse ncig) kom ua tiav "tiag - tsis siv neeg kev pheej hmoo" thiab tsis muaj kev pheej hmoo ntau dua. rau tshuaj zoo thiab kev nyab xeeb. Cov tuam txhab lag luam yuav tsum tau ua tib zoo saib xyuas kev tswj hwm kev tswj hwm thiab thev naus laus zis tshiab, txuas ntxiv txhim kho cov phiaj xwm kev sib cais ntawm ob lub yeeb nkab, thiab xyuas kom muaj kev txhim kho dual ntawm kev ua raws cai thiab kev ua haujlwm ntau lawm.
