1. Raws li cov cai ntawm EU kev txiav txim siab cov saw, cov txheej txheem seem seem nrog F0 Ntau dua lossis sib npaug ntawm 8 tuaj yeem xaiv yog tias nws tsis tuaj yeem ncav cuag 121 degree thiab ua kom tsis muaj menyuam hauv 15 feeb, cov lus nug yog: yog tias cov khoom tuaj yeem ncav cuag 121 degree thiab ua kom tsis muaj menyuam hauv 12 feeb, ces yuav tsis xaiv 121 degree thiab 10 feeb? Ib yam li ntawd, yog tias nws tuaj yeem ncav cuag 10 feeb, ces 8 feeb tsis tuaj yeem tso cai, tag nrho cov F0 Ntau dua lossis sib npaug rau 8?
Teb: Los ntawm tus qauv lej ntawm kev tua cov kab mob microbial, nyob rau hauv tib qho kev ua qias tuaj, qhov siab dua qhov kev ua kom tsis muaj menyuam F{{0}} tus nqi, qhov siab dua qhov kev ua kom tsis muaj menyuam. Yog li, nws yog qhov pom tseeb tias txhawm rau txo qhov kev pheej hmoo ntawm cov kab mob seem hauv cov khoom, nws yog qhov tsim nyog los xaiv tus nqi siab F0 ntau npaum li qhov ua tau.
2. Raws li cov khoom lag luam ruaj khov, nws tuaj yeem ua tau raws li 121 degree, 8 feeb thiab 115 degree, 30 feeb. Yam xwm txheej twg yuav tsum nyiam?
Teb: Txawm hais tias qhov khoom ntawm lub cev thiab tshuaj zoo stability, theoretically F{{0}} qhov tseem ceeb tau los ntawm ob qho xwm txheej no yuav luag sib npaug, nws tsis muaj teeb meem qhov twg yog qhov nyiam. Txawm li cas los xij, hauv kev tsim khoom tiag tiag, qhov kub nkag mus rau hauv cov khoom hauv lub tshuab kom tsis muaj menyuam, qhov sib txawv ntawm F0 qhov tseem ceeb tau txais los ntawm cov khoom nyob rau hauv ntau qhov chaw ntawm lub sterilizer, thiab qhov sib txawv ntawm F0 ntawm cov khoom hauv sib txawv batch sterilization yuav tsum tau txiav txim siab. Txoj kev ua kom tsis muaj menyuam nrog qhov sib txawv me me hauv kev faib hluav taws xob thiab qhov sib txawv me me ntawm cov khoom F0 tus nqi yuav tsum raug xaiv.
3. Cov kev ua kom tsis muaj menyuam hauv cov ntaub ntawv thov yog "121 degree, sterilization rau 30 feeb". Puas yog tus qauv no?
Teb: "121 degree, sterilize rau 30 feeb" nws tus kheej tsis yog rau lub davhlau ya nyob twg kom tsis muaj menyuam, vim nws yuav luag tsis tuaj yeem suav tus nqi F0 li no. Kev qhia txog kev ua kom tsis muaj menyuam tuaj yeem xa mus rau Suav Pharmacopoeia 2005 tsab ntawv ntxiv rau ob txoj kev ua kom tsis muaj menyuam 168, 121 degree 15min lossis 116 degree 40min.
4. Puas tsim nyog siv tib txoj kev ua kom tsis muaj menyuam rau 10ml thiab 20ml txhaj tshuaj ntawm tib yam?
Teb: Tib hom 10ml thiab 20ml txhaj tshuaj tuaj yeem ua kom tsis muaj menyuam hauv tib txoj kev, tab sis yuav tsum tau ua ib qho kev ntsuam xyuas thermal nkag mus rau qhov ntsuas kub ntawm cov qauv sib txawv, thiab txoj kev ua kom tsis muaj menyuam yuav tsum tau ua kom tsis muaj menyuam. cov khoom ntim loj.
5. Thaum xaiv cov txheej txheem sterilization ntawm kev ua kom tsis muaj menyuam siab tshaj plaws, nws yuav cuam tshuam nrog cov khoom zoo, xws li cov khoom muaj feem xyuam thiab kev ruaj ntseg., Yuav ua li cas sib npaug qhov tsis sib xws? Tsis tas li ntawd, cov tshuaj txhaj tshuaj yog muag nyob rau txawv teb chaws, Puas yog tsim nyog los ua kev tshawb fawb txog kev xaiv cov txheej txheem kom tsis muaj menyuam thaum thov rau kev siv hauv tsev?
Teb: Qhov tseeb, nyob rau hauv cov txheej txheem ntawm kev xaiv cov txheej txheem kom tsis muaj menyuam, kev kawm txog cov qauv kev hloov pauv zoo raws li kev ua kom tsis muaj menyuam sib txawv yuav tsum tau ua. Cov txheej txheem ntawm kev xaiv cov txheej txheem kom tsis muaj menyuam kuj yog cov txheej txheem ntawm kev ntsuas qhov ntsuas kom tsis muaj menyuam thiab (cov qauv zoo) ntsuas lub cev thiab tshuaj. Nyob rau hauv cov ntaub ntawv ntawm cov khoom uas muaj kev xav tau kev kho mob, kev xaiv ntawm sterilization txheej txheem yuav tsum tau raws li nyob rau hauv lub siab tshaj plaws ntawm sterility kom paub tseeb tias nws yuav ua tau. Rau cov hmoov txhaj tshuaj ua lag luam txawv teb chaws, kev siv cov tshuaj txhaj tshuaj yuav tsum tau kawm thaum lub sij hawm tshaj tawm hauv tsev. Yog tias cov tshuaj tseem ceeb yog qhov tsis ruaj khov tiv thaiv tshav kub thiab noo noo, tib cov tshuaj txhaj tshuaj raws li txawv teb chaws tuaj yeem siv tau; yog tias tsis tiv thaiv tshav kub, Rau dej tsis ruaj khov, ib daim ntawv ntau npaum li cas nrog rau qib siab ntawm kev ua kom tsis muaj menyuam yuav tsum raug xaiv raws li qhov xwm txheej ntawm cov tshuaj tseem ceeb.
6. Lub hauv paus ntsiab lus xaiv ntawm cov txheej txheem sterilization yog xav kom F0 Ntau dua lossis sib npaug rau 12 es tsis txhob F0 Ntau dua lossis sib npaug rau 8; los yog F0 Ntau dua lossis sib npaug li 8 ua tiav?
Teb: thov xa mus rau qhov kev txiav txim siab ntawm EU txheej txheem kev ua kom tsis muaj menyuam.
7. Puas yog txoj kev ciaj sia nyob hauv txoj kev txiav txim siab tseem nyiam qhov kub ntawm 121 degree?
Teb: Tsis tas li. Nws yog txiav txim siab raws li kev ruaj ntseg ntawm cov khoom. Yog tias qhov kub siab dua thiab lub sijhawm luv luv tuaj yeem ua tau raws li txoj kev muaj sia nyob, ces qhov kub thiab txias, thiab kev ua kom tsis muaj menyuam ntev dua yog qhov zoo dua rau cov khoom. Yog tias cov khoom tsis tuaj yeem tiv taus qhov kub siab ntawm 121 degree, ces qhov kub thiab txias tuaj yeem txo qis thiab xyuas kom meej tias qhov seem seem ntawm cov kab mob tsawg dua 10-6.
8. Rau cov tshuaj thermally tsis ruaj khov (xws li cov protein, cov khoom siv roj ntsha, thiab lwm yam), cov txheej txheem tsim cov aseptic yuav tsum raug txheeb xyuas ncaj qha.
Teb: Rau cov tshuaj thermally tsis ruaj khov (xws li cov proteins, cov khoom siv roj ntsha, thiab lwm yam), cov txheej txheem aseptic yuav tsum tau kawm ua ntej los xyuas seb puas yuav siv cov tshuaj tsis huv ntxiv rau cov txheej txheem aseptic, lossis cov txheej txheem aseptic sib dhos; Tom qab ntawd txheeb xyuas cov txheej txheem.
9. Puas muaj kev pov thawj ntawm ntau yam tsis tau teev tseg hauv cov txheej txheem ua tiav ntawm cov khoom tsim ua ntej daim ntawv thov npe khoom?
Teb: Kev tswj kev sau npe tshuaj tau teev tseg tias tom qab tus neeg thov tau thov rau "daim ntawv thov sau npe tshuaj", tus neeg thov yuav raug ceeb toom kom thov kev tshuaj xyuas ntawm qhov chaw mus rau lub chaw tswj xyuas cov tshuaj pov thawj yog tias tus neeg thov ua tau raws li qhov xav tau tom qab siv tshuaj. kev ntsuam xyuas qhov chaw xyuas. Lub hom phiaj ntawm kev tshuaj xyuas ntawm qhov chaw yog txhawm rau paub meej tias qhov ua tau ntawm cov txheej txheem tsim khoom, ib pawg ntawm cov qauv yuav tsum tau coj mus rau tib lub sijhawm, thiab cov qauv tsim khoom yuav tsum ua raws li GMP cov cai. Yog li thaum thov rau npe khoom, koj yuav tsum muaj kev paub txaus ntawm cov txheej txheem siv rau kev tsim cov khoom lag luam raug cai. Qhov kev nkag siab no yog ua raws li tag nrho cov txheej txheem ntawm cov khoom thiab cov txheej txheem kev txhim kho, kev nthuav dav, cov khoom siv thiab kev txheeb xyuas qhov system, thiab cov ntaub ntawv pov thawj batch ntau lawm. Lub hom phiaj ntawm cov ntaub ntawv pov thawj yog los ua pov thawj tias cov txheej txheem tuaj yeem tsim cov khoom tsim nyog nyob rau hauv cov txheej txheem teev tseg. Yog li ntawd, ua ntej pib nrog cov ntaub ntawv pov thawj, koj yuav tsum nkag siab tag nrho thiab muaj peev xwm tswj tau ntau yam tseem ceeb sib txawv hauv cov txheej txheem.
1 0. Thaum kuaj xyuas cov txheej txheem kom tsis muaj menyuam, qhov ntsuas ntsuas ntsuas feem ntau yog muab tso rau ib sab ntawm lub tshuab ua kom tsis muaj menyuam. Dab tsi yog qhov yuav tsum tau ua rau qhov kub thiab txias sib txawv ntawm ob? Peb puas yuav tsum ua raws li tus qauv pov thawj thiab tsuas yog tso cai sib txawv ntawm ± 0.5 degree?
Teb: Feem ntau hais lus:
① Cov ntaub ntawv kaw cia ywj pheej thiab kev soj ntsuam xyuas uas tuaj nrog lub tshuab tsis muaj menyuam yuav tsum ua kom tiav cov ntaub ntawv pov thawj txaus, thiab tom qab ntawd kho qhov sib txawv uas twb muaj lawm;
② Qhov tseeb ntawm qhov ntsuas kub ntsuas qhov ntsuas tau siv rau kev kuaj xyuas yuav tsum zoo dua li cov ntaub ntawv kaw lus thiab kev sojntsuam sojntsuam uas tuaj nrog lub sterilizer;
③Ib lub luag haujlwm ntawm kev txheeb xyuas nws tus kheej yog los kho qhov kev soj ntsuam xyuas thiab kev sojntsuam cov ntaub ntawv uas tuaj nrog lub sterilizer kom ua tiav qhov ntsuas kub zoo dua thaum siv ib txwm siv. Tam sim no, tsis muaj ib lo lus hais tias "tsuas yog tso cai rau qhov sib txawv ntawm ±0.5 degree".
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11. Nyob rau hauv tib txoj kab ntau lawm ntawm kev txhaj tshuaj loj, yog tias muaj cov tshuaj tua kab mob uas yuav tsum tau ua kom tsis muaj menyuam cov khoom ntawm ntau yam kev qhia tshwj xeeb (xws li 250ml, 100ml) thiab cov khoom uas muaj qhov sib txawv ntawm kev ua kom tsis muaj menyuam (xws li qhov sib txawv kom tsis muaj menyuam thiab lub sijhawm), ces yuav ua li cas. los tsim cov ntawv pov thawj ntawm kev faib hluav taws xob thiab kev nkag mus rau cov cua sov thaum lub sijhawm ua haujlwm thiab rov siv dua? Puas yog cov kev qhia tshwj xeeb thiab kev ua kom tsis muaj menyuam yog ib tus neeg siv tau?
Teb: Feem ntau hais lus, ntau yam kev qhia tshwj xeeb thiab ntau yam kev ua kom tsis muaj menyuam yuav tsum tau txheeb xyuas nyias. Sterilization ntawm cov khoom sib xyaw ntawm cov khoom sib txawv tsis pom zoo tshwj tsis yog tias muaj ntau cov ntaub ntawv cuam tshuam tuaj yeem txheeb xyuas.
12. Nyob rau hauv tus txheej txheem ntawm kev txheeb xyuas los yog reverifying lub ntub cua sov sterilizer, thaum xyuas qhov kev faib tawm ntawm tshav kub thiab tshav kub nkag, yog hais tias 12 los yog 16 thermocouples teem nyob rau hauv lub txee rau qhov kub thiab txias, qhov chaw txias pom yuav txawv nyob rau hauv peb cov ntaub ntawv pov thawj, dab tsi. yuav tsum tau ua yog tias qhov xwm txheej no tshwm sim?
Answer: Generally speaking, the cold point of no-load heat distribution should be around a certain location, otherwise it may be caused by equipment, pressure, incomplete air replacement, steam quality and other reasons. For loading thermal penetration, the cold point of the large volume injection (LVP, >100ml) nyob rau hauv geometric centre ntawm cov khoom thiab raws li ntsug axis nyob rau hauv qab ntawm cov khoom, tab sis validation yog yuav tsum tau.Qhov chaw ntawm lub txias point yog tsis raug rau me me ntim txhaj tshuaj vim hais tias cov tshuaj heats ntawm yuav luag tib tus nqi. raws li sterilizer.
Tsis tas li ntawd, kev taw qhia ntawm lub thawv kuj cuam tshuam rau qhov chaw ntawm qhov chaw txias, thiab thaum lub thawv tig los yog flipped, tej zaum yuav tsis pom qhov txias txias.Yog tias qhov chaw thau khoom tsis tu ncua, lub peev xwm yog tib yam, tsis muaj teeb meem ntawm chav nkag mus, thiab lwm yam, thiab qhov chaw txias tseem tsis tuaj yeem rov tshwm sim, qhov tsis paub tseeb hauv cov cuab yeej siv, txheej txheem, siab, chav dej zoo, thiab lwm yam, yuav tsum tau kuaj xyuas.
13. Dab tsi yog qhov txawv ntawm tag nrho cov khoom siv hluav taws xob faib hluav taws xob thiab tsis muaj hluav taws xob xa hluav taws xob raws li cov txiaj ntsig ntawm kev ua kom tsis muaj menyuam?
Teb: Ob qhov kev ntsuam xyuas ntsuas qhov kub thiab txias hauv chav kom tsis muaj menyuam, tab sis lawv tsis cuam tshuam txog qhov kub thiab txias tau txais txiaj ntsig hauv cov khoom, yog li lawv tsis tuaj yeem cuam tshuam ncaj qha rau kev ua kom tsis muaj menyuam ntawm cov khoom. mus rau hauv cov khoom.In the verification process, heat distribution tests of no-load, full-load and product heat penetration tau ua tiav.Lub hom phiaj tseem ceeb ntawm cov kev ntsuam xyuas no yog nthuav tawm ntau lub hom phiaj cov ntaub ntawv raws li qhov ua tau nrog ob peb qhov kev ntsuam xyuas. raws li qhov ua tau.Cov txiaj ntsig ntawm qhov kev sim yav dhau los muab cov ntaub ntawv rau kev sim tom qab.
14. Puas yog tag nrho cov khoom siv hluav taws xob xa hluav taws xob tau ua nrog lub raj mis khoob lossis nrog lub raj mis infusion uas muaj WFI?
Teb: Tag nrho cov khoom siv hluav taws xob xa hluav taws xob yog ua nrog cov qauv simulated.
15. Yog hais tias lub loading hom nyob rau hauv cov ntaub ntawv pov thawj yog ib nrab load los yog tag nrho cov load, nws puas yuav tsum tau xyuas yog hais tias nws yog nyob nruab nrab ntawm tag nrho load thiab ib nrab load nyob rau hauv lub yav tom ntej ntau lawm?
Teb: Rau cov loads ntawm tag nrho cov load thiab ib nrab load, nws raug nquahu kom siv simulated cov khoom filling kom ncav cuag tag nrho cov load los xyuas kom meej tias lub loading hom ntawm ntau lawm yog raws li nyob rau hauv validation.
16. Yuav ua li cas rau qhov ntsuas kub nkag?
Teb: Lub hom phiaj ntawm kev ntsuas cua sov yog los txiav txim qhov "qhov txias tshaj plaws" nyob rau hauv lub sterilization chamber loading, thiab kom paub meej tias qhov point tau txais asepsis txaus guarantee tus nqi nyob rau hauv lub predetermined sterilization txheej txheem, uas yog, cov seem ntawm cov kab mob tsawg dua. tshaj lossis sib npaug ntawm 10-6 thiab qhov sib txawv ntawm qhov ntsuas kub ntawm txhua qhov ntsuas qhov ntsuas thiab qhov nruab nrab ntawm qhov ntsuas kub hauv chav kom tsis muaj menyuam tsawg dua lossis sib npaug li 2.5 degree .Kev txheeb xyuas yuav tsum tau ua rau kev hloov pauv hauv kev ua haujlwm uas yuav cuam tshuam rau kev ua kom tsis muaj menyuam thiab paub meej txog txoj kev ua haujlwm.Piv txwv li, thaum lub hau npog stainless hlau ntxiv rau txhua lub tais kom tsis muaj menyuam, lub sijhawm cua sov hauv cov khoom siv tiag tiag (kev daws teeb meem) yog 2 feeb tom qab ntawd yam tsis muaj lub hau npog, yog li ntxiv 2 feeb rau cov txheej txheem kom tsis muaj menyuam. Qhov kev tso kawm ntawm lub thermocouple yog ua raws li tag nrho cov load heat distribution test raws tu qauv thiab tus qauv thermocouple muab tso rau hauv nruab nrab ntawm cov tshuaj sterilization.
17, Dab tsi yog lub tswv yim ntawm cov qauv simulated hauv kev ntsuas kub nkag, xa mus rau cov qauv me me hauv chav kuaj?
Teb: Cov qauv simulated hauv kev ntsuas thermal nkag mus rau cov qauv nrog tib lub thermal nkag mus rau qhov kev ua tau zoo li cov qauv tiag tiag, tsis yog cov qauv kuaj me me.
18, Puas yog hom kev ntsuas lom rau kev sim microbial kev sib tw yuav tsum raug xaiv raws li ntau yam? Yuav xaiv li cas?
Teb: Hom thiab kev xaiv ntawm bioindicator rau kev sib tw microbial tuaj yeem xa mus rau Suav Pharmacopoeia 2005 tsab ntawm qhov thib ob ntawm daim ntawv ntxiv 169 sterilization method.
19, Kev txiav txim siab ntawm cov kab mob microbial ua ntej kom tsis muaj menyuam?
Teb: Membrane filtration yog txoj kev siv ntau tshaj plaws. Nws yuav tsum raug txheeb xyuas ua ntej siv.
20, Cov kab mob microbial txwv qhov ntsuas ntawm cov khoom yog 0CFU, thiab tsis pom muaj kab mob tiv thaiv kab mob. Yog li ntawd, bacillus subtilis nrog tus nqi qis dua me ntsis D yuav siv tau los ua ib qho kev qhia lom neeg rau kev txheeb xyuas hauv cov txheej txheem pov thawj?
Teb: 1). Tsis muaj kev sib raug zoo ntawm cov txiaj ntsig ntawm kev ntsuas microbial txwv thiab kev xaiv ntawm Bacillus subtilis nrog tus nqi qis dua D me ntsis raws li kev ntsuas lom.
2). Raws li cov lus nug cov lus nug, nws tuaj yeem txiav txim siab tias txoj kev muaj sia nyob qhov yuav ua kom tsis muaj menyuam yog siv.Rau txoj kev ciaj sia taus txoj kev ua kom tsis muaj menyuam los kuaj qhov muaj sia nyob muaj peev xwm tuaj yeem xaiv qhov ntsuas lom, thiab tsuas yog vim cov khoom lossis ntim nws tus kheej tsis tuaj yeem dais ntau dhau. tua, thiab xaiv los sib piv cov txheej txheem tswj nruj, thiab cov kab mob thawj zaug tswj cov khoom lag luam, lossis ua ke nrog cov txheej txheem aseptic pom, thiab lwm yam, thiab tom qab ntawd xaiv qhov ntsuas kev ntsuas lom neeg, ntsuas qhov nruab nrab cov ntsiab lus ntawm cov kab mob N{{1} }, rau tsis pub tsawg tshaj 4 gradient kab mob kom muaj nuj nqis, batch, kom muaj nuj nqis ntawm cov khoom txaus ua ntej thiab tom qab sterilization ntawm microbial txwv kuaj (yog tias tsim nyog, kuj xav mus kuaj nrog txawv sterilization lub sij hawm), nrhiav thiab tau ntau tshaj qhov poob ntawm rau Cov qib logarithmic ntawm lub xeev parameter, Nyob rau hauv cov xwm txheej uas tus nqi ntawm F0 nyob nruab nrab ntawm 8 txog 12, tus nqi ntawm D tuaj yeem suav tau.