GMP-raws li Total Organic Carbon tsom xam rau cov tshuaj dej thiab ntxuav validation, nrog 21 CFR Part 11-npaj audit trails thiab system suitability testing built in.
Tag Nrho Organic Carbon (TOC) yog qhov ceev, tsis yog - qhia tshwj xeeb ntawm cov organic paug hauv cov dej tshuaj thiab cov qauv kuaj xyuas. Qhov chaw kuaj TOC cov ntaub ntawv pub ncaj qha rau hauv batch tso tawm lossis ntxuav kev txiav txim siab, kev ntseeg tau ntawm cov cuab yeej, kev ntsuas kev tsim nyog, thiab cov ntaub ntawv kev ncaj ncees ua qhov tseem ceeb raws li qhov kev ntsuas raw nws tus kheej - txoj kev tshawb xyuas tsis muaj zog tuaj yeem ua rau muaj kev cuam tshuam tsis zoo thaum kuaj xyuas.
USP General Tshooj<643>txhais TOC qhov kev xeem thiab cov txheej txheem tsim nyog rau cov dej siv hauv kev tsim tshuaj, thaum<645>npog tus khub conductivity test. USP<1231>(Dej rau Pharmaceutical Purposes) muab cov ntsiab lus dav dav ntawm kev saib xyuas kev cia siab ntawm dej. Qhov twg TOC cov ntaub ntawv txhawb nqa kev txiav txim siab, FDA 21 CFR Part 11 tswj hwm cov ntaub ntawv hluav taws xob thiab kos npe rau cov ntaub ntawv tshwm sim.
01
Siab Zoo
Integrated Hoobkas lub zog los txhawb txhua yam ntawm daim kab xev customization, nrog daim ntawv puag, ntaub puag, kua nplaum, txheej tag nrho cov khoom raw khoom muaj peev xwm
02
Khoom siv Advanced
Integrated Hoobkas lub zog los txhawb txhua yam ntawm daim kab xev customization, nrog daim ntawv puag, ntaub puag, kua nplaum, txheej tag nrho cov khoom raw khoom muaj peev xwm
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Pab neeg tshaj lij
Integrated Hoobkas lub zog los txhawb txhua yam ntawm daim kab xev customization, nrog daim ntawv puag, ntaub puag, kua nplaum, txheej tag nrho cov khoom raw khoom muaj peev xwm
04
Kev Pabcuam Kev Cai
Integrated Hoobkas lub zog los txhawb txhua yam ntawm daim kab xev customization, nrog daim ntawv puag, ntaub puag, kua nplaum, txheej tag nrho cov khoom raw khoom muaj peev xwm
Peb cov kev daws teeb meem
Peb GMP TOC analyzer ua tau UV-ib -sulfate oxidation nrog kev sib txawv conductivity nrhiav tau nrog ua - hauv USP<643>kev ntsuam xyuas qhov tsim nyog, thiab tsim kom muaj Tshooj 11-cov ntaub ntawv xeem ua raws nrog kev soj ntsuam tag nrho thiab kos npe hauv hluav taws xob. Lub module yog tsim los rau kev kuaj lub rooj ntev zaum saum toj kawg nkaus thiab inline kws tshuaj dej system saib xyuas, thiab tuaj yeem teeb tsa rau qhov ntsuas qhov ntsuas qhov sib txawv thiab qhov dav 1-1000 ppb ntsuas ntau yam nrog ntau hom -test hom. Raws li cov chaw tsim khoom, peb muab ib nrab- kev pabcuam calibration ib xyoos ib zaug, ceev cov khoom seem, ua kom tiav cov ntaub ntawv pov thawj thiab ib puag ncig-txoj haujlwm thoob ntiaj teb kev txhawb nqa.
TOC cov khoom sib piv
| Qauv |
TOC TA-2.0
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TOC TA-3.0
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TOC TA-3.5
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TOC TA-5.0
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| cov khoom |
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| Daim ntawv thov Scenario | online / offline / Cleaning validation | Online | Online | Ntau -Pioint Saib Xyuas (txog 100 Channel) |
| Kev ntsuas ntau | 1 ~ 1000 hli | 1 ~ 1000 hli | 1 ~ 1000 hli | 1 ~ 1000 hli |
| Conductivity Detection Range | 0.055μS/cm ~ 8000μS/cm | 0.055μS/cm ~ 8000μS/cm | 0.055μS/cm ~ 8000μS/cm | 0.055μS/cm ~ 6000μS/cm |
| Kev daws teeb meem | 0.001 mg / L | 0.001 mg / L | 0.001 mg / L | 0.001 mg / L |
| Teb Sijhawm | Tsawg dua los yog sib npaug li 5 mins | Tsawg dua los yog sib npaug li 60s | Tsawg dua los yog sib npaug li 60s | Tsawg dua los yog sib npaug li 60s |
| Audit Trail | 4-theem kev nkag mus tswj (21 CFR PART 11 ua raws), Ntau dua lossis sib npaug rau 3 xyoos cia | 4-theem kev nkag mus tswj (21 CFR PART 11 ua raws), Ntau dua lossis sib npaug rau 3 xyoos cia | 4-theem kev nkag mus tswj (21 CFR PART 11 ua raws), Ntau dua lossis sib npaug rau 5 xyoo cia | 4-theem kev nkag mus tswj (21 CFR PART 11 ua raws), Ntau dua lossis sib npaug rau 3 xyoos cia |
| Qhov hnyav | 8, 5kg | 8, 5kg | 8 ,7kg | 8,4kq ua |
| Qhov Zoo Tshaj Plaws | Txhawb 3-cov ntsiab lus sib npaug hauv online, kev sim offline, tus nqi qis qis | Ib leeg/ntau-lub sijhawm taw tes- faib saib xyuas IP- ntsuas vaj tse, ua tau raws li cov cai tswj hwm | Teb ceev ceev, ntev - cov ntaub ntawv khaws cia, yooj yim calibration ports | Txhawb nqa txog li 8 tus saib xyuas cov ntsiab lus, UV static oxidation txoj cai, siab stability |
| qhov ntau thiab tsawg | 400*240*270 | 300*210*250 | 300*150*400 | 300*210*250 |
| tus nqi | $ Tau txais Quote los ntawm Kev Muag Khoom | $ Tau txais nqe lus los ntawm Kev Muag Khoom | $ Tau txais nqe lus los ntawm Kev Muag Khoom | $ Tau txais Quotes los ntawm Kev Muag Khoom |
FAQ
Q1: Dab tsi yog qhov kev ntsuas qhov tsim nyog rau TOC, thiab vim li cas nws tseem ceeb?
A1: Kev ntsuam xyuas qhov tsim nyog, raws li USP<643>, txheeb xyuas cov neeg soj ntsuam cov lus teb uas siv cov qauv paub thiab cov txheej txheem - kev daws teeb meem tsim nyog ua ntej kev sim ua qauv, paub meej tias cov cuab yeej ua haujlwm tsis pub dhau qhov txwv tsis pub siv rau hnub siv.
Q2: Txoj kev tshawb nrhiav TOC yog dab tsi feem ntau rau cov dej tshuaj?
A2: High-kub combustion oxidation thiab UV/per-sulfate oxidation yog ob txoj hauv kev siv dav tshaj plaws, txhua tus nrog kev lag luam tawm - tawm hauv rhiab heev, qauv dhau los, thiab kev saib xyuas.
Q3: Puas yog TOC kuaj hloov microbial kuaj ntawm cov dej?
A3: Tsis yog - TOC ntsuas cov pa roj carbon monoxide ua lub npe rau cov tshuaj lom neeg / cov kab mob sib kis thiab siv ib sab, tsis yog siv, kuaj microbial thiab conductivity.
Q4: GMP TOC analyzer txhawb 21 CFR Part 11 ua raws li cas?
A4: Los ntawm cov yam ntxwv xws li kev tshuaj xyuas txoj hauv kev, lub luag haujlwm -raws li kev tswj xyuas kev nkag, kos npe hauv hluav taws xob, thiab ruaj ntseg, cov ntaub ntawv xa tawm tau khi rau txhua qhov kev xeem khiav.