Cell Culture Medium / Biotechnology Laboratory Test Plan
01
Ib txoj kev sim kuaj mob uas suav nrog TOC, cov khoom seem, thiab cov ntaub ntawv raw cov ntaub ntawv txheeb xyuas muaj feem xyuam rau cov kab lis kev cai ntawm tes nruab nrab thiab cov txheej txheem biotechnology kev tswj kom zoo.
02
ICH Q5A / Q5D thiab Q6B muab kev qhia dav dav ntawm kev ua tus cwj pwm thiab kev tswj xyuas cov khoom siv biotechnological, thaum USP<643>/<645>siv qhov twg TOC thiab kev ntsuam xyuas conductivity yog siv rau cov txheej txheem dej lossis cov khoom tsis sib xws.
03
Qhov twg ib leeg - siv tshuab koom nrog, USP<1207>-Txoj cai kaw cov thawv kaw kom ncaj ncees tau siv ntau dua rau cov hnab thiab cov khoom sib txuas ua ib feem ntawm txoj hauv kev kom muaj kev sib kis ntau dua.
Peb cov kev daws teeb meem
Peb biotechnology lab kuaj kev npaj ua keTOC tag nrho cov organic carbon analyzers, khov taw tes osmometers, Raman raw khoom txheeb xyuas cov ntaub ntawv txheeb xyuas, thiab ntim kaw cov khoom ntsuas kev ncaj nceesrau hauv ib qho kev sib koom ua haujlwm uas suav nrog kev txais cov khoom siv raw, hauv - txheej txheem dej / tsis zoo, thiab ib zaug - siv kev ncaj ncees. Txhua lub cuab yeej qhia ib hom ntaub ntawv los ua kom yooj yim batch cov ntaub ntawv muab tso ua ke. Raws li cov chaw tsim khoom peb muabintegrated turnkey solution quotation, full-set GMP validation support nrog rau IQ/OQ/PQ cov ntaub ntawv, ruaj khov luv luv lead-lub sij hawm xa tuaj, unified technical kev cob qhia, thiab raws li Part 11-raws li cov ntaub ntawv kev pab cuam kev koom ua ke.
Cov khoom
Freezing Point Osmometer FPSOM{0}}V2.0
Lub Freezing Point Osmometer FPOSM-V3.0
Online Total Organic Carbon Analyzer TA-3.0
Online Total Organic Carbon Analyzer TA-5.0
Offline Total Organic Carbon Analyzer TA-10
Loj Ntau Tag Nrho Organic cabon analyzer TA-100
FAQ
Q1: Vim li cas cell kab lis kev cai nruab nrab zoo xav tau ntau-point test es tsis yog ib daim tshev?
A1: Cov kab mob sib kis lossis qhov sib txawv tuaj yeem nkag mus rau ntau theem - cov khoom siv raw yog tus kheej, dej / tsis huv purity, lossis ib zaug - siv cov thawv ntim khoom ncaj ncees - yog li qhov ntsuas ib zaug tsis tuaj yeem npog tag nrho cov kev pheej hmoo.
Q2: Yuav ua li cas ib leeg - siv qhov kev ntsuas kev ncaj ncees txawv ntawm cov vial CCIT?
A2: Cov hnab ntim tau yooj yim thiab cov khoom sib txuas yuav tsum muaj cov txheej txheem kev sim (xws li lub siab lwj) haum rau cov uas tsis yog- cov geometries nruj, tsis zoo li lub tshuab nqus tsev vacuum los yog siab - txoj kev voltage ntau dua nrog cov vials nruj.
Q3: Puas yog TOC kev sim siv rau cov kab lis kev cai xov tooj ntawm tes ncaj qha, lossis tsuas yog rau dej / buffers?
A3: TOC feem ntau yog siv rau cov txheej txheem dej thiab cov khoom tsis sib xws es tsis yog qhov nruab nrab ntawm nws tus kheej, muab qhov nruab nrab cov ntsiab lus hauv cov organic.
Q4: Cov phiaj xwm kev sim no puas tuaj yeem ntsuas los ntawm lab- nplai rau GMP kev tsim khoom?
A4: Yog lawm, tib hom kev ntsuas siv rau ntawm ob qhov ntsuas, txawm hais tias qhov ntsuas zaus thiab qhov kev siv tau nruj heev feem ntau nce mus los ntawm txoj kev txhim kho mus rau GMP ntau lawm.