Mycoplasma Pharmacopoeia Methods
Kev npaj thiab kev tswj xyuas zoo ntawm cov tsiaj cell matrix rau kev tsim khoom thiab kev sim tshuaj lom neeg yuav tsum tau ua raws li cov cai ntawm 2025 tsab ntawm Suav Pharmacopoeia, General Tshooj 3301 Mycoplasma Tests, USP<63>MYCOPLASMA TESTS, thiab EP 2.6.7 MYCOPLASMAS, thiab cov txheej txheem kab lis kev cai thiab qhia txog kab lis kev cai ntawm tes (DNA txoj kev staining) uas ua tau raws li kev cai yuav tsum tau muab.
Sterility Test Pharmacopoeia Methods
Cov kev ntsuam xyuas tsis muaj menyuam yog ua raws li qhov yuav tsum tau muaj ntawm Tshooj 1101, Kev Xeem Sterility, ntawm 2025 tsab ntawm Suav Pharmacopoeia, EP 2.6.1. STERILITY, thiab USP<71>STERILITY TESTS, muab cov membrane filtration thiab ncaj qha inoculation txoj kev uas ua tau raws li kev cai. Txhua qhov kev kuaj tsis muaj menyuam yog ua nyob rau hauv Chav Kawm A cais, nrog kev saib xyuas ib puag ncig txuas ntxiv mus thoob plaws txoj kev sim.
01
Kev ntsuam xyuas tsim nyog
Kev ntsuam xyuas kev tsim nyog tuaj yeem ua tiav ntawm ntau yam kev kuaj ntsuas raws li kev tswj hwm kev cai kom paub meej tias qhov tsim nyog ntawm txoj kev kuaj sterility ntawm cov qauv kuaj.
02
Membrane Filtration Method
Siv cov lim lim kaw, txoj kev no tuaj yeem lim cov qauv kuaj ntau thiab ua haujlwm zoo rau cov tshuaj tiv thaiv kab mob microbial. Nws yog txoj kev sim uas nyiam tshaj plaws rau cov qauv ntsuas lim.
03
Direct Inoculation Method
Tsim nyog rau cov qauv kuaj uas tsis tuaj yeem kuaj tau siv cov membrane pom, suav nrog cov uas tsis yog- qhia meej aqueous cov kev daws teeb meem xws li kev tshem tawm, cov qauv kuaj tsis zoo, tsis yog- dej- cov qauv kuaj cov kua dej, thiab cov khoom siv kho mob tsis muaj menyuam.
Mycobacterium Pharmacopoeia Methods
Kev npaj thiab kev tswj xyuas zoo ntawm cov tsiaj cell matrix rau kev tsim khoom thiab kev sim tshuaj lom neeg raws li cov cai ntawm EP 2.6.2 MYCOBACTERIA hauv xyoo 2025 ntawm Suav Pharmacopoeia tau ua los ntawm kev siv cov kab lis kev cai los muab kev kuaj mob mycobacterial uas ua tau raws li kev cai tswj hwm.
Mycoplasma ceev txoj kev
Peb muab cov kev pabcuam kev lees paub rau kev lag luam muaj mycoplasma NAT cov khoom siv tshawb nrhiav sai, xa mus rau European Pharmacopoeia (EP 2.6.7) thiab Tebchaws Meskas Pharmacopeia (USP<77>). Txawm hais tias cov ntaub ntawv pov thawj ntawm cov khoom siv siv tau tuaj yeem hloov pauv cov txheej txheem kev ua tau zoo, kev tsim nyog siv tau ntawm cov qauv tiag tiag tseem tsim nyog. Yog li ntawd, thaum kuaj xyuas mycoplasma NAT txoj kev kuaj pom, peb tuaj yeem siv cov khoom siv cov ntaub ntawv pov thawj raws li lub hauv paus thiab tom qab ntawd ua qhov tsim nyog validation ntawm cov qauv tiag tiag.
• Raws li lwm txoj hauv kev coj noj coj ua: NAT txoj kev xav kom pom tus nqi tsawg dua lossis sib npaug li 10 CFU / mL.
• Raws li lwm txoj hauv kev qhia txog kab lis kev cai ntawm tes: NAT txoj kev xav kom pom tus nqi tsawg dua lossis sib npaug li 100 CFU / mL.
Txoj kev kuaj Sterility sai
Kev ntsuam xyuas microbiological ntawm cov xov tooj ntawm tes- cov khoom siv raws li tau ua raws li cov cai ntawm EP tshooj<2.6.27>, USP tshooj<72>, thiab 2025 tsab ntawm Suav Pharmacopoeia 9406 Cov Lus Qhia rau Kev Tshawb Fawb Microbiological. Nruab nrog bioMérieux BACT / ALERT 3D aseptic cov cuab yeej kuaj sai sai, nws muab kev kuaj aseptic uas ua tau raws li kev cai tswj hwm.
Txoj kev nrawm rau Mycobacteria: Siv qPCR fluorescent sojntsuam txoj kev, tshwj xeeb primers thiab probes (FAM-labeled) amplify thiab ntes 16S rRNA coding cheeb tsam nyob rau hauv mycobacterial genome, qualitatively kuaj mycobacterial DNA nyob rau hauv cov qauv. Nws npog ntau tshaj 100 mycobacterial DNA sequences; qhov kev tshawb pom yog ceev, tshwj xeeb, thiab txhim khu kev qha.