Pyrogens, feem ntau xa mus rau cov kab mob pyrogens, yog qee qhov microbial metabolites, cov kab mob corpses, thiab endotoxins. Thaum cov pyrogens nkag mus rau tib neeg lub cev, lawv tuaj yeem cuam tshuam rau lub cev tiv thaiv kab mob, ua rau muaj cov tsos mob xws li ua daus no, ua daus no, ua npaws, tawm hws, xeev siab, ntuav, thiab txawm tias muaj teeb meem loj xws li coma, cev qhuav dej, thiab txawm tuag. Cov tshuaj tua kab mob xws li formaldehyde thiab hydrogen peroxide tsis tuaj yeem tshem tawm cov pyrogens tag nrho, thiab vim lawv cov cua sov muaj zog, cov cuab yeej siv hluav taws xob ntub dej tsis yooj yim los rhuav tshem lawv cov haujlwm. Yog li ntawd, qhuav cua sov kom tsis muaj menyuam tau dhau los ua ib txoj hauv kev zoo rau tshem tawm cov pyrogens, xav tau cov cuab yeej tshwj xeeb kom tsis muaj menyuam - cov khoom siv cua sov kom tsis muaj menyuam.
Kev ziab tshav kub kom tsis muaj menyuam yog cov khoom siv tseem ceeb uas ua lub luag haujlwm tseem ceeb hauv kev lag luam xws li tshuaj thiab zaub mov. Los ntawm kev tshawb fawb txog kev ua kom tsis muaj cua sov qhuav, kev ua kom tsis muaj menyuam thiab zoo ntawm cov khoom tuaj yeem ua kom ntseeg tau, ua kom muaj kev noj qab haus huv rau pej xeem thiab kev nyab xeeb, thiab ua lub luag haujlwm tseem ceeb hauv kev ua kom tsis muaj menyuam. Nws txoj haujlwm ua haujlwm yog kom sov lub thawv nrog cua kub qhuav, ua kom tsis muaj menyuam sai thiab tshem tawm pyrogen. Qhov ntsuas kub kom tsis muaj menyuam feem ntau yog teem rau ntawm 160 ℃ ~ 180 ℃ kom ntseeg tau tias cov khoom tsis muaj cov kab mob nquag, thaum lub sijhawm tshem tawm pyrogen kub feem ntau yog nyob nruab nrab ntawm 200 ℃ ~ 350 ℃. Cov ntawv txuas ntxiv ntawm xyoo 2010 tsab ntawm Suav Pharmacopoeia tau hais tias "txoj kev ua kom tsis muaj menyuam - txoj kev ua kom tsis muaj menyuam qhuav" yuav tsum 250 ℃ × 45 feeb ntawm kev ua kom tsis muaj cua sov tuaj yeem tshem tawm cov tshuaj pyrogenic los ntawm cov khoom ntim khoom tsis muaj menyuam.
Cov khoom siv ntawm cov khoom siv cua sov kom tsis muaj menyuam feem ntau yog cov hlau tsis muaj steel, uas yuav tsum tau ua kom lub puab thiab sab nrauv ntawm lub thawv kom polished, tiaj tus, du, tsis muaj pob lossis khawb. Cov kiv cua siv nyob rau hauv qhov kub-kub yuav tsum muaj peev xwm tiv taus qhov kub thiab txias txog li 400 ℃, thiab cov khoom siv kuj yuav tsum muaj kev ntsuas kub, kaw, luam ntawv, tswb thiab lwm yam haujlwm, nrog rau kev saib xyuas cua siab thiab kev ua kom tsis muaj menyuam hauv online. txhua ntu.
Raws li GMP cov tseev kom muaj, cov cua kub kom tsis muaj menyuam qhuav tau muab tso rau hauv Qib A, thiab kev huv huv ntawm thaj chaw ua haujlwm tseem yuav tsum tau ua kom tau raws li qhov yuav tsum tau ua ntawm Qib 100. Yuav kom ua tau raws li qhov yuav tsum tau ua, cov cua kub kom tsis muaj menyuam qhuav yuav tsum tau nruab nrog kev ua haujlwm siab. huab cua lim, thiab vim lawv qhov tshwj xeeb qhov kub thiab txias ib puag ncig, cov cua kub resistant high-efficiency lim yuav tsum raug xaiv. Kev kub siab tiv taus thiab cov lim dej ua tau zoo ua lub luag haujlwm tseem ceeb hauv cov cua kub kom tsis muaj menyuam. Tom qab cua sov, huab cua kub yuav tsum dhau los ntawm lub lim kom huv si txog li 100 qib thiab ua tau raws li cov txheej txheem.
Kev siv cov lim dej kub thiab ua haujlwm siab tuaj yeem txo cov pa phem ntawm cov kab mob, ntau yam, thiab pyrogens. Rau cov kev xav tau ntawm kev ua kom tsis muaj menyuam, nws yog ib qho tseem ceeb uas yuav tau xaiv cov ntxaij lim dej uas muaj kev nyab xeeb thiab txhim khu kev qha. Nyob rau hauv cov txheej txheem tseem ceeb no, FAF high-temperature resistant series cov khoom muab kev tiv thaiv zoo rau cov cua kub kom tsis muaj menyuam, ua kom muaj kev nyab xeeb thiab ua haujlwm ntawm cov txheej txheem ntau lawm.
Post lub sij hawm: Aug-01-2023