Cov txiaj ntsig zoo thiab qhov tsis zoo ntawm cov tshuaj khov kho tshuab ziab khaub ncaws
(1) Kev ua cov tshuaj ua kua yog yooj yim, uas yooj yim yooj yim cov txheej txheem ntawm kev ua haujlwm aseptic. Txheej txheem kom kom qhuav-kom ua tiav ntawm qhov kub tsawg, yog li nws yog qhov tshwj xeeb tshaj yog cov tshuaj tiv thaiv cua sov. Npaj xws li cov protein ntau thiab cov kab mob me hauv biopharmaceuticals yuav tsis muaj kev txwv lossis poob roj ntsha thaum Lyophilization txheej txheem. Yog li ntawd, khov-kom qhuav thev naus laus zis yog siv dav hauv cov tshuaj.
(2) thaum lub sijhawm ntsuas kub tsawg dua, kev ploj ntawm qee cov khoom siv volatile hauv cov tshuaj ua haujlwm yog qhov tsawg heev.
(3) thaum lub sij hawm khov-kom qhuav txheej txheem, kev ua haujlwm ntawm cov kab mob thiab cov khoom qub yog tswj thiab ruaj khov ntawm cov hmoov nplej qhuav yog txhim kho.
(4) Vim tias ziab yog nqa tawm hauv lub xeev khov, qhov ntim ntawm cov qauv npaj tsis hloov, cov qauv qub yog tswj hwm, thiab qhov tshwm sim ntawm cov siab yuav tsis tshwm sim.
(5) Cov tshuaj qhuav yog xoob thiab ntxeem tau, nyob rau hauv daim txhuam cev, tshem tawm cov dej nrawm thiab rov qab ua nws cov khoom qub yuav luag tam sim ntawd. Lyophilized cov qauv yog tshwj xeeb yog cov dej-soluble.
(6) Ua kom qhuav-kom qhuav yog nqa tawm hauv qab me me oxygen, yog li qee cov khoom yooj yim oxidizable hauv lub vijtsam npaj yog tiv thaiv.
(7) Ua kom kom qhuav-kom qhuav tuaj yeem tshem tawm ntau dua 95% ~ 96% ntawm cov dej hauv cov hmoov yeeb tshuaj tuaj yeem khaws cia kom ntev los tsis muaj kev cuam tshuam.
Cov khoom yuav tsum tau khov rau qhov kub thiab txias hauv qab no lub ntsej muag ua ntej lub sijhawm ua ntej khov, thiab cov khoom lag luam tsis tuaj yeem tshaj qhov kub ncua qhov kub thaum lub sijhawm Sublimation. Yog li ntawd, lub eutectic kub yog qhov pub tshaj plaws kub nyob rau hauv lub pre-khov thiab sublimation theem ntawm cov khoom.
