Li-pyrogens, haholo-holo tse buang ka li-pyrogens tsa baktheria, ke li-microbial metabolites, litopo tsa baktheria le li-endotoxins.Ha li-pyrogen li kena 'meleng oa motho, li ka senya tsamaiso ea' mele ea 'mele ea ho itšireletsa mafung, tsa baka letoto la matšoao a kang ho tsieleha, ho tsieleha, feberu, ho fufuleloa, ho nyekeloa ke pelo, ho hlatsa, esita le liphello tse tebileng tse kang koma, ho oa, esita le lefu.Likokoana-hloko tse tloaelehileng tse kang formaldehyde le hydrogen peroxide ha li khone ho felisa li-pyrogen ka ho feletseng, 'me ka lebaka la ho hanyetsa mocheso o matla, lisebelisoa tsa ho thibela mocheso o metsi li thata ho senya mosebetsi oa tsona ka ho feletseng.Ka hona, sterilization ea mocheso e omileng e fetohile mokhoa o sebetsang oa ho tlosa li-pyrogens, tse hlokang lisebelisoa tse khethehileng tsa sterilization - lisebelisoa tsa kotopo ea mocheso o omileng.
Tonelo e omileng ea ho thibela mocheso ke sesebelisoa sa bohlokoa sa tšebetso se bapalang karolo ea bohlokoa liindastering tse kang meriana le lijo.Ka mekhoa ea mahlale ea ho thibela mocheso o omileng, ho hloeka le boleng ba lihlahisoa ho ka netefatsoa, ho netefatsa bophelo bo botle le polokeho ea sechaba, le ho bapala karolo ea bohlokoa moleng oa ho tlatsa tlhahiso e nyopa.Molao-motheo oa eona oa ho sebetsa ke ho futhumatsa setshelo ka moea o chesang o omileng, ho finyella sterilization e potlakileng le ho tlosoa ha pyrogen.Thempereichara ea sterilization e atisa ho behoa ho 160 ℃ ~ 180 ℃ ho netefatsa hore sehlahisoa ha se na likokoana-hloko tse sebetsang, ha mocheso oa ho tlosa pyrogen hangata o pakeng tsa 200 ℃ ~ 350 ℃.Sehlomathiso sa khatiso ea 2010 ea Chinese Pharmacopoeia se bolela hore "mokhoa oa sterilization - mokhoa o omileng oa ho thibela mocheso" o hloka metsotso e 250 ℃ × 45 ea mocheso o omileng o ka tlosa lintho tsa pyrogenic ka katleho lijaneng tsa ho paka lihlahisoa.
Thepa ea thepa ea kotopo ea mocheso o omileng hangata ke tšepe e sa hloekang, e hlokang hore bokantle ba ka hare le bo ka ntle ba lebokose le bentšitsoe, bo bataletse, bo boreleli, bo se na maqhutsu kapa likhopo.Fene e sebelisoang karolong ea mocheso o phahameng e tlameha ho khona ho mamella mocheso ho fihlela ho 400 ℃, 'me lisebelisoa li boetse li hloka ho ba le tlhokomelo ea mocheso, ho rekota, ho hatisa, alamo le mesebetsi e meng, hammoho le ho hlahloba khatello ea moea le mesebetsi ea ho etsa sterilization ea inthaneteng. karolo ka 'ngoe.
Ho ea ka litlhoko tsa GMP, lithanele tsa ho thibela mocheso o omileng li kentsoe libakeng tsa Mophato oa A, 'me bohloeki ba sebaka sa mosebetsi le bona bo hloka ho fihlela tlhoko ea Kereiti ea 100. Ho fihlela tlhokahalo ena, lithanele tsa ho thibela mocheso o omileng li hloka ho hlomelloa ka ts'ebetso e phahameng. lihloela tsa moea, 'me ka lebaka la tikoloho ea tsona e khethehileng ea mocheso o phahameng, li-filters tse hanyetsanang le mocheso o phahameng li tlameha ho khethoa.Lisefe tse hanyetsanang le mocheso o phahameng le tse sebetsang hantle li bapala karolo ea bohlokoa likotopong tse omeletseng tsa ho thibela mocheso.Kamora ho futhumatsa, moea oa mocheso o phahameng o tlameha ho feta sefeneng ho netefatsa bohloeki ba maemo a fihlang ho 100 le ho fihlela litlhoko tsa ts'ebetso.
Tšebeliso ea li-filters tse nang le mocheso o phahameng le tse sebetsang hantle haholo li ka fokotsa tšilafalo ea likokoana-hloko, likaroloana tse fapaneng le li-pyrogens.Bakeng sa litlhoko tsa maemo a hlapang, ho bohlokoa ho khetha lihloela tse bolokehileng le tse tšepahalang tse hanyetsanang le mocheso o phahameng.Ts'ebetsong ena e mahlonoko, lihlahisoa tsa FAF tse hanyetsanang le mocheso o phahameng oa mocheso li fana ka tšireletso ea boleng bo phahameng bakeng sa lithanele tse omeletseng tsa mocheso, ho netefatsa polokeho le katleho ea ts'ebetso ea tlhahiso.
Nako ea poso: Aug-01-2023