Iipyrogens, ikakhulu zibhekisa kwipyrogens yebhaktiriya, ezinye ze-microbial metabolites, izidumbu zebhaktiriya, kunye ne-endotoxins. Xa ii-pyrogens zingena emzimbeni womntu, zinokuphazamisa amajoni omzimba, zibangele uthotho lweempawu ezinje ngokubanda, ukubanda, umkhuhlane, ukubila, isicaphucaphu, ukugabha, kunye neziphumo ezimandundu ezifana ne-coma, ukuwa, kunye nokufa. Izibulali-ntsholongwane eziqhelekileyo ezifana ne-formaldehyde kunye ne-hydrogen peroxide azikwazi ukuphelisa ngokupheleleyo i-pyrogens, kwaye ngenxa yokumelana nobushushu obuqinileyo, izixhobo zokuvala ubushushu obumanzi kunzima ukutshabalalisa ngokupheleleyo umsebenzi wabo. Ke ngoko, ukuvala ubushushu obomileyo kube yindlela esebenzayo yokususa iipyrogens, ezifuna izixhobo ezikhethekileyo zokuvala inzalo - izixhobo ezomileyo zokucoca ubushushu.
Itonela yokucoca ubushushu sisixhobo esibalulekileyo esidlala indima ebalulekileyo kumashishini afana namayeza kunye nokutya. Ngeendlela zesayensi zokuvala ubushushu obumileyo, ubunyumba kunye nomgangatho weemveliso unokuqinisekiswa, ukuqinisekisa impilo yoluntu kunye nokhuseleko, kunye nokudlala indima ebalulekileyo kumgca wokuzalisa imveliso enyumba. Umgaqo wayo wokusebenza kukufudumeza isikhongozeli ngomoya owomileyo oshushu, ukuphumeza inzala ngokukhawuleza kunye nokususwa kwepyrogen. Ubushushu bokwenza inzala buqhele ukusetwa ku-160 ℃~180 ℃ ukuqinisekisa ukuba imveliso ayiqulathanga iintsholongwane ezisebenzayo, ngelixa ubushushu bokususwa kwepyrogen buhlala buphakathi kwama-200 ℃~350 ℃. Isihlomelo soshicilelo lwe-2010 ye-Pharmacopoeia yaseTshayina ichaza ukuba "indlela yokuvala inzalo - indlela yokucima ubushushu obumileyo" idinga i-250 ℃ × i-45 imizuzu yokushisa okutshisayo kunokususa ngokufanelekileyo izinto ze-pyrogenic kwiibhotile zokupakisha imveliso eyinyumba.
Izinto ezisetyenziswa kwitonela yobushushu obomileyo zidla ngokuba yintsimbi engenasici, efuna indawo yangaphakathi nangaphandle yebhokisi icocwe, icwecwe, igudileyo, ingabi namaqhuma okanye imikrwelo. I-fan esetyenziswa kwicandelo lobushushu obuphezulu kufuneka ikwazi ukumelana namaqondo obushushu ukuya kuthi ga kwi-400 ℃, kwaye izixhobo zikwafuna ukubeka iliso lobushushu, ukurekhoda, ukuprinta, i-alamu kunye neminye imisebenzi, kunye nokujongwa koxinzelelo lomoya kunye nemisebenzi yokuvala inzala kwi-intanethi. icandelo ngalinye.
Ngokweemfuno ze-GMP, iitonela zokucima ubushushu ezomileyo zifakwe kwiindawo zeBanga A, kwaye ukucoceka kwendawo yokusebenza kufuneka kuhlangabezane nemfuneko yeBanga le-100. izihluzi zomoya, kwaye ngenxa yendawo yazo ekhethekileyo yobushushu obuphezulu, izihluzi ezinokumelana nobushushu obuphezulu kufuneka zikhethwe. Izihluzi ezikwaziyo ukumelana nobushushu obuphezulu kunye nezisebenzayo zidlala indima ebalulekileyo kwiitonela zokuvala ubushushu. Emva kokufudumeza, umoya ophezulu wokushisa kufuneka udlule kwisihlunu ukuze uqinisekise ukucoceka ukuya kumanqanaba angama-100 kwaye uhlangabezane neemfuno zenkqubo.
Ukusetyenziswa kwezihluzi ezinobushushu obuphezulu kunye nomgangatho ophezulu kunokunciphisa ungcoliseko lwemicroorganisms, amasuntswana ahlukeneyo, kunye neepyrogens. Ngeemfuno zeemeko zemveliso engcolileyo, kubalulekile ukukhetha izihluzo ezikhuselekileyo nezithembekileyo ezinobushushu obuphezulu obuxhathisayo. Kule nkqubo ibaluleke kakhulu, i-FAF i-high-temperature resistant series series ibonelela ngokhuseleko olukumgangatho ophezulu kwiitonela zokushisa ubushushu, ukuqinisekisa ukhuseleko kunye nokusebenza kakuhle kwenkqubo yokuvelisa.
Ixesha lokuposa: Aug-01-2023