Ama-pyrogens, ikakhulukazi abhekisela kuma-pyrogens amagciwane, angama-microbial metabolites, izidumbu zebhaktheriya, nama-endotoxins.Lapho ama-pyrogens engena emzimbeni womuntu, angaphazamisa isimiso somzimba sokuzivikela ezifweni, abangele uchungechunge lwezimpawu ezinjengokugodola, ukugodola, imfiva, ukujuluka, isicanucanu, ukuhlanza, ngisho nemiphumela engathi sína enjengokoma, ukuwa, ngisho nokufa.Izibulala-magciwane ezivamile ezifana ne-formaldehyde ne-hydrogen peroxide azikwazi ukuqeda ngokuphelele ama-pyrogens, futhi ngenxa yokumelana nokushisa okuqinile, imishini yokuvala inzalo yokushisa okumanzi kunzima ukubhubhisa umsebenzi wabo ngokuphelele.Ngakho-ke, ukuvala inzalo yokushisa okomile sekuyindlela ephumelelayo yokukhipha ama-pyrogens, okudinga imishini ekhethekile yokuvala inzalo - imishini yomhubhe wokushisa omile.
Umhubhe wokukhipha inzalo yokushisa okomile uyithuluzi lenqubo elibalulekile elidlala indima ebalulekile ezimbonini ezifana nemithi nokudla.Ngezindlela zesayensi zokuvala inzalo yokushisa okomile, ubunyumba kanye nekhwalithi yemikhiqizo kungaqinisekiswa, kuqinisekiswe impilo yomphakathi nokuphepha, futhi kubambe iqhaza elibalulekile emgqeni wokugcwalisa wokukhiqiza oyinyumba.Umgomo wayo wokusebenza ukushisa isitsha ngomoya oshisayo owomile, ukufeza inzalo esheshayo nokususwa kwe-pyrogen.Izinga lokushisa lokuvala inzalo livamise ukusethwa ku-160 ℃~180 ℃ ukuze kuqinisekiswe ukuthi umkhiqizo awuqukethe ama-microorganisms asebenzayo, kuyilapho izinga lokushisa lokukhipha i-pyrogen ngokuvamile liphakathi kuka-200 ℃~350 ℃.Isithasiselo sohlelo luka-2010 lwe-Chinese Pharmacopoeia sibeka ukuthi "indlela yokuvala inzalo - indlela yokuvala inzalo yokushisa okomile" idinga imizuzu engu-250 ℃ × 45 yokushisa okomile inzalo ingasusa ngempumelelo izinto ze-pyrogenic ezitsheni zokupakisha eziyinyumba.
Impahla yomshini wokukhipha inzalo yokushisa okomile ngokuvamile iyinsimbi engagqwali, edinga ukuthi indawo engaphakathi nengaphandle yebhokisi ipholishwe, ibe sicaba, ibushelelezi, ingabi namaqhubu noma imihuzuko.I-fan esetshenziswa esigabeni sokushisa okuphezulu kumele ikwazi ukumelana namazinga okushisa afinyelela ku-400 ℃, futhi okokusebenza kudinga nokuba nokuqapha izinga lokushisa, ukurekhoda, ukuphrinta, i-alamu neminye imisebenzi, kanye nokuqapha umfutho womoya kanye nemisebenzi yokuvala inzalo ku-inthanethi isigaba ngasinye.
Ngokwezidingo ze-GMP, imigudu eyomile yokuvala inzalo yokushisa ifakwe ezindaweni zeBanga A, futhi ukuhlanzeka kwendawo yokusebenza kufanele kuhlangabezane nezidingo zeBanga le-100. izihlungi zomoya, futhi ngenxa yemvelo yazo ekhethekile enezinga lokushisa eliphezulu, izihlungi ezikwazi ukumelana nokushisa okuphezulu kufanele zikhethwe.Izihlungi ezimelana nezinga lokushisa eliphezulu nezisebenza kahle zidlala indima ebalulekile emiseleni yokuvala ukushisa okomile.Ngemva kokufudumeza, umoya onezinga lokushisa eliphezulu kufanele udlule esihlungini ukuze uqinisekise ukuhlanzeka okufika kumazinga angu-100 futhi uhlangabezane nezidingo zenqubo.
Ukusetshenziswa kwezihlungi ezinokushisa okuphezulu nezisebenza kahle kakhulu kunganciphisa ukungcoliswa kwama-microorganisms, izinhlayiya ezihlukahlukene, nama-pyrogens.Ngezidingo zezimo zokukhiqiza eziyinyumba, kubalulekile ukukhetha izihlungi eziphephile nezithembekile ezimelana nezinga lokushisa eliphezulu.Kule nqubo ebucayi, imikhiqizo yochungechunge lwe-FAF yokumelana nezinga lokushisa eliphezulu ihlinzeka ngokuvikeleka kwekhwalithi ephezulu emhubheni wokukhipha inzalo yokushisa okomile, iqinisekisa ukuphepha nokusebenza kahle kwenqubo yokukhiqiza.
Isikhathi sokuthumela: Aug-01-2023