Embonini yezemithi, yonke inqubo yokukhiqiza ihlobene nokuphepha kwezimpilo zeziguli. Ukusuka ekukhetheni impahla eluhlaza kuya ezinqubweni zokukhiqiza, kusukela ekuhlanzweni kwemishini kuya ekulawuleni indawo ezungezile, noma yikuphi ukungcola okuncane kungase kuholele ezingozini zekhwalithi yezidakamizwa. Phakathi kwalezi zixhumanisi ezibalulekile, ii-pharmaceutical pure steam generatorisibe ngesinye sezisetshenziswa ezisemqoka zokuqinisekisa ukuphepha kwezidakamizwa ngenxa yeqhaza lazo elingenakuthathelwa indawo. Ayinikezeli nje kuphela iziqinisekiso ezithembekile zokukhiqizwa kwe-aseptic, kodwa futhi isebenza njengetshe legumbi elibalulekile lemboni yezokwelapha yesimanje ukuze iye emazingeni aphezulu kanye nekhwalithi ephezulu.

Isitimu esihlanzekile: umzila wokuphila wokukhiqizwa kwemithi

Izidingo zokuhlanzeka ekukhiqizweni kwemithi zicishe zibe lukhuni. Noma ngabe imijovo, i-biologics, imithi yokugoma, noma imishanguzo yezakhi zofuzo, okokusebenza, amapayipi, iziqukathi, ngisho nendawo yomoya ehilelekile enqubweni yabo yokukhiqiza kufanele kubulawe amagciwane ngokuphelele. Isitimu esihlanzekile (esaziwa nangokuthi "isitimu sebanga lezemithi") sesiphenduke indawo yokuvala inzalo ethandwayo embonini yezemithi ngenxa yokushisa kwaso okuphezulu kanye nokungabikho kwezinsalela zamakhemikhali.

Umthwali oyinhloko wokuvala inzalo

Isitimu esihlanzekile singangena ngokushesha ezindongeni ze-microbial cell futhi sibulale ngokuphelele amagciwane, amagciwane, nezinhlamvu ngokusebenzisa izinga lokushisa eliphezulu (imvamisa engaphezu kuka-121 ℃) kanye nomfutho ophezulu. Uma kuqhathaniswa nezibulala magciwane zamakhemikhali, ukuvalwa kwesitimu okumsulwa akunayo ingcuphe eyinsalela, ikakhulukazi elungele okokusebenza neziqukathi ezihlangana ngqo nezidakamizwa. Isibonelo, ukuvala inzalo kwezinto zokusebenza ezibalulekile njengemigqa yokugcwalisa umjovo, imishini yokomisa iqhwa, nama-bioreactors kuncike ekungeneni kahle kwesitimu esimsulwa.

Ukuqina kwezindinganiso zekhwalithi

Ngokwezidingo ze-GMP, isitimu esihlanzekile sezemithi kufanele sihlangabezane nezinkomba ezintathu ezibalulekile:

Awukho umthombo wokushisa: Umthombo wokushisa uwukungcola okubulalayo okungabangela ukusabela kwemfiva ezigulini futhi kufanele kususwe ngokuphelele.

Amanzi ajiyile ahlangabezana nendinganiso: Ikhwalithi yamanzi ngemva kokujiya kwesitimu esihlanzekile idinga ukuhlangabezana namanzi omjovo (i-WFI) ajwayelekile, ane-conductivity engu-≤ 1.3 μ S/cm.

Inani elifanelekile lokomisa: Ukoma kwesitimu kufanele kube ≥ 95% ukuze kugwenywe amanzi awuketshezi aphazamise umphumela wokuvala inzalo.

Ukufakwa kwesicelo esigcwele senqubo

Kusukela ekubulaweni inzalo ku-inthanethi (i-SIP) yemishini yokukhiqiza kuye ekugxiliseni umoya emakamelweni ahlanzekile, kusukela ekuhlanzweni kwezingubo ezingenalutho kuya emigwaqweni yenqubo yokubulala amagciwane, isitimu esihlanzekile sigijima kuwo wonke umjikelezo wokuphila wokukhiqizwa kwemithi. Ikakhulukazi endaweni yokusebenzela yokulungiselela i-aseptic, ijeneretha yesitimu ehlanzekile "iwumthombo wamandla oyinhloko" osebenza cishe amahora angama-24 ngosuku ngaphandle kokuphazamiseka.

Ukuqamba Okusha Kwezobuchwepheshe Kwe-Pharmaceutical Pure Steam Generator

Ngokukhula kwesidingo sekhwalithi, ukusebenza kahle, nokuvikelwa kwemvelo embonini yezemithi, ubuchwepheshe bamajeneretha angenasimusi nawo buhlala bugqobhoza. Imishini yesimanje izuze ukuvikeleka okuphezulu nokusebenza kahle kwamandla ngokuklama okuhlakaniphile kanye nemodular.

Ukuthuthuka kobuchwepheshe obuyisisekelo

Ubuchwepheshe be-multi-effect distillation: Ngokuthola amandla ezigaba eziningi, amanzi aluhlaza (imvamisa amanzi ahlanzekile) aguqulwa abe isitimu esimsulwa, ehlisa ukusetshenziswa kwamandla ngaphezu kuka-30% uma kuqhathaniswa nezisetshenziswa zendabuko.

Ukulawula okuhlakaniphile: kufakwe isistimu yokuqapha ezenzakalelayo, ukuthola ngesikhathi sangempela ukomisa kwesitimu, izinga lokushisa, nokucindezela, i-alamu ezenzakalelayo nokulungiswa kwezimo ezingajwayelekile, ukugwema amaphutha okusebenza komuntu.

Idizayini yekhabhoni ephansi: ukwamukela amadivaysi okubuyisela ukushisa kwemfucuza ukuze kuncishiswe ukumosheka kwamandla, ngokuhambisana nenkambiso yenguquko eluhlaza embonini yezemithi.

'Umshwalense okabili' wokuqinisekisa ikhwalithi

Amajeneretha esimanje ahlanzekile anesitimu ngokuvamile afakwe izindlela zokuqinisekisa ikhwalithi ezimbili:

Uhlelo lokuqapha ku-inthanethi: Ukuqapha ngesikhathi sangempela sokuhlanzeka kwesitimu ngokusebenzisa amadivaysi afana namamitha wokusebenza kanye nabahlaziyi be-TOC.
Idizayini e-Redundant: isipele sephampu ekabili, ukuhlunga kwezigaba eziningi kanye neminye imiklamo iqinisekisa ukusebenza okuzinzile kwemishini uma kwenzeka ukwehluleka kungazelelwe.

Ukuvumelana nezimo ekuphenduleni izimfuno eziyinkimbinkimbi

Amajeneretha omusi ahlanzekile angenziwa ngezifiso izinkambu ezisafufusa ezifana ne-biopharmaceuticals kanye nokwelashwa kwamaseli. Isibonelo, okokusebenza okusetshenziselwa ukukhiqizwa komuthi wokugoma we-mRNA kudinga ukuhlangabezana nezimfuneko eziphakeme ezingabizi, futhi ezinye izinkampani zethule ubuchwepheshe be-"ultra pure steam" ukulawula izinga le-endotoxin emanzini ajiyile angaphansi kuka-0.001 EU/mL.
Ngokuthuthuka okusheshayo kwama-biopharmaceuticals, kuye kwabekwa izidingo eziphakeme zekhwalithi yesitimu esihlanzekile. Ukukhiqizwa kwemithi emisha efana nezidakamizwa zofuzo kanye namasosha omzimba we-monoclonal kudinga indawo ehlanzekile yesitimu. Lokhu kuletha inselele entsha yobuchwepheshe kumajeneretha angenasimusi.

Umqondo wokukhiqiza oluhlaza ushintsha ukucabanga kokuklama kwamajeneretha omusi. Ukusetshenziswa kwemishini yokonga ugesi, izinto ezivikela imvelo, kanye nokuthuthukiswa kwezinhlelo zokuphatha ezihlakaniphile konke kushayela imboni endleleni esimeme kakhudlwana.

Ukusetshenziswa kobuchwepheshe obuhlakaniphile kubunjwa kabusha imodi yokusebenza yamajeneretha angenasimusi. Ukuqaliswa kokuqapha okukude, ukunakekelwa okubikezelwayo, ukulungiswa okuhlakaniphile kanye neminye imisebenzi akuthuthukisi nje ukusebenza kahle kwemishini, kodwa futhi kunikeza isiqiniseko sekhwalithi esithembeke kakhulu sokukhiqizwa kwezidakamizwa.

Namuhla, njengoba ukuphepha kwezidakamizwa kuya ngokuya kubaluleka, ukubalulekaamajeneretha e-steam ahlanzekile emithiliya ligqama. Akuyona nje into ebalulekile yokukhiqiza izidakamizwa, kodwa futhi iyisithiyo esibalulekile sokuqinisekisa ukuphepha kwemithi yomphakathi. Ngokuthuthuka okuqhubekayo kobuchwepheshe, amajeneretha angenasimusi ngokungangabazeki azodlala indima enkulu embonini yezemithi futhi enze umnikelo omkhulu empilweni yabantu.