Kwishishini lamayeza, yonke inkqubo yokuvelisa inxulumene nokhuseleko lobomi bezigulane. Ukusuka ekukhethweni kwezinto ezikrwada ukuya kwiinkqubo zemveliso, ukusuka ekucoceni izixhobo ukuya kulawulo lokusingqongileyo, naluphi na ungcoliseko oluncinci lunokukhokelela kumngcipheko womgangatho wamachiza. Phakathi kwala makhonkco abalulekileyo, iijenereyitha yomphunga oxutywe namayezaibe sesinye sezixhobo ezingundoqo zokuqinisekisa ukhuseleko lweziyobisi ngenxa yendima yalo engenakubuyiselwa. Ayinikezeli kuphela iziqinisekiso ezithembekileyo zemveliso ye-aseptic, kodwa ikwasebenza njengelitye lembombo elibalulekileyo kushishino lwamayeza lwanamhlanje ukuya kwimigangatho ephezulu kunye nomgangatho ophezulu.

Umphunga ococekileyo: indlela yokuphila kwimveliso yamayeza

Iimfuno zococeko kwimveliso yamayeza ziphantse zibe ngqongqo. Nokuba zizitofu, iibhayoloji, izitofu, okanye amayeza emfuza, izixhobo, imibhobho, izikhongozeli, kwanemekobume yomoya ebandakanyekayo kwinkqubo yabo yokuvelisa kufuneka ivalwe ngocoselelo. Umphunga ococekileyo (okwaziwa ngokuba "ngumphunga womgangatho wonyango") uye waba yeyona ndlela ithandwayo yokuvala inzala kwishishini lamayeza ngenxa yobushushu obuphezulu kunye nokungabikho kweentsalela zeekhemikhali.

Oyena mntu uthwala inzala

Umphunga ococekileyo unokungena ngokukhawuleza kwiindonga ze-microbial cell kwaye ubulale ngokupheleleyo ibhaktheriya, iintsholongwane, kunye ne-spores ngokusebenzisa ubushushu obuphezulu (ngokuqhelekileyo bungaphezulu kwe-121 ℃) kunye noxinzelelo oluphezulu. Xa kuthelekiswa nezibulala-zintsholongwane zemichiza, ukuvala inzala ngomphunga omsulwa akunabungozi obushiyekileyo, ingakumbi obulungele izixhobo kunye nezikhongozeli ezidibana ngqo namachiza. Umzekelo, ukwenziwa inzala kwezixhobo eziphambili ezifana nemigca yokuzalisa inaliti, oomatshini bokumisa umkhenkce, kunye ne-bioreactors kuxhomekeke ekungeneni ngokufanelekileyo komphunga ococekileyo.

Ukungqongqo kwemigangatho yomgangatho

Ngokweemfuno ze-GMP, umphunga ococekileyo wamayeza kufuneka uhlangabezane nezalathi ezingundoqo ezintathu:

Akukho mthombo wobushushu: Umthombo wobushushu ngungcoliseko obulalayo onokubangela ukusabela komkhuhlane kwizigulana kwaye kufuneka ususwe ngokupheleleyo.

Amanzi ahlanganisiweyo adibana nomgangatho: Umgangatho wamanzi emva kokucolwa komphunga ococekileyo kufuneka uhlangabezane namanzi omgangatho wokutofa (WFI), kunye ne-conductivity ye-≤ 1.3 μ S/cm.

Ixabiso lokoma elifanelekileyo: Ukomisa komphunga kufuneka kube ≥ 95% ukunqanda amanzi angamalwelo achaphazela isiphumo sokuvala inzala.

Inkqubo epheleleyo yokugubungela isicelo

Ukusuka kwi-intanethi ye-intanethi (SIP) yezixhobo zokuvelisa ukuya ku-humidification yomoya kumagumbi acocekileyo, ukusuka ekucoceni impahla engcolileyo ukuya kwimibhobho yenkqubo yokubulala iintsholongwane, umphunga ococekileyo uhamba kuwo wonke umjikelo wokuphila wemveliso yamayeza. Ngokukodwa kwindawo yokusebenzela yokulungiselela i-aseptic, ijenereyitha yomphunga ococekileyo "ngowona mthombo wamandla" ohamba phantse iiyure ezingama-24 ngosuku ngaphandle kokuphazamiseka.

Ukwenziwa ngokutsha kweTekhnoloji yeGenereyitha yoMphunga oPure we-Pharmaceutical

Ngokunyuka kwemfuno yomgangatho, ukusebenza kakuhle, kunye nokhuseleko lokusingqongileyo kwishishini lamayeza, itekhnoloji yeejenereyitha zomphunga ococekileyo nazo zihlala zigqobhoza. Izixhobo zanamhlanje zifezekise ukhuseleko oluphezulu kunye nokusebenza kakuhle kwamandla ngoyilo olukrelekrele kunye noyilo lweemodyuli.

Ukuphumelela kwitekhnoloji ephambili

Itekhnoloji ye-Multi effect distillation: Ngokubuyiselwa kwamandla amanqanaba amaninzi, amanzi akrwada (adla ngokucocwa amanzi) aguqulwa abe ngumphunga ococekileyo, anciphise ukusetyenziswa kwamandla ngaphezu kwe-30% xa kuthelekiswa nezixhobo zemveli.

Ulawulo oluhlakaniphile: luxhotyiswe ngenkqubo yokujonga ngokuzenzekelayo, ukufumanisa ngexesha langempela ukomisa komphunga, ubushushu, kunye noxinzelelo, i-alamu ezenzekelayo kunye nokulungiswa kweemeko ezingaqhelekanga, ukuphepha iimpazamo zokusebenza kwabantu.

Uyilo lwekhabhoni ephantsi: ukwamkela izixhobo zokubuyiswa kobushushu ukuze kuncitshiswe inkunkuma yamandla, ngokuhambelana nenguqu yohlaza kushishino lwamayeza.

'Iinshurensi ezimbini' zoqinisekiso lomgangatho

Iijenereyitha zangoku ezisulungekileyo zomphunga zihlala zixhotyiswe ngeendlela ezimbini zokuqinisekisa umgangatho:

Inkqubo yokubeka iliso kwi-Intanethi: Ukujongwa kwexesha lokwenyani lokucoceka komphunga ngokusebenzisa izixhobo ezinjengeemitha zokuqhuba kunye nabahlalutyi be-TOC.
Uyilo lwe-Redundant: i-backup pump ezimbini, ukuhluzwa kwamanqanaba amaninzi kunye nolunye uyilo luqinisekisa ukusebenza okuzinzile kwezixhobo kwimeko yokusilela ngokukhawuleza.

Ukuguquguquka ekuphenduleni iimfuno ezinzima

Iijenereyitha zomphunga ezicocekileyo zinokwenziwa ngokwezifiso kwiinkalo ezivelayo ezifana ne-biopharmaceuticals kunye nonyango lweeseli. Umzekelo, izixhobo ezisetyenziselwa ukuveliswa kwesitofu sokugonya i-mRNA kufuneka zihlangabezane neemfuno eziphezulu zokungabi ntsholongwane, kwaye ezinye iinkampani ziye zazisa ubuchwepheshe be-"ultra pure steam" ukulawula inqanaba le-endotoxin kumanzi ajikisiweyo angaphantsi kwe-0.001 EU/mL.
Ngophuhliso olukhawulezayo lwe-biopharmaceuticals, iimfuno eziphezulu zibekwe phambili kumgangatho womphunga ococekileyo. Ukuveliswa kwamachiza amatsha afana namachiza emfuza kunye ne-monoclonal antibodies kufuna indawo ecocekileyo yomphunga. Oku kuzisa umngeni omtsha wobuchwepheshe kwiijenereyitha zomphunga.

Ingcamango yemveliso eluhlaza iguqula indlela yokucinga yoyilo lweejenereyitha zomphunga ococekileyo. Ukusetyenziswa kwezixhobo zokonga umbane, imathiriyeli ehambelana nokusingqongileyo, kunye nophuhliso lweenkqubo zolawulo ezikrelekrele zonke ziqhuba ishishini ukuya kwicala elizinzileyo.

Ukusetyenziswa kobuchwephesha obukrelekrele kubunjwa ngokutsha indlela yokusebenza yeejenereyitha zomphunga ococekileyo. Ukuphunyezwa kokubeka iliso okude, ukugcinwa kwangaphambili, ukulungiswa okuhlakaniphile kunye neminye imisebenzi ayiphuculi nje ukusebenza kwezixhobo zokusebenza, kodwa ibonelela ngokuqinisekiswa komgangatho othembekileyo wokuveliswa kweziyobisi.

Namhlanje, njengoko ukhuseleko lweziyobisi luxatyiswa ngakumbi, ukubalulekaiijenereyitha zomphunga zamayezaisiya iduma ngakumbi. Ayisiso isixhobo esifunekayo sokuvelisa amachiza kuphela, kodwa ikwangumqobo obalulekileyo wokuqinisekisa ukhuseleko lwamayeza oluntu. Ngokuqhubela phambili okuqhubekayo kwetekhnoloji, iijenereyitha zomphunga ococekileyo ngokungathandabuzekiyo ziya kudlala indima enkulu kwishishini lamayeza kwaye zenze igalelo elikhulu kwimpilo yabantu.