Kumzi-mveliso wamachiza, yonke inkqubo yemveliso ihambelana nokukhuseleka kobomi bezigulana. Ukusuka ekukhetheni izinto ezibonakalayo kwimveliso, ezisuka kwizixhobo ukucoca kulawulo lwendalo, naluphi na ungcoliseko oluncinci lunokubangela ukuba lukhokele kwimingcipheko yomgangatho weziyobisi. Phakathi kwezi zikhonkco ziphambili, iI-PharmemaceOutical Hleerator ecocekileyoUbe sesinye sezixhobo eziphambili zokuqinisekisa ukhuseleko lweziyobisi ngenxa yendima yayo engenakufikelelwe. Ayisinikanga kuphela isiqinisekiso semveliso ethembekileyo kuphela, kodwa ikwasebenza njengelitye elibalulekileyo lomzi-mveliso wamachiza wemihla ngemihla ukuya kwimigangatho ephezulu kunye nomgangatho ophezulu.

I-Steam emsulwa: i-feeline yemveliso yamayeza

Iimfuneko zokucoceka kwimveliso yamayeza ziphantse zaziwa. Nokuba yimbalwane, i-biologics, amayeza, okanye izixhobo zemfuza, izixhobo, izitya, izitya, kunye nendawo yomoya ebandakanyekayo kwimveliso yazo kufuneka ibulawe. I-Steam emsulwa (ikwabizwa ngokuba "yi-Steam Caeam Caeam") iye yaba yindawo ekhethiweyo ye-chill kwishishini lamayeza ngenxa yobushushu obuphezulu kunye nokungabikho kweendawo zokuhlala.

Umthwali ophambili we-sterilization

I-Steam emsulwa inokukhawuleza ingene kwiindonga zeseli ze-microbial kwaye ixhela ngokupheleleyo intsholongwane, intsholongwane, kwaye isebenzisa ubushushu obuphezulu (ihlala ingaphezulu kwe-121 ℃) kunye noxinzelelo oluphezulu. Xa kuthelekiswa nabathengisi beechiza zemichiza, i-Steam Steam Steam ayinamngcipheko oshiyekileyo, ngakumbi ngokufanelekileyo kwizixhobo kunye nezixhobo ezingena ngokuthe ngqo namachiza. Umzekelo, ukucocwa kwezixhobo eziphambili ezifana nemigca yokugcwalisa intsholongwane, oomatshini bokumisa abakhululekileyo, kunye neebhayiloji zixhomekeka kwi-Pouttion esebenzayo yeSteam.

Isilumkiso semigangatho esemgangathweni

Ngokutsho kweemfuno ze-GMP, amayeza amayeza acocekileyo kufuneka afezekise izikhombisi ezintathu eziphambili:

Akukho mthombo wobushushu: Umthombo wobushushu ngumthombo wobuxoki onokubangela ukuphendula kwe-fever kwizigulana kwaye kufuneka zisuswe ngokupheleleyo.

Amanzi ancitshisiweyo ahlangabezana nomgangatho: Umgangatho wamanzi emva kokufumana i-Steam Steen Convents kufuneka uhlangane namanzi kwinaliti (WFI), ukuqhubela phambili kwe-Intanethi 1.3 μ ye / cm.

Ixabiso elomileyo lokwakha

Inkqubo epheleleyo yenkqubo

Ukusuka kwi-Intanethi ye-Intanethi Ngakumbi kwindibano yocweyo yase-Aseptic, umvelisi ococekileyo we-steam ngu "umthombo wamandla ombane" oqhuba phantse iiyure ezingama-24 ngosuku ngaphandle kokuphazamiseka

Ubugcisa betekhnoloji ye-PHERMACECATION STEAM PEAMRMER

Ngemfuno eyandayo yomgangatho, ukusebenza kakuhle, kunye nokukhusela isisingqongileyo kwishishini lamayeza, itekhnoloji yeemvavanyo ezimsulwa i-Steam Steam ikwahlala idlula. Izixhobo zanamhlanje ziphumelele ukhuseleko oluphezulu kunye nokusebenza ngokuphumelelayo ngoyilo olukrelekrele nomhlambi wemodyuli.

Ukuqhekeka kwiTekhnoloji ephambili

Itekhnoloji yokufunda ngamanqanaba ePhezulu: Ukubuyiselwa kwamandla amanqanaba amanqanaba amaninzi, amanzi aphantsi (ahlala amanzi acocekileyo) aguqulwa abe ngumtya ococekileyo, ukunciphisa ukusetyenziswa kwamandla ngaphezulu kwe-30% ngokuthelekiswa nezixhobo zesiko.

Ulawulo olukrelekrele: Ixhotyiswe ngenkqubo yokubeka iliso ngokuzenzekelayo, ukufumanisa okwenyani kwexesha, ubushushu, kunye noxinzelelo, i-alamu ezenzekelayo kunye nohlengahlengiso lweempazamo ezingaqhelekanga, ukuphepha iimpazamo zomsebenzi wabantu.

Uyilo oluphantsi lwekhabhoni: Ukwamkela izixhobo zokubuyiswa kobushushu bokubuyisela inkunkuma ukunciphisa inkunkuma yamandla, ngokuhambelana nendlela yenguqu eluhlaza yeshishini lamayeza.

'I-inshurensi ezimbini' yokuqinisekiswa komgangatho

Imihlambi emihle ye-Steam yanamhlanje ixhotyiswe ngeendlela zokuqinisekisa umgangatho oziphethe kakuhle:

Inkqubo yokujonga iliso kwi-Intanethi: Ukuhlolwa kwexesha lokwenyani lokufumana ubunyulu be-steam ngezixhobo ezinje ngeemitha zokuziphatha kunye nohlalutyo lwe-toc.
Uyilo olungafunekiyo: I-pump youndu ye-pumputer, filli-filtical filling kunye nolunye uyilo lwezinto eziyinye zokuqinisekisa ukusebenza kwezixhobo kwimeko yequbuliso.

Ukuguquguquka ekuphenduleni kwiimfuno ezintsonkothileyo

Abavelisi abacocekileyo be-Steam bangenza ngokwezifiso kumacandelo avelileyo anje ngee-biophapharmaceuticals kunye nonyango lweseli. Umzekelo, izixhobo ezisetyenziselwa ukuveliswa kwe-MRNA iMveliso yoLungelelwaniso kufuneka ihambelane neemfuno eziphezulu ze-Entele, kwaye ezinye iinkampani zizise itekhnoloji ye-Endotoxin kwi-0.001 EU / ML.
Ngophuhliso olukhawulezileyo lwee-biophapharmaceuticals, iimfuno eziphezulu zibekelwe phambili kumgangatho we-Steam emsulwa. Ukuveliswa kwamachiza amatsha anjengeengcambu zeziyobisi kunye nee-antibodies ze-monoclon kufuna indawo ecocekileyo ye-subr. Oku kuveza umngeni omtsha wetekhnoloji yeemveliso ezicocekileyo ze-Steam Steam.

Umxholo wemveliso eluhlaza utshintsha uyilo lokucinga ngemijelo ecocekileyo ye-Steam Steam. Ukusetyenziswa kwezixhobo zokonga amandla, izixhobo ezinobuntu ngokusingqongileyo, kunye nophuhliso lweenkqubo zolawulo olukrelekrele zonke ziqhuba ishishini ukuya kwicala elizinzileyo.

Ukusetyenziswa kwetekhnoloji ekrelekrele kuphinda kwenziwe kwakhona imowudi yokusebenza yabavelisi be-steam steam. Ukuphunyezwa kokubek'esweni okude, uhlengahlengiso oluqiqisiweyo kunye nokulungelelaniswa kobuchule kunye neminye imisebenzi ayiphuluki nje impumelelo kwenkqubo yezixhobo, kodwa ikwabonelela ngokuqinisekiswa komgangatho othembekileyo kwimveliso yeziyobisi.

Namhlanje, njengoko ukhuseleko lweziyobisi luye luxabisa, ukubaluleka kweamayeza acocekileyo acocekileyoiyaziwa kakhulu. Ayisiyo nje isixhobo esifanelekileyo semveliso yamachiza, kodwa nesithintelo esibalulekileyo sokuqinisekisa ukhuseleko lwamayeza oluntu. Ngokuqhubela phambili kwetekhnoloji yeTekhnoloji, abavelisi abacocekileyo bengathandabuzekiyo bayadlala indima enkulu kwishishini lamayeza kwaye benza iminikelo emikhulu kwimpilo yabantu.