Isityalo samayeza sanamhlanje eMelika esakhiwe ngokupheleleyo yinkampani yaseTshayina-Shanghai VEN Pharmatech Engineering, yeyokuqala kwaye ibaluleke kakhulu kushishino lobunjineli bamayeza eTshayina.

I-IVEN iyile yaza yakha le fektri yanamhlanje ngetekhnoloji yamva nje ephezulu, igumbi elicocekileyo, oomatshini bokuvelisa, izixhobo zelebhu, kunye nazo zonke izixhobo zokusebenza zihambelana ngokungqongqo nomgangatho we-US FDA cGMP. Le projekthi ikwahlangabezana ne-USP43, ISPE, ASME BPE, kunye neminye imigangatho kunye neemfuno zase-US ezinxulumene nayo, yaqinisekiswa ngenkqubo yolawulo lomgangatho we-GAMP5.

IUmgca wokuzalisa ingxowa ye-IVyamkela ukuprinta ngokuzenzekelayo, ukwenza iingxowa, ukuzalisa kunye nokutywina. Emva koko, inkqubo yokubulala iintsholongwane yesiphelo ezenzekelayo yenza ukuba iingxowa ze-IV zilayishwe kwaye zikhutshwe ngokuzenzekelayo ziirobhothi kwiitreyi zokubulala iintsholongwane, kwaye iitreyi zingena kwaye ziphume ngokuzenzekelayo kwi-autoclave. Emva koko, iingxowa ze-IV ezicociweyo zihlolwe ngumatshini wokufumanisa ukuvuza ombane ophezulu kunye nomatshini wokuhlola okubonakalayo ngokuzenzekelayo, ukujonga ukuvuza, amasuntswana angaphakathi kunye neziphene zengxowa ngendlela ethembekileyo.

Umgca wokupakisha ozenzekelayo ngokupheleleyo odibanisa ukusuka ekusongweni kweengxowa ezine, ibhokisi yokuthumela imithwalo ivuleka, ukupakisha ngerobhothi, ukufakwa kwesatifikethi kunye nencwadi yemiyalelo, ukulinganisa kunye nokwaliwa kwi-intanethi, ukutywinwa kwebhokisi yokuthumela, ukuprinta ngokuhlolwa kwekhamera, de kube kufakwe iipalethi ngokuzenzekelayo, kunye nokusonga iipalethi ngaphezulu.

Ukususela ekucocweni kwamanzi ukuya ekulungisweni kwesisombululo ukuya kwimveliso yokugqibela, yonke inkqubo yemveliso ifezekisa ukwenziwa kwezinto ngokuzenzekelayo okuphezulu okunciphisa kakhulu iindleko zomsebenzi, kunciphisa umngcipheko wongcoliseko, kwaye kwandisa ukusebenza kakuhle kwemveliso kunye nomgangatho ongcono.

Ngemizamo engapheliyo yeminyaka engama-20, i-IVEN Pharmatech yakhe iiprojekthi ezininzi zokuguqula amayeza kumazwe angaphezu kwama-20 kwaye ithumela ngaphandle amawaka ezixhobo kumazwe angaphezu kwama-60. Siza kuhlala sizama 'ukudala ixabiso kubathengi', sizise iiprojekthi ezibaluleke ngakumbi kubathengi bethu kwihlabathi liphela.