Iplanti yamayeza yanamhlanje e-USA eyakhiwe ngokupheleleyo yinkampani yaseTshayina-Shanghai VEN Pharmatech Engineering, yeyokuqala kunye nesiganeko esibalulekileyo kwishishini lobunjineli bamayeza eTshayina.

I-VEN iyilwe yaza yakha lo mzi-mveliso wale mihla onobuchwephesha obuphezulu bamva nje, igumbi elicocekileyo, oomatshini bokuvelisa, izixhobo zelabhoratri, kunye nazo zonke izinto eziluncedo zithobela ngokungqongqo umgangatho we-US FDA cGMP. Le projekthi ikwadibana ne-USP43, i-ISPE, i-ASME BPE, kunye neminye imigangatho ehambelana ne-US kunye neemfuno, yaqinisekiswa ngenkqubo yolawulo lwekhwalithi ye-GAMP5.

IUmgca wokuzalisa ingxowa ye-IVyamkela ukuprinta okuzenzekelayo, ukwenza ingxowa, ukuzaliswa kunye nokutywinwa. Emva koko, i-othomathikhi ye-terminal sterilization system iqonda ukuba ii-IV iingxowa zokulayisha ngokuzenzekelayo kunye nokuthuthwa kweerobhothi kwiitreyi zokucoca, kwaye iitreyi zihamba ngokuzenzekelayo kwaye ziphuma kwi-autoclave. Emva koko, iingxowa ze-IV ezihlambulukileyo zihlolwe ngumatshini wokukhangela ukuvuza kwe-auto high-voltage kunye nomatshini wokuhlola obonakalayo, ukujonga zombini ukuvuza, amasuntswana angaphakathi kunye neziphene zebhegi ngendlela ethembekileyo.

Umgca wokupakisha ogqibeleleyo ozenzekelayo odibanisayo ukusuka ekusongelweni kokuhamba kweengxowa ze-IV, ibhokisi yokuthumela evulekileyo, ukupakishwa ngerobhothi, ukufakwa kwesatifikethi kunye nencwadana yomyalelo, ukulinganisa i-intanethi kunye nokukhatywayo, ukutywinwa kwebhokisi yokuthumela, ukuprintwa ngokuhlolwa kwekhamera, kude kube yi-auto palletizing, kunye nokugubungela ngaphezulu kweepalethi.

Ukusuka kunyango lwamanzi ukuya ekulungiseni isisombululo ukuya kwimveliso yokugqibela, yonke inkqubo yokuvelisa ifikelela kwi-automation ephezulu enciphisa kakhulu iindleko zabasebenzi, ukunciphisa umngcipheko wongcoliseko, kunye nokwandisa ukusebenza kakuhle kwemveliso kunye nomgangatho ongcono.

Ngeminyaka engama-20 yemizamo engaguqukiyo, i-IVEN Pharmatech iye yakha iiprojekthi ezininzi ze-pharmaceutical turnkey kumazwe angaphezu kwama-20 kwaye yathumela amawaka ezixhobo kumazwe angaphezu kwama-60. Siya kuhlala silandela 'Yenza ixabiso kubathengi', sizise iiprojekthi ezibaluleke ngakumbi kubathengi bethu kwihlabathi liphela.