Imboni yesimanje eyenza imithi e-USA eyakhiwe ngokuphelele yinkampani yaseShayina–I-Shanghai VEN Pharmatech Engineering, ingeyokuqala futhi iyingqophamlando embonini yobunjiniyela bezemithi yase-China.

I-IVEN yakhela futhi yakha le fekthri yesimanje ngobuchwepheshe bakamuva obuphezulu, igumbi elihlanzekile, imishini yokukhiqiza, imishini yaselabhorethri, nazo zonke izinsiza zihambisana ngokuqinile nezinga le-US FDA cGMP. Le phrojekthi futhi ihlangabezana ne-USP43, i-ISPE, i-ASME BPE, nezinye izinga nemfuneko ehlobene yase-US, yaqinisekiswa ngohlelo lokuphatha ikhwalithi lwe-GAMP5.

IIV umugqa wokugcwalisa isikhwamaithatha ukuphrinta okuzenzakalelayo, ukwenza izikhwama, ukugcwalisa nokuvala. Ngemva kwalokho, i-automatic terminal sterilization system ibona ukuthi izikhwama ze-IV zilayisha futhi zithululwa ngamarobhothi kumathileyi abulalayo, futhi amathreyi angena ephuma ngokuzenzakalelayo esuka ku-autoclave. Khona-ke, izikhwama ze-IV ezifakwe inzalo zihlolwa umshini wokubona ukuvuza kwe-auto high-voltage kanye nomshini wokuhlola okuzenzakalelayo, ukuhlola kokubili ukuvuza, izinhlayiya ezingaphakathi kanye nokukhubazeka kwesikhwama ngendlela ethembekile.

Ulayini wokupakisha ozenzakalelayo ophelele ohlanganisa kusukela ekugoqweni kokugeleza kwezikhwama ze-IV, ibhokisi lokuthumela liyambuleka, ukupakishwa ngerobhothi, ukufakwa kwesitifiketi kanye nebhukwana lemiyalo, isisindo se-inthanethi nokwenqatshwa, ukuvalwa kwebhokisi lokuthumela, ukuphrinta ngokuhlolwa kwekhamera, kuze kube yilapho i-auto palletizing, kanye nokusonga ngaphezulu kwamaphalethi.

Kusukela ekuhlanzweni kwamanzi kuya ekulungiseni isixazululo kuye emkhiqizweni wokugcina, yonke inqubo yokukhiqiza ifinyelela ezishintshayo eziphezulu ezinciphisa kakhulu izindleko zabasebenzi, zinciphise ubungozi bokungcola, futhi andise ukusebenza kahle kokukhiqiza kanye nekhwalithi engcono.

Ngemizamo engapheli yeminyaka engama-20, i-IVEN Pharmatech yakhe inqwaba yemiklamo ye-turnkey yezemithi emazweni angaphezu kwama-20 futhi yathumela izinkulungwane zemishini emazweni angaphezu kuka-60. Sizohlala siphishekela okuthi 'Dala Inani Lamakhasimende', silethe amaphrojekthi abaluleke kakhulu kumakhasimende ethu emhlabeni wonke.