Isitshalo semithi sesimanje e-USA esakhiwe ngokuphelele yinkampani yaseShayina–I-Shanghai VEN Pharmatech Engineering, kungokokuqala futhi kuyingqophamlando embonini yobunjiniyela bemithi yaseShayina.

I-IVEN yaklama futhi yakha le fektri yesimanje ngobuchwepheshe bamuva obuphezulu, igumbi elihlanzekile, imishini yokukhiqiza, imishini yelabhorethri, kanye nazo zonke izinsizakusebenza zihambisana ngokuqinile nezindinganiso ze-US FDA cGMP. Le phrojekthi ihlangabezana nezindinganiso ze-US ze-US ezihambisanayo, i-ISPE, i-ASME BPE, kanye nezinye izindinganiso kanye nezimfuneko zase-US ezihlobene, yaqinisekiswa ngohlelo lokuphatha ikhwalithi lwe-GAMP5.

IUmugqa wokugcwalisa isikhwama se-IVyamukela ukuphrinta okuzenzakalelayo, ukwakha izikhwama, ukugcwalisa kanye nokuvala. Ngemva kwalokho, uhlelo lokubulala izinambuzane oluzenzakalelayo luvumela ukuthi izikhwama ze-IV zilayishwe futhi zithulwe ngokuzenzakalelayo ngamarobhothi ziye kumathileyi okubulala izinambuzane, bese amathileyi ehamba ngokuzenzakalelayo evela ku-autoclave. Ngemuva kwalokho, izikhwama ze-IV ezihlanziwe zihlolwe ngomshini wokuthola ukuvuza okuphezulu kwamandla kagesi kanye nomshini wokuhlola okuzenzakalelayo, ukuze kuhlolwe kokubili ukuvuza, izinhlayiya ezingaphakathi kanye nokukhubazeka kwesikhwama ngendlela ethembekile.

Umugqa wokupakisha ozenzakalelayo ngokuphelele ohlanganisa kusukela ekugoqweni kwezikhwama ezine, ibhokisi lokuthumela liyavuleka, ukupakisha ngerobhothi, ukufakwa kwesitifiketi kanye nencwadi yemiyalelo, ukulinganisa nokwenqatshwa ku-inthanethi, ukuvala ibhokisi lokuthumela, ukuphrinta ngokuhlolwa kwekhamera, kuze kube yilapho kupakishwa ngokuzenzakalelayo, kanye nokugoqwa kwamaphalethi ngaphezulu.

Kusukela ekuhlanzweni kwamanzi kuya ekulungisweni kwesisombululo kuya emkhiqizweni wokugcina, yonke inqubo yokukhiqiza ifinyelela ezenzakalelayo ephezulu enciphisa kakhulu izindleko zomsebenzi, inciphise ingozi yokungcola, futhi inyuse ukusebenza kahle kokukhiqiza kanye nekhwalithi engcono.

Ngemizamo engapheli yeminyaka engama-20, i-IVEN Pharmatech yakhe amaphrojekthi amaningi okuguqula imithi emazweni angaphezu kwama-20 futhi ithumela izinkulungwane zemishini emazweni angaphezu kwama-60. Sizohlala siphishekela 'ukudala inani lamakhasimende', silethe amaphrojekthi awusizo kakhulu kumakhasimende ethu emhlabeni wonke.