Iphrojekthi yokuqala yeFekthro ye-Turncy yaseFharmacech yasekhaya eyakhiwe e-United States

Iphrojekthi ye-Turnkey-1
I-Turnkey Project-11

I-InHner Pharmaterchkuhlonishwe ukuthi kwenziweIphrojekthi ye-Turnkey Efektri yokuqala yemithi eyakhelwe inkampani yaseChina e-United States. Lesi sikhwama sanamuhla esithambile somthamo wevolumu (LVP) sekhemisi yakhelwe futhi sakhiwa ekulandeleni ngokuqinile namazinga we-US CGMP. Ihlanganisa indawo ephelele yabantwana abacishe babe ngu-4,600㎡, enabangaphezu kuka-3,000㎡ ezindawo ezihlanzekile, kufaka phakathi umhlangano wokukhiqiza oneminyaka engu-2,300 Isakhiwo sezitshalo sihlukaniswe ngezindawo ezintathu ezinkulu: elebhu, ukukhiqizwa kanye kanye nasizayo, ngamunye afakwe nezinhlelo ezenziwe ngezifiso zomoya. Indawo yelebhu ihlukaniswe ngokuya ngezidingo zokuhlola: Igumbi lokuhlola eliqondile (i-Ahu-6101 / I-ISO Class 8), Igumbi Lokuhlola I-Ahu-6102 / Iso Lisebenzisa I-Class 7) Indawo yokukhiqiza ifakwe amayunithi akhethekile ahlanzekile ngokusho kwezimpawu zokucubungula, njengokuhlanza (ahu-6106 / Iso Class 8), ukulungiswa kwesisombululo se-Ahu-6107 / iso (ahu-6109 / iso 7). Indawo ezayo ifakwe uhlelo lokufaka umoya we-Ahu-6108.

Imishini yokukhiqiza ebalulekile ihlanganisa ubuchwepheshe be-automation Umugqa wokupakisha ongezansi ufinyelela ukusebenza okusheshayo kwezikhwama ezingama-70 / umzuzu wemikhiqizo engu-500ML, ehlanganisa izinqubo eziyi-18 ezinjengokupakishwa komcamelo ozenzakalelayo, ukuhlakanipha okunengqondo, kanye nokwenqatshwa kwe-inthanethi. Uhlelo lwamanzi luhlanganisa ukulungiswa kwamanzi oku-5T / h / h / h / h / h / h dincilled manzi umshini, kanye ne-500kg Pure Steam generator, ngokuqapha online kwamapharamitha asemqoka anjengezinga lokushisa ne-toc.

Lesi sitshalo sihambisana namazinga aphesheya anjenge-FDA, i-USP43, i-ISPE, ne-ASME Bpe, futhi siqinisekiswe ngohlelo lokulawulwa kwekhwalithi ye-GAMP lususe amandla okukhiqiza / ihora le-500ML) ukuhlangabezana nezidingo zokulawula izidakamizwa zomhlaba wonke.

I-Turnkey Project-6
I-TurnKey Project-7

Isikhathi sePosi: Feb-27-2025

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