i-America esenyakatho
he USA IV bag turnkey project, iphrojekthi yokuqala ye-turnkey yezemithi e-United States eyenziwa yinkampani yaseShayina - IVEN Pharmatech, isanda kuphothula ukufakwa kwayo. Lokhu kuphawula ingqophamlando ebalulekile embonini yezemithi yaseChina.
I-VEN yaklama futhi yakha le mboni yesimanje ngokuhambisana ngokuqinile nezinga le-US CGMP. Ifekthri ithobelana nemithetho ye-FDA, i-USP43, imihlahlandlela ye-ISPE, kanye nezimfuneko ze-ASME BPE, futhi iye yaqinisekiswa ngohlelo lokuphatha ikhwalithi lwe-GAMP5, oluvumela uhlelo oluphelele lokulawula ikhwalithi oluhlanganisa yonke inqubo kusukela ekuphathweni kwempahla eluhlaza kuya ekugcinweni komkhiqizo ophelile.
Imishini yokukhiqiza eyinhloko ihlanganisa ubuchwepheshe bokuzenzakalela: umugqa wokugcwalisa wamukela uhlelo olugcwele lokuxhumanisa lokugcwalisa-isikhwama sokugcwalisa, futhi uhlelo lokukhipha uketshezi luqaphela ukuhlanza nokuhlanza inzalo kwe-CIP/SIP, futhi ifakwe umshini wokubona ukuvuza okukhipha amandla aphezulu kanye nomshini wokuhlola ukukhanya okuzenzakalelayo kwamakhamera amaningi. Ulayini wokupakisha ongemuva ufinyelela ukusebenza okushesha kakhulu kwezikhwama ezingama-70/min emikhiqizweni engu-500ml, ukuhlanganisa izinqubo eziyi-18 ezifana nokufaka izikhwama ezizenzakalelayo, i-palletizing ehlakaniphile kanye nesisindo se-inthanethi kanye nokwenqaba. Uhlelo lwamanzi luhlanganisa 5T/h ukulungiswa kwamanzi ahlanzekile, 2T/h umshini wamanzi distilled kanye 500kg pure umusi generator, ngokuqapha inthanethi lokushisa, TOC kanye nezinye imingcele key.
Lesi sikhungo sithobela izindinganiso zamazwe ngamazwe njenge-FDA, i-USP43, i-ISPE, i-ASME BPE, njll., futhi sesiphumelele ukuqinisekiswa kwesistimu yokuphatha ikhwalithi ye-GAMP5, sakha uhlelo lokulawula ikhwalithi oluphelele kusukela ekucutshungulweni kwezinto ezingavuthiwe ukuya ekugcinweni komkhiqizo ophelile, okuqinisekisa ukuthi imikhiqizo yokugcina esterilized enekhono lokukhiqiza lonyaka lezikhwama ezingu-3,000 / ihora ngokuvumelana nezimfuneko eziqondile zomhlaba wonke (500m) ezemithi.
I-Asia Ephakathi
Emazweni amahlanu ase-Asia Ephakathi, imikhiqizo eminingi yemithi ithengwa emazweni angaphandle. Ukulandela iminyaka eminingana yokusebenza kanzima, sisize amakhasimende ukuthi akhiqize izinkampani ezithaka imithi kulawa mazwe ahlinzeke ngemikhiqizo ethengekayo kubasebenzisi basekhaya. E-Kazakhstan, sakhe imboni enkulu edidiyelwe yemithi, okuhlanganisa imigqa yokukhiqiza ye-IV-solution yezikhwama ezimbili ezithambile kanye nemigqa yokukhiqiza imijovo yama-ampoules amane.
E-Uzbekistan, sakhe imboni yemithi ye-PP ibhodlela le-IV ekwazi ukukhiqiza amabhodlela ayizigidi eziyi-18 ngonyaka. Imboni ayigcini nje ngokubalethela izinzuzo ezinkulu kwezomnotho, kodwa futhi inikeza abantu bendawo ithuba lokuthola ukwelashwa okungabizi kakhulu.
Russia
E-Russia, nakuba imboni yemithi isungulwe kahle, imishini eminingi nobuchwepheshe obusetshenziswayo isiphelelwe yisikhathi. Ngemuva kokuvakashela kaningi abahlinzeki bemishini yaseYurophu nabaseShayina, umkhiqizi omkhulu wekhambi lesixazululo lomjovo ezweni wasikhethela iphrojekthi yabo ye-PP bottle IV-solution. Lesi sikhungo singakhiqiza amabhodlela e-PP ayizigidi ezingama-72 ngonyaka.
Afrika
E-Afrika, amazwe amaningi asesigabeni sokuthuthuka futhi abantu abaningi abanakho ukufinyelela okwanele kwezempilo. Njengamanje, sakha isikhwama esithambile i-IV-solution ifektri yemithi eNigeria, ekwazi ukukhiqiza izikhwama ezithambile eziyizigidi ezingama-20 ngonyaka. Sibheke ngabomvu ukukhiqiza izimboni zemithi ezisezingeni eliphezulu e-Afrika. Ithemba lethu ukusiza abantu base-Afrika ngokuhlinzeka ngemishini ezoholela emikhiqizweni ephephile yemithi.
Emaphakathi Mpumalanga
Imboni yemithi eMpumalanga Ephakathi isencane, kodwa bebekhuluma ngezindinganiso ezibekwe yi-FDA e-US ngekhwalithi yemikhiqizo yezokwelapha. Amakhasimende ethu avela eSaudi Arabia akhiphe i-oda lephrojekthi ye-turnkey yesikhwama esithambile engu-IV engakhiqiza izikhwama ezithambile ezingaphezu kwezigidi ezingu-22 ngonyaka.
Kwamanye amazwe ase-Asia, imboni yemithi inesisekelo esiqinile, kodwa izinkampani eziningi zinenkinga yokusungula izimboni ezisezingeni eliphezulu ze-IV-solution. Elinye lamakhasimende ethu ase-Indonesia, ngemuva kokukhetha, likhethe ukucubungula imboni yezokwelapha enesixazululo sezinga eliphezulu se-IV. Sesiqedile isigaba 1 sephrojekthi ye-turnkey eyenza ukukhiqizwa kwamabhodlela angu-8000 ngehora. Isigaba sesi-2 esizokwenza ukuthi amabhodlela/ihora ayi-12,000 aqale ukufakwa ngasekupheleni kuka-2018.