i-America esenyakatho
Iphrojekthi ye-USA IV bag turnkey, iphrojekthi yokuqala ye-pharmacy turnkey e-United States eyenziwe yinkampani yaseShayina - i-IVEN Pharmatech, isanda kuqedela ukufakwa kwayo. Lokhu kuphawula ingqophamlando ebalulekile embonini yemithi yaseShayina.
I-IVEN yaklama futhi yakha le fektri yesimanje ngokuhambisana ngokuqinile nezindinganiso ze-US CGMP. Ifektri ihambisana nemithethonqubo ye-FDA, i-USP43, iziqondiso ze-ISPE, kanye nezimfuneko ze-ASME BPE, futhi iqinisekiswe ngohlelo lokuphatha ikhwalithi lwe-GAMP5, okuvumela uhlelo oluphelele lokulawula ikhwalithi oluhlanganisa yonke inqubo kusukela ekuphathweni kwezinto zokusetshenziswa kuya ekugcinweni kwempahla yomkhiqizo oqediwe.
Imishini yokukhiqiza eyisihluthulelo ihlanganisa ubuchwepheshe bokuzenzakalela: umugqa wokugcwalisa usebenzisa uhlelo lokuxhumanisa olugcwele lwenqubo yokugcwalisa izikhwama zokunyathelisa, kanti uhlelo lokukhipha uketshezi luhlanza futhi luhlanza i-CIP/SIP, futhi luhlonyiswe ngedivayisi yokuthola ukuvuza kokukhipha okunamandla aphezulu kanye nomshini wokuhlola ukukhanya okuzenzakalelayo onamakhamera amaningi. Umugqa wokupakisha wangemuva ufeza ukusebenza okusheshayo kwamasaka angu-70/min emikhiqizweni engu-500ml, uhlanganisa izinqubo ezingu-18 ezifana nokufaka izikhwama zemicamelo okuzenzakalelayo, ukufaka amaphalethi ngobuhlakani kanye nokulinganisa nokulahla ku-inthanethi. Uhlelo lwamanzi luhlanganisa ukulungiswa kwamanzi ahlanzekile angu-5T/h, umshini wamanzi ohluziwe ongu-2T/h kanye nejenereyitha yomusi ehlanzekile engu-500kg, ngokuqapha izinga lokushisa ku-inthanethi, i-TOC kanye nezinye izinhlaka ezibalulekile.
Lesi sitshalo sihambisana nezindinganiso zomhlaba wonke ezifana ne-FDA, i-USP43, i-ISPE, i-ASME BPE, njll., futhi sesiphumelele ukuqinisekiswa kohlelo lokuphathwa kwekhwalithi lwe-GAMP5, sakha uhlelo lokulawula ikhwalithi oluphelele kusukela ekucutshungulweni kwezinto zokusetshenziswa kuya ekugcinweni komkhiqizo oqediwe, siqinisekisa ukuthi imikhiqizo yokugcina ehlanjululwe ngokubulala amagciwane enomthamo wokukhiqiza waminyaka yonke wamasaka angu-3,000/ihora (izincazelo ezingu-500ml) ihambisana nezidingo zomthetho zomhlaba wonke zemithi.
I-Asia Ephakathi
Emazweni amahlanu ase-Asia Ephakathi, imikhiqizo eminingi yemithi ingeniswa ivela kwamanye amazwe. Ngemva kweminyaka eminingana yokusebenza kanzima, sisize amakhasimende ukuthi akhiqize izinkampani zemithi kula mazwe ahlinzeke ngemikhiqizo engabizi kubasebenzisi basekhaya. EKazakhstan, sakhe imboni enkulu yemithi ehlanganisiwe, ehlanganisa imigqa emibili yokukhiqiza i-IV-solution yesikhwama esithambile kanye nemigqa emine yokukhiqiza i-ampoules.
E-Uzbekistan, sakha ifektri yemithi yebhodlela le-PP elinesisombululo se-IV ekwazi ukukhiqiza amabhodlela ayizigidi ezingu-18 ngonyaka. Le fektri ayigcini nje ngokubalethela izinzuzo ezinkulu zomnotho, kodwa futhi inikeza abantu bendawo ukufinyelela ekwelashweni kwezokwelapha okungabizi kakhulu.
ERussia, yize imboni yezemithi isizinzile, imishini eminingi kanye nobuchwepheshe obusetshenziswayo sekuphelelwe yisikhathi. Ngemva kokuvakashela kaningi abahlinzeki bemishini baseYurophu nabaseShayina, umkhiqizi wemithi omkhulu kunabo bonke ezweni wasikhethela iphrojekthi yabo yesisombululo se-PP bottle IV. Lesi sikhungo singakhiqiza amabhodlela e-PP ayizigidi ezingu-72 ngonyaka.
I-Afrika
E-Afrika, amazwe amaningi asesigabeni sokuthuthuka futhi abantu abaningi abanakho ukufinyelela okwanele kwezempilo. Njengamanje, sakha ifektri yemithi ye-soft bag IV-solution eNigeria, ekwazi ukukhiqiza izikhwama ezithambile eziyizigidi ezingama-20 ngonyaka. Sibheke phambili ekukhiqizeni izimboni zemithi zezinga eliphezulu e-Afrika. Ithemba lethu ukusiza abantu base-Afrika ngokuhlinzeka ngemishini ezoholela emikhiqizweni yemithi ephephile.
Emaphakathi Mpumalanga
Imboni yezemithi eMpumalanga Ephakathi isafufusa, kodwa ibilokhu ibhekisela ezindinganisweni ezibekwe yi-FDA e-US zekhwalithi yemikhiqizo yezokwelapha. Amakhasimende ethu avela eSaudi Arabia akhiphe i-oda lephrojekthi ephelele yesisombululo se-IV-solution turnkey yesikhwama esithambile engakhiqiza izikhwama ezithambile ezingaphezu kwezigidi ezingu-22 ngonyaka. E-Iraq, sisize amakhasimende amaningi ekusunguleni izitshalo zezemithi, okunegalelo ekuthuthukisweni komkhakha wezempilo wase-Iraq.
INingizimu-mpumalanga ye-Asia
INingizimu-mpumalanga ye-Asia inenani elikhulu labantu abanengqalasizinda yezempilo ebuthaka kanye nesidingo esikhulu. Sisungule izimboni zemithi ezishintshashintshayo emazweni afana neLaos, Thailand, Vietnam, kanye ne-Indonesia. Omunye wamakhasimende ethu ase-Indonesia, ngemuva kokukhetha, wakhetha ukucubungula ifektri yemithi ye-IV-solution ephezulu. Siqede isigaba sokuqala sephrojekthi ye-turnkey evumela ukukhiqizwa kwamabhodlela angu-8000 ngehora. Isigaba sesi-2 esizokwenza amabhodlela angu-12,000 ngehora saqala ukufakwa ngasekupheleni kuka-2018.
