amantla Emelika
Iprojekthi ye-USA IV bag turnkey, iprojekthi yokuqala ye-turnkey yamayeza eMelika eyenziwe yinkampani yaseTshayina - i-IVEN Pharmatech, isandula ukugqiba ukufakelwa kwayo. Oku kubonisa isiganeko esibalulekileyo kwishishini lamayeza laseTshayina.
I-IVEN iyile kwaye yakha le fektri yanamhlanje ngokuhambelana ngokungqongqo nomgangatho we-US CGMP. Le fektri ithobela imigaqo ye-FDA, i-USP43, izikhokelo ze-ISPE, kunye neemfuno ze-ASME BPE, kwaye iqinisekiswe ngenkqubo yolawulo lomgangatho we-GAMP5, ivumela inkqubo ebanzi yokulawula umgangatho egubungela yonke inkqubo ukusuka ekuphathweni kwezinto eziluhlaza ukuya kwindawo yokugcina imveliso egqityiweyo.
Izixhobo zemveliso eziphambili zidibanisa ubuchwepheshe bokuzenzekela: umgca wokuzalisa usebenzisa inkqubo epheleleyo yokudibanisa iingxowa zokuprinta, kwaye inkqubo yokukhupha ulwelo ifezekisa ukucoca nokubulala iintsholongwane kwi-CIP/SIP, kwaye ixhotyiswe ngesixhobo sokufumanisa ukuvuza kokukhupha umbane esine-voltage ephezulu kunye nomatshini wokuhlola ukukhanya okuzenzakalelayo wekhamera ezininzi. Umgca wokupakisha wangasemva ufezekisa ukusebenza ngesantya esiphezulu seengxowa ezingama-70/min kwiimveliso ezingama-500ml, udibanisa iinkqubo ezili-18 ezifana nokufaka imithwalo yemiqamelo ngokuzenzekelayo, ukufaka iipalethi ngobuchule kunye nokulinganisa kunye nokulahlwa kwi-intanethi. Inkqubo yamanzi ibandakanya ukulungiswa kwamanzi acocekileyo angama-5T/h, umatshini wamanzi acocekileyo angama-2T/h kunye nejenereyitha yomphunga ecocekileyo engama-500kg, kunye nokubeka esweni ubushushu kwi-intanethi, i-TOC kunye nezinye iiparameter eziphambili.
Esi sityalo sihambelana nemigangatho yamazwe ngamazwe efana ne-FDA, i-USP43, i-ISPE, i-ASME BPE, njl.njl., kwaye siphumelele ukuqinisekiswa kwenkqubo yolawulo lomgangatho ye-GAMP5, senza inkqubo yolawulo lomgangatho wenkqubo yonke ukusuka ekucutshungulweni kwezinto eziluhlaza ukuya kwindawo yokugcina imveliso egqityiweyo, ukuqinisekisa ukuba iimveliso zokugqibela ezicociweyo ezinomthamo wokuvelisa ngonyaka weengxowa ezingama-3,000/ngeyure (iinkcukacha ezingama-500ml) ziyahambelana neemfuno zomthetho zehlabathi jikelele zamayeza.
I-Asia Ephakathi
Kumazwe amahlanu aseMbindi Asia, uninzi lweemveliso zamayeza zithunyelwa kwamanye amazwe. Emva kweminyaka eliqela yokusebenza nzima, siye sanceda abathengi ukuba bavelise iinkampani zamayeza kula mazwe ukuba zibonelele ngemveliso efikelelekayo kubasebenzisi basekhaya. EKazakhstan, sakhe umzi-mveliso omkhulu wamayeza odibeneyo, kuquka imigca emibini yemveliso yesisombululo se-IV esineengxowa ezithambileyo kunye nemigca emine yemveliso ye-ampoules.
E-Uzbekistan, sakhe umzi-mveliso wamayeza webhotile ye-PP enesisombululo se-IV onokukwazi ukuvelisa iibhotile ezili-18 lezigidi ngonyaka. Lo mzi-mveliso awuzisi nje kuphela iingenelo ezinkulu kwezoqoqosho, kodwa ukwanika abantu basekuhlaleni ithuba lokufumana unyango olufikelelekayo.
ERashiya, nangona ishishini lamayeza lizinzile, uninzi lwezixhobo kunye nobuchwepheshe obusetyenzisiweyo abudalanga. Emva kokutyelela abathengisi bezixhobo baseYurophu naseTshayina, umenzi wamayeza omkhulu wesisombululo se-injection kweli lizwe wasikhethela iprojekthi yabo yesisombululo se-IV sebhotile ye-PP. Esi sakhiwo sinokuvelisa iibhotile ze-PP ezizigidi ezingama-72 ngonyaka.
Afrika
E-Afrika, amazwe amaninzi akwinqanaba lophuhliso kwaye abantu abaninzi abanalo ukufikelela okwaneleyo kwezempilo. Okwangoku, sakha umzi-mveliso wamayeza we-soft bag IV-solution eNigeria, onokukwazi ukuvelisa iibhegi ezithambileyo ezingama-20 ezigidi ngonyaka. Silangazelela ukuvelisa iifektri zamayeza ezikumgangatho ophezulu e-Afrika. Ithemba lethu kukunceda abantu base-Afrika ngokubonelela ngezixhobo eziya kubangela iimveliso zamayeza ezikhuselekileyo.
Phakathi empuma
Ishishini lamayeza eMbindi Mpuma lisaqala, kodwa bebesoloko bebhekisa kwimigangatho ebekwe yi-FDA e-US yomgangatho weemveliso zonyango. Abathengi bethu abavela eSaudi Arabia bakhuphe iodolo yeprojekthi epheleleyo yesisombululo se-IV-solution turnkey yebhegi ethambileyo enokuvelisa iibhegi ezithambileyo ezingaphezu kwezigidi ezingama-22 ngonyaka. E-Iraq, sincede abathengi abaninzi ekusekeni izityalo zamayeza, nto leyo enegalelo ekuphuculeni icandelo lezempilo lase-Iraq.
Mzantsi-mpuma weAsia
Umzantsi-mpuma we-Asia uqhayisa ngabantu abaninzi abaneziseko zempilo ezibuthathaka kunye nemfuno enkulu. Simisele izityalo zamayeza kumazwe afana neLaos, Thailand, Vietnam, kunye ne-Indonesia. Omnye wabathengi bethu base-Indonesia, emva kokukhetha, wakhetha ukucubungula umzi-mveliso wamayeza odidi oluphezulu lwe-IV-solution. Sigqibe isigaba soku-1 seprojekthi yamayeza evumela ukuveliswa kweebhotile ezingama-8000 ngeyure. Isigaba sesi-2 esiya kuvumela iibhotile ezili-12,000 ngeyure saqala ukufakwa ekupheleni kuka-2018.
