Kwishishini lamayeza elikhula ngokukhawuleza kwihlabathi liphela namhlanje, unyango lwe-intravenous infusion (IV), njengekhonkco eliphambili kunyango lwezonyango, lubeke imigangatho ephezulu engakaze ibonwe ngaphambili yokhuseleko lwamayeza, uzinzo, kunye nokusebenza kakuhle kwemveliso. I-Multi Chamber IV Bag, enoyilo lwayo olukhethekileyo lwegumbi, inokufezekisa ukuxubana kwangoko kwamayeza kunye nezinyibilikisi, iphucula kakhulu ukuchaneka kwamayeza kunye nokulula kwawo. Ibe yindlela ekhethwayo yokupakisha amalungiselelo anzima afana nesondlo se-parenteral, amayeza e-chemotherapy, ii-antibiotics, njl. Nangona kunjalo, ukuveliswa kweemveliso ezinjalo kufuna iimfuno ezingqongqo kakhulu zobuchwepheshe bezixhobo, indawo ecocekileyo, kunye nokuthobela imithetho. Ababoneleli beenkonzo zobunjineli kuphela abanolwazi olunzulu lobugcisa kunye namava eprojekthi yehlabathi abanokubonelela ngezisombululo ezithembekileyo ngokwenene.

Njengenkokeli yehlabathi kwicandelo lobunjineli bezonyango, i-IVEN Pharmatech Engineering, enamava angaphezu kweminyaka engama-30 kwishishini leyeza, izibophelele ekuboneleleni abathengi behlabathi ngeenkonzo zobunjineli ezinikezelwa ngokukodwa ukusuka kuyilo lwenkqubo, ukuhlanganiswa kwezixhobo ukuya kwisiqinisekiso sokuthobela imithetho.Umgca weMveliso yeZingxobo zeChamber IV ezininziAyihlanganisi nje kuphela ubuchwepheshe obuphambili bokuzenzekela, kodwa ikwanenzuzo ephambili yokuthobela i-100% imigaqo yamazwe ngamazwe efana ne-EU GMP kunye ne-US FDA cGMP, inceda iinkampani zamayeza ukuba zenze iimveliso ezinexabiso eliphezulu kwaye zithathe amathuba emarike yehlabathi.

Umgca weMveliso yeZixhobo zeMulti Chamber IV Intelligent: Ukuchaza ngokutsha umda phakathi kokusebenza kakuhle kunye nokhuseleko

Umgca wemveliso yebhegi ye-IVEN yegumbi elininzi yenzelwe ukuhlangabezana nemingeni yokuveliswa kwefomyula enzima. Ngokusebenzisa amaqela amane etekhnoloji entsha, inceda abathengi ukuba baphume kwiingxaki zemveli zemveliso:

1. Ukubumba okuhambelanayo kwegumbi elininzi kunye netekhnoloji yokuzalisa echanekileyo
Iingxowa zemveli zegumbi elinye zixhomekeke kumanyathelo okuxuba angaphandle, abeka umngcipheko wokungcola okunqamlezileyo kwaye azisebenzi kakuhle. I-IVEN isebenzisa inkqubo yefilimu ephumayo enezingqimba ezininzi kunye ne-thermoforming. Ngokusebenzisa ii-molds ezichanekileyo kunye nolawulo lobushushu, iigumbi ezizimeleyo ezi-2-4 zinokwenziwa kwisitampu esinye, kunye namandla okwahlulahlula angaphezu kwe-50N/15mm phakathi kweegumbi, ukuqinisekisa ukuba akukho kuvuza ngexesha lokuthuthwa nokugcinwa. Inkqubo yokuzalisa izisa ipompo yokuzalisa enezitishi ezininzi eqhutywa yi-magnetic levitation linear motor, enobuncinci bokuzalisa obuchanekileyo be-± 0.5%, exhasa uhlengahlengiso olubanzi ukusuka kwi-1mL ukuya kwi-5000mL, evumelana ngokugqibeleleyo neemfuno zokupakisha ze-viscosity fluids ezahlukeneyo ezifana nezisombululo zezondlo kunye namayeza e-chemotherapy.

2. Inkqubo yoqhagamshelo olungenazintsholongwane evalekileyo ngokupheleleyo
Ukusombulula ingxaki yokulawulwa kweentsholongwane kwiingxowa zegumbi ezininzi ezixutywe kwangaphambili, i-IVEN iphuhlise isixhobo sokuqalisa i-SafeLink ™ Aseptic esinelungelo lobunikazi. Esi sixhobo sisebenzisa uyilo lwe-laser pre cutting weaking layer, kunye nendlela yokuqalisa uxinzelelo loomatshini. Abasebenzi bezonyango kufuneka bacinezele ngesandla esinye kuphela ukuze bafumane unxibelelwano olungenazintsholongwane phakathi kwamagumbi, bephepha umngcipheko wenkunkuma yeglasi enokuthi iveliswe ziivalvu ezisongwayo zendabuko. Emva kokuqinisekiswa ngumntu wesithathu, ukusebenza kokutywina koqhagamshelo olusebenzayo kuhlangabezana nomgangatho we-ASTM F2338-09, kwaye amathuba okungena kweentsholongwane angaphantsi kwe-10 ⁻⁶.

3. Inkqubo yokuhlola nokulandelelwa kobukrelekrele bokwenziwa
Umgca wemveliso udibanisa inkqubo yokufumanisa i-AI X-ray eneemowudi ezimbini, efumanisa ngokuchanekileyo iziphene zefilimu, ukuzalisa ukuphambuka kwenqanaba lolwelo, kunye nokuthembeka kokutywinwa kwegumbi ngokusebenzisa iikhamera ze-CCD ezinesisombululo esiphezulu kunye ne-micro focus X-ray imaging. Ii-algorithms zokufunda ngokunzulu zinokuchonga ngokuzenzekelayo iziphene zemingxuma kwinqanaba le-0.1mm, kunye nesantya sokufumanisa esingeyonyani esingaphantsi kwe-0.01%. Kwangaxeshanye, ibhegi nganye yokufaka i-infusion ifakwe itshiphu ye-RFID ukuze kufumaneke ukulandeleka okupheleleyo ukusuka kwiibhetshi zezinto eziluhlaza, iiparameter zemveliso ukuya kubushushu bokujikeleza kwegazi, ukuhlangabezana neemfuno ze-serialization ze-FDA DSCSA (uMthetho woKhuseleko lweCandelo loNikezelo lweZilwanyana zaMachiza).

4. Isisombululo sokubulala iintsholongwane esiqhubekayo esonga amandla
Ikhabhinethi yesiqhelo yokubulala iintsholongwane eyenzeka rhoqo ineendawo ezibuhlungu zokusetyenziswa kwamandla aphezulu kunye nomjikelo omde. I-IVEN kunye namaqabane ayo aseJamani baphuhlise inkqubo yeRotary Steam in Place (SIP) ngokubambisana, eyamkela uyilo lwenqaba yokutshiza ejikelezayo ukuze idale ukuxinana kwigumbi lomphunga elishushu kakhulu. Ingagqiba ukubulala iintsholongwane kwimizuzu eli-15 kwi-121 ℃, igcine amandla angama-35% xa kuthelekiswa neendlela zemveli. Inkqubo ixhotyiswe ngomlawuli we-B&R PLC ozenzele ngokwakhe, onokurekhoda kwaye agcine idatha yokusasazwa kobushushu bebhetshi nganye (ixabiso le-F ₀ ≥ 15), kwaye ivelise ngokuzenzekelayo iirekhodi zebhetshi ze-elektroniki ezihambelana ne-21 CFR Part 11.

Ukuzibophelela kwe-IVEN: inethiwekhi yeenkonzo zehlabathi egxile kwimpumelelo yabathengi

Siyazi kakuhle ukuba izixhobo zodidi lokuqala kufuneka zihambelane nenkonzo yodidi lokuqala.IVEN Iseke amaziko obuchwephesha kumazwe ali-12 kwihlabathi liphela, ibonelela ngokuxilongwa okukude iiyure ezisi-7 x ezingama-24 kunye nenkxaso yokuphendula kwindawo yokusebenza iiyure ezingama-48. Iqela lethu linokubonelela ngeenkonzo ezenzelwe wena emva kokuthengisa ngokusekelwe kumahluko kwimigaqo kwimimandla eyahlukeneyo.

Kwixesha lonyango oluchanekileyo kunye namayeza alungiselelwe wena, iingxowa zokufaka i-intravenous zegumbi elininzi ziyawuguqula umda wonyango lwe-parenteral. I-IVEN Pharmatech Engineering yakha ibhulorho eya kwixesha elizayo kwiinkampani zamayeza zehlabathi ngobuchule bayo obugqwesileyo bobunjineli kunye nokulandela ukuthobela imithetho. Nokuba yiprojekthi ezintsha okanye ukuphuculwa kwamandla, umgca wethu wemveliso okrelekrele uya kuba liqabane lakho elithembekileyo.

Nxibelelana ne-IVENiqela leengcali ngoko nangoko ukuze ufumane izisombululo ezenzelwe wena kunye namabali empumelelo yehlabathi!