Kwishishini lanamhlanje eliphuhlayo loxubo-mayeza kwihlabathi jikelele, unyango lwe-intravenous infusion (IV), njengekhonkco eliphambili kunyango lwezonyango, lubeke imigangatho ephezulu engazange ibonwe ngaphambili yokhuseleko lwamachiza, uzinzo kunye nokusebenza kakuhle kwemveliso. I-Multi Chamber IV Bag, kunye noyilo olukhethekileyo lwegumbi, inokufikelela ngokukhawuleza ukuxutywa kweziyobisi kunye ne-solvents, ukuphucula kakhulu ukuchaneka kwamayeza kunye nokulula. Iye yaba yifom yokupakisha ekhethwayo ukulungiselela amalungiselelo antsonkothileyo njengesondlo sabazali, amachiza echemotherapy, amayeza okubulala iintsholongwane, njl. Ngababoneleli beenkonzo zobunjineli kuphela abanokuqokelelana okunzulu kobugcisa kunye namava eprojekthi yehlabathi abanokubonelela ngezisombululo ezithembekileyo ngokwenene.

Njengomkhokeli wamazwe ngamazwe kwinkalo yobunjineli bezonyango, i-IVEN Pharmatech Engineering, engaphezulu kweminyaka engama-30 yamava kwishishini lezoxubo, izimisele ukubonelela abathengi behlabathi jikelele ngeenkonzo zobunjineli bezobunjineli be-turnkey ukusuka kwinkqubo yoyilo, ukuhlanganiswa kwezixhobo ukuya kwisatifikethi sokuthotyelwa. YethuMulti Chamber IV Bag Production Lineayidibanisi kuphela itekhnoloji ye-automation, kodwa ikwanenzuzo engundoqo ye-100% yokuthotyelwa kwemigaqo yamazwe ngamazwe efana ne-EU GMP kunye ne-US FDA cGMP, inceda iinkampani ezixuba amayeza ngokufanelekileyo ukwenza iimveliso eziphezulu zexabiso kunye nokubamba amathuba emarike yehlabathi.

Multi Chamber IV Bag Intelligent Production Line: Ukuchaza kwakhona umda phakathi kokuSebenza kunye noKhuseleko

I-VEN's multi chamber infusion bag production line yenzelwe ukuhlangabezana nemingeni yemveliso enzima yokuvelisa. Ngamaqela amane eteknoloji entsha, inceda abathengi ukuba baphule imiqobo yemveliso yemveli:

1. Multi chamber synchronous molding kunye neteknoloji yokuzalisa ngokuchanekileyo
Iingxowa eziqhelekileyo zegumbi elilodwa zithembele kumanyathelo okuxuba angaphandle, abeka umngcipheko wokungcoliswa komnqamlezo kwaye angasebenzi kakuhle. I-VEN ithatha inkqubo yefilimu ene-multi-layer co extruded thermoforming process. Ngokusebenzisa ukubunjwa okuchanekileyo okuphezulu kunye nolawulo lwe-gradient yokushisa, amagumbi azimeleyo angama-2-4 anokwakheka kwisitampu esisodwa, kunye namandla okwahlula ngaphezu kwe-50N / 15mm phakathi kwamagumbi, ukuqinisekisa ukuvuza kwe-zero ngexesha lokuthutha kunye nokugcinwa. Inkqubo yokuzalisa ingenisa impompo yokuzalisa i-multi-channel eqhutywa yi-magnetic levitation linear motor, kunye nokuchaneka okuncinci kokuzaliswa kwe-± 0.5%, ukuxhasa uhlengahlengiso olubanzi ukusuka kwi-1mL ukuya kwi-5000mL, ukulungelelanisa ngokugqibeleleyo kwiimfuno zokupakisha ezahlukeneyo ze-viscosity fluids ezifana nezisombululo zezondlo kunye neziyobisi ze-chemotherapy.

2. Inkqubo yoqhagamshelo olungenazintsholongwane oluvalwe ngokupheleleyo
Ukusombulula ingxaki yolawulo lwe-microbial kwiingxowa zamagumbi amaninzi axutywe ngaphambili, i-VENN iphuhlise isixhobo sokuvula esine-Patent SafeLink ™ Aseptic. Isixhobo samkela i-laser pre cutting ebuthathaka uyilo lomaleko, oludityaniswe nomatshini wokubangela uxinzelelo. Abasebenzi bezonyango kufuneka bacudise kuphela ngesandla esinye ukuze bafikelele kunxibelelwano olungenazintsholongwane phakathi kwamagumbi, benqanda umngcipheko wobutyobo beglasi obunokuthi iveliswe ziivalvu zokusonga zemveli. Emva kokuqinisekiswa komntu wesithathu, ukusebenza kokutywinwa koqhagamshelo olusebenzayo kuhambelana nomgangatho we-ASTM F2338-09, kwaye amathuba okuhlaselwa kwe-microbial angaphantsi kwe-10 ⁻⁶.

3. Inkqubo yokuhlola ingqiqo ye-Artificial intelligence kunye ne-traceability
Umgca wemveliso udibanisa i-AI X-ray yenkqubo yokukhangela i-double-mode, efumanisa ngokufanelekileyo iziphene zefilimu, ukuzalisa ukuphambuka kwinqanaba le-liquid, kunye negumbi lokutywina ingqibelelo ngokusebenzisa iikhamera zeCCD ezinesisombululo esiphezulu kunye ne-micro focus X-ray imaging. I-algorithms yokufunda enzulu inokuchonga ngokuzenzekelayo iziphene ze-pinhole kwinqanaba le-0.1mm, kunye nesantya sokufumanisa ubuxoki obungaphantsi kwe-0.01%. Kwangaxeshanye, ibhegi nganye yokufakela ifakelwe itshiphu yeRFID ukuze kufumaneke ukulandeleka ngokupheleleyo ukusuka kwiibhetshi zemathiriyeli ekrwada, iiparamitha zemveliso ukuya kwiqondo lobushushu lokujikeleza, ukuhlangabezana neemfuno zolandelelwano lwe-FDA DSCSA (uMthetho woKhuseleko lweSixokelelwano seDrug Supply Chain).

4. Ukonga amandla ngokuqhubekayo isisombululo sokuvala inzala
Ikhabhinethi yesiqhelo yokuvala inzala ineentlungu zokusebenzisa amandla aphezulu kunye nomjikelo omde. I-IVEN kunye namaqabane ayo aseJamani baye baqulunqa ngokudibeneyo inkqubo ye-Rotary Steam in Place (SIP), eyamkela i-design tower tower tower ejikelezayo ukudala isiphithiphithi kwigumbi elitshisa kakhulu. Inokugqiba ukuvala inzala kwimizuzu eli-15 kwi-121 ℃, yonga amandla angama-35% xa kuthelekiswa neendlela zakwantu. Inkqubo ixhotyiswe nge-self-developed controller B & R PLC, enokurekhoda kwaye igcine idatha yokusabalalisa i-thermal yebhetshi nganye (i-F ₀ ixabiso ≥ 15), kwaye ivelise ngokuzenzekelayo iirekhodi ze-electronic batch ezihambelana ne-21 CFR Icandelo 11.

Ukuzibophezela kwe-VEN: inethiwekhi yenkonzo yehlabathi jikelele egxile kwimpumelelo yabathengi

Siyazi kakuhle ukuba izixhobo zodidi lokuqala kufuneka zihambelane nenkonzo yodidi lokuqala.IVEN uye waseka amaziko obugcisa kumazwe e-12 kwihlabathi jikelele, ukubonelela nge-7 × i-24-iyure yokuxilongwa ekude kunye neyure ye-48 yenkxaso yokuphendula kwisayithi. Iqela lethu linokubonelela ngeenkonzo ezenziwe ngokwezifiso emva kokuthengisa ngokusekelwe kumahluko kwimimiselo kwimimandla eyahlukeneyo.

Ngexesha lamayeza achanekileyo kunye namayeza omntu, iingxowa ezininzi ze-intravenous infusion zilungisa imida yonyango lwabazali. I-IVEN Pharmatech Engineering yakha ibhulorho kwikamva kwiinkampani zamachiza zehlabathi kunye nobuchule bayo obubalaseleyo bobunjineli kunye nokusukela ekugqibeleni ukuthotyelwa. Nokuba ziiprojekthi ezintsha okanye ukuphuculwa kwamandla, umgca wethu wemveliso okrelekrele uya kuba liqabane lakho elithembekileyo.

Qhagamshelana ne-VENIqela leengcali ngoko nangoko kwizisombululo ezilungiselelweyo kunye namabali empumelelo yehlabathi!