Embonini yezokwelapha yomhlaba wonke ethuthuka ngokushesha namuhla, ukwelashwa nge-intravenous infusion (IV), njengesixhumanisi esibalulekile kwezokwelapha, kubeke amazinga aphezulu angakaze abonwe okuphepha kwemithi, ukuzinza, kanye nokusebenza kahle kokukhiqiza. I-Multi Chamber IV Bag, enomklamo wayo oyingqayizivele wegumbi, ingafinyelela ukuxubana okusheshayo kwemithi kanye nezinyibilikisi, ithuthukise kakhulu ukunemba kwemithi kanye nokulula kwayo. Sekuyifomu lokupakisha elikhethwayo lamalungiselelo ayinkimbinkimbi njengokudla okunempilo kwabazali, imithi yamakhemikhali, ama-antibiotic, njll. Kodwa-ke, ukukhiqizwa kwemikhiqizo enjalo kudinga izidingo eziqinile kakhulu zobuchwepheshe bemishini, indawo ehlanzekile, kanye nokuhambisana. Abahlinzeki bezinsizakalo zobunjiniyela kuphela abanokuqongelela okujulile kobuchwepheshe kanye nesipiliyoni sephrojekthi yomhlaba wonke abanganikeza izixazululo ezinokwethenjelwa ngempela.

Njengomholi wamazwe ngamazwe emkhakheni wobunjiniyela bezokwelapha, i-IVEN Pharmatech Engineering, enolwazi olungaphezu kweminyaka engama-30 embonini yezokwelapha, izibophezele ekuhlinzekeni amakhasimende omhlaba wonke ngezinsizakalo zobunjiniyela ezisebenza ndawonye kusukela ekwakhiweni kwezinqubo, ukuhlanganiswa kwemishini kuya ekuqinisekisweni kokuhambisana nemithetho.Umugqa Wokukhiqiza Izikhwama Zegumbi Eliningi IVayigcini nje ngokuhlanganisa ubuchwepheshe obusezingeni eliphezulu bokuzenzakalela, kodwa futhi inenzuzo eyinhloko yokuthobela imithetho yamazwe ngamazwe njenge-EU GMP kanye ne-US FDA cGMP, okusiza izinkampani zemithi ukuthi zidale ngempumelelo imikhiqizo enenani eliphezulu futhi zibambe amathuba emakethe yomhlaba wonke.

Umugqa Wokukhiqiza Ohlakaniphile Wezikhwama Eziningi Zegumbi Lesine: Ukuchaza Kabusha Umngcele Phakathi Kokusebenza Kahle Nokuphepha

Umugqa wokukhiqiza izikhwama zokufaka i-IVEN ezinamakamelo amaningi wenzelwe ukubhekana nezinselele zokukhiqizwa kwefomula eyinkimbinkimbi. Ngokusebenzisa amaqoqo amane obuchwepheshe obusha, kusiza amakhasimende ukuthi adlule ezinkingeni zokukhiqiza zendabuko:

1. Ukubumba okuhambisanayo kwamakamelo amaningi kanye nobuchwepheshe bokugcwalisa obunembile
Izikhwama zendabuko zegumbi elilodwa zithembele ezinyathelweni zokuxuba zangaphandle, ezibeka ingozi yokungcoliswa okuphambene futhi azisebenzi kahle. I-IVEN isebenzisa inqubo yefilimu ekhishwe ngezingqimba eziningi enezinhlangothi ezintathu. Ngokusebenzisa izikhunta ezinembile kakhulu kanye nokulawula izinga lokushisa, amakamelo azimele angu-2-4 angakhiwa ngokunyathela okukodwa, ngamandla okuhlukanisa angaphezu kuka-50N/15mm phakathi kwamakamelo, okuqinisekisa ukuthi akukho ukuvuza ngesikhathi sokuthutha nokugcina. Inqubo yokugcwalisa yethula iphampu yokugcwalisa eneziteshi eziningi eqhutshwa yinjini eqondile ye-magnetic levitation, enokunemba kokugcwalisa okungenani okungu-± 0.5%, esekela ukulungiswa kobubanzi obuhlukahlukene kusukela ku-1mL kuya ku-5000mL, evumelana ngokuphelele nezidingo zokupakisha zoketshezi oluhlukile lwe-viscosity njengezixazululo zezakhamzimba kanye nemithi ye-chemotherapy.

2. Uhlelo lokuxhuma olungenamagciwane oluvalwe ngokuphelele
Ukuze kuxazululwe inkinga yokulawulwa kwamagciwane ezikhwameni zamakamelo amaningi ezixutshwe kusengaphambili, i-IVEN isungule idivayisi yokusebenzisa i-SafeLink ™ Aseptic enelungelo lobunikazi. Le divayisi isebenzisa ukwakheka kwesendlalelo sokunciphisa ukusika nge-laser, kuhlanganiswe nendlela yokucindezela ngomshini. Abasebenzi bezokwelapha badinga kuphela ukucindezelwa ngesandla esisodwa ukuze bafinyelele ukuxhumana okuhlanzekile phakathi kwamakamelo, begwema ingozi yemfucumfucu yengilazi engase ikhiqizwe ngama-valve avamile okugoqwa. Ngemva kokuqinisekiswa komuntu wesithathu, ukusebenza kokuvala kokuxhumeka okusebenzayo kuhlangabezana nezindinganiso ze-ASTM F2338-09, futhi amathuba okuhlasela kwamagciwane angaphansi kuka-10 ⁻⁶.

3. Uhlelo lokuhlola nokubona lobuhlakani bokwenziwa
Umugqa wokukhiqiza uhlanganisa uhlelo lokuthola i-AI X-ray olunemodi ephindwe kabili, olubona ngokuzenzakalelayo amaphutha efilimu, ukugcwalisa ukuphambuka kwezinga loketshezi, kanye nobuqotho bokuvala igumbi ngamakhamera e-CCD anesinqumo esiphezulu kanye ne-micro focus X-ray imaging. Ama-algorithms okufunda okujulile angabona ngokuzenzakalelayo amaphutha emigodini ezingeni le-0.1mm, ngesilinganiso sokutholwa okungamanga esingaphansi kuka-0.01%. Ngesikhathi esifanayo, isikhwama ngasinye sokufaka sifakwe nge-chip ye-RFID ukuze kufezwe ukulandeleka okugcwele kusukela kumaqoqo ezinto zokusetshenziswa, amapharamitha okukhiqiza kuya ekushiseni kokujikeleza kwegazi, kuhlangatshezwane nezidingo zokulandelela ze-FDA DSCSA (Umthetho Wokuphepha Kokunikezwa Kwezidakamizwa).

4. Isixazululo sokubulala inzalo esiqhubekayo esonga amandla
Ikhabhinethi yendabuko yokubulala amagciwane ngezikhathi ezithile inezindawo ezibuhlungu zokusebenzisa amandla amaningi kanye nomjikelezo omude. I-IVEN kanye nabalingani bayo baseJalimane bathuthukise ngokuhlanganyela uhlelo lwe-Rotary Steam in Place (SIP), olusebenzisa umklamo wombhoshongo wokufutha ojikelezayo ukuze kudalwe ukuxokozela ekamelweni lomusi elishisa kakhulu. Lungaqeda ukubulala amagciwane zingakapheli imizuzu eyi-15 ku-121 ℃, longe amandla angu-35% uma kuqhathaniswa nezindlela zendabuko. Uhlelo luhlonyiswe ngesilawuli se-B&R PLC esizithuthukisile, esingaqopha futhi sigcine idatha yokusatshalaliswa kokushisa kweqembu ngalinye (inani le-F ₀ ≥ 15), futhi sikhiqize ngokuzenzakalelayo amarekhodi e-batch kagesi ahambisana ne-21 CFR Part 11.

Ukuzibophezela kwe-IVEN: inethiwekhi yesevisi yomhlaba wonke egxile empumelelweni yamakhasimende

Siyazi kahle ukuthi imishini yekilasi lokuqala idinga ukuhambisana nesevisi yekilasi lokuqala.I-IVEN Isungule izikhungo zobuchwepheshe emazweni ayi-12 emhlabeni jikelele, ihlinzeka ngokuxilongwa okukude amahora angama-7 × angama-24 kanye nokusekelwa kokuphendula endaweni amahora angama-48. Ithimba lethu lingahlinzeka ngezinsizakalo ezenziwe ngokwezifiso ngemuva kokuthengisa ngokusekelwe ekwehlukeni kwemithethonqubo ezifundeni ezahlukene.

Esikhathini somuthi onembile kanye nemithi eyenzelwe wena, izikhwama zokufaka imithambo yegazi ezinamakamelo amaningi zishintsha imingcele yokwelashwa kwe-parenteral. I-IVEN Pharmatech Engineering yakha ibhuloho eliya esikhathini esizayo lezinkampani zemithi zomhlaba wonke ngobuchwepheshe bayo obuhle kakhulu bobunjiniyela kanye nokuphishekela ukuhambisana nemithetho. Kungakhathaliseki ukuthi amaphrojekthi amasha noma ukuthuthukiswa kwamandla, umugqa wethu wokukhiqiza ohlakaniphile uzoba umlingani wakho othembekile kakhulu.

Xhumana ne-IVENithimba lochwepheshe ngokushesha ukuthola izixazululo ezenziwe ngokwezifiso kanye nezindaba zempumelelo zomhlaba wonke!