I-OEB5 Injectable oncology vial turnkey plant
IVEN Pharmatechngumthengisi ophambili wezityalo ezitshintshiweyo ezibonelela ngesisombululo sobunjineli esidibeneyo kwifektri yamayeza yehlabathi jikelele efana nesisombululo se-IV, isitofu, i-oncology njl.njl., ngokuhambelana ne-EU GMP, i-US FDA cGMP, i-PICS, kunye ne-WHO GMP.
Sinikezela ngoyilo lweprojekthi olufanelekileyo, izixhobo ezikumgangatho ophezulu kunye nenkonzo eyenzelwe wena kwiifektri ezahlukeneyo zamayeza nezonyango ukusuka ku-A ukuya ku-Z kwisisombululo se-IV esingeyo-PVC esithambileyo, isisombululo se-IV sebhotile ye-PP, isisombululo se-IV seglasi, iVial kunye ne-Ampoule efakwayo, iSyrup, iiTablets kunye neeCapsules, ityhubhu yokuqokelelwa kwegazi leVacuum njl.
Yintoni equkwa sisityalo se-IVEN Injectable oncology turnkey:
Izisombululo zobunjineli ezidityanisiweyo ze-IVEN zomzi-mveliso weebhotile ze-oncology ezifakwa kwi-pharmaceutical ziquka igumbi elicocekileyo, inkqubo yokulawula ngokuzenzekelayo kunye nokubeka iliso, inkqubo yonyango lwamanzi e-pharmaceutical, inkqubo yokulungiselela nokusasaza isisombululo, ukuhlamba iibhotile - ukubulala iintsholongwane kunye nokususa iintsholongwane - ukuzalisa - ukuvala - ukuvala - ukuhlamba ngaphandle, inkqubo yokomisa ngekhenkcezisi, inkqubo yokwahlukanisa, inkqubo yokupakisha, inkqubo yezothutho ezenzekelayo, inkqubo yolawulo lomgangatho, ilabhoratri ephakathi kunye njl. Igxile kwiimfuno zomthengi ngamnye, i-IVEN yenza ngokwezifiso izisombululo zobunjineli kubasebenzisi abakwi:
1. Ukuhlamba ibhotile ye-oncology efakwa ngenaliti - ukubulala iintsholongwane kunye nokususa i-pyrogenation - ukuzalisa - ukuvala - ukuvala - umgca wokuvelisa ukuhlamba ngaphandle:
Lo mgca usetyenziselwa ukuvelisa ii-vials ze-oncology ezifakwa kwi-injection, eziqulathe oomatshini aba-5: Umatshini wokuhlamba i-Full Servo Driven Vertical Ultrasonic, i-Hot Air Circulation Sterilizing & Depyrogenation Tunnel, umatshini wokugcwalisa ii-vial oqhutywa yi-Full Servo Driven, umatshini wokuvala ii-vial kunye nomatshini wokuhlamba wangaphandle.
Emva kokuzalisa, iya kumisa kancinci ize ilungele ukomiswa ngokukhenkcezisiweyo, emva koko iye kumatshini wokugquma, emva koko, iya kumatshini wokuhlamba wangaphandle. Sisebenzisa inkqubo yokulinganisa ekwi-intanethi yomatshini wokugcwalisa, iimveliso ezingafanelekiyo ziya kwaliwa ngokuzenzekelayo.
1. Ukuhlamba
2. Ukubulala iintsholongwane kunye nokususa iintsholongwane
3. Ukuzalisa kunye nokuMisa
4. Ukugquma
5. Ukuhlamba ngaphandle
6. igqityiwe
2. Qandisa idryer kunye nenkqubo yokulayisha nokukhulula ngokuzenzekelayo:
Kwiimveliso ezifakwe i-lyophilized, emva kokuzalisa kunye nokumisa kancinci, ziya kuthunyelwa kwi-freezer dryer (i-Lyophilizer) ngokuzenzekelayo ngenkqubo yokulayisha ngokuzenzekelayo, emva kokuba ifakwe i-lyophilized, ziya kuthunyelwa kumatshini wokugquma ngenkqubo yokukhupha ngokuzenzekelayo.
3. Inkqubo yokuzahlula:
Njengoko i-oncology iyimveliso enobuthi, singaxhobisa nge-isolator ukugcina ukhuseleko lwabaqhubi kwiimveliso, ukuqinisekisa ukuba inkqubo yemveliso ikhuselekile ngokupheleleyo phantsi kwenkqubo yokuzahlula.
Intshayelelo emfutshane
1. Umqhubi wahlulwe ngokupheleleyo kwindawo yemveliso ecocekileyo nengenazintsholongwane.
2. Indawo yemveliso yangaphakathi ekumgangatho we-A. Igumbi lokucoca langaphandle elikumgangatho we-C/D.
3. Kuphela onokuvula i-isolator emva kokuvalwa kwenkqubo, ukuqinisekiswa kuyimfuneko ukuze uqalise kwakhona.
4. Yenza ngokwezifiso i-HPVS ukuze ibulale iintsholongwane ngaphakathi.
5. Inkqubo yokujikeleza kwegazi evaliweyo.
6.Adopt HEPA air inletting, i-membrane inokukhusela ukuhamba komoya okufanayo kunye nesihluzi.
7. Ulwakhiwo lwangaphakathi olungenamthungo, uyilo olujikelezayo.
8.Adopt isitywina esinomoya kwiifestile ezivulekileyo kunye neeglavu.
9. Kwiimveliso ezinobuthi, sebenzisa uyilo oluphuma kwingxowa.
Eminye Imisebenzi
1. Inkqubo ye-CIP/SIP (i-SIP nge-VHP).
2. Ukubeka esweni iinxalenye kwi-intanethi.
3. Isampuli yeParticle eViable Airborne.
4. Ijenereyitha yeHydrogen Dioxide eVavisiweyo.
5. Isikhangeli sokuvuza kweGlavu.
6. I-Anemometer.
I-7.H/T Sensor.
8. Uvavanyo lwe-ATEX.
9. Imodyuli yoVavanyo lwe-Equinox Sterility.
10. Isixhobo sokuthatha isampuli yomoya.
11. Indlu yokutshintsha isihluzi esingena ebhegini.
4. Inkqubo yokupakisha:
Ingagqiba ukuhlolwa kokukhanya okuzenzekelayo kwe-oncology ye-vial efakwa kwi-injection, ukuhlolwa kokuvuza, ukulebhelisha, i-blister kunye nokupakisha ibhokisi ephambili, kunye nokupakisha ibhokisi yokuthumela.
Singaxhobisa ngokuvulwa kwebhokisi yokuthumela ngokuzenzekelayo, incwadi yemiyalelo kunye nokufakwa kwesatifikethi, ukupakisha ibhokisi, ukuvalwa kwebhokisi, ukulebhelisha, inkqubo yokulandelela idatha, kunye nenkqubo yokwala ngokuzenzekelayo, enokulandula iibhokisi ngobunzima obungalunganga, okanye ezo zinelebheli engafanelekiyo.
5. Unyango lwamanzi ngamayeza:
Ibandakanya ukucocwa kwamanzi acocekileyo (2RO+EDI), isixhobo sokucoca amanzi (WFI), kunye nejenereyitha yomphunga ecocekileyo. Itanki yePW kunye netanki yeWFI nazo zifakiwe.
6. Igumbi elicocekileyo kunye ne-HVAC
Ibandakanya iiphaneli zodonga zegumbi ezicocekileyo, iiphaneli zesilingi, iifestile, iingcango, umgangatho, izibane, iyunithi yokuphatha umoya, izihluzi ze-HEPA, imibhobho yomoya, inkqubo yokulawula ezenzekelayo njl. Ukugcina inkqubo yokuvelisa i-oncology ye-vial efakwayo ikhuselekile phantsi kwendawo yeClass C + Isolator.
7. Isixhobo esimnyama
Ibandakanya inkqubo ye-air compressor kunye nenkqubo yebhoyila yokubonelela ngomoya ocinezelweyo kunye nomphunga ofunekayo wokuvelisa i-oncology ye-vial efakwayo.
8. Ilebhu
Ibandakanya zonke iintlobo zezixhobo zovavanyo lwelabhoratri, kunye nefenitshala yelabhoratri yokuvavanya iisampulu ze-oncology ye-vial efakwayo kunye nezinto eziluhlaza, ezifana negumbi lokuqina, i-HPLC, ukufunxwa kweatomic, i-ultraviolet spectrometer, i-fourier transform infrared spectrometer njl.njl.
9. Inkqubo yokusasazwa kunye nemibhobho
Ibandakanya zonke iintlobo zemibhobho yenkqubo kunye nemibhobho yemizi-mveliso efunekayo kwisityalo se-incology esifakwa kwi-injection vial, njengamanzi acocekileyo, amanzi okujova, umphunga ococekileyo, amanzi okupholisa, amanzi abandayo, umoya ocinezelweyo, umphunga wemizi-mveliso njl.
IVENUkuba neqela lobuchwephesha nobunjineli elinobuchule kakhulu, uqeqesho lwethu olukwindawo kunye nenkxaso emva kokuthengisa inokunika isiqinisekiso sobuchwepheshe sexesha elide kwisityalo sakho se-NON-PVC IV fluid turnkey:
Uluhlu olupheleleyo lwamaxwebhu lunokukunceda ufumaneIsatifikethi se-GMP kunye ne-FDAkwisityalo sakho se-IV fluid ngokulula (Kubandakanya i-IQ / OQ / PQ / DQ / FAT / SAT njl. zombini ngesiNgesi nangesiTshayina):
Ubungcali kunye namava e-IV anokukunceda ugqibe isityalo se-turnkey sesisombululo se-IV ngexesha elifutshane kwaye uphephe zonke iintlobo zeengozi ezinokubakho:
IVENUkuba neqela lobuchwephesha nobunjineli elinobuchule kakhulu, uqeqesho lwethu olukwindawo kunye nenkxaso emva kokuthengisa inokunika isiqinisekiso sobuchwepheshe sexesha elide kwisityalo sakho se-NON-PVC IV fluid turnkey:
Ukuza kuthi ga ngoku, sele sinikezele ngamakhulu eeseti zezixhobo zamayeza kunye nezixhobo zonyango kumazwe angaphezu kwama-50.
Okwangoku, sincede abathengi bethu ukubawakha izityalo ezingaphezu kwama-20 ze-turnkey zamayeza nezonyangoeUzbekistan, eTajikistan, eIndonesia, eThailand, eSaudi Arabia, e-Iraq, eNigeria, eUganda, eTanzania, e-Ethiopia, eMyanmar njl.njl., ikakhulu ngenxa yesisombululo se-IV, ii-vials ezifakwa kwi-injection kunye nee-ampoules. Zonke ezi projekthi ziphumelele kakhulu kubathengi bethu nakurhulumente wabo.
Sikwathumele nomgca wethu wokuvelisa isisombululo se-IV eJamani.
Isityalo sebhotile ye-IV e-Indonesia
Isityalo sebhotile ye-Vietnam IV
Isityalo sebhotile ye-Uzbekistan IV
Isityalo se-turnkey esifakwa kwi-vial eThailand
Isityalo sebhotile ye-IV saseTajikistan
