I-OEB5 Injectable oncology turnkey plant
I-IVEN Pharmatechingumhlinzeki ophambili wezitshalo ezishintshayo ezihlinzeka ngesisombululo sobunjiniyela esihlanganisiwe sefektri yemithi yomhlaba wonke njengesixazululo se-IV, umuthi wokugomela, i-oncology njll., ngokuhambisana ne-EU GMP, i-US FDA cGMP, i-PICS, kanye ne-WHO GMP.
Sinikeza umklamo wephrojekthi onengqondo kakhulu, imishini esezingeni eliphezulu kanye nensizakalo eyenziwe ngokwezifiso ezimbonini ezahlukene zemithi nezokwelapha kusukela ku-A kuya ku-Z zesisombululo se-IV sesikhwama esithambile esingeyona i-PVC, isisombululo se-IV sebhodlela le-PP, isisombululo se-IV sebhodlela lengilazi, i-Vial & Ampoule efakwayo, i-Syrup, amaphilisi nama-Capsule, i-Vacuum blood collection tube njll.
Yini ehlanganisa isitshalo se-IVEN Injectable oncology vial turnkey plant:
Izixazululo zobunjiniyela ezihlanganisiwe ze-IVEN zefektri yama-vial e-oncology ejova ngemithi zifaka igumbi elihlanzekile, uhlelo lokulawula okuzenzakalelayo nokuqapha, uhlelo lokwelapha amanzi emithi, uhlelo lokulungiselela nokusabalalisa izixazululo, ukuwasha ama-vial - ukuhlanza nokususa i-pyrogenation - ukugcwalisa - ukuvimba - ukuvala - ukuwasha kwangaphandle, uhlelo lokomisa oluqandisiwe, uhlelo lokuhlukaniswa, uhlelo lokupakisha, uhlelo lokuhambisa oluzenzakalelayo, uhlelo lokulawula ikhwalithi, ilabhorethri ephakathi nokunye. Igxile ezidingweni zamakhasimende ngabanye, i-IVEN yenza ngezifiso izixazululo zobunjiniyela ngokucophelela kubasebenzisi ku:
1. Ukuwashwa kwebhodlela le-oncology elijovwayo - ukubulala amagciwane kanye nokususa i-pyrogenation - ukugcwalisa - ukuvimba - ukuvala - umugqa wokukhiqiza ukuwasha wangaphandle:
Lo mugqa usetshenziselwa ukukhiqiza ama-vial e-oncology ajovayo, aqukethe imishini emi-5: Umshini Wokuwasha Oqondile Oqhutshwa Yi-Servo, Umhubhe Wokuhlanza Nokuhlanzwa Komoya Oshisayo, Umshini Wokugcwalisa Ama-Vial Oqhutshwa Yi-Servo, Umshini Wokuvala Ama-Vial kanye Nomshini Wokuwasha Wangaphandle.
Ngemva kokugcwalisa, kuzoya ekuvimbeni kancane futhi kulungele ukomiswa ngeqhwa, bese kuthuthelwa emshinini wokumboza, ngemva kwalokho, kuzoya emshinini wokuwasha wangaphandle. Sisebenzisa uhlelo lokulinganisa oluku-inthanethi lomshini wokugcwalisa, imikhiqizo engafaneleki izokwenqatshwa ngokuzenzakalelayo.
1. Ukugeza
2. Ukuhlanza nokususa i-pyrogenation
3. Ukugcwalisa Nokumisa
4. Ukuvala isivalo
5. Ukugeza Kwangaphandle
6. kuqediwe
2. I-dryer eqandisiwe kanye nohlelo lokulayisha nokulayisha ngokuzenzakalelayo:
Ngemikhiqizo efakwe i-lyophilized, ngemva kokugcwalisa kanye nokuvala kancane, izothunyelwa efrijini ukuze yomise umshini wokomisa (i-Lyophilizer) ngokuzenzakalelayo ngohlelo lokulayisha oluzenzakalelayo, ngemva kokufakwa i-lyophilized, izothunyelwa emshinini wokumboza ngohlelo lokulayisha oluzenzakalelayo.
3. Uhlelo lokuhlukaniswa:
Njengoba i-oncology ingumkhiqizo onobuthi, singahlomisa nge-isolator ukuze sivikele abaqhubi emikhiqizweni, ukuqinisekisa ukuthi inqubo yokukhiqiza ivikelwe ngokugcwele ngaphansi kohlelo lokuhlukaniswa.
Isingeniso Esifushane
1. I-Operator ihlukaniswe ngokuphelele nendawo yokukhiqiza engcolile.
2. Indawo yokukhiqiza yangaphakathi esezingeni le-A. Igumbi lokuhlanza langaphandle elisezingeni le-C/D.
3. Kuphela okungavula i-isolator ngemva kokuvalwa kwesistimu, ukuqinisekiswa kuyadingeka ukuze kuqalwe kabusha.
4. Yenza ngokwezifiso i-HPVS ukuze ihlanzwe ngaphakathi.
5. Uhlelo lokujikeleza kwegazi oluvaliwe.
6.Adopt HEPA air inlet, i-membrane ingavikela kokubili ukugeleza komoya okufanayo kanye nesihlungi.
7. Isakhiwo sangaphakathi esingenamthungo, umklamo ojikelezayo.
8. Yamukela uphawu olufuthwayo kokubili umnyango ovulekile kanye namafasitela egilavu.
9. Ngemikhiqizo enobuthi, sebenzisa umklamo wokukhipha esikhwameni.
Eminye Imisebenzi
1. Uhlelo lwe-CIP/SIP (i-SIP nge-VHP).
2. Ukuqapha Okuku-inthanethi Kwe-Particle Counter.
3. Isampula Yezinhlayiya Eziphilayo Ezihambayo Emoyeni.
4. Ijeneretha ye-Hydrogen Dioxide Enomswakama.
5. Isitholi Sokuvuza Segilavu.
6. I-Anemometer.
7. Inzwa ye-H/T.
8. Isilinganiso se-ATEX.
9. Imodyuli Yokuhlola Ukungazali Kwe-Equinox.
10. Idivayisi Yokusampula Umoya.
11. Indlu Yokushintsha Isihlungi Esingena Esikhwameni.
4. Uhlelo lokupakisha:
Ingaqeda ukuhlolwa kokukhanya okuzenzakalelayo kwe-vial oncology okujova, ukuhlolwa kokuvuza, ukulebula, i-blister enokupakisha kwekhathoni okuyinhloko, kanye nokupakisha kwekhathoni yokuthumela.
Singahlomisa ngokuvulwa kwebhokisi lokuthumela okuzenzakalelayo, incwadi yemiyalelo kanye nokufakwa kwesitifiketi, ukupakisha ibhokisi, ukuvalwa kwebhokisi, ukulebula, uhlelo lokulandelela idatha, kanye nohlelo lokwenqaba okuzenzakalelayo, okungawenqaba amabhokisi anesisindo esingalungile, noma lawo anelebula elingafaneleki.
5. Ukwelashwa kwamanzi ngemithi:
Kuhlanganisa ukwelashwa kwamanzi ahlanzekile (2RO+EDI), umshini wokuhlanza amanzi (WFI), kanye nejeneretha yomusi emsulwa. Ithangi le-PW kanye nethangi le-WFI nakho kufakiwe.
6. Igumbi elihlanzekile kanye ne-HVAC
Kuhlanganisa amaphaneli odonga ahlanzekile egumbi, amaphaneli ophahleni, amafasitela, iminyango, phansi, ukukhanyisa, iyunithi yokuphatha umoya, izihlungi ze-HEPA, amapayipi omoya, okuthusayo, uhlelo lokulawula okuzenzakalelayo njll. Ukugcina inqubo yokukhiqiza i-vial oncology ejovayo ivikelekile ngaphansi kwendawo ye-Class C + Isolator.
7. Usizo olumnyama
Ihlanganisa uhlelo lwe-air compressor kanye nohlelo lwe-boiler ukuze kuhlinzekwe umoya ocindezelwe kanye nomusi odingekayo ukuze kukhiqizwe umdlavuza we-vial ojovayo.
8. Ilebhu
Ihlanganisa zonke izinhlobo zezinsimbi zokuhlola elebhu, kanye nefenisha yelebhu yokuhlola amasampula e-vial oncology ajovayo kanye nezinto zokusetshenziswa, njengegumbi lokuqina, i-HPLC, ukumuncwa kwe-athomu, i-ultraviolet spectrometer, i-fourier transform infrared spectrometer njll.
9. Ukusabalalisa kanye nohlelo lwamapayipi
Kuhlanganisa zonke izinhlobo zepayipi lenqubo kanye nepayipi lezimboni elidingekayo esitshalweni se-turnkey se-vial oncology esijovayo, njengamanzi ahlanzekile, amanzi okujova, umusi omsulwa, amanzi apholile, amanzi abandayo, umoya ocindezelwe, umusi wezimboni njll.
I-IVENsinethimba lobuchwepheshe nobunjiniyela elichwepheshile kakhulu, ukuqeqeshwa kwethu endaweni kanye nokusekelwa kwangemva kokuthengisa kunganikeza isiqinisekiso sobuchwepheshe sesikhathi eside sesitshalo sakho se-NON-PVC IV fluid turnkey:
IVEN Uhlu oluphelele lwemibhalo lungakusiza ukuthi utholeIsitifiketi se-GMP kanye ne-FDAkalula ngesitshalo sakho se-IV fluid (Kubandakanya i-IQ / OQ / PQ / DQ / FAT / SAT njll. kokubili ngesiNgisi nangesiShayina):
Ubungcweti nolwazi lwe-IV lungakusiza ukuqeda isitshalo se-turnkey sesisombululo se-IV ngesikhathi esifushane futhi ugweme zonke izinhlobo zezingozi ezingaba khona:
I-IVENsinethimba lobuchwepheshe nobunjiniyela elichwepheshile kakhulu, ukuqeqeshwa kwethu endaweni kanye nokusekelwa kwangemva kokuthengisa kunganikeza isiqinisekiso sobuchwepheshe sesikhathi eside sesitshalo sakho se-NON-PVC IV fluid turnkey:
Kuze kube manje, sesivele sinikeze amakhulu amasethi emishini yezokwelapha kanye nemishini yezokwelapha emazweni angaphezu kwama-50.
Okwamanje, sisize amakhasimende ethu ukuthiwakha izitshalo zokuguqula imithi kanye nezokwelapha ezingaphezu kuka-20e-Uzbekistan, eTajikistan, e-Indonesia, eThailand, eSaudi Arabia, e-Iraq, eNigeria, e-Uganda, eTanzania, e-Ethiopia, eMyanmar njll., ikakhulukazi ngesisombululo se-IV, ama-vial nama-ampoules ajovwayo. Wonke la maphrojekthi athole amakhasimende ethu kanye nohulumeni wawo imibono emihle.
Sithumele futhi umugqa wethu wokukhiqiza izixazululo ze-IV eJalimane.
Isitshalo sebhodlela le-IV lase-Indonesia
Isitshalo sebhodlela le-Vietnam IV
Isitshalo sebhodlela i-Uzbekistan IV
Isitshalo se-turnkey esifakwa ebhodleleni laseThailand
Isitshalo sebhodlela iTajikistan IV
