OEB5 Umjovo we-oncology vial turnkey plant
I-VEN Pharmatechungumphakeli oyingqalabutho wezitshalo ze-turnkey ezihlinzeka ngesisombululo sobunjiniyela esididiyelwe semboni yemithi yomhlaba wonke njengesixazululo se-IV, umgomo, i-oncology njll., ngokuhambisana ne-EU GMP, i-US FDA cGMP, i-PICS, ne-WHO GMP.
Sihlinzeka ngomklamo onengqondo kakhulu wephrojekthi, okokusebenza kwekhwalithi ephezulu kanye nensizakalo eyenziwe ngokwezifiso ezimbonini ezahlukene zemithi nezokwelapha kusukela ku-A kuya ku-Z ngesisombululo se-IV yesikhwama esithambile esingesona se-PVC, isisombululo sebhodlela le-PP IV, isisombululo se-Glass vial IV, Isitsha Esijova & I-Ampoule, Isiraphu, amaphilisi namaphilisi, ishubhu lokuqoqa igazi leVacuum njll.
Ifaka ini i-VENN Injectable oncology vial turnkey plant:
Izixazululo ezididiyelwe zobunjiniyela ze-VEN zefekthri ye-oncology efakwa emithini ye-oncology zifaka igumbi elihlanzekile, uhlelo lokulawula okuzenzakalelayo nokuqapha, uhlelo lokwelapha amanzi okwelapha, uhlelo lokulungiselela isixazululo nokusabalalisa, ukugeza i-vial - inzalo kanye ne-depyrogenation - ukugcwalisa - ukumisa - ukuvala - ukugeza kwangaphandle, iqhwa. isistimu yokomisa, isistimu yokuhlukanisa abantu, isistimu yokupakisha, isistimu yezinto ezizenzakalelayo, isistimu yokulawula ikhwalithi, ilabhorethri emaphakathi nokunye.
1.Ukugeza ibhodlela le-oncology ngomjovo - ukuvala inzalo kanye nokukhipha inzalo - ukugcwalisa - ukumisa - ukuvala - umugqa wokukhiqiza wangaphandle wokuwasha:
Lo mzila usetshenziselwa ukukhiqiza izitsha ze-oncology ezijovayo, ezihlanganisa imishini engu-5: Umshini Wokuwasha Ogcwele I-Servo Driven Vertical Ultrasonic, Umhubhe Oshisayo We-Hot Air Circulation Sterilizing & Depyrogenation, Umshini Wokugcwalisa I-Vial Ogcwele I-Servo Driven, Umshini Wokugcwalisa I-Vial Capping kanye Nomshini Wokuwasha Wangaphandle.
Ngemuva kokugcwalisa, izoya ku-semi-stoppering futhi ilungele ukomiswa yiqhwa, bese ithuthela emshinini we-capping, ngemva kwalokho, izoya emshinini wokuwasha wangaphandle. Samukela uhlelo lokukala oluku-inthanethi lomshini wokugcwalisa, imikhiqizo engafanelekile izonqatshwa ngokuzenzakalelayo.
1. Ukugeza
2. Ukuvala inzalo kanye nokukhipha inzalo
3. Ukugcwalisa & Ukumisa
4. Capping
5. Ukuwashwa Kwangaphandle
6. uqedile
2.Isomisi esiqandisiwe kanye nesistimu yokulayisha nokukhipha okuzenzakalelayo:
Ngemikhiqizo ye-lyophilized, ngemuva kokugcwalisa kanye nokumisa kancane, izodluliswa ukuze i-dryer iqhwa (i-Lyophilizer) ngokuzenzakalelayo ngohlelo lokulayisha okuzenzakalelayo, ngemuva kwe-lyophilized, luzodluliselwa emshinini we-capping nge-auto unloading system.
3.Isistimu yokuhlukanisa :
Njengoba i-oncology ingumkhiqizo onobuthi, singahlomisa nge-isolator ukuze sigcine ukuphepha kwabaqhubi emikhiqizweni, ukuze siqiniseke ukuthi inqubo yokukhiqiza ivikelwe ngokugcwele ngaphansi kwesistimu yokuhlukaniswa.
Isingeniso esifushane
I-1.Operator ihlukaniswe ngokuphelele nendawo yokukhiqiza eyinyumba ebalulekile.
2.Izinga lendawo yokukhiqiza yangaphakathi. Igumbi elihlanzekile lezinga le-C/D langaphandle.
3.Kuphela okungavula isihlukanisi ngemva kokuvalwa kwesistimu, ukuqinisekiswa kuyadingeka ukuze kuqalwe kabusha.
4.Yenza ngendlela oyifisayo i-HPVS yokuvala inzalo yangaphakathi.
5.Sealed circulation system.
6.Adopt HEPA air inletting, ulwelwesi lungavikela kokubili ukugeleza komoya okufanayo kanye nesihlungi.
7.Isakhiwo sangaphakathi esingenamthungo, umklamo ojikelezayo.
8.Adopt inflatable seal yakho kokubili umnyango ovulekile namawindi amagilavu.
9.Ngemikhiqizo enobuthi, sebenzisa idizayini yokuphuma esikhwameni esikhwameni.
Eminye Imisebenzi
1.CIP/SIP uhlelo (SIP by VHP).
2.I-Particle Counter Online Monitoring.
3.Airborne Viable Particle Sampler.
4.Ijeneretha Ye-Hydrogen Dioxide Eshisayo.
5.Ukuvuza komtshina weGlove.
6.I-Anemometer.
7.H/T Inzwa.
8.ATEX Isilinganiso.
9.I-Equinox Sterility Test Module.
10.Idivayisi Yesampula Yomoya.
11.Isihlungi Sokuphuma Esikhwameni Sishintsha Izindlu.
4.Isistimu yokupakisha:
Ingakwazi ukuqedela ukuhlolwa kokukhanya okuzenzakalelayo kwe-vial oncology, ukuhlola ukuvuza, ukulebula, amabhamuza anokupakishwa kwebhokisi eliyinhloko, kanye nokupakishwa kwebhokisi lokuthumela.
Singahlomisa ngokuvuleka kwebhokisi lokuthumela okuzenzakalelayo, imanuwali yeziqondiso nokufakwa kwesitifiketi, ukupakisha amabhokisi, ukuvala amabhokisi, ukulebula, isistimu yokulandelela idatha, nohlelo lokwenqaba okuzenzakalelayo, olunganqaba amabhokisi anesisindo esingalungile, noma lawo anelebula elingafaneleki.
5. Ukwelashwa kwamanzi ngomuthi:
Kuhlanganisa ukuhlanzwa kwamanzi ahlanzekile (2RO+EDI), i-water distiller (WFI), kanye nejeneretha yesitimu esihlanzekile. Ithangi le-PW nethangi le-WFI lifakiwe futhi.
6.Igumbi elihlanzekile ne-HVAC
Kuhlanganisa amaphaneli ezindonga zamakamelo ahlanzekile, amaphaneli osilingi, amafasitela, iminyango, phansi, ukukhanya, iyunithi yokubamba umoya, izihlungi ze-HEPA, imigudu yomoya, okuthusayo, uhlelo lokulawula okuzenzakalelayo njll. Ukugcina inqubo yokukhiqiza i-vial oncology yomjovo ivikelekile ngaphansi kwemvelo ye-Class C + Isolator. .
7.Usizo olumnyama
Kuhlanganisa isistimu ye-compressor yomoya kanye nesistimu yokubilisa ukuze kunikezwe umoya ocindezelwe odingekayo kanye nesitimu sokukhiqizwa kwe-vial oncology yomjovo.
8.Ilabhorethri
Kuhlanganisa zonke izinhlobo zamathuluzi okuhlola elebhu, kanye nefenisha yelebhu yokuhlola amasampula e-vial oncology afakwa umjovo nezinto ezingavuthiwe, njengegumbi lokuzinza, i-HPLC, ukumuncwa kwe-athomu, i-ultraviolet spectrometer, i-fourier transform infrared spectrometer njll.
9.Ukusabalalisa nohlelo lwamapayipi
Kuhlanganisa zonke izinhlobo zepayipi lenqubo kanye nepayipi lezimboni ezidingekayo embonini yomjovo ye-vial oncology turnkey, njengamanzi ahlanzekile, amanzi omjovo, isitimu esihlanzekile, amanzi okupholisa, amanzi abandayo, umoya ocindezelweyo, umusi wezimboni njll.
I-VENube nethimba elichwepheshile lezobuchwepheshe nobunjiniyela, ukuqeqeshwa kwethu endaweni kanye nokwesekwa kwangemva kokuthengisa kunganikeza isiqinisekiso sobuchwepheshe sesikhathi eside sesitshalo sakho sokujika ukhiye we-NON-PVC IV:
I-VEN Uhlu olugcwele lwamadokhumenti lungakusiza ukuthi utholeIsitifiketi se-GMP ne-FDAngesitshalo sakho esiwuketshezi se-IV kalula (Kubandakanya i-IQ / OQ / PQ / DQ / FAT / SAT njll kokubili ngesiNgisi nesiShayina):
Ubungcweti nesipiliyoni se-VEN kungakusiza ukuthi uqedele isitshalo sonke se-IV solution turnkey ngesikhathi esifushane futhi ugweme zonke izinhlobo zezingozi ezingaba khona:
I-VENube nethimba elichwepheshile lezobuchwepheshe nobunjiniyela, ukuqeqeshwa kwethu endaweni kanye nokwesekwa kwangemva kokuthengisa kunganikeza isiqinisekiso sobuchwepheshe sesikhathi eside sesitshalo sakho sokujika ukhiye we-NON-PVC IV:
Kuze kube manje, sesivele sinikeze amakhulukhulu emishini yokwenza imithi kanye nemishini yezokwelapha emazweni angaphezu kuka-50.
Ngaleso sikhathi, sisize amakhasimende ethu ukuthiwakha izitshalo ezingu-20+ zemithi kanye nezokwelaphae-Uzbekistan, Tajikistan, Indonesia, Thailand, Saudi, Iraq, Nigeria, Uganda, Tanzania, Ethiopia, Myanmar njll, ikakhulukazi ngesisombululo se-IV, izitsha ezijovwayo nama-ampoules. Wonke la maphrojekthi azuze amakhasimende ethu kanye nokuphawula kwawo okuphezulu kukahulumeni.
Siphinde sathumela umugqa wethu wokukhiqiza isixazululo se-IV eJalimane.
Indonesia IV ibhodlela turnkey plant
Vietnam IV ibhodlela turnkey plant
Uzbekistan IV ibhodlela turnkey plant
Thailand Umjovo vial turnkey plant
Tajikistan IV ibhodlela turnkey plant
