OEB5 jakisoni wa oncology vial turnkey chomera
Malingaliro a kampani VEN Pharmatechndi omwe amapereka upangiri wa zomera za turnkey zomwe zimapereka njira zophatikizira zamakina a fakitale yamankhwala padziko lonse lapansi monga njira ya IV, katemera, oncology etc., motsatira EU GMP, US FDA cGMP, PICS, ndi WHO GMP.
Timapereka mamangidwe abwino kwambiri a projekiti, zida zapamwamba kwambiri komanso ntchito zosinthidwa makonda kumafakitale osiyanasiyana azachipatala ndi zamankhwala kuchokera ku A mpaka Z kwa Non-PVC thumba lofewa IV yankho, PP botolo IV yankho, Glass vial IV yankho, jekeseni Vial & Ampoule, Syrup, Mapiritsi & Makapisozi, Vacuum zosonkhanitsira magazi chubu etc.
Kodi VEN Injectable oncology vial turnkey chomera chimaphatikizapo chiyani:
Mayankho ophatikizika a IVEN opangira ma jekeseni a oncology akuphatikizapo chipinda choyera, zowongolera zokha ndi zowunikira, njira yopangira madzi, kukonza njira ndi kugawa, kutsuka kwa vial - kutsekereza ndi depyrogenation - kudzaza - kuyimitsa - kutsekereza - kutsuka kwakunja, kuyimitsa kuyimitsa, kudzipatula, dongosolo lodzipatula, dongosolo loyang'anira zinthu, dongosolo loyang'anira mayendedwe, makina owongolera, makina owongolera, makina owongolera ndi zina. Zofuna zamakasitomala, VEN imasintha mwamakonda mayankho aukadaulo kwa ogwiritsa ntchito pa:
1.Kuchapira kwa jekeseni wa oncology - kutsekereza ndi depyrogenation - kudzaza - kuyimitsa - kutsekera - chingwe chopangira kutsuka chakunja:
Mzerewu umagwiritsidwa ntchito popanga jekeseni Mbale za oncology, zomwe zimakhala ndi makina 5: Makina Ochapira a Full Servo Driven Vertical Ultrasonic, Hot Air Circulation Sterilizing & Depyrogenation Tunnel, Full Servo Driven Vial Filling-Stoppering Machine, Vial Capping Machine ndi External Washing Machine.
Pambuyo podzaza, imapita ku semi-stoppering ndikukonzekera kuumitsa, kenako ndikusunthira ku makina osindikizira, pambuyo pake, imapita kumakina ochapira akunja. Timatengera makina oyezera pa intaneti pamakina odzaza, zinthu zosayenerera zidzakanidwa zokha.
1. Kusamba
2. Sterilizing & Depyrogenation
3. Kudzaza & Kuyimitsa
4. Kujambula
5. Kutsuka Kwakunja
6. anamaliza
2.Freeze chowumitsira ndi makina odzaza ndi kutsitsa:
Pazinthu zokhala ndi lyophilized, mutatha kudzaza ndi kuyimitsa pang'ono, zimaperekedwa kuti muwumitse chowumitsira (Lyophilizer) pokhapokha kudzera pa makina ojambulira ma auto, pambuyo pa lyophilized, zimaperekedwa kumakina otsekera ndi auto unloading system.
3.Isolation system :
Popeza oncology ndi chinthu chapoizoni, titha kukhala ndi zida zodzipatula kuti tisunge chitetezo chaogwiritsa ntchito pazogulitsa, kuwonetsetsa kuti njira yopangirayo imatetezedwa kwathunthu pansi padzipatula.
Mawu Oyamba Mwachidule
1.Operator imasiyanitsidwa kwathunthu ndi malo opangira osabala.
2.A mlingo mkati kupanga malo. Chipinda choyera cha C/D chakunja.
3.Only akhoza kutsegula wodzipatula pambuyo kutseka dongosolo, kutsimikizika n'kofunika kuyambiransoko.
4.Sinthani HPVS kuti mutseke mkati.
5.Sealed circulation system.
6.Adopt HEPA mpweya inletting, nembanemba angathe kuteteza yunifolomu mpweya kuyenda ndi fyuluta.
7.Mapangidwe amkati osasunthika, mapangidwe ozungulira.
8.Adopt inflatable chisindikizo pazitseko zonse zotseguka ndi mawindo a magolovesi.
9.Pazinthu zapoizoni, gwiritsani ntchito kapangidwe ka bag-in-bag-out.
Ntchito Zina
1.CIP/SIP dongosolo (SIP ndi VHP).
2.Particle Counter Online Monitoring.
3.Airborne Viable Particle Sampler.
Jenereta ya 4.Nvaporized Hydrogen Dioxide.
5.Leak Detector ya Glove.
6.Anemometer.
7.H/T Sensor.
Mtengo wa 8.ATEX.
9.Equinox Sterility Test Module.
10.Air Sampling Chipangizo.
11.Chikwama-muchikwama-kunja Sefa Kusintha Nyumba.
4.Packing system:
Itha kumaliza jekeseni wa vial oncology yowunikira basi, kuyang'anira kutayikira, kulemba zilembo, matuza okhala ndi makatoni oyambira, ndikunyamula makatoni.
Titha kukhala ndi kutsegulira kwa makatoni otumizira okha, buku la malangizo ndi kuyika satifiketi, kulongedza makatoni, kusindikiza makatoni, kulemba zilembo, makina otsata deta, ndi makina okanira magalimoto, omwe amatha kukana makatoni okhala ndi kulemera kolakwika, kapena omwe ali ndi zilembo zosayenerera.
5. Mankhwala opangira madzi:
Zimaphatikizapo kuyeretsa madzi oyeretsedwa (2RO + EDI), distiller yamadzi (WFI), ndi jenereta yoyera ya nthunzi. PW tank ndi WFI tank ikuphatikizidwanso.
6.Clean chipinda & HVAC
Zimaphatikizapo mapanelo a khoma lazipinda zoyera, mazenera, mazenera, zitseko, pansi, kuyatsa, mpweya wothandizira mpweya, HEPA Zosefera, ma ducts a mpweya, zoopsa, dongosolo loyendetsa galimoto etc.
7.Black zothandiza
Zimaphatikizapo makina a air compressor ndi boiler system kuti apereke mpweya ndi nthunzi yofunikira popanga jekeseni wa vial oncology.
8. Laboratory
Zimaphatikizapo zida zonse zoyezera ma labu, ndi mipando ya labu kuyesa zitsanzo za vial oncology ndi zopangira, monga chipinda chokhazikika, HPLC, mayamwidwe a atomiki, ma ultraviolet spectrometer, ma infrared spectrometer osintha zina.
9.Distribution & pipeline system
Zimaphatikizapo mitundu yonse ya mapaipi opangira ndi mafakitale omwe amafunikira mu jekeseni wa vial oncology turnkey plant, monga madzi oyeretsedwa, madzi a jekeseni, nthunzi yoyera, madzi ozizira, madzi ozizira, mpweya woponderezedwa, nthunzi ya mafakitale etc.
VENkhalani ndi gulu laukadaulo laukadaulo ndi uinjiniya, maphunziro athu apamtunda ndi chithandizo chapambuyo pa malonda angakupatseni chitsimikizo chanthawi yayitali chaukadaulo wanu wa NON-PVC IV fungulo lamadzimadzi:
VEN Zolemba zambiri zitha kukuthandizani kuti mupezeSatifiketi ya GMP & FDAkwa chomera chanu chamadzimadzi cha IV mosavuta (Kuphatikiza IQ / OQ / PQ / DQ / FAT / SAT ndi zina zonse mu Chingerezi ndi Chitchaina):
Katswiri ndi luso la VEN zitha kukuthandizani kumaliza IV solution turnkey chomera munthawi yochepa kwambiri ndikupewa zoopsa zamitundu yonse:
VENkhalani ndi gulu laukadaulo laukadaulo ndi uinjiniya, maphunziro athu apamtunda ndi chithandizo chapambuyo pa malonda angakupatseni chitsimikizo chanthawi yayitali chaukadaulo wanu wa NON-PVC IV fungulo lamadzimadzi:
Mpaka pano, tapereka kale zida zopangira mankhwala ndi zida zamankhwala kumayiko opitilira 50.
Panthawiyi, tinathandiza makasitomala athuanamanga 20+ mankhwala ndi mankhwala turnkey zomeraku Uzbekistan, Tajikistan, Indonesia, Thailand, Saudi, Iraq, Nigeria, Uganda, Tanzania, Ethiopia, Myanmar ndi zina, makamaka chifukwa cha IV yankho, jekeseni Mbale ndi ampoules. Ntchito zonsezi zidapambana makasitomala athu ndi ndemanga zawo zapamwamba za boma.
Tidatumizanso njira yathu yopangira IV ku Germany.
Indonesia IV botolo turnkey chomera
Vietnam IV botolo turnkey chomera
Uzbekistan IV botolo turnkey chomera
Thailand Injectable vial turnkey chomera
Tajikistan IV botolo turnkey chomera
