OEB5 jakisoni wa oncology vial turnkey chomera

Chiyambi Chachidule:

IVEN Pharmatech ndiye mpainiya wopereka mbewu za turnkey zomwe zimapereka njira zophatikizira zamafakitale opanga mankhwala padziko lonse lapansi monga IV solution, 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 azamankhwala ndi zamankhwala kuchokera ku A mpaka Z kwa Non-PVC chikwama chofewa IV yankho, PP botolo IV yankho, Glass vial IV yankho, Injectable Vial & Ampoule, Syrup, Mapiritsi & Makapisozi, Vuta wotolera magazi chubu etc.

Titumizireni imelo

Tsatanetsatane wa Zamalonda

Zolemba Zamalonda

Mafotokozedwe Akatundu:

Kodi VEN Injectable oncology vial turnkey chomera chimaphatikizapo chiyani:

Kanema wa Zamalonda

Kufotokozera kwakukulu

Mayankho ophatikizika a IVEN opangira ma jekeseni a jekeseni a oncology akuphatikizapo chipinda choyera, makina owongolera ndi kuyang'anira, njira yopangira madzi, kukonza njira ndi kugawa, kuchapa vial - sterilizing ndi depyrogenation - kudzaza - kuyimitsa - kutsekereza - kutsuka kunja, kuzizira. drying system, Isolation system, packing system, automatic logistics system, control system, labotale yapakati ndi zina. Poyang'ana zofuna za makasitomala, IVEN imapanga makonda aukadaulo kwa ogwiritsa ntchito pa:

* Ntchito yofunsira uinjiniya
*Kusankha njira zopangira
* Kusankha kwachitsanzo cha zida ndi makonda
* Kukhazikitsa ndi kutumiza
*Kutsimikizira zida ndi ndondomeko
* Kutumiza kwaukadaulo wopanga
* Zolemba zolimba komanso zofewa
* Maphunziro a ogwira ntchito zaluso ndi zina zotero.

Masitepe opangira zinthu

1.Kuchapira kwa jekeseni wa oncology - kutsekereza ndi depyrogenation - kudzaza - kuyimitsa - kutsekera - chingwe chochapira 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 kutsitsa ndi kutsitsa pagalimoto:

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.

5. Mankhwala opangira madzi:

Zimaphatikizapo kuyeretsa madzi oyeretsedwa (2RO + EDI), distiller yamadzi (WFI), ndi jenereta yoyera ya nthunzi.PW tank ndi WFI tank ikuphatikizidwanso.

7.Clean chipinda & HVAC:

Zimaphatikizapo mapanelo a khoma lazipinda zoyera, mapanelo a denga, mazenera, zitseko, pansi, kuyatsa, mpweya wothandizira mpweya, zosefera za HEPA, ma ducts a mpweya, zoopsa, makina oyendetsa galimoto etc. .

8.Black zofunikira

Zimaphatikizapo makina a air compressor ndi boiler system kuti apereke mpweya ndi nthunzi zofunika kuti apange jekeseni wa vial oncology.

9. 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.

10.Kugawa & dongosolo la mapaipi:

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.

Ubwino:

IVEN ili ndi gulu laukadaulo laukadaulo komanso uinjiniya, maphunziro athu apatsogolo ndi chithandizo pambuyo pogulitsa atha kukupatsani chitsimikizo chanthawi yayitali cha chomera chanu chojambulira cha vial oncology turnkey:

IVEN Zolemba zambiri zitha kukuthandizani kuti mupeze satifiketi ya GMP & FDA ya 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:

Makasitomala a VEN opangira mankhwala akunja kwanyanja:

Mpaka pano, tapereka kale zida zopangira mankhwala ndi zida zamankhwala kumayiko opitilira 50.

Panthawiyi, tinathandiza makasitomala athu kupanga 20+ mankhwala ndi mankhwala turnkey zomera ku Uzbekistan, Tajikistan, Indonesia, Thailand, Saudi, Iraq, Nigeria, Uganda, Tanzania, Ethiopia, Myanmar etc, makamaka kwa IV solution, jekeseni mbale ndi ampoules.Ntchito zonsezi zidapambana makasitomala athu ndi ndemanga zawo zapamwamba za boma.

Tidatumizanso njira yathu yopangira IV ku Germany.