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OEB5 jakisoni wa oncology vial turnkey chomera

Chiyambi Chachidule:

IVEN Pharmatech ndiye mpainiya woperekera 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 azachipatala 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.


Tsatanetsatane wa Zamalonda

Zogulitsa Tags

Mafotokozedwe Akatundu:

IVEN Pharmatech ndiye mpainiya woperekera 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 azachipatala 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.

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Kodi VEN Injectable oncology vial turnkey chomera chimaphatikizapo chiyani:

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Kanema wa Zamalonda

Kufotokozera kwakukulu

Mayankho ophatikizika a IVEN opangira ma jekeseni a jekeseni a oncology akuphatikizapo chipinda choyera, zowongolera zokha ndi zowunikira, njira yochizira 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.

Njira zogwirira ntchito

1.Kuchapira kwa vial jekeseni ya oncology - kutsekereza ndi depyrogenation - kudzaza - kuyimitsa - kutsekera - chingwe chochapira chakunja:

Mzerewu umagwiritsidwa ntchito popanga jekeseni Mbale za oncology, zomwe zimakhala ndi makina a 5: Full Servo Driven Vertical Ultrasonic Washing Machine, 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-stappering ndikukonzekera kuumitsa kuzizira, kenako ndikusunthira ku makina a capping, pambuyo pake, imapita kumakina ochapira akunja.Timatengera makina oyezera pa intaneti pamakina odzaza, zinthu zosayenerera zidzakanidwa zokha.

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1. Kusamba

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2. Sterilizing & Depyrogenation

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3. Kudzaza & Kuyimitsa

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4. Kujambula

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5. Kutsuka Kwakunja

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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.

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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 pazigawo zodzipatula.

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 yokha, 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 yofunikira popanga jekeseni wa vial oncology.

9. Laboratory:

Zimaphatikizapo zida zonse zoyezera 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 ndi uinjiniya, maphunziro athu apatsogolo ndi chithandizo pambuyo pogulitsa atha kukupatsani chitsimikizo chanthawi yayitali cha chomera chanu chojambulira cha vial oncology turnkey:

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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):

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Katswiri ndi luso la VEN zitha kukuthandizani kumaliza IV solution turnkey chomera munthawi yochepa kwambiri ndikupewa zoopsa zamitundu yonse:

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Makasitomala a VEN opangira mankhwala akunja kwanyanja:

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

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

Tidatumizanso njira yathu yopangira IV ku Germany.

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Indonesia IV botolo turnkey chomera

Vietnam IV botolo turnkey chomera

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Uzbekistan IV botolo turnkey chomera

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Thailand Injectable vial turnkey chomera

Tajikistan IV botolo turnkey chomera

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Saudi Arabia IV bag turnkey plant

Kuthekera kwamtundu wa VEN jekeseni wa oncology vial turnkey chomera:

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