Chomera cha OEB5 cholowetsa jakisoni wa khansa

Chomera cha OEB5 chobayira matenda a oncology chotembenukira Chithunzi Chowonetsedwa

Chiyambi Chachidule:

IVEN Pharmatech ndiye kampani yoyamba kupereka mankhwala opangira mankhwala omwe amapereka njira zophatikizira zaukadaulo zamafakitale padziko lonse lapansi monga mankhwala a IV, katemera, khansa ndi zina zotero, motsatira malamulo a EU GMP, US FDA cGMP, PICS, ndi WHO GMP.

Timapereka kapangidwe ka polojekiti koyenera kwambiri, zida zapamwamba kwambiri komanso ntchito yokonzedwa ku mafakitale osiyanasiyana azachipatala ndi azachipatala kuyambira A mpaka Z kuti tipeze yankho la IV lopanda PVC, yankho la IV la botolo la PP, yankho la IV la botolo lagalasi, Botolo lobayira & Ampoule, Madzi, Mapiritsi ndi Makapisozi, chubu chosonkhanitsira magazi ndi zina zotero.

Tumizani imelo kwa ife

Tsatanetsatane wa Zamalonda

Ma tag a Zamalonda

IVEN Pharmatechndi kampani yotsogola yopereka mafakitale ofunikira omwe amapereka njira zophatikizira zaukadaulo zamafakitale opanga mankhwala padziko lonse lapansi monga njira ya IV, katemera, khansa ndi zina zotero, motsatira malamulo a EU GMP, US FDA cGMP, PICS, ndi WHO GMP.

Kodi chomera cha IVEN Injectable oncology turnkey chimaphatikizapo chiyani?

Chomera cha OEB5 cholowetsa jakisoni wa khansa

Mayankho ophatikizidwa a IVEN aukadaulo opangira ma vial opangira jakisoni wa mankhwala akuphatikizapo chipinda choyera, njira yowongolera yokha ndi kuyang'anira, njira yochizira madzi a mankhwala, njira yokonzekera ndi kugawa mayankho, kutsuka ma vial - kuyeretsa ndi kuchotsa poizoni - kudzaza - kutseka - kuphimba - kutsuka kwakunja, njira yowumitsa yozizira, njira yodzipatula, njira yolongedza, njira yolumikizira yokha, njira yowongolera khalidwe, labotale yayikulu ndi zina zotero. Poganizira zofunikira za makasitomala payekhapayekha, IVEN imasintha mayankho aukadaulo mosamala kwa ogwiritsa ntchito pa:

Utumiki wopereka upangiri wauinjiniya

Kusankha ndi kusintha zida zamtundu

Kutsimikizira zida ndi njira

Zolemba zolimba komanso zofewa

Kusankha njira zopangira

Kukhazikitsa ndi kukhazikitsa

Kusamutsa ukadaulo wopanga

Maphunziro a ogwira ntchito aluso ndi zina zotero.

Iven imapereka mayankho athunthu aukadaulo pazinthu zamankhwala ndi zamankhwala padziko lonse lapansi, kuphatikiza zipinda zoyera, zochita zokha, kuchiza madzi ...

Masitepe Ogwirira Ntchito Zamalonda

1. Kutsuka m'botolo la oncology lobayidwa jakisoni - kuyeretsa ndi kuchotsa poizoni m'thupi - kudzaza - kutseka - kuphimba - mzere wopanga zovala zakunja:

Mzerewu umagwiritsidwa ntchito popanga ma vial oyambitsa matenda a khansa omwe amabayidwa, omwe ali ndi makina 5: Makina Ochapira Okhazikika Oyendetsedwa ndi Servo, Tunnel Yotentha Yotentha Yotenthetsera ndi Kuchotsa Ma Vial, Makina Odzaza Ma Vial Oyendetsedwa ndi Servo, Makina Ophimba Ma Vial ndi Makina Ochapira Akunja.

Pambuyo podzaza, idzaikidwa mu semi-stoppering ndipo idzakonzeka kuumitsa mufiriji, kenako idzasamutsidwira ku makina ophimba, pambuyo pake, idzapita ku makina ochapira akunja. Timagwiritsa ntchito njira yoyezera kulemera pa intaneti ya makina odzaza, zinthu zosayenerera zidzakanidwa zokha.

1. Kusamba

2. Kuyeretsa ndi Kuchotsa poizoni m'thupi

3. Kudzaza & Kutseka

4. Kuphimba

5. Kusamba Kunja

6. yatha

2. Kuwumitsa choumitsira ndi kutsitsa makina odziyimira pawokha:

Pazinthu zopangidwa ndi lyophilized, zikadzazidwa ndi kutsekedwa pang'ono, zidzatumizidwa ku makina owumitsira (Lyophilizer) zokha kudzera mu makina odzaza okha, zikatumizidwa ku makina ophimba ndi makina otulutsira okha.

3. Dongosolo lodzipatula:

Popeza oncology ndi chinthu choopsa, titha kukhala ndi chodzipatula kuti titeteze ogwira ntchito ku zinthuzo, kuti tiwonetsetse kuti njira yopangira zinthuyo yatetezedwa mokwanira pansi pa dongosolo lodzipatula.

Chiyambi Chachidule

1. Wogwira ntchitoyo walekanitsidwa kwathunthu ndi malo opangira zinthu zoyera.
2. Malo opangira mkati mwa chipinda chokhala ndi mulingo wa A. Chipinda choyera chakunja chokhala ndi mulingo wa C/D.
3. Chokhacho chomwe chingatsegule chodzipatula pambuyo poti makina azimitsidwa, kutsimikizira ndikofunikira kuti muyambitsenso.
4. Sinthani HPVS kuti muyeretsedwe mkati.
5. Dongosolo lozungulira lotsekedwa.
6. Adopt HEPA air inlet, nembanemba imatha kuteteza kuyenda kwa mpweya wofanana komanso fyuluta.
7. Kapangidwe ka mkati kopanda msoko, kapangidwe kozungulira.
8. Tengani chisindikizo chopumira chomwe chingagwiritsidwe ntchito pa zitseko zotseguka komanso mawindo a magolovesi.
9. Pa zinthu zoopsa, gwiritsani ntchito kapangidwe kake kotuluka m'thumba.

Ntchito Zina

1. Kachitidwe ka CIP/SIP (SIP ndi VHP).
2. Kuwunika kwa Tinthu Paintaneti.
3. Choyezera Tinthu Tomwe Tingathe Kuuluka.
4. Jenereta ya Hydrogen Dioxide Yopangidwa ndi Utsi.
5. Chowunikira Kutuluka kwa Magolovesi.
6. Chiyerekezo cha Anemometer.
7.H/T Sensor.
8. ATEX Rating.
9. Gawo Loyesera Kusabereka la Equinox.
10. Chipangizo Choyezera Mpweya.
11. Nyumba Yosinthira Sefa Yochokera M'thumba.

4. Dongosolo lolongedza:

Imatha kumaliza kuyang'anira kuwala kwa botolo lobayira, kuyang'anira kutuluka kwa madzi, kulemba zilembo, kuyika chithuza ndi kulongedza makatoni, ndi kulongedza makatoni.
Tikhoza kukhala ndi makina otsegulira makatoni otumizira okha, buku la malangizo ndi kuyika satifiketi, kulongedza makatoni, kutseka makatoni, kulemba zilembo, njira yotsatirira deta, ndi njira yokana yokha, zomwe zingakane makatoniwo ndi kulemera kolakwika, kapena omwe ali ndi chizindikiro chosayenerera.

5. Mankhwala a madzi:

Zimaphatikizapo kuyeretsa madzi (2RO+EDI), chotsukira madzi (WFI), ndi jenereta ya nthunzi yeniyeni. Tanki ya PW ndi thanki ya WFI zikuphatikizidwanso.

6. Chipinda choyera & HVAC

Zimaphatikizapo mapanelo oyera a m'chipinda, mapanelo a padenga, mawindo, zitseko, pansi, magetsi, chipangizo chogwiritsira ntchito mpweya, zosefera za HEPA, machubu a mpweya, njira yowopsa, makina owongolera okha ndi zina zotero. Kuteteza njira yopangira khansa ya m'mphuno pogwiritsa ntchito jakisoni pansi pa malo a Class C + Isolator.

7. Zida zakuda

Ikuphatikizapo makina opopera mpweya ndi makina ophikira boiler kuti apereke mpweya wopanikizika ndi nthunzi wofunikira popanga khansa ya m'mabotolo.

8. Laboratory

Zimaphatikizapo mitundu yonse ya zida zoyesera labu, ndi mipando ya labu yoyesera zitsanzo za jakisoni wa vial oncology ndi zinthu zopangira, monga chipinda chokhazikika, HPLC, kuyamwa kwa atomiki, ultraviolet spectrometer, fourier transform infrared spectrometer ndi zina zotero.

9. Kugawa ndi njira yoyendetsera mapaipi

Ikuphatikizapo mitundu yonse ya mapaipi opangira ntchito ndi mapaipi amafakitale omwe amafunikira mu chomera chopangira jakisoni wa vial oncology, monga madzi oyeretsedwa, madzi obayira, nthunzi yoyera, madzi ozizira, madzi ozizira, mpweya wopanikizika, nthunzi yamafakitale ndi zina zotero.

Kuchuluka kwa IVEN Injectable Oncology Vial Turnkey Plant

Chithandizo chaukadaulo ndi chithandizo cha pambuyo pogulitsa

IVENTili ndi gulu la akatswiri aukadaulo komanso mainjiniya, maphunziro athu omwe tili nawo komanso chithandizo chathu chogulitsa pambuyo pogulitsa chingakupatseni chitsimikizo chaukadaulo cha nthawi yayitali pa fakitale yanu yopanda PVC IV fluid turnkey:

Zolemba zonse za IVEN zingakuthandizeni kupezaSatifiketi ya GMP ndi FDAPa chomera chanu chamadzimadzi cha IV mosavuta (Kuphatikiza IQ / OQ / PQ / DQ / FAT / SAT etc zonse mu Chingerezi ndi Chitchaina):

Ukadaulo ndi chidziwitso cha IVEN zingakuthandizeni kumaliza chomera chonse cha IV solution turnkey munthawi yochepa kwambiri ndikupewa zoopsa zosiyanasiyana zomwe zingachitike:

Makasitomala a mafakitale a IVEN ochokera kunja kwa dzikolo

Mpaka pano, tapereka kale zida zambirimbiri zamankhwala ndi zida zachipatala kumayiko opitilira 50.

Pakadali pano, tinathandiza makasitomala athu kutianamanga zomera zopitilira 20 zopangira mankhwala ndi zamankhwalaku Uzbekistan, Tajikistan, Indonesia, Thailand, Saudi Arabia, Iraq, Nigeria, Uganda, Tanzania, Ethiopia, Myanmar ndi zina zotero, makamaka mankhwala a IV, ma botolo obayira jakisoni ndi ma ampoules. Mapulojekiti onsewa adakopa makasitomala athu ndi boma lawo kuti alandire ndemanga zabwino.

Tinatumizanso mzere wathu wopanga mankhwala a IV ku Germany.