OEB5 Gutera inshinge oncology vial turnkey igihingwa
Ibisobanuro ku bicuruzwa:
IVEN Pharmatech niyambere itanga ibihingwa bya turnkey bitanga igisubizo cyubwubatsi bwinganda zikora imiti kwisi yose nka IV igisubizo, urukingo, onkologiya nibindi, hubahirijwe EU GMP, US FDA cGMP, PICS, na OMS GMP.
Dutanga igishushanyo mbonera cyumushinga, ibikoresho byujuje ubuziranenge hamwe na serivisi yihariye ku nganda zitandukanye zimiti nubuvuzi kuva A kugeza kuri Z kubitari PVC byoroshye umufuka wa IV, igisubizo cya PP icupa rya IV, igisubizo cya Glass vial IV, Injection Vial & Ampoule, Sirup, Tableti & Capsules, Vacuum ikusanya amaraso nibindi.
Niki IVEN Injectable oncology vial turnkey igihingwa kirimo:
Video y'ibicuruzwa
Ibisobanuro nyamukuru
IVEN ihuriweho nubushakashatsi bwibikorwa bya farumasi yatewe inshinge zirimo uruganda rufite isuku, sisitemu yo kugenzura no kugenzura, sisitemu yo gutunganya amazi yimiti, uburyo bwo gutegura no gukwirakwiza, gukaraba vial - steriliza na depyrogenation - kuzuza - guhagarika - gufata - gukaraba hanze, gukonjesha sisitemu yo kumisha, sisitemu yo kwigunga, sisitemu yo gupakira, sisitemu yo gutanga ibikoresho byikora, sisitemu yo kugenzura ubuziranenge, laboratoire nkuru n'ibindi. Yibanze kubisabwa kubakiriya ku giti cyabo, IVEN ihitamo ibisubizo byubwubatsi neza kubakoresha kuri:
Serivisi ishinzwe ubujyanama mbere yubuhanga
* Guhitamo inzira yumusaruro
* Ibikoresho byo guhitamo ibikoresho no kubitunganya
* Gushiraho no gutangiza
* Kwemeza ibikoresho nibikorwa
* Kohereza ikoranabuhanga mu bicuruzwa
* Inyandiko zikomeye kandi yoroshye
* Amahugurwa y'abakozi bafite ubuhanga nibindi.
Intambwe yo gukora ibicuruzwa
1.Gutera inshinge oncology vial washing - sterilizing and depyrogenation - kuzuza - guhagarika - gufata - umurongo wo gukaraba hanze:
Uyu murongo ukoreshwa mukubyara inshinge za oncology, zigizwe nimashini 5: Imashini yuzuye ya Servo Driven Vertical Ultrasonic Imashini yo gukaraba, Umuyaga ushyushye wo kuzunguruka Sterilizing & Depyrogenation Umuyoboro, Servo Yuzuye Yuzuye Imashini Yuzuza-Guhagarika Imashini, Imashini ifata imashini hamwe n’imashini yo gukaraba hanze.
Nyuma yo kuzuza, izajya muri kimwe cya kabiri ihagarara kandi yiteguye gukonjesha gukonjesha, hanyuma yimuke kuri capping imashini, nyuma yibyo, izajya mumashini imesa hanze.Twemeje sisitemu yo gupima kumurongo kugirango yuzuze imashini, ibicuruzwa bitujuje ibyangombwa bizahita byangwa.
1. Gukaraba
2. Sterilizing & Depyrogenation
3. Kuzuza & Guhagarika
4. Gufata
5. Gukaraba hanze
6. birangiye
2.Gukonjesha icyuma na sisitemu yo gupakira no gupakurura:
Kubicuruzwa bya lyofilize, nyuma yo kuzuza no guhagarika igice, bizashyikirizwa gukonjesha byumye (Lyophilizer) mu buryo bwikora binyuze muri sisitemu yo gupakira amamodoka, nyuma ya lyofilize, bizashyikirizwa imashini zifata sisitemu yo gupakurura imodoka.
3. Sisitemu yo kwigunga:
Nkuko oncology ari ibicuruzwa bifite uburozi, turashobora guha ibikoresho hamwe na wenyine kugirango umutekano wabakoresha utangire ibicuruzwa, kugirango tumenye neza ko inzira yumusaruro irinzwe byimazeyo muri sisitemu yo kwigunga.
Intangiriro
1.Operator yatandukanijwe rwose nigice cyingenzi cya sterile.
2.Urwego rwimbere rwimbere.Urwego rwa C / D icyumba gisukuye.
3.Gusa ushobora gufungura akato nyuma yo guhagarika sisitemu, kwemeza birakenewe kugirango reboot.
4.Koresha HPVS kugirango uhindurwe imbere.
5. Sisitemu yo kuzenguruka ifunze.
6.Kwemerera kwinjiza ikirere cya HEPA, membrane irashobora kurinda ikirere kimwe hamwe nayunguruzo.
7.Imiterere yimbere yimbere, igishushanyo mbonera.
8.Kwemeza ikidodo cyugururiwe umuryango wuguruye hamwe nidirishya rya gants.
9.Ku bicuruzwa bifite uburozi, koresha igikapu-mu-mufuka.
Indi mirimo
1.CIP / SIP sisitemu (SIP na VHP).
2.Ibice byo Kurwanya Gukurikirana Kumurongo.
3.Airborne Viable Particle Sampler.
4. Umuyoboro wa Hydrogen Dioxide Generator.
5.Gushakisha Ikariso.
6.Anometero.
7.H / T.
8.Urutonde.
9.Equinox Sterility Module.
10.Ibikoresho byo gutoranya indege.
11.Isakoshi-mu mufuka-hanze Akayunguruzo Guhindura Amazu.
4.Gupakira sisitemu:
Irashobora kurangiza inshinge za vial oncology kugenzura urumuri rwikora, kugenzura kumeneka, kuranga, blist hamwe no gupakira amakarito yibanze, no kohereza amakarito.
Turashobora ibikoresho hamwe no kohereza amakarito yikora yoherejwe, amabwiriza yigitabo hamwe nicyemezo cyo gushyiramo, gupakira amakarito, gufunga amakarito, kuranga, sisitemu yo gukurikirana amakuru, hamwe na sisitemu yo kwanga imodoka, ishobora kwanga amakarito afite uburemere butari bwiza, cyangwa izifite ikirango kitujuje ibyangombwa.
5.Gutunganya amazi yimiti:
Harimo gutunganya amazi meza (2RO + EDI), imashini itanga amazi (WFI), hamwe na generator ikora neza.Ikigega cya PW na tank ya WFI nayo irimo.
5.Gutunganya amazi yimiti:
Harimo gutunganya amazi meza (2RO + EDI), imashini itanga amazi (WFI), hamwe na generator ikora neza.Ikigega cya PW na tank ya WFI nayo irimo.
7.Icyumba gisukuye & HVAC:
Harimo ibyumba bisukuye byicyumba, ibisenge, idirishya, inzugi, hasi, kumurika, ishami rishinzwe ikirere, akayunguruzo ka HEPA, imiyoboro yumuyaga, ubwoba, sisitemu yo kugenzura ibinyabiziga nibindi. .
8.Gukoresha akamaro
Harimo sisitemu yo guhumeka ikirere hamwe na sisitemu yo guteka kugirango itange umwuka ukenewe hamwe na parike kugirango ikorwe na vial oncology.
9.Laboratory:
Harimo ubwoko bwose bwibikoresho byo gupima laboratoire, nibikoresho byo muri laboratoire kugirango bipimishe ingero za vial oncology sample hamwe nibikoresho fatizo, nka chambre stabilite, HPLC, kwinjiza atome, ultraviolet spectrometer, fourier transform infrared spectrometer nibindi.
10.Gusaranganya & sisitemu y'imiyoboro:
Harimo ubwoko bwose bwimiyoboro itunganijwe hamwe numuyoboro winganda ukenera muruganda rwa vial oncology inshinge, nkamazi meza, amazi yatewe, amavuta meza, amazi akonje, amazi akonje, umwuka ucanye, umwuka winganda nibindi.
Ibyiza:
IVEN ifite itsinda ryinzobere mu bya tekiniki n’ubuhanga, amahugurwa yacu kurubuga hamwe ninkunga yo kugurisha irashobora gutanga ibyiringiro byigihe kirekire bya tekinike kubihingwa byatewe na vial oncology turnkey plant:
IVEN Urutonde rwuzuye rushobora kugufasha kubona icyemezo cya GMP & FDA kubihingwa byawe bya IV byoroshye (Harimo IQ / OQ / PQ / DQ / FAT / SAT nibindi haba mucyongereza no mubushinwa):
IVEN umwuga n'uburambe birashobora kugufasha kurangiza igisubizo cya IV igisubizo cya turnkey mugihe gito kandi ukirinda ingaruka zose zishobora kubaho:
IVEN mu mahanga imiti ya farumasi yimiti abakiriya:
Kugeza ubu, tumaze gutanga ibikoresho byinshi bya farumasi nibikoresho byubuvuzi mubihugu birenga 50.
Hagati aho, twafashije abakiriya bacu kubaka uruganda rwa farumasi n’ubuvuzi 20+ muri Uzubekisitani, Tajigistan, Indoneziya, Tayilande, Arabiya Sawudite, Iraki, Nijeriya, Uganda, Tanzaniya, Etiyopiya, Miyanimari n'ibindi, cyane cyane ku gisubizo cya IV, inzoka zatewe inshinge na ampules.Iyi mishinga yose yatsindiye abakiriya bacu na leta yabo ibitekerezo byinshi.
Twongeye kandi kohereza mu Budage umurongo wa IV wo gukemura.
Indoneziya IV icupa ryibihingwa
Vietnam IV icupa ryibihingwa
Uzubekisitani IV icupa ryibihingwa
Tayilande Gutera inshinge vial turnkey igihingwa
Tajikistan IV icupa ryibihingwa
Arabiya Sawudite IV umufuka wibihingwa
Ubushobozi bwa IVEN yatewe inshinge oncology vial turnkey igihingwa:
