Non-PVC yoroshye umufuka wa IV igisubizo cya turnkey
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 Non-PVC yoroshye igikapu IV igisubizo cya turnkey umushinga urimo:
Video y'ibicuruzwa
Ibisobanuro nyamukuru
IVEN ihuriweho nubushakashatsi bwibikorwa bya farumasi nubuvuzi birimo icyumba gisukuye, kugenzura-kugenzura no kugenzura, sisitemu yo gutunganya amazi yimiti, sisitemu yo gutegura no gutanga ibisubizo, sisitemu yo kuzuza no gupakira, sisitemu yo gutanga ibikoresho, sisitemu yo kugenzura ubuziranenge, laboratoire nkuru nibindi. Yibanze kubakiriya basabwa kugiti cyabo, IVEN ihitamo ibisubizo byubwubatsi 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.Nta-PVC umufuka woroshye IV igisubizo Gushiraho-Kuzuza-Gufunga umurongo wo gukora:
Uyu murongo ukoreshwa mugukora umufuka wa IV na firime itari PVC (PP), no kurangiza gukora imifuka, gucapa, kuzuza no gufunga imashini imwe.
Ingano yimifuka ya IV iri hagati ya 100ml - 5000ml.Gusa ukeneye igice cyisaha kugirango uhindure uva mubunini ujya mubindi.Ifite igishushanyo cyihariye cya 130mm z'ubugari kugirango ibike firime, irashobora kandi kumenya gukoresha 100% ya firime, nta bikoresho byangiza.
Sisitemu yo gusenya:
Ikoreshwa muguhindura umufuka wa IV urangiye ukoresheje amazi ashyushye kuri 121 ℃.Igihe cyo kuboneza urubyaro gishobora kuva kuminota 15 - 30 ukurikije tekinoroji itandukanye ikenerwa, ubushyuhe bwo guhagarika ibintu burashobora guhinduka.
Turashobora guha ibikoresho hamwe na mashini ya IV yapakurura imashini zipakurura no gupakurura, nanone byikora sterisizike ya gare itanga sisitemu nkuburyo bwo guhitamo.
3.Gupakira sisitemu:
Irashobora kurangiza isakoshi ya IV yumisha, gutahura, kugenzura urumuri, kurenga no gupakira 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.
4. 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.Uburyo bwo gutegura igisubizo:
Ikoreshwa mu kuvanga imiti n'amazi yo gutera.Dufite ibikoresho 2 byo gutegura ibisubizo, hamwe na Mettler-Toledo yikoreza selile, hamwe na sisitemu yo gukurura magnetique.
6.Icyumba cyera & HVAC:
Harimo ibyumba bisukuye byicyumba, ibisenge, idirishya, inzugi, hasi, kumurika, ishami rishinzwe gutwara ikirere, akayunguruzo ka HEPA, imiyoboro yumuyaga, ubwoba, sisitemu yo kugenzura ibinyabiziga nibindi. .
7.Gukoresha akamaro
Harimo sisitemu yo guhumeka ikirere hamwe na sisitemu yo guteka kugirango itange umwuka ukenewe hamwe na parike kugirango bitari PVC byoroshye umufuka wa IV.
8.Laboratory:
Harimo ubwoko bwose bwibikoresho byo gupima laboratoire, nibikoresho byo muri laboratoire kugirango bipimishe urugero rwimifuka ya IV nibikoresho fatizo, nkicyumba gihamye, HPLC, kwinjiza atome, ultraviolet spectrometer, fourier transform infrared spectrometer nibindi.
9.Gusaranganya & sisitemu:
Harimo ubwoko bwose bwimiyoboro itunganyirizwa hamwe numuyoboro winganda ukenera muruganda rutari PVC IV rwumufuka, nkamazi meza, amazi yatewe, amavuta meza, amazi akonje, amazi akonje, umwuka ucanye, umwuka winganda nibindi.
Ibyiza byingenzi bya IVEN Non-PVC umufuka woroshye umufuka wa IV igisubizo:
* Gukoresha firime 100%: ntamwanya wimyanda uri hagati yimifuka ibiri ya IV, kugabanya ibikoresho ningufu.
* Sisitemu yo gushyushya no gusudira yizewe: Menya neza ko igipimo cyo kumeneka ku mifuka ya IV kiri munsi ya 0.03%.
* Guhindura byihuse: Gusa ukeneye amasaha 0.5-1 kugirango uhindure uva mubunini bwa IV ujya mubindi.
* Imiterere yoroheje, gabanya 1/3 cy'uburebure bwa mashini, uzigame umwanya wicyumba nigiciro cyo gukora.
* Sisitemu ihamye yo kohereza no kohereza: koresha igishushanyo cya combo-port, ukeneye sisitemu 1 yo kugenzura, 1 HMI na 1 ukora.
* Kuzuza neza nozzle: Emera kuzuza ipatanti yuzuye, nta gisubizo kirenze, nta kubyara ibice mugihe cyo kuzuza imifuka ya IV.
* Gutahura ibinyabiziga hamwe na sisitemu yo kwanga amakosa yo kwanga imifuka ya IV itujuje ibyangombwa nyuma yo gusudira.
Ikiguzi cyo kuzigama ipatanti ya IVEN yagenewe imifuka ya IV:
a.Igishushanyo cyihariye cya IV gifite ubugari bwa 130mm, umufuka umwe wa IV urashobora kubika firime 10mm kurusha abandi batanga.
b.Nta mpfabusa hagati yimifuka ya IV nitsinda, gukoresha firime 100%.
c.Ushobora kuzigama imifuka 250 iv kurenza kuri buri muzingo wa firime kurenza izindi zifite ubugari bwa 135mm
IVEN ifite itsinda ryubuhanga nubuhanga bwubuhanga, amahugurwa yacu kurubuga hamwe ninkunga yo kugurisha birashobora gutanga ibyemezo byigihe kirekire bya tekinike kubihingwa bya NON-PVC IV byamazi:
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 bwurwego rwa IVEN Non-PVC umufuka woroshye IV igisubizo cya turnkey igihingwa:
| Ingingo | Ibirimo | ||||||||
| Icyitegererezo | SRD1A | SRD2A | SRS2A | SRD3A | SRD4A | SRS4A | SRD6A | SRD12A | |
| Ubushobozi bwumusaruro | 100ML | 1000 | 2200 | 2200 | 3200 | 4000 | 4000 | 5500 | 10000 |
| 250ML | 1000 | 2200 | 2200 | 3200 | 4000 | 4000 | 5500 | 10000 | |
| 500ML | 900 | 2000 | 2000 | 2800 | 3600 | 3600 | 5000 | 8000 | |
| 1000ML | 800 | 1600 | 1600 | 2200 | 3000 | 3000 | 4500 | 7500 | |
| Inkomoko y'imbaraga | 3 Icyiciro 380V 50Hz | ||||||||
| Imbaraga | 8KW | 22KW | 22KW | 26KW | 32KW | 28KW | 32KW | 60KW | |
| Umuvuduko ukabije w'ikirere | Umwuka wumye kandi utarimo amavuta, isuku ni 5um, umuvuduko urenze 0.6Mpa.Imashini izahita iburira kandi ihagarare mugihe umuvuduko muke | ||||||||
| Gukoresha ikirere gikonje | 1000L / mim | 2000L / mim | 2200L / mim | 2500L / mim | 3000L / mim | 3800L / mim | 4000L / mim | 7000L / mim | |
| Umuyaga mwiza | Umuvuduko wumwuka uhumanye urenze 0.4Mpa, isuku ni 0.22um | ||||||||
| Gukoresha ikirere gisukuye | 500L / min | 800L / min | 600L / min | 900L / min | 1000L / min | 1000L / min | 1200L / min | 2000L / min | |
| Ubukonje bw'amazi | > 0.5kgf / cm2 (50kpa) | ||||||||
| Gukoresha Amazi akonje | 100L / H. | 300L / H. | 100L / H. | 350L / H. | 500L / H. | 250L / H. | 400L / H. | 800L / H. | |
| Kurya Azote | Ukurikije ibyo umukiriya asabwa bidasanzwe, dushobora gukoresha azote kugirango turinde imashini, umuvuduko ni 0.6Mpa.Imikoreshereze iri munsi ya 45L / min | ||||||||
| Urusaku | <75dB | ||||||||
| Icyumba gisabwa | Ubushyuhe bwibidukikije bugomba ≤26 ℃, ubuhehere: 45% -65%, Mak.ubuhehere bugomba kuba munsi ya 85% | ||||||||
| Ingano muri rusange | 3.26x2.0x2.1m | 4.72x2.6x2.1m | 8x2.97x2.1m | 5.52x2.7x2.1m | 6.92x2.6x2.1m | 11.8x2.97x2.1m | 8.97x2.7x2.25m | 8.97x4.65x2.25m | |
| Ibiro | 3T | 4T | 6T | 5T | 6T | 10T | 8T | 12T | |
IVEN Atari PVC umufuka woroshye IV igisubizo cya turnkey igihingwa kirashobora kuguha ubwoko butandukanye bwibishushanyo:
