OEB5 Injectable oncology turnkey plant ikoreshwa mu gutwika agacupa
IVEN Pharmatechniyo sosiyete y’intangarugero mu gutanga inganda zikora imiti ijyanye n’igihe, itanga ibisubizo by’ubuhanga ku nganda zikora imiti ku isi nka IV solution, urukingo, kanseri n’ibindi, hakurikijwe amabwiriza ya EU GMP, US FDA cGMP, PICS, na WHO GMP.
Dutanga igishushanyo mbonera cy’umushinga gikwiye, ibikoresho byiza cyane na serivisi yihariye ku nganda zitandukanye z’imiti n’ubuvuzi kuva kuri A kugeza kuri Z ku gikoresho cyoroshye cya IV kidakoresha PVC, igisubizo cya IV mu icupa rya PP, igisubizo cya IV mu icupa ry’ikirahure, Agacupa gaterwamo inshinge n’agafu, Sirupe, Ibinini n’udupfukamunwa, umuyoboro wo gukusanya amaraso mu cyuma n’ibindi.
Ni iki IVEN Injectable oncology oncology turnkey plant irimo:
Uburyo bwa IVEN bwo gukora imashini zikoreshwa mu ikoranabuhanga mu ruganda rw’udupira tw’imiti duterwamo kanseri burimo icyumba gisukuye, uburyo bwo kugenzura no kugenzura, uburyo bwo gutunganya amazi mu miti, uburyo bwo gutegura no gukwirakwiza imiti, uburyo bwo koza udupira - gusukura no gusukura - kuzuza - guhagarika - gufunga - gukaraba hanze, uburyo bwo kumisha mu buryo bwa frigo, uburyo bwo kwitandukanya, uburyo bwo gupakira, uburyo bwo gutwara ibintu bwikora, uburyo bwo kugenzura ubuziranenge, laboratwari nkuru n'ibindi. Ishingiye ku byo abakiriya bakeneye ku giti cyabo, IVEN ihindura ibisubizo by’ubuhanga mu buryo bwitondewe ku bakoresha kuri:
1. Gukaraba agacupa gaterwamo kanseri - gusukura no gukaraba - kuzuza - guhagarika - gupfundikira - umurongo wo gukora imyenda yo hanze:
Uyu murongo ukoreshwa mu gukora uducupa twa kanseri duterwa mu buryo bw'inshinge, tugizwe n'imashini 5: Imashini ikarabya ikoresheje uburyo bwa "Full Servo Driven Vertical Ultrasonic Messaging Machine", "Hot Air Circulation Sterilizing & Depyrogenation Tunnel", Imashini ikarabya ikoresha uburyo bwa "Full Servo Driven Vial Filling-Stoppering Machine", Imashini ikarabya ikoresheje uburyo bwa "Vial Capping Machine" n'imashini ikarabya hanze.
Nyuma yo kuzuza, izajya ishyirwa mu gice cyo gufunga hanyuma ikoreshwe ku buryo bwo kumisha, hanyuma ijye mu mashini ifunga, nyuma yaho, izajya mu mashini yo hanze yo kumesa. Dukoresha uburyo bwo gupima ibyuma byo kuzuza kuri interineti, ibicuruzwa bitujuje ibisabwa bizakwangwa ako kanya.
1. Gukaraba
2. Gusukura no Gukuraho uruhu
3. Kuzuza no Guhagarika
4. Gupfundikira
5. Gukaraba inyuma
6. kurangiza
2. Gukonjesha icyuma cyumisha no gupakira ibikoresho byikora:
Ku bicuruzwa bya lyophilized, nyuma yo kuzuza no guhagarika gato, bizajyanwa mu buryo bwikora mu cyuma cyumisha (Lyophilizer) binyuze muri sisitemu yo gushyiramo ibikoresho byikora, nyuma yo gushyirwamo lyophilized, bizajyanwa mu mashini ifunga ibikoresho hifashishijwe sisitemu yo gupakurura ibikoresho yikora.
3. Sisitemu yo kwitandukanya:
Kubera ko kanseri ari ikintu cy’uburozi, dushobora gukoresha indolesiyo kugira ngo turinde umutekano w’abakora ibicuruzwa, kugira ngo tumenye neza ko inzira yo kubikora irinzwe neza hifashishijwe uburyo bwo kwitandukanya.
Intangiriro ngufi
1. Umukoresha atandukanye burundu n'agace k'umusaruro kadafite impanuka.
2. Ahantu ho gukorera ibikoresho imbere hafite urwego rwo hejuru. Icyumba cyo hanze gifite isuku yo mu rwego rwa C/D.
3. Ishobora gufungura igenzura nyuma yo gufunga sisitemu gusa, kwemeza ni ngombwa kugira ngo wongere ukoreshe.
4. Hindura HPFS kugira ngo ikoreshwe mu buryo bwo kwirinda indwara imbere mu mubiri.
5. Sisitemu yo kuzenguruka kw'amaraso ifunze.
6. Koresha HEPA air injirira, membrane ishobora kurinda urujya n'uruza rw'umwuka kimwe ndetse n'akayunguruzo.
7. Imiterere y'imbere idafite umugozi, igishushanyo mbonera cyuzuye.
8. Shyiraho agapfunyika gashobora guhumekwa haba ku muryango ufunguye ndetse no ku madirishya y'uturindantoki.
9. Ku bintu birimo uburozi, koresha imiterere y'ibicuruzwa bisohoka mu mufuka.
Izindi nshingano
1. Sisitemu ya CIP/SIP (SIP na VHP).
2. Gukurikirana uduce duto kuri interineti.
3. Isuzuma ry'uduce duto dushobora gukoreshwa mu kirere.
4.Jenereta ya Hydrogen Dioxide ivamo umwuka.
5. Igikoresho cyo gupima aho utwikiriye uturindantoki dusohoka.
6. Igipimo cy'umuvuduko w'amaraso.
7. Isensa ya H/T.
8. Isuzuma rya ATEX.
9. Isuzuma rya Equinox ryo kuvura indwara zo mu nda.
10. Igikoresho cyo gupima umwuka.
11. Inzu yo guhinduramo akayunguruzo gashyirwa mu gikapu.
4. Sisitemu yo gupakira:
Ishobora kurangiza gusuzuma urumuri rw’imashini ikoresheje agacupa, kugenzura amazi asohoka, gushyiramo ikimenyetso, gupfunyika hamwe n’agapfunyika k’ibanze, no gupfunyika agapfunyika mu gapfunyika.
Dushobora gushyiraho uburyo bwo gufungura amakarito yo kohereza mu buryo bwikora, igitabo cy'amabwiriza n'uburyo bwo gushyiramo icyemezo, gupakira amakarito, gufunga amakarito, gushyiraho ibirango, uburyo bwo gukurikirana amakuru, na sisitemu yo kwanga amakuru mu buryo bwikora, bishobora kwanga amakarito afite uburemere butari bwo, cyangwa afite ibirango bidafite ishingiro.
5. Gutunganya amazi mu buryo bw'imiti:
Harimo gusukura amazi meza (2RO + EDI), icyuma gisukura amazi (WFI), na moteri y'umwuka isukuye. Harimo na tanki ya PW na tanki ya WFI.
6. Isuku y'icyumba n'ibikoresho byo mu rugo
Irimo isuku ku nkuta z'icyumba, ibisenge, amadirishya, inzugi, hasi, amatara, icyuma gifata umwuka, filter za HEPA, imiyoboro y'umwuka, uburyo bwo gukumira, sisitemu yo kugenzura imodoka n'ibindi. Kugira ngo uburyo bwo gukora kanseri y'ibinini iterwa n'inshinge burindwe mu buryo busanzwe munsi y'ibidukikije bya Class C + Isolator.
7. Ikoreshwa ry'umukara
Irimo sisitemu yo gukamya umwuka n'uburyo bwo gukamya umuyaga kugira ngo haboneke umwuka ufunze n'umwuka uhagije wo gukora kanseri y'ibinini.
8. Laboratwari
Irimo ubwoko bwose bw'ibikoresho byo gupima muri laboratwari, n'ibikoresho byo muri laboratwari byo gupima ingero za oncology ziterwa n'imashini n'ibikoresho fatizo, nka stability chamber, HPLC, atomic absorption, ultraviolet spectrometer, fourier transform infrared spectrometer n'ibindi.
9. Sisitemu yo gukwirakwiza no gukoresha imiyoboro
Irimo ubwoko bwose bw'imiyoboro ikoreshwa mu gutunganya no gukwirakwiza imiti mu nganda ikenerwa mu ruganda rukora imiti igabanya ubukana bw'ibinini, nk'amazi meza, amazi aterwa, umwuka mwiza, amazi akonje, amazi akonje, umwuka ufunze, umwuka uva mu nganda n'ibindi.
IVENDufite itsinda ry’abahanga mu bya tekiniki n’ubwubatsi, amahugurwa yacu yo ku kazi n’ubufasha nyuma yo kugurisha bishobora gutanga icyizere cy’igihe kirekire ku ruganda rwawe rudakoresha PVC IV fluid turnkey:
IVEN Urutonde rwuzuye rw'inyandiko rushobora kugufasha kubonaIcyemezo cya GMP na FDAku ruganda rwawe rw'amazi ya IV byoroshye (Harimo IQ / OQ / PQ / DQ / FAT / SAT nibindi byombi mu Cyongereza no mu Gishinwa):
Umwuga n'uburambe bya IVEN bishobora kugufasha kurangiza uruganda rwuzuye rwa IV mu gihe gito kandi ukirinda ingaruka zose zishobora kubaho:
IVENDufite itsinda ry’abahanga mu bya tekiniki n’ubwubatsi, amahugurwa yacu yo ku kazi n’ubufasha nyuma yo kugurisha bishobora gutanga icyizere cy’igihe kirekire ku ruganda rwawe rudakoresha PVC IV fluid turnkey:
Kugeza ubu, tumaze gutanga ibikoresho amagana by’imiti n’ibikoresho by’ubuvuzi mu bihugu birenga 50.
Hagati aho, twafashije abakiriya bacuyubatse inganda zirenga 20 zikora imiti n'ubuvuzimuri Uzbekistan, Tajikistan, Indoneziya, Tayilande, Sawudite, Iraki, Nijeriya, Uganda, Tanzaniya, Etiyopiya, Miyanimari n'ahandi, ahanini bikorerwa umuti wa IV, uducupa tw'inshinge n'udupfukamunwa. Iyi mishinga yose yahesheje abakiriya bacu n'ubuyobozi bwabo ibitekerezo byiza.
Twanashyize mu Budage umurongo wacu wo gukora imiti ya IV.
Uruganda rukora amacupa ya IV muri Indoneziya
Uruganda rukora amacupa ya IV muri Vietnam
Uruganda rwa Uzbekistan IV rukora amacupa yo gucukura
Uruganda rwo muri Tayilande rukoresha agacupa gashyirwamo inshinge
Uruganda rwa Tajikistan IV rukora amacupa yo gucukura
