Icyumba gisukuye ni iki?
Ibyumba bisukuye, bizwi kandi nk'ibyumba bitarimo ivumbi, bikunze gukoreshwa mu rwego rwo kubyaza umusaruro inganda cyangwa ubushakashatsi bwa siyansi, harimo gukora imiti, ibiryo, CRTs, LCDs, OLEDs, na microLED yerekana.Ibyumba bisukuye byashizweho kugirango bigumane urugero ruto cyane, nk'umukungugu, ibinyabuzima byo mu kirere, cyangwa imyuka ihumeka.
Mubyukuri, icyumba gisukuye gifite urwego rwanduye rwanduye, rugaragazwa numubare wibice kuri metero kibe / kuri metero kibe kubunini bwagenwe.Icyumba gisukuye gishobora kandi kwerekeza ku mwanya uwo ari wo wose wakira aho umwanda ugabanuka ndetse n’ibindi bipimo by’ibidukikije nkubushyuhe, ubushuhe, n’umuvuduko bigenzurwa.
Icyumba gisukuye cya GMP ni iki?
Mu buryo bwa farumasi, icyumba gisukuye bivuga icyumba cyujuje ibisobanuro bya GMP byasobanuwe mubisobanuro bya GMP (urugero, Umugereka wa 1 w’ubumwe bw’ibihugu by’Uburayi n’amabwiriza ya PIC / S GMP, hamwe n’andi mahame n’amabwiriza asabwa n’ubuyobozi bw’ubuzima bwaho ).Ni ihuriro ryubwubatsi, gukora, kurangiza, no kugenzura ibikorwa (ingamba zo kugenzura) bisabwa kugirango uhindure icyumba gisanzwe mubyumba bisukuye.
Ukurikije ibipimo bijyanye n’ibigo bya FDA, bashyizeho amabwiriza akomeye kandi asobanutse ku bakora imiti mu nganda zimiti.Uburyo bwiza bwo gukora ibicuruzwa (GMP) bwo gukora imiti yimiti idahwitse yateguwe kugirango harebwe niba imiti itekanye kandi irimo ibintu byavuzwe hamwe ninshi.Ibipimo ngenderwaho bigamije kugabanya ibyago byo kwanduza mikorobe, uduce, na pyrogene.Aya mabwiriza, azwi kandi mubikorwa byiza byo gukora (cGMP), akubiyemo inzira yumusaruro, kugenzura ubuziranenge, gupakira, abakozi, nibikoresho bya GMP.
Mu gukora ibiyobyabwenge bidafite sterile nibikoresho byubuvuzi, muri rusange ntabwo hakenewe ibyumba byo mu rwego rwo hejuru bisukuye, mu gihe kugirango hakorwe imiti itanduye, nk'imiti ya molekile n’imiti y’ubukorikori, byanze bikunze hakenewe ibyumba bisukuye byo mu rwego rwo hejuru - GMP ibyumba bisukuye.Turashobora gusobanura ibidukikije kugirango habeho imiti itavura nibicuruzwa bikomoka ku binyabuzima dushingiye ku kirere cyiza cya GMP no mu byiciro.
Ukurikije ibisabwa bijyanye n’amabwiriza ya GMP, umusaruro w’ibiyobyabwenge cyangwa ibikomoka ku binyabuzima bigabanyijemo ibice bine: A, B, C, na D.
Inzego zishinzwe kugenzura ubu zirimo: ISO, USP 800, na Leta zunze ubumwe za Amerika 209E (byahoze, biracyakoreshwa).Itegeko ry’ubuziranenge n’umutekano (DQSA) ryashyizweho mu Gushyingo 2013 kugira ngo rikemure impfu ziterwa n’ibiyobyabwenge n’ibintu bikomeye bibi.Itegeko ry’ibiribwa, ibiyobyabwenge, n’amavuta yo kwisiga (FD&C Act) rishyiraho umurongo ngenderwaho na politiki byihariye by’abantu.50.Uruganda rwahawe uruhushya binyuze mu kigo gishinzwe ibiryo n'ibiyobyabwenge (FDA).
DERSION Icyumba gisukuye
1. GUSHYIRA MU BIKORWA BYOROSHE
Inyungu igaragara yibyumba bisukuye ni uko byoroshye kandi byihuse gushiraho.Ntibagomba kubakwa guhera kandi ntibizahagarika ibikorwa byawe hamwe nibyumweru cyangwa amezi yo kubaka.Byakozwe mubikoresho byabugenewe no kubishushanya, kuburyo bishobora gushyirwaho muminsi cyangwa ibyumweru.Muguhitamo icyumba gisukuye cya DERSION, umuryango wawe urashobora kwirinda gutinda hanyuma ugatangira gukoresha ubwiherero bwawe hafi ako kanya.
Ikirenzeho, igishushanyo cya DERSION cyerekana byoroshye guteranya cyangwa gusenya ibyumba byacu bisukuye kandi byubukungu kubyongeraho.Ibi bivuze ko abakiriya bacu bafite uburyo bworoshye bwo kongeramo, cyangwa gukuramo, ubwiherero bwabo bwashyizweho nkuko ibikenewe mumuryango wabo bihinduka.Kuberako ibyumba byacu bisukuye ntabwo ari ibyubaka bihoraho, bisaba amafaranga make yo kugura hamwe nigiciro gito cyo kubungabunga.
2. GUKORA UMUNTU
Ubwiherero busanzwe bukoresha ibice bya filteri ya HEPA na ULPA kugirango bikureho ibintu biturutse mu kirere kandi bikomeze kwanduza byibuze bikenewe.DERSION itanga ubwiherero butandukanye nibikoresho byogusukura bishobora gufasha umuryango wawe kubahiriza ibipimo bya ISO, FDA, cyangwa EU.Byombi byogusukura software hamwe na rigidwall byujuje ibyangombwa ISO 8 kugeza ISO 3 cyangwa Icyiciro A kugeza Icyiciro cya D kugeza ku cyiciro cy’isuku ry’ikirere.Ubwiherero bwacu bugoye ni igisubizo gihenze cyo kuzuza ibisabwa USP797.
Ibyiza byibyumba bisukuye mubyumba bisanzwe bisukuye nibyinshi.Ubushobozi bwabo, kwishyiriraho byoroshye no kububungabunga, hamwe nibikorwa mugihe bituma bahitamo neza kubigo cyangwa amashyirahamwe akeneye ibidukikije byisuku kugirango akore ako kanya.Muri DERSION twemera ubwiza bwibicuruzwa byogusukura nubworoherane batanga kubakiriya bacu.Kubindi bisobanuro byukuntu ibyo bicuruzwa bishobora gufasha umuryango wawe guhaza ibyo ukeneye, reba software yacu na rigidwall modular isukuye ibyumba.
