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GMP FARMACEUTICAL CLEAN ICYUMWERU CYIZA

icyumba gisukuye
gmp icyumba gisukuye
icyumba cya farumasi

Icyumba cy’imiti cya GMP kigomba kuba gifite ibikoresho byiza byo kubyaza umusaruro, uburyo bwiza bwo kubyaza umusaruro, gucunga neza ubuziranenge hamwe na sisitemu yo gupima neza kugira ngo ibicuruzwa byanyuma (harimo umutekano w’ibiribwa n’isuku) byujuje ibisabwa n’amabwiriza.

1. Kugabanya ahantu ho kubaka hashoboka

Amahugurwa afite urwego rwisuku ntisaba ishoramari rinini gusa, ahubwo afite nigiciro kinini cyisubiramo nkamazi, amashanyarazi, na gaze.Muri rusange, urwego rwisuku rwicyumba gisukuye, niko ishoramari, gukoresha ingufu nigiciro.Kubwibyo, hashingiwe ku kuzuza ibisabwa kugirango umusaruro ube, ahantu hubatswe icyumba gisukuye hagomba kugabanywa bishoboka.

2. Kugenzura byimazeyo imigendekere yabantu nibikoresho

Icyumba gisukuye cya farumasi kigomba kuba gifite abantu bagenewe ibintu.Abantu bagomba kwinjira bakurikije uburyo bwateganijwe bwo kwezwa, kandi umubare wabantu ugomba kugenzurwa cyane.Usibye imiyoborere isanzwe yo kweza abakozi binjira kandi basohoka mucyumba cy’imiti cya farumasi, kwinjira no gusohoka ibikoresho fatizo n’ibikoresho bigomba no kunyura mu buryo bwo kweza kugira ngo bitagira ingaruka ku isuku y’icyumba gisukuye.

3. Imiterere ishyize mu gaciro

(1) Ibikoresho biri mucyumba gisukuye bigomba gutondekwa neza bishoboka kugirango bigabanye ubuso bwicyumba gisukuye.

(2) Nta madirishya mucyumba gisukuye cyangwa icyuho kiri hagati yidirishya nicyumba gisukuye kugirango ufunge koridor yo hanze.

(3) Urugi rwicyumba gisukuye rurasabwa kuba rwumuyaga, kandi indege zishyirwa kumuryango no gusohoka kwabantu nibintu.

(4) Ibyumba bisukuye byurwego rumwe bigomba gutegurwa hamwe bishoboka.

(5) Ibyumba bisukuye byinzego zitandukanye byateguwe kuva kurwego rwo hasi kugeza kurwego rwo hejuru.Imiryango igomba gushyirwaho hagati yibyumba byegeranye.Itandukaniro ryumuvuduko uhuye rigomba gutegurwa ukurikije urwego rwisuku.Mubisanzwe, ni nka 10Pa.Icyerekezo cyo gufungura umuryango cyerekeza mucyumba gifite isuku ihanitse.

(6) Icyumba gisukuye kigomba gukomeza umuvuduko mwiza.Umwanya uri mucyumba gisukuye urahujwe kugirango ukurikirane urwego rwisuku, kandi hariho itandukaniro ryumuvuduko uhuye kugirango wirinde umwuka uva mucyumba cyo hasi gisukuye gusubira mu cyumba cyo hejuru gisukuye.Itandukaniro ryumuvuduko wa net hagati yibyumba byegeranye bifite urwego rutandukanye rwisuku yumwuka bigomba kuba birenze 10Pa, itandukaniro ryumuvuduko ukabije hagati yicyumba gisukuye (agace) nikirere cyo hanze kigomba kuba kirenze 10Pa, kandi umuryango ugomba gukingurwa werekeza kuri icyumba gifite urwego rwo hejuru rwisuku.

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4. Komeza umuyoboro wijimye bishoboka

Kugirango huzuzwe ibisabwa kurwego rwisuku y amahugurwa, imiyoboro itandukanye igomba guhishwa bishoboka.Ubuso bw'inyuma bw'imiyoboro yagaragaye bugomba kuba bworoshye, imiyoboro itambitse igomba kuba ifite mezzanine ya tekinike cyangwa tuneli ya tekiniki, naho imiyoboro ihanamye yambukiranya amagorofa igomba kuba ifite ibiti bya tekiniki.

5. Imitako yimbere igomba kuba nziza mugusukura

Urukuta, amagorofa no hejuru hejuru yicyumba gisukuye bigomba kuba byoroshye nta gucikamo cyangwa gukusanya amashanyarazi ahamye.Imigaragarire igomba kuba ikomeye, nta bice biguye, kandi ikabasha kwihanganira isuku no kuyanduza.Ihuriro riri hagati yinkuta nigorofa, inkuta ninkuta, inkuta nigisenge bigomba gukorwa muri arc cyangwa izindi ngamba zigomba gufatwa kugirango igabanuka ryumukungugu kandi ryorohereze isuku.


Igihe cyo kohereza: Ugushyingo-08-2023