UKRAINE LABORATORY: ICYUMWERU CYIZA CYIZA NA FFUS

Mu 2022, umwe mu bakiriya bacu bo muri Ukraine yatwegereye adusaba gukora ibyumba byinshi byo muri laboratoire ya ISO 7 na ISO 8 kugira ngo duhinge ibihingwa mu nyubako yari isanzwe yubahiriza ISO 14644. Twahawe inshingano zo gukora no gukora umushinga wuzuye. . Vuba aha ibintu byose byageze kurubuga kandi byiteguye gushyirwaho ibyumba bisukuye. Kubwibyo, ubu turashaka gukora incamake yuyu mushinga.

Igiciro cyubwiherero ntabwo gishora imari cyane, ariko bitewe numubare ukenewe wo guhanahana ikirere no gukora neza. Imikorere irashobora kubahenze cyane, kuko ubuziranenge bwikirere bushobora kugumaho gusa hamwe no guhora ukora. Tutibagiwe n'imikorere ikoresha ingufu no gukomeza kubahiriza amahame yubwiherero bituma ubwiherero bumwe mubikorwa remezo byingenzi byikoranabuhanga na laboratoire.

Igishushanyo no Gutegura Icyiciro

Kubera ko tuzobereye mubyumba byubatswe byubatswe kugirango dukenere inganda zitandukanye, twakiriye neza ikibazo twizeye ko tuzashobora gutanga igisubizo cyoroshye, cyigiciro cyinshi gishobora no kurenga kubiteganijwe. Mugihe cyo gushushanya, twashizeho igishushanyo kirambuye cyumwanya usukuye wagombaga gushyiramo ibyumba bikurikira:

Urutonde rwibyumba bisukuye

Ikigereranyo gisanzwe: Igishushanyo hamwe nogukoresha ikirere (AHU)

Ubwa mbere, twateguye icyumba gakondo gisukuye gifite ubushyuhe nubushuhe bwa AHU kandi dukora imibare kubiciro byose. Usibye gushushanya no gukora ibyumba bisukuye, itangwa ryambere hamwe na gahunda ibanza harimo ishami rishinzwe gutwara ikirere hamwe na 15-20% kuruta ibyoherezwa mu kirere. Gahunda yumwimerere yakozwe hakurikijwe amategeko yo gutembera kwa laminar hamwe nogutanga no kugaruka hamwe na H14 HEPA muyunguruzi.

Umwanya wose usukuye ugomba kubakwa ugizwe na m2 50, bivuze cyane ibyumba bito bisukuye.

Ibiciro Byinshi Iyo Byashizweho na AHU

Igiciro cyishoramari cyubwiherero bwuzuye kiratandukanye bitewe na:

· Urwego rukenewe rw'isuku y'icyumba gisukuye;

· Ikoranabuhanga ryakoreshejwe;

Ingano y'ibyumba;

Kugabana umwanya usukuye.

Ni ngombwa kumenya ko kugirango muyungurure no guhana ikirere neza, hakenewe ingufu nyinshi cyane kuruta urugero nko mubiro bisanzwe. Tutibagiwe ko ibyumba bisukuye bifunze kandi bisaba umwuka mwiza.

Muri uru rubanza, umwanya usukuye wagabanijwe cyane ku gice gito cyane, aho ibyumba 3 bito (Laboratoire # 1, Laboratoire # 2, Sterile yinjira) byari bifite isuku ya ISO 7 na ISO 8, bigatuma ubwiyongere bugaragara bwambere ikiguzi cy'ishoramari. Byumvikane neza, igiciro kinini cyishoramari nacyo cyahungabanije umushoramari, kuko ingengo yuyu mushinga yari mike. 

Ongera uhindure hamwe nigiciro cyiza cya FFU

Bisabwe numushoramari, twatangiye gushakisha uburyo bwo kugabanya ibiciro. Imiterere y'icyumba gisukuye kimwe n'umubare w'inzugi n'amasanduku yatambutse byatanzwe, nta kuzigama byongeye kugerwaho hano. Ibinyuranye, guhindura sisitemu yo gutanga ikirere byasaga nkigisubizo kigaragara.

Kubwibyo, ibisenge byibyumba byahinduwe nkibisubirwamo, ingano yumwuka isabwa yabazwe kandi ugereranije nuburebure bwicyumba kiboneka. Kubwamahirwe, hari umwanya uhagije wo kongera uburebure. Igitekerezo cyari ugushyira FFU mu gisenge, hanyuma ukahaha umwuka mwiza mubyumba bisukuye ukoresheje filteri ya HEPA hifashishijwe sisitemu ya FFU (ibice byungurura abafana). Umwuka wo kugaruka uzengurutswe hifashishijwe imbaraga za rukuruzi zinyuze mu miyoboro yo mu kirere ku kayira kegereye inkuta, zishyirwa mu rukuta, ku buryo nta mwanya wabuze.

Bitandukanye na AHU, FFU yemerera umwuka gutembera muri buri karere kugirango wuzuze ibisabwa muri ako karere.

Mugihe cyo kongera gushushanya, twashyizemo icyuma gishyiraho icyuma gikonjesha binyuze mu gisenge gifite ubushobozi buhagije, bushobora gushyushya no gukonjesha umwanya. FFUs zateguwe kugirango zitange umwuka mwiza mu kirere.

Kuzigama Ikiguzi Byagezweho

Kuvugurura byavuyemo kuzigama gukomeye nkuko igishushanyo gishya cyemerewe gukuramo ibintu byinshi bihenze nka

· AHU;

· Sisitemu yuzuye yuzuye hamwe nibintu bigenzura;

Imashini zifite moteri.

Igishushanyo gishya kigizwe na sisitemu yoroshye cyane itagabanya cyane ikiguzi cyishoramari, ariko kandi iganisha kumafaranga make yo gukora kuruta sisitemu ya AHU.

Bitandukanye nigishushanyo mbonera, sisitemu yongeye kugaragara ihuye ningengo yumushoramari, nuko twasezeranye kumushinga.

Umwanzuro

Ukurikije ibisubizo byagezweho, hashobora kuvugwa ko ishyirwa mubikorwa ryibyumba bisukuye hamwe na sisitemu ya FFU yubahiriza ibipimo bya ISO14644 cyangwa GMP bishobora gutuma igiciro kigabanuka. Inyungu yikiguzi irashobora kugerwaho kubijyanye nigishoro nigiciro cyo gukora. Sisitemu ya FFU irashobora kandi kugenzurwa byoroshye, bityo, nibiba ngombwa, icyumba gisukuye gishobora gushyirwa kuruhuka mugihe cyigihe kitari gito.