Icyumba gisukuye ni ahantu hagenzurwa byihariye aho ibintu nk'umubare w'uduce tw'umwuka, ubushuhe, ubushyuhe n'amashanyarazi adahindagurika bishobora kugenzurwa kugira ngo hagerwe ku bipimo byihariye by'isuku. Ibyumba bisukuye bikoreshwa cyane mu nganda zigezweho nka semiconductors, electronics, farumasi, indege, aerospace na biomedicine.
Mu bipimo ngenderwaho mu gucunga umusaruro w’imiti, icyumba gisukuye gigabanyijemo ibyiciro bine: A, B, C na D.
Icyiciro cya A: Ahantu hashobora gukoreshwa ibintu bishobora guteza akaga gakomeye, nko mu byuzuze, aho imiyoboro y'amazi n'ibikoresho bifunguye bihurira n'ibikoresho byanduye, hamwe n'aho ibikorwa byo guteranya cyangwa guhuza bikorerwa, bigomba gushyirwaho imbonerahamwe y'amazi anyura mu cyerekezo kimwe kugira ngo bigumane ibidukikije. Sisitemu y'amazi inyura mu cyerekezo kimwe igomba gutanga umwuka ku buryo bungana mu gace ikoreramo, umuvuduko w'umwuka wa 0.36-0.54m/s. Hagomba kubaho amakuru agaragaza uko amazi anyura mu cyerekezo kimwe kandi akagenzurwa. Mu gasanduku gafunze, gafite agakoresho cyangwa uturindantoki, umuvuduko w'umwuka muke ushobora gukoreshwa.
Icyiciro cya B: bivuze agace k'inyuma aho agace k'inyuma ka A gaherereye kugira ngo hakorerwe ibikorwa bishobora guteza akaga nko gutegura no kuzuza ibinyabutabire.
Icyiciro cya C na D: bivuga ahantu hasukuye hatagize intambwe zikomeye cyane mu gukora imiti idafite imiti.
Dukurikije amabwiriza ya GMP, inganda z’imiti zo mu gihugu cyanjye zigabanya ahantu hasukuye mo ibyiciro bine bya ABCD nk’uko byavuzwe haruguru hashingiwe ku bipimo nko gusukura umwuka, umuvuduko w’umwuka, ingano y’umwuka, ubushyuhe n’ubushuhe, urusaku n’ibikubiye mu mikorobe.
Ingano z'ahantu hasukuye zigabanyijwe hakurikijwe ubwinshi bw'uduce duto tw'umwuka mu kirere. Muri rusange, uko agaciro kaba gato, niko isuku iba nyinshi.
1. Isuku y'umwuka yerekeza ku bunini n'umubare w'uduce (harimo na mikorobe) turi mu mwuka kuri buri gice cy'ubunini bw'umwanya, ari na cyo gipimo ngenderwaho cyo gutandukanya urwego rw'isuku rw'umwanya.
Static yerekeza ku mimerere nyuma y’uko sisitemu yo gukonjesha mu cyumba isukuye imaze gushyirwaho kandi ikora neza, kandi abakozi bo mu cyumba gisukuye bamaze kuva aho hantu bakisukura ubwabo mu gihe cy’iminota 20.
Ihindagurika bivuze ko icyumba gisukuye gikorera mu buryo busanzwe, ibikoresho bikora neza, kandi abakozi babigenewe bakora hakurikijwe ibisabwa.
2. Igipimo ngenderwaho cya ABCD gikomoka kuri GMP yashyizweho n'Ishami ry'Umuryango w'Abibumbye ryita ku Buzima (OMS), ari na cyo gipimo rusange cy'imicungire y'ubuziranenge bw'imiti mu nganda zikora imiti. Ubu gikoreshwa mu turere twinshi ku isi, harimo n'Umuryango w'Ubumwe bw'u Burayi n'Ubushinwa.
Verisiyo ya kera ya GMP yo mu Bushinwa yakurikije amahame ngenderwaho y’Abanyamerika yo gutanga amanota (icyiciro cya 100, icyiciro cya 10.000, icyiciro cya 100.000) kugeza igihe verisiyo nshya y’amahame ngenderwaho ya GMP yashyizwe mu bikorwa mu 2011. Inganda z’imiti zo mu Bushinwa zatangiye gukoresha amahame ngenderwaho ya OMS yo gushyira mu byiciro no gukoresha ABCD kugira ngo zimenye urwego rw’ahantu hasukuye.
Andi mahame ngenderwaho yo gushyira mu byiciro ibyumba bisukuye
Icyumba cy’isuku gifite amahame atandukanye yo gutanga amanota mu turere no mu nganda zitandukanye. Amahame ngenderwaho ya GMP yashyizweho mbere, kandi hano ahanini tumenyekanisha amahame ngenderwaho ya Amerika n’amahame ya ISO.
(1). Ihame ry'Ubuziranenge rya Amerika
Igitekerezo cyo gushyira amanota mu cyumba cyo gusukura cyatanzwe bwa mbere na Leta Zunze Ubumwe za Amerika. Mu 1963, hashyizweho umurongo ngenderwaho wa mbere wa leta ku gice cya gisirikare cy’icyumba cyo gusukura: FS-209. Amahame ngenderwaho azwi yo mu cyiciro cya 100, icyiciro cya 10000 n’icyiciro cya 100000 byose bikomoka kuri iri hame. Mu 2001, Leta Zunze Ubumwe za Amerika zahagaritse gukoresha umurongo ngenderwaho wa FS-209E maze zitangira gukoresha umurongo ngenderwaho wa ISO.
(2). Ibipimo ngenderwaho bya ISO
Amahame ngenderwaho ya ISO atangwa n'Umuryango Mpuzamahanga Ushinzwe Ubuziranenge muri ISO kandi areba inganda nyinshi, atari inganda zikora imiti gusa. Hari ibyiciro icyenda kuva ku cyiciro cya mbere kugeza ku cya 9. Muri byo, icyiciro cya 5 kingana n'icyiciro cya B, icyiciro cya 7 kingana n'icyiciro cya C, naho icyiciro cya 8 kingana n'icyiciro cya D.
(3). Kugira ngo hemezwe urwego rw'agace gasukuye ko mu cyiciro cya A, ingano y'ingero za buri gice cyo gufatiraho ingero ntigomba kuba munsi ya metero kibe 1. Urwego rw'uduce tw'ikirere mu gace gasukuye ko mu cyiciro cya A ni ISO 5, hamwe n'uduce duhagaze ≥5.0μm nk'igipimo ntarengwa. Urwego rw'uduce tw'ikirere mu gace gasukuye ko mu cyiciro cya B (static) ni ISO 5, kandi rurimo uduce duhagaze tw'ingano ebyiri mu mbonerahamwe. Ku duce dusukuye two mu cyiciro cya C (static na dynamic), urwego rw'uduce tw'ikirere ni ISO 7 na ISO 8. Ku duce dusukuye two mu cyiciro cya D (static) urwego rw'uduce tw'ikirere ni ISO 8.
(4). Mu kwemeza urwego, hagomba gukoreshwa agakoresho ko kwimura ivumbi gafite umuyoboro mugufi wo gupima kugira ngo hirindwe ko uduce duto duhagaze duto cyane (≥5.0μm) tudakwirakwira mu muyoboro muremure wo gupima w’uburyo bwo gupima bwa kure. Muri sisitemu y’amazi anyura mu cyerekezo kimwe, hagomba gukoreshwa imitwe yo gupima isokinetic.
(5) Isuzuma rihoraho rishobora gukorwa mu gihe cy'ibikorwa bisanzwe no mu buryo bwo kuzuza ibikoresho byifashishijwe mu buryo bwa "culture medium" kugira ngo hagaragazwe ko urwego rw'isuku rugezweho, ariko isuzuma rijyanye n'uburyo bwo kuzuza ibikoresho byifashishwa mu buryo bwa "culture medium" risaba isuzuma rihoraho mu gihe "kimeze nabi cyane".
Icyumba gisukuye cyo mu cyiciro cya A
Icyumba cy’isuku cya Class A, kizwi kandi nka class 100 clean room cyangwa ultra-clean room, ni kimwe mu byumba bifite isuku yo hejuru cyane. Gishobora kugenzura umubare w’uduce kuri metero kibe mu kirere kugeza munsi ya 35.5, ni ukuvuga ko umubare w’uduce turenze cyangwa ungana na 0.5um muri buri metero kibe y’umwuka ntushobora kurenza 3.520 (duhamye kandi duhindagurika). Icyumba cy’isuku cya Class A gifite ibisabwa bikomeye kandi gisaba gukoresha filters za hepa, kugenzura umuvuduko utandukanye, sisitemu yo gutembera k’umwuka hamwe na sisitemu yo kugenzura ubushyuhe n’ubushuhe buhoraho kugira ngo kigere ku bisabwa byacyo byo ku isuku yo hejuru. Icyumba cy’isuku cya Class A gikoreshwa cyane cyane mu gutunganya ibikoresho by’ikoranabuhanga, imiti ikoreshwa mu buvuzi, gukora ibikoresho by’ikoranabuhanga, indege n’ibindi.
Icyumba cy'isuku cyo mu cyiciro cya B
Ibyumba byo mu cyiciro cya B binatwa ibyumba byo mu cyiciro cya 1000 bisukuye. Isuku yabyo ni ntoya cyane, bigatuma umubare w'uduce turenze cyangwa ungana na 0.5um kuri metero kibe y'umwuka ugera kuri 3520 (static) na 352000 (dynamic). Ibyumba byo mu cyiciro cya B bisukuye akenshi bikoresha filters zikoresha ubushobozi bwo gusohora imyuka n'uburyo bwo gusohora imyuka kugira ngo bigenzure ubushuhe, ubushyuhe n'itandukaniro ry'umuvuduko w'ikirere cyo mu nzu. Ibyumba byo mu cyiciro cya B bisukuye bikoreshwa cyane cyane mu buvuzi bw'ibinyabuzima, mu nganda zikora imiti, mu mashini zikora neza no mu nganda zikora ibikoresho n'ahandi.
Icyumba cy'isuku cyo mu cyiciro cya C
Ibyumba byo mu rwego rwa C binatwa ibyumba byo mu rwego rwa 10.000 bisukuye. Isuku yabyo ni ntoya cyane, bigatuma umubare w'uduce turenze cyangwa ungana na 0.5um kuri metero kibe y'umwuka ugera kuri 352.000 (static) na 352.0000 (dynamic). Ibyumba byo mu rwego rwa C bikunze gukoresha filters za hepa, kugenzura umuvuduko mwiza, imikorere y'umwuka, kugenzura ubushyuhe n'ubushuhe n'ubundi buryo kugira ngo bigere ku bipimo byihariye by'isuku. Ibyumba byo mu rwego rwa C bikoreshwa cyane cyane mu by'imiti, mu gukora ibikoresho by'ubuvuzi, mu mashini zikora neza no mu gukora ibikoresho by'ikoranabuhanga n'ibindi.
Icyumba cyo gusukura cyo mu cyiciro cya D
Ibyumba byo mu cyiciro cya D binatwa ibyumba byo mu cyiciro cya 100.000 bisukuye. Isuku yabyo ni ntoya cyane, bigatuma umubare w'uduce turenze cyangwa ungana na 0.5um kuri metero kibe y'umwuka ugera kuri 3.520.000 (static). Ibyumba byo mu cyiciro cya D bisukuye bikoresha filter zisanzwe za hepa hamwe na sisitemu y'ibanze yo kugenzura umuvuduko mwiza n'imiyoboro y'umwuka kugira ngo bigenzure ibidukikije byo mu nzu. Ibyumba byo mu cyiciro cya D bisukuye bikoreshwa cyane cyane mu nganda rusange, gutunganya no gupakira ibiribwa, gucapa, kubika ibintu n'ahandi.
Inzego zitandukanye z'ibyumba bisukuye zifite uburyo bwazo bwo kubikoresha, bugomba gutoranywa hakurikijwe ibyo bikenewe mu buryo bufatika. Mu bikorwa bifatika, kugenzura ibidukikije by'ibyumba bisukuye ni akazi k'ingenzi cyane, gasaba gusuzuma ibintu byinshi mu buryo burambuye. Imiterere n'imikorere bya siyansi n'ibikwiye ni byo byonyine bishobora kwemeza ireme n'ituze ry'ibyumba bisukuye.
Igihe cyo kohereza: Werurwe-07-2024