Icyumba gisukuye ni ibidukikije bigenzurwa bidasanzwe aho ibintu nk'umubare w'uduce duto two mu kirere, ubushuhe, ubushyuhe n'umuriro w'amashanyarazi bihoraho bishobora kugenzurwa kugira ngo bigerweho neza. Ibyumba bisukuye bikoreshwa cyane mu nganda zikoranabuhanga cyane nka semiconductor, electronics, farumasi, indege, icyogajuru na biomedicine.
Mu micungire y’imicungire y’imiti, icyumba gisukuye kigabanyijemo ibice 4: A, B, C na D.
Icyiciro A: Ahantu ho gukorera hashobora kwibasirwa cyane, nko kuzuza ahantu, uduce twa reberi ihagarara hamwe nibikoresho bipfunyika bipfunyika bihuye neza nimyiteguro idasanzwe, hamwe n’ahantu hakorerwa ibikorwa byo guteranya aseptike cyangwa guhuza ibikorwa, bigomba kuba bifite ameza akorera aterekejwe. kubungabunga ibidukikije by'akarere. Sisitemu yo gutembera idafite icyerekezo igomba gutanga umwuka neza aho ikorera ifite umuvuduko wumwuka wa 0.36-0.54m / s. Hagomba kubaho amakuru yo kwerekana imiterere yimigendekere idahwitse kandi igenzurwa. Mugihe gifunze, cyitaruye cyangwa agasanduku k'isanduku, umuvuduko wo mu kirere urashobora gukoreshwa.
Icyiciro B: bivuga agace kinyuma aho icyiciro A gisukuye giherereye kubikorwa byago byinshi nko gutegura aseptic no kuzuza.
Icyiciro C na D: bivuga ahantu hasukuye hamwe nintambwe zidafite akamaro mukubyara ibicuruzwa bivura imiti.
Nkurikije amabwiriza ya GMP, uruganda rw’imiti mu gihugu cyanjye rugabanya ahantu hasukuye mu nzego 4 za ABCD nkuko byavuzwe haruguru hashingiwe ku bipimo nk’isuku ry’ikirere, umuvuduko w’ikirere, ubwinshi bw’ikirere, ubushyuhe n’ubushuhe, urusaku n'ibirimo mikorobe.
Urwego rwahantu hasukuye rugabanijwe ukurikije ubunini bwibice byahagaritswe mukirere. Muri rusange nukuvuga, agaciro gake, niko urwego rwisuku ruri hejuru.
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Static bivuga leta nyuma yo gushyirwaho uburyo bwo guhumeka ibyumba bisukuye bimaze gushyirwaho kandi bigakora neza, kandi abakozi bo mubyumba bisukuye bimuye ikibanza kandi biyeza muminota 20.
Dynamic bivuze ko icyumba gisukuye kimeze mumikorere isanzwe, ibikoresho bikora mubisanzwe, nabakozi bagenwe bakora bakurikije ibisobanuro.
2. Ibipimo ngenderwaho bya ABCD biva muri GMP yatangajwe n’umuryango w’ubuzima ku isi (OMS), ikaba ari uburyo rusange bwo gucunga neza imiti y’imiti mu nganda z’imiti. Kugeza ubu ikoreshwa mu turere twinshi ku isi, harimo Umuryango w’ubumwe bw’ibihugu by’Uburayi n’Ubushinwa.
Ubushinwa bwa kera bwa GMP bwakurikije ibipimo by'abanyamerika (icyiciro cya 100, icyiciro 10,000, icyiciro 100.000) kugeza igihe hashyizwe mu bikorwa verisiyo nshya y’ibipimo bya GMP mu mwaka wa 2011. Inganda z’imiti mu Bushinwa zatangiye gukoresha ibipimo ngenderwaho bya OMS no gukoresha ABCD mu gutandukanya U urwego rwahantu hasukuye.
Ibindi byumba bisukuye mubyiciro
Icyumba gisukuye gifite ibipimo bitandukanye mu turere n'inganda zitandukanye. Ibipimo bya GMP byatangijwe mbere, kandi hano turamenyekanisha cyane cyane ibipimo byabanyamerika hamwe na ISO.
(1). Ibipimo by'Abanyamerika
Igitekerezo cyo gutondekanya icyumba gisukuye cyatanzwe bwa mbere na Amerika. Mu 1963, hashyizweho urwego rwa mbere rwa federasiyo ku gice cya gisirikare cy’icyumba gisukuye: FS-209. Icyiciro kimenyerewe 100, icyiciro 10000 nicyiciro 100000 ibipimo byose biva muriki gipimo. Mu 2001, Amerika yahagaritse gukoresha FS-209E hanyuma itangira gukoresha ISO.
(2). Ibipimo bya ISO
Ibipimo bya ISO bisabwa n’umuryango mpuzamahanga ushinzwe ubuziranenge ISO kandi bikubiyemo inganda nyinshi, ntabwo ari imiti yimiti gusa. Hariho urwego icyenda kuva mucyiciro1 kugeza mucyiciro cya 9. Muri bo, icyiciro cya 5 gihwanye nicyiciro B, icyiciro cya 7 gihwanye nicyiciro C, naho icyiciro cya 8 gihwanye nicyiciro D.
(3). Kwemeza urwego rwicyiciro A gisukuye, ingano yikitegererezo ya buri cyitegererezo ntishobora kuba munsi ya metero kibe 1. Urwego rw'ibice byo mu kirere mu cyiciro A ahantu hasukuye ni ISO 5, hamwe nuduce twahagaritswe ≥5.0μm nkibipimo ntarengwa. Urwego rw'ibice byo mu kirere mu cyiciro B gisukuye (static) ni ISO 5, kandi ikubiyemo ibice byahagaritswe bifite ubunini bubiri mumeza. Kubyiciro C bisukuye ahantu (static na dinamike), urwego rwibice byo mu kirere ni ISO 7 na ISO 8. Ku cyiciro D ahantu hasukuye (static) urwego rwibice byo mu kirere ni ISO 8.
(4). Mugihe cyemeza urwego, hagomba gukoreshwa icyuma kigabanya ivumbi hamwe nigituba kigufi cyikitegererezo kigomba gukoreshwa kugirango wirinde ≥5.0μm uduce duto twahagaritswe gutura mumiyoboro miremire ya sisitemu ya kure. Muri sisitemu yo gutembera idafite icyerekezo, isokinetic sampling imitwe igomba gukoreshwa.
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Icyiciro Icyumba gisukuye
Icyumba A icyumba gisukuye, kizwi kandi nk'icyumba 100 gisukuye cyangwa icyumba gisukuye cyane, ni kimwe mu byumba bisukuye bifite isuku nyinshi. Irashobora kugenzura umubare wibice kuri metero kibe mukirere kugeza munsi ya 35.5, nukuvuga, umubare wibice birenze cyangwa bingana na 0.5um muri buri metero kibe yumuyaga ntibishobora kurenga 3,520 (static na dinamike). Icyiciro A icyumba gisukuye gifite ibisabwa cyane kandi bisaba gukoresha filtri ya hepa, kugenzura umuvuduko ukabije, uburyo bwo kuzenguruka ikirere hamwe na sisitemu ihoraho yubushyuhe hamwe nubushyuhe bwo kugenzura kugirango bagere kubyo basabwa cyane. Icyiciro A Icyumba gisukuye gikoreshwa cyane cyane mugutunganya microelectronics, biofarmaceuticals, gukora ibikoresho byuzuye, icyogajuru nizindi nzego.
Icyiciro cya B icyumba gisukuye
Ibyumba B byo mu cyiciro B bisukuye nabyo byitwa ibyumba 1000 bisukuye. Urwego rwabo rufite isuku ruri hasi cyane, rutuma umubare wibice birenze cyangwa bingana na 0.5um kuri metero kibe yumuyaga kugera kuri 3520 (static) na 352000 (dinamike). Ibyumba B bisukuye mubyiciro B mubisanzwe bifashisha neza-muyunguruzi hamwe na sisitemu yo gusohora kugirango igenzure ubuhehere, ubushyuhe nubushyuhe butandukanye bwibidukikije. Ibyumba bisukuye byo mu cyiciro B bikoreshwa cyane cyane mubuzima bwa biomedicine, gukora imiti, imashini zisobanutse no gukora ibikoresho nizindi nzego.
Icyumba C cyicyumba gisukuye
Ibyumba bisukuye byo mu cyiciro C nabyo byitwa ibyumba 10,000 bisukuye. Urwego rwabo rufite isuku ruri hasi cyane, rutuma umubare wibice birenze cyangwa bingana na 0.5um kuri metero kibe yumuyaga kugera kuri 352.000 (static) na 352.0000 (dinamike). Icyumba C gisukura ibyumba bisanzwe bikoresha akayunguruzo ka hepa, kugenzura umuvuduko mwiza, kuzenguruka ikirere, ubushyuhe nubushuhe nubundi buryo bwikoranabuhanga kugirango bigere kubipimo byihariye byisuku. Ibyumba byo mu cyiciro cya C bisukurwa cyane cyane mubikoresho bya farumasi, gukora ibikoresho byubuvuzi, imashini zitomoye no gukora ibikoresho bya elegitoronike nizindi nzego.
Icyumba D icyumba gisukuye
Icyumba D gisukura ibyumba byitwa kandi ibyumba 100.000 byumba bisukuye. Urwego rwabo rwisuku ruri hasi cyane, rutuma umubare wibice birenze cyangwa bingana na 0.5um kuri metero kibe yumuyaga kugera kuri 3,520.000 (static). Icyumba D gisukura ibyumba bisanzwe bikoresha filteri isanzwe ya hepa hamwe nuburyo bwiza bwo kugenzura umuvuduko hamwe na sisitemu yo kuzenguruka ikirere kugirango igenzure ibidukikije murugo. Ibyumba D byo mu cyiciro cya D bikoreshwa cyane cyane mubikorwa rusange byinganda, gutunganya ibiryo no gupakira, gucapa, ububiko nubundi buryo.
Inzego zitandukanye zibyumba bisukuye zifite aho zigarukira, zigomba gutoranywa ukurikije ibikenewe. Mubikorwa bifatika, kugenzura ibidukikije byibyumba bisukuye nigikorwa cyingenzi cyane, kirimo gusuzuma byimazeyo ibintu byinshi. Gusa igishushanyo cya siyansi kandi gishyize mu gaciro nigikorwa gishobora kwemeza ubuziranenge n’umutekano w’ibidukikije bisukuye.
Igihe cyo kohereza: Werurwe-07-2024