Icyumba gisukuye ni ibidukikije byihariye byagenzuwe muburyo bumwe mu buryo bwo mu kirere, ubushuhe, amashanyarazi n'amashanyarazi bihamye bishobora kugenzurwa kugirango bigere ku bipimo byihariye. Ibyumba bisukuye bikoreshwa cyane mu nganda z'uburebure bwa tekinoroji nka semictondu, ibikoresho bya elegitoroniki, ifirisi, indege, aerospace na biomedicine.
Mubisobanuro byo gucunga imiti yibicuruzwa, icyumba gisukuye kigabanyijemo ibice 4: A, B, C na D.
Icyiciro A: Ahantu hakorerwa ingaruka nyinshi, nko kuzuza ahantu hashobora guhagarara kubungabunga ibidukikije byakarere. Sisitemu yo guhuza burundu igomba gutanga umwuka neza mukarere kakazi hamwe numuvuduko wo mu kirere wa 0.36-0.54m / s. Hagomba kubaho amakuru kugirango yerekane imiterere yubutengururwe kandi bugenzurwe. Mu buryo bufunze, bwitaruye cyangwa agasanduku k'ibikoresho, umuvuduko wo hasi urashobora gukoreshwa.
Icyiciro B: bivuga agace k'inyuma aho icyiciro agace kasukuye kaherereye mu bikorwa byo hejuru nko gutegura no kuzuza.
Icyiciro C na D: Reba ahantu hasukuye hamwe nintambwe nke zingenzi mugukora ibicuruzwa bya farumasi.
Dukurikije amabwiriza ya GMP, inganda zanjye z'imiti igabanya aho zisukuye mu nzego 4 za ABCD nkuko byavuzwe haruguru mu kirere nk'isuku, ubushyuhe, urusaku n'ibirimo n'ibintu bya mikorobe.
Urwego rw'ahantu hasukuye rutandukanijwe dukurikije ibitekerezo byahagaritswe mu kirere. Muri rusange, muto agaciro, hejuru kurwego rwisuku.
1. Isuku yumwuka yerekana ubunini numubare wibice (harimo mikorobe) bikubiye mu kirere ku bunini bwumwanya, nicyo gipimo cyo gutandukanya urwego rwisuku rwumwanya.
Static yerekeza kuri leta nyuma yicyumba cyo guhumeka neza mubyumba byashizwemo kandi bikora neza, kandi abakozi bafite ibyumba byimuye kurubuga no kwisukura iminota 20.
Dynamike bivuze ko icyumba gisukuye ari mubihe bisanzwe byakazi, ibikoresho bikorwa bisanzwe, kandi abakozi bagenewe gukora bakurikije ibisobanuro.
2. Gutanga amanota ya ABCD biva muri GMP itangajwe n'umuryango w'ubuzima ku isi (NINDE), aribwo buryo bwo gukora imiti isanzwe mu nganda za farumasi. Kugeza ubu ikoreshwa mu turere twinshi ku isi, harimo n'umuryango w'ubumwe bw'ibihugu by'Uburayi n'Ubushinwa.
Igishinwa cya kera cya GMP cyakurikiye ibipimo ngenderwaho bya Amerika (icyiciro cya 100, icyiciro 10,000, icyiciro cya 100.000) kugeza ishyirwa mu bikorwa rya verisiyo nshya ya GMP. Inganda za farumasi ya GMP urwego rw'ahantu hasukuye.
Ibindi Bisukuye Ibipimo ngenderwaho
Icyumba gisukuye gifite amahame atandukanye yo gutanga amanota hamwe ninganda. Ibipimo bya GMP byatangijwe mbere, kandi hano duharanira cyane cyane ibipimo byabanyamerika no gutanga.
(1). Abanyamerika
Igitekerezo cyo gutangaza icyumba cyo gutanga amanota cyasabwe na Amerika. Mu 1963, amahame ya mbere ya federasiyo yo mucyumba cya gisirikare cy'icyumba cyiza yatangijwe: FS-209. Icyiciro kimenyerewe 100, icyiciro 10000 na mubyiciro ibipimo 100000 byose biva muriki gipimo. Mu 2001, Amerika yahagaritse gukoresha FS-209E itangazo itangira gukoresha isonga.
(2). ISO
Ibipimo ngenderwaho byatangajwe n'umuryango mpuzamahanga ushinzwe ibipimo ISO kandi bikubiyemo inganda nyinshi, ntabwo ari inganda za farumasi gusa. Hariho urwego icyenda kuva mu cyiciro1 kugeza mu cyiciro cya 9. Muri bo, icyiciro cya 5 gihwanye n'icyiciro b, icyiciro cya 7 gihwanye n'icyiciro C, kandi icyiciro cya 8 gihwanye n'icyiciro D.
(3). Kwemeza urwego rwishuri ahantu hasukuye, icyitegererezo cya buri ngingo yicyitegererezo ntizigomba kuba munsi yumurongo wa Cubic. Urwego rwibice byikirere mubyiciro ahantu hasukuye ni IMA 5, hamwe nibice bihagarikwa ≥51μm nkibipimo ntarengwa. Urwego rwibice byikirere mubyiciro b ahantu hasukuye (static) ni iso 5, kandi bikubiyemo ibice bikoreshwa mubunini bubiri mumeza. Ku cyiciro c ahantu hasukuye (static na dinamic), urwego rwibice byindege ni iso 7 na ISO 8. Kuri School D Uturere dusukuye (static) urwego rwibice byikirere ni iso 8.
(4). When confirming the level, a portable dust particle counter with a shorter sampling tube should be used to prevent ≥5.0μm suspended particles from settling in the long sampling tube of the remote sampling system. Muri sisitemu yo guhuza amakuru, imitwe ya Isokinetic igomba gukoreshwa.
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Icyiciro icyumba gisukuye
Icyiciro Icyumba gisukuye, kizwi kandi nkamasomo 100 Icyumba Cyera cyangwa Icyumba gisukuye, nimwe mubyumba bisukuye hamwe nisuku nyinshi. Irashobora kugenzura umubare wibice kuri cubic ikirenge munsi ya 35.5, ni ukuvuga, umubare wibice birenze cyangwa 0.5um muri buri metero nyinshi zumwuka ntushobora kurenza 3.520 (static na dinatike). Ibyiciro icyumba gisukuye gifite ibyangombwa bikabije kandi bisaba gukoresha muyunguruzi wa Hepa, kugenzura igitutu, uburyo bwo kuzenguruka ikirere no kugereranya ubushyuhe buhoraho no kurwanya ubushyuhe bwo guhora no kuri desidete kugirango tugere ku bisabwa byabo byinshi. Ibyiciro ibyumba bisukuye bikoreshwa cyane muburyo bwa microelecronics, ibinyabuzima, inganda zikoreshwa, aerospace nibindi bice.
Icyiciro B Icyumba gisukuye
Icyiciro B Ibyumba bisukuye nabyo byitwa amasomo 1000 isukuye. Urwego rwabo rwisuku rutandukana, rutuma umubare wibice birenze cyangwa bingana na 0.5um kuri metero Cubic yo kugera kuri 3520 (static) na 352000 (Dynamic). Icyiciro B Ibyumba bisukuye mubisanzwe bikoresha uburyo bwo muyungurura neza hamwe na sisitemu yuzuye kugirango igenzure ubushuhe, ubushyuhe n'imiterere yumuvuduko byabahangano. Icyiciro B Ibyumba bisukuye bikoreshwa cyane muri biobicine, inganda za farumasi, imashini zishingiye ku imashini nigikoresho
Icyiciro c icyumba gisukuye
Icyiciro C Ibyumba bisukuye nabyo byitwa amasomo 10,000. Urwego rwabo rwisuku rutandukanye, rutuma umubare wibice birenze cyangwa bingana na 0.5um kuri metero Cubic kugirango ugere kuri 352.000 (static) na 352.0000 (Dynamic). Icyiciro C Ibyumba bisukuye mubisanzwe bikoresha muyunguruzi wa Hepa, kugenzura ibintu byiza, kuzenguruka ikirere, ubushyuhe nubushuhe n'ubushuhe n'ubundi buhanga bwo kugera ku bipimo byihariye. Icyiciro C Ibyumba bisukuye bikoreshwa cyane muri farumasi, ibikoresho byo gukora ibikoresho byubuvuzi, imashini za elegisine nibikoresho bya elegitoroniki nibice bikora ibice.
Icyiciro D Icyumba Cyuzuye
Icyiciro D Ibyumba bisukuye nabyo byitwa amasomo 100.000 isukuye. Urwego rwabo rwisuku rutandukana, rutuma umubare wibice birenze cyangwa bingana na 0.5um kuri metero Cucy kugirango ugere ku 3,520.000 (static). Icyiciro D Ibyumba D Ubusanzwe Koresha Akayunguruzo ka Hepa hamwe nimbogamizi zibanze zo kugenzura no kuzenguruka ikirere kugirango bigenzure ibidukikije. Icyiciro D Ibyumba D bikoreshwa cyane cyane mu musaruro rusange w'inganda, gutunganya ibiryo no gupakira, gucapa, guhuza no kubika no mu bindi bibanza.
Inzego zitandukanye z'ibyumba bisukuye bifite urugero rwabo bwite, zigomba gutoranywa ukurikije ibikenewe. Mubikorwa bifatika, ibidukikije byibyumba bisukuye ninshingano ikomeye, irimo gutekereza cyane kubintu byinshi. Gusa ibishushanyo mbonera byubumenyi kandi byumvikana birashobora kwemeza ireme kandi ituje ryicyumba cyiza.
Igihe cya nyuma: Werurwe-07-2024