Kamuri rakachena inzvimbo inodzorwa zvakanyanya umo zvinhu zvakaita sehuwandu hwezvidimbu zviri mumhepo, hunyoro, tembiricha uye magetsi asingachinji zvinogona kudzorwa kuti pave nezvinodiwa zvekuchenesa. Makamuri akachena anoshandiswa zvakanyanya mumaindasitiri epamusoro-soro akadai sema semiconductors, electronics, pharmaceuticals, aviation, aerospace uye biomedicine.
Mumitemo yekugadzirwa kwemishonga, nzvimbo yakachena yakakamurwa kuita mazinga mana: A, B, C naD.
Kirasi A: Nzvimbo dzekushanda dzine njodzi huru, dzakadai senzvimbo dzekuzadza, nzvimbo dzine mabara erabha uye midziyo yekurongedza yakavhurika inosangana zvakananga nezvigadzirwa zvisina utachiona, uye nzvimbo dzinoitirwa kuungana kweaseptic kana mabasa ekubatanidza, dzinofanira kunge dzakashongedzerwa netafura yekushanda yekuyerera kwemhepo inoenderana nedivi rimwe chete kuti ichengetedze mamiriro enzvimbo yacho. Sisitimu yekuyerera kwemhepo inoenderana nedivi rimwe chete inofanira kupa mhepo zvakaenzana munzvimbo yayo yekushanda nekumhanya kwemhepo kwe0.36-0.54m/s. Panofanira kunge paine data rekuratidza mamiriro ekuyerera kwemhepo inoenderana nedivi rimwe chete uye kusimbiswa. Mubhokisi remushandisi rakavharwa, rakaparadzana kana remagirovhosi, kumhanya kwemhepo kwakaderera kunogona kushandiswa.
Kirasi B: zvinoreva nzvimbo yekumashure uko nzvimbo yakachena yekirasi A inowanikwa kuitira mabasa ane njodzi huru akadai sekugadzirira nekuzadza mvura isina utachiona.
Kirasi C naD: zvinoreva nzvimbo dzakachena dzisina matanho akakosha pakugadzira mishonga isina utachiona.
Zvichienderana nemitemo yeGMP, indasitiri yemishonga yenyika yangu inokamura nzvimbo dzakachena kuita mazinga mana eABCD sezvataurwa pamusoro apa zvichibva pane zviratidzo zvakaita sekuchena kwemhepo, kumanikidzwa kwemhepo, huwandu hwemhepo, tembiricha nehunyoro, ruzha uye huwandu hwehutachiona.
Mazinga enzvimbo dzakachena anokamurwa zvichienderana nehuwandu hwezvinhu zvakasungirirwa mumhepo. Kazhinji, kukosha kwacho kudiki, kuchena kwacho kunowedzera.
1. Kuchena kwemhepo zvinoreva saizi nehuwandu hwezvidimbu (kusanganisira tupukanana) zviri mumhepo pahuwandu hwenzvimbo, inova ndiyo chiyero chekusiyanisa mwero wekuchena kwenzvimbo.
Izwi rekuti Static rinoreva mamiriro ezvinhu mushure mekunge sisitimu yekutonhodza yemukamuri yakachena yaiswa uye yashanda zvizere, uye vashandi vemukamuri yakachena vabuda panzvimbo yacho vozvichenesa kwemaminitsi makumi maviri.
Kuchinja-chinja zvinoreva kuti imba yakachena iri mumamiriro akajairika ekushanda, michina iri kushanda zvakanaka, uye vashandi vakasarudzwa vari kushanda zvinoenderana nezvinodiwa.
2. Muyero weABCD wekuyera unobva kuGMP yakaburitswa neWorld Health Organization (WHO), inova ndiyo nzira inowanzo shandiswa pakugadzirisa mhando dzemishonga muindasitiri yemishonga. Parizvino inoshandiswa munzvimbo zhinji pasi rose, kusanganisira European Union neChina.
Shanduro yekare yeGMP yekuChina yakatevera mwero wekuAmerica wekupa mamakisi (kirasi 100, kirasi 10,000, kirasi 100,000) kusvika pakatanga kushandiswa mwero mutsva weGMP muna 2011. Indasitiri yemishonga yekuChina yakatanga kushandisa mwero wekupatsanura weWHO uye inoshandisa ABCD kusiyanisa mwero wenzvimbo dzakachena.
Mimwe mitemo yekupatsanura makamuri akachena
Makamuri akachena ane mwero wakasiyana wekuyera munzvimbo dzakasiyana nemaindasitiri. Mwero weGMP wakambotangwa kare, uye pano tinonyanya kuunza mwero weAmerica nemwero weISO.
(1). American Standard
Pfungwa yekuyera clean room yakatanga kukurudzirwa neUnited States. Muna 1963, mwero wekutanga wehurumende wechikamu chemauto checlean room wakatangwa: FS-209. Mwero wekirasi 100, kirasi 10000 uye kirasi 100000 zvese zvinobva pamwero uyu. Muna 2001, United States yakarega kushandisa mwero weFS-209E ndokutanga kushandisa mwero weISO.
(2). Mipimo yeISO
Mitemo yeISO yakakurudzirwa neInternational Organisation for Standardization ISO uye inosanganisira maindasitiri akawanda, kwete indasitiri yemishonga chete. Kune mazinga mapfumbamwe kubva mukirasi 1 kusvika mukirasi 9. Pakati pawo, kirasi 5 yakaenzana nekirasi B, kirasi 7 yakaenzana nekirasi C, uye kirasi 8 yakaenzana nekirasi D.
(3). Kuti zvisimbiswe kuti nzvimbo yakachena yeClass A yakaenzana, huwandu hwesampuli hwenzvimbo yega yega yekuyedza haifanirwe kunge iri pasi pe1 cubic meter. Huremu hwezvinhu zviri mumhepo munzvimbo dzakachena dzeclass A iISO 5, nezvikamu zvakasungirirwa ≥5.0μm semuganho wepakati. Huremu hwezvinhu zviri mumhepo munzvimbo yakachena yeclass B (static) iISO 5, uye hunosanganisira zvikamu zvakasungirirwa zvehukuru huviri patafura. Kune nzvimbo dzakachena dzeclass C (static ne dynamic), huwandu hwezvinhu zviri mumhepo iISO 7 neISO 8 zvakateerana. Kune nzvimbo dzakachena dzeclass D (static) huwandu hwezvinhu zviri mumhepo iISO 8.
(4). Pakusimbisa mwero, chirauro cheguruva chinotakurika chine chubhu pfupi yesampuro chinofanira kushandiswa kudzivirira kuti ≥5.0μm zvidimbu zvakamiswa zvisagare muchubhu refu yesampuro yesystem yesampuro iri kure. Munzira imwe chete, misoro yesampuro yeisokinetic inofanira kushandiswa.
(5) Kuedza kwakasimba kunogona kuitwa panguva yekushanda kwenguva dzose uye panguva yekuzadza zvinhu nenzira yekufananidzira kuratidza kuti hutsanana hwakasimba hunowanikwa, asi bvunzo yekuzadza zvinhu nenzira yekufananidzira inoda bvunzo "dzakanyanya kuipa".
Kamuri rakachena reKirasi A
Kamuri reKirasi A rakachena, iro rinozivikanwawo sekamuri re100 rakachena kana kuti kamuri rakachena zvakanyanya, ndeimwe yemakamuri akachena zvikuru ane hutsanana hwakanyanya. Rinogona kudzora huwandu hwezvidimbu pa cubic foot mumhepo kusvika pasi pe35.5, kureva kuti, huwandu hwezvidimbu zvakakura kupfuura kana zvakaenzana ne0.5um mu cubic meter yega yega yemhepo hahugone kudarika 3,520 (static uye dynamic). Kamuri reKirasi A rakachena rine zvinodiwa zvakasimba uye rinoda kushandiswa kwemafirita ehepa, differential pressure control, air circulation systems uye constant tembiricha uye hunyoro control systems kuti zvizadzise zvinodiwa zvavo zvekuchena kwakanyanya. Kamuri reKirasi A rakachena rinonyanya kushandiswa mu microelectronics processing, biopharmaceuticals, precision instrument manufacturing, aerospace nedzimwe nzvimbo.
Kamuri rakachena reKirasi B
Makamuri eClass B akachena anonziwo makamuri eClass 1000 akachena. Hutsanana hwavo hwakaderera, zvichiita kuti huwandu hwezvinhu zvakakura kupfuura kana zvakaenzana ne0.5um pa cubic meter yemhepo husvike 3520 (static) uye 352000 (dynamic). Makamuri eClass B akachena anowanzo shandisa mafirita anoshanda zvakanyanya uye masisitimu ekubudisa hunyoro kudzora musiyano wehunyoro, tembiricha uye kumanikidzwa kwenzvimbo yemukati. Makamuri eClass B akachena anonyanya kushandiswa mukurapa kwemishonga, kugadzira mishonga, michina chaiyo uye kugadzira zvishandiso nezvimwewo.
Kamuri rekuchenesa reClass C
Makamuri akachena eClass C anonziwo makamuri akachena eClass 10,000. Hutsanana hwavo hwakaderera, zvichiita kuti huwandu hwezvinhu zvakakura kupfuura kana zvakaenzana ne0.5um pa cubic meter yemhepo husvike 352,000 (static) uye 352,0000 (dynamic). Makamuri akachena eClass C anowanzo shandisa mafirita ehepa, kudzora kumanikidzwa kwakanaka, kutenderera kwemhepo, kudzora tembiricha nehunyoro nedzimwe tekinoroji kuti awane mwero wekuchena kwawo chaiwo. Makamuri akachena eClass C anonyanya kushandiswa mumishonga, kugadzira zvishandiso zvekurapa, michina chaiyo uye kugadzira zvikamu zvemagetsi nedzimwe nzvimbo.
Kamuri rekuchenesa reKirasi D
Makamuri eClass D akachena anonziwo makamuri eClass 100,000 akachena. Hutsanana hwavo hwakaderera, zvichiita kuti huwandu hwezvinhu zvakakura kupfuura kana zvakaenzana ne0.5um pa cubic meter yemhepo husvike 3,520,000 (static). Makamuri eClass D akachena anowanzo shandisa mafirita ehepa akajairwa uye masisitimu ekudzora kumanikidzwa kwakanaka uye kutenderera kwemhepo kudzora nharaunda yemukati. Makamuri eClass D akachena anonyanya kushandiswa mukugadzira maindasitiri, kugadzira chikafu nekurongedza, kudhinda, kuchengetedza zvinhu nezvimwe.
Matanho akasiyana emakamuri akachena ane mashandisirwo awo, ayo anofanira kusarudzwa zvichienderana nezvinodiwa chaizvo. Mukushandiswa kunoshanda, kudzora nharaunda yemakamuri akachena ibasa rakakosha zvikuru, rinosanganisira kufunga zvakawanda. Dhizaini nekushanda kwesainzi uye zvine musoro chete ndizvo zvinogona kuve nechokwadi chekuti nharaunda yakachena yemakamuri yakasununguka ine mhando uye kugadzikana.
Nguva yekutumira: Kurume-07-2024