Imba yakachena inzvimbo inodzorwa zvakanyanya umo zvinhu zvakaita sehuwandu hwezvimedu mumhepo, humidity, tembiricha uye static magetsi zvinogona kudzorwa kuti zvizadzise zviyero zvekuchenesa. Makamuri akachena anoshandiswa zvakanyanya mumaindasitiri epamusoro-soro akadai semiconductors, zvemagetsi, zvemishonga, zvendege, aerospace uye biomedicine.
Mumagadzirirwo ekugadzirwa kwemishonga, imba yakachena yakakamurwa kuita 4 mazinga: A, B, C uye D.
Kirasi A: Nzvimbo dzine njodzi yekushanda zvakanyanya, senge nzvimbo dzekuzadza, nzvimbo idzo madhiramu ekumisa erabha uye akavhurika midziyo yekurongedza ari kudhumana neasina kugadzirira, uye nzvimbo dzinoitwa aseptic kana mashandiro ekubatanidza, dzinofanirwa kuve dzakashongedzerwa neunidirectional kuyerera kwetafura yekushandisa. kuchengetedza mamiriro ezvakatipoteredza enzvimbo. Iyo unidirectional flow system inofanirwa kupa mhepo zvakaenzana munzvimbo yayo yekushanda nemhepo velocity ye0.36-0.54m/s. Panofanira kunge paine data kuratidza mamiriro eiyo unidirectional kuyerera uye kusimbiswa. Mune yakavharwa, yakasarudzika opareta kana bhokisi regirovhosi, yakaderera mhepo velocity inogona kushandiswa.
Kirasi B: inoreva nzvimbo yekumashure uko kirasi A nzvimbo yakachena inowanikwa kune yakanyanya-njodzi maoparesheni senge aseptic kugadzirira uye kuzadza.
Kirasi C uye D: nongedzera kunzvimbo dzakachena dzine nhanho dzisina kukosha mukugadzirwa kwemishonga isina hutachiona.
Zvinoenderana nemirairo yeGMP, indasitiri yemishonga yenyika yangu inokamura nzvimbo dzakachena kuita 4 nhanho dzeABCD sepamusoro zvichibva pane zviratidzo zvakaita sekuchena kwemhepo, mhepo yemhepo, huwandu hwemhepo, tembiricha uye humidity, ruzha uye microbial content.
Iwo mazinga enzvimbo dzakachena akakamurwa zvichienderana nekusangana kwezvimedu zvakamiswa mumhepo. Kazhinji kutaura, kudiki kukosha, kunowedzera hutsanana.
1. Kuchena kwemhepo kunoreva hukuru uye nhamba yezvimedu (kusanganisira tupukanana) zviri mumhepo pachiyero chechikamu chenzvimbo, inova chiyero chekusiyanisa kuchena kwenzvimbo.
Static inoreva nyika mushure meiyo yakachena kamuri yekufefetera mhepo yakaiswa uye inoshanda zvizere, uye yakachena mukamuri vashandi vakabvisa saiti uye kuzvichenura kwemaminetsi makumi maviri.
Dynamic inoreva kuti imba yakachena iri mumamiriro ekushanda, michina iri kushanda zvakajairika, uye vashandi vakasarudzwa vari kushanda zvinoenderana nezvinodiwa.
2. Magiredhi eABCD anobva kuGMP yakashambadzirwa neWorld Health Organisation (WHO), inova yakajairika kugadzirwa kwemishonga kutariswa kwemhando yepamusoro muindasitiri yemishonga. Parizvino inoshandiswa mumatunhu mazhinji pasirese, kusanganisira European Union neChina.
ChiChinese chekare vhezheni yeGMP yakatevera zviyero zvekuAmerica (kirasi 100, kirasi 10,000, kirasi 100,000) kusvika pakuitwa kweiyo vhezheni itsva yeGMP zviyero muna 2011. Indasitiri yemishonga yekuChina yakatanga kushandisa zviyero zveWHO uye kushandisa ABCD kusiyanisa mazinga enzvimbo dzakachena.
Mimwe yakachena kamuri yemhando zviyero
Imba yakachena ine akasiyana magiredhi zviyero munzvimbo dzakasiyana uye maindasitiri. Iwo maGMP mazinga akaunzwa kare, uye pano isu tinonyanya kusuma maAmerican zviyero uye ISO zviyero.
(1). American Standard
Pfungwa yekuisa kamuri yakachena yakatanga kutaurwa neUnited States. Muna 1963, yekutanga chiyero chemubatanidzwa chechikamu chemauto chekamuri yakachena chakatangwa: FS-209. Iyo yakajairika kirasi 100, kirasi 10000 uye kirasi 100000 zviyero zvese zvakatorwa kubva pane iyi chiyero. Muna 2001, United States yakamira kushandisa FS-209E standard uye yakatanga kushandisa ISO standard.
(2). ISO zviyero
ISO zviyero zvinokurudzirwa neInternational Organisation for Standardization ISO uye inovhara akawanda maindasitiri, kwete chete indasitiri yemishonga. Pane zvipfumbamwe kubva mukirasi1 kusvika mukirasi 9. Pakati pavo, kirasi 5 yakaenzana nekirasi B, kirasi 7 yakaenzana nekirasi C, uye kirasi 8 yakaenzana nekirasi D.
(3). Kusimbisa mwero weKirasi A nzvimbo yakachena, vhoriyamu yesampling yeimwe sampling poindi haifanire kunge iri pasi pe1 cubic mita. Chiyero chezvimedu zvinofambiswa nemhepo mukirasi A nzvimbo dzakachena iISO 5, ine zvimedu zvakamiswa ≥5.0μm seyero yekugumira. Chiyero chezvimedu zvinofambiswa nemhepo mukirasi B yakachena nzvimbo (static) ndeye ISO 5, uye inosanganisira yakamiswa zvidimbu zvesaizi mbiri patafura. Kunzvimbo dzakachena dzekirasi C (static uye dynamic), mazinga ezvimedu zvemhepo ndeye ISO 7 uye ISO 8 zvakateerana. Kunzvimbo dzakachena dzekirasi D (static) chiyero chezvikamu zvemhepo ndeye ISO 8.
(4). Kana uchisimbisa nhanho, inotakurika huruva particle counter ine ipfupi sampling chubhu inofanirwa kushandiswa kudzivirira ≥5.0μm yakamiswa zvimedu kubva pakugadzika muchubhu refu resampling yeiyo kure sampling system. Mune unidirectional kuyerera masisitimu, isokinetic sampling misoro inofanirwa kushandiswa.
(5) Kuyedzwa kwesimba kunogona kuitwa panguva yemaitiro ekuita uye tsika yepakati inoteedzerwa kuzadza nhanho kuratidza kuti hutsanana hutsanana hunowanikwa, asi tsika yepakati inoteedzerwa yekuzadza bvunzo inoda kuyedza kune simba pasi pe "yakaipisisa mamiriro".
Kirasi A imba yakachena
Kirasi A imba yakachena, inozivikanwawo sekirasi 100 kamuri yakachena kana yekupedzisira-yakachena kamuri, imwe yemakamuri akachena kwazvo ane hutsanana hwepamusoro. Inogona kudzora nhamba yezvikamu pa cubic foot mumhepo kusvika pasi pe 35.5, kureva kuti, nhamba yezvikamu zvakakura kudarika kana zvakaenzana ne 0.5um mune imwe neimwe cubic mita yemhepo haigoni kudarika 3,520 (static uye dynamic). Kirasi Imba yakachena ine zvinodiwa zvakanyanya uye inoda kushandiswa kwehepa mafirita, kusiyanisa kudzvanywa kwekudzora, mhepo inotenderera masisitimu uye inogara tembiricha uye humidity yekudzora masisitimu kuti vazadzikise zvavanoda zvehutsanana. Kirasi A makamuri akachena anonyanya kushandiswa mukugadzira microelectronics, biopharmaceuticals, chaiyo kugadzira chiridzwa, aerospace uye mamwe minda.
Kirasi B imba yakachena
Makamuri akachena eKirasi B anonziwo makamuri akachena ekirasi 1000. Hutsanana hwadzo hwakaderera, zvichiita kuti huwandu hwezvikamu zvakakura kupfuura kana kuenzana ne0.5um pa cubic mita yemhepo kusvika pa3520 (static) uye 352000 (dynamic). Makamuri akachena eKirasi B anowanzo shandisa mafirita epamusoro-soro uye masisitimu ekupedza simba kudzora hunyoro, tembiricha uye kusiyana kwekumanikidza kwenzvimbo yemukati. Makamuri akachena eKirasi B anonyanya kushandiswa mubiomedicine, kugadzira mishonga, machina chaiwo uye kugadzira chiridzwa uye mimwe minda.
Kirasi C imba yakachena
Dzimba dzakachena dzeKirasi C dzinonziwo makamuri ekirasi gumi 000 akachena. Hutsanana hwadzo hwakaderera, zvichibvumira huwandu hwezvikamu zvakakura kupfuura kana kuenzana ne0.5um pa cubic mita yemhepo kusvika 352,000 (static) uye 352,0000 (dynamic). Kirasi C dzakachena makamuri anowanzo shandisa hepa mafirita, yakanaka kudzvanya kudzora, kutenderera kwemhepo, tembiricha uye humidity control uye mamwe matekinoroji kuzadzisa iwo chaiwo hutsanana mwero. Makamuri akachena eKirasi C anonyanya kushandiswa mumishonga, kugadzirwa kwemidziyo yekurapa, muchina chaiwo uye kugadzira zvinhu zvemagetsi nemimwe minda.
Kirasi D yakachena imba
Dzimba dzakachena dzeKirasi D dzinonziwo makamuri akachena ekirasi 100,000. Hutsanana hwadzo hwakaderera, zvichibvumira huwandu hwezvikamu zvakakura kupfuura kana kuenzana ne0.5um pa cubic mita yemhepo kusvika 3,520,000 (static). Kirasi D dzakachena makamuri anowanzo shandisa akajairwa hepa mafirita uye ekutanga akasimba ekudzora kudzvinyirira uye mhepo kutenderera masisitimu kudzora nharaunda yemukati. Kirasi D dzakachena makamuri anonyanya kushandiswa mune zvakajairika kugadzirwa kwemaindasitiri, kugadzira chikafu uye kurongedza, kudhinda, kuchengetera uye mimwe minda.
Matanho akasiyana emakamuri akachena ane chiyero chavo chekushandisa, icho chinofanira kusarudzwa maererano nezvinodiwa chaizvo. Mumashandisirwo anoshanda, kutonga kwezvakatipoteredza kwemakamuri akachena ibasa rakakosha, rinosanganisira kutarisisa kwakadzama kwezvinhu zvakawanda. Chete zvesainzi uye zvine musoro dhizaini nekushanda zvinogona kuve nechokwadi chemhando uye kugadzikana kwenzvimbo yakachena yekamuri.
Nguva yekutumira: Mar-07-2024