Kamuri yakachena inzvimbo inonyanya kudzorwa munzvimbo iyo sehuwandu hwezvinhu zvevakadzvanywa mumhepo, humreity, tembiricha uye magetsi emagetsi anogona kudzorwa kuti awane zviyero zvekuchenesa. Makamuri akachena anoshandiswa zvakanyanya muzvikwata zveTezvina zveTechina senge semiconducanyika, magetsi, mishonga, mishonga, austorme uye bionypace uye bionyicine.
Muchishongedzo chekugadzira manejimendi manejimendi, imba yakachena yakakamurwa kuita mana mazinga: A, B, C uye D.
Kirasi A: Nzvimbo dzine njodzi dzinozadza, dzakadai sekuzadza nzvimbo, nzvimbo dzinovhurika dzimba dzekurongedza zvakarukwa kana mabasa ezvibvumirano anoitwa, anofanirwa kuve akashongedzerwa kuyerera kwekuyerera tafura inoshanda kuchengetedza mamiriro ekunze enzvimbo iyi. Iyo isingaverengeki inoyerera system inofanirwa kugovera mhepo zvakanyanya munzvimbo yayo yekushanda ine Air velocity ye 0.36-0.554m / s. Panofanira kuve ne data rekuratidza mamiriro ekuyerera kwekusavimbika uye ivhu. Mune yakavharwa, yakasarudzika operator kana glove bhokisi, repasi remhepo velocity inogona kushandiswa.
Kirasi B: inoreva nharaunda yekumashure iyo kirasi iyo nzvimbo yakachena nzvimbo inowanikwa kune huwandu hwepamusoro-njodzi dzakadai sekugadzirira kweseptic uye kuzadza.
Kirasi C uye D: Tarisa kune nzvimbo dzakachena nematanho akakosha mukugadzirwa kwezvinhu zvisina kujairika zvigadzirwa.
Sekureva kweGMP Mitemo, nyika yangu yemiindasitiri inokonzeresa nzvimbo dzakachena kuita nzvimbo dzeABCD seyakagadzirwa nemhepo, mhepo, tembiricha uye humrex uye mhepo uye micorhobi.
Mazinga enzvimbo dzakachena dzakakamurwa zvichienderana nekushambidzika kwekumiswa zvimedu mumhepo. Kazhinji kutaura, zvidiki kukosha, iyo yakakwira iyo yekuchenesa chikamu.
1.
Static inoreva mamiriro ezvinhu mushure mekuchenesa kamuri yemhepo mamiriro ekugadzirisa mamiriro akaiswa uye akazara anoshanda, uye akachenuruka emaketi evashandi vakazvinatsa mari yacho uye kuzvinatsa kwemaminetsi makumi maviri.
Dynamic zvinoreva kuti kamuri yakachena iri mune yakajairika yekushanda mamiriro, zvishandiso zviri kushanda zvakajairika, uye vashandi vakasarudzwa vari kushanda maererano nezviri kutaurwa.
2. Izvo zvino zvinoshandiswa mumatunhu mazhinji pasi rese, kusanganisira iyo European Union neChina.
Chinese shanduro yeGMP yakateedzera mari yeAmerican Gradding mazinga enzvimbo dzakachena.
Mamwe Akachena Akachena Kamuri Mari
Kuchenesa kamuri kuve nemitemo yakatarwa yekutakura mumatunhu akasiyana uye maindasitiri. Iyo GMP zviyero zvakambosvitswa kare, uye pano isu tinonyanya kuunza zviyero zveAmerica uye iso zviyero.
(1). American Standard
Pfungwa yeGrading Kamuri Yakachena Yakatangwa Yakatangwa neUnited States. Muna 1963, iyo yekutanga federal mwero wechiuto chikamu chekamuri yakachena yaive yatangwa: FS-209. Kirasi inozivikanwa 100, kirasi 10000 uye kirasi 100000 zviyero zvese zvinotorwa kubva pane izvi chiyero. Muna 2001, United States yakamira kushandisa FS-209E Standard uye yakatanga kushandisa ISOS.
(2). ISO ZVESE
ISO MARI DZINOGONESWA NENYAYA DZESVONDO REMUNYENGETSI YEMAHARA Kune mazinga mapfumbamwe kubva mukirasi1 kuenda kukirasi 9. Pakati pavo, kirasi 5 yakaenzana nekirasi b, kirasi yakaenzana nekirasi c, uye kirasi 8 yakaenzana nekirasi D.
(3). Kuti usimbise mwero wekirasi nzvimbo yakachena, iyo sampling vhoriyamu yeimwe neimwe sampling point haizove isingasviki 1 cubic meter. Chikamu chechikamu chemhepo mukirasi nzvimbo dzakachena dzisitso 5, nezvimisikidzo zvimisikidzwa Chikamu chechikamu chemhepo muClass B yakachena nzvimbo (Static) iso 5, uye inosanganisira zvimisikidzo zveshuwa zviviri patafura. Yekirasi c akachena nzvimbo (static uye dynamic), mazinga emhepo yemhepo Kune kirasi d dzakachena nzvimbo (static) iyo mwero weyeveri wemhepo
(4). Paunenge uchisimbisa mwero, guruva rinotakurika rinopindirana nehuremu hwekusimudzira tube rinofanira kushandiswa kudzivirira Mune zvisina kufanira inoyerera system, isokinetic sampling misoro misoro inofanira kushandiswa.
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Kirasi imba yakachena
Kirasi kamuri yakachena, inozivikanwawo sekirasi 100 kamuri yekuchena kamuri kana imba yakachena-yakachena, ndeimwe yemakamuri akachena ane hukasha hwepamusoro. Inogona kudzora huwandu hwezvikamu pamusuwo mudenga mumhepo kusvika pasi pe 35.5, izvo zvimedu zvevakakura kupfuura kana kuenzana nemamita imwe neimwe haikwanisi kupfuura 3,520 (static uye dynamic). Kirasi imba yakachena ine zvinodiwa kwazvo uye inoda kushandiswa kweHEPA mafirita, kusiyanisa kudzvinyirira kudzora, mhepo inotenderera masisitimu uye tembiricha uye yekunyorovedzera tembiricha kuti uwane yavo yakanyanya kuchena. Kirasi makamuri akachena anonyanya kushandiswa mu microelectronics, biophagemaWeuteals, abecdion kuridzwa kugadzira, kusimba uye mamwe minda.
Kirasi B yakachena kamuri
Kirasi B makamuri akachena anodaidzwawo kirasi 1000 makamuri akachena. Chikamu chavo chechenje chinhambwe chakaderera, uchibvumira nhamba yezvikamu zvakakura kupfuura kana kuenzana ne 0.5um paCubic metres yekuve kusvika 3520 (Static) uye 352000). Kirasi B makamuri akachena anowanzo shandisa zvakakwirira-kushanda mafirita uye masisitimu ekunyanyisa kudzora humidity, tembiricha uye kumanikidza kusiyanisa kwenzvimbo yemukati. Kirasi B makamuri akachena anonyanya kushandiswa muBioMidicine, mishonga yekugadzira inogadzira, uye michina yekugadzira uye mamwe minda.
Kirasi c yakachena kamuri
Kirasi C makamuri akachena anodawo kunzi kirasi zviuru gumi zvemakamuri akachena. Chikamu chavo chechenje chinhambwe chakaderera, uchibvumira nhamba yezvikamu zvakakura kupfuura kana kuenzana ne 0.5um pa cubic metres yekukwana kusvika ku350,000) uye 352,0000 (Dynamic). Kirasi c makamuri akachena anowanzo shandisa HEPA mafirita, zvakanaka kumanikidza kudzora, kutenderera kwemhepo, kupisa uye humwe hutongi kuti uwane zviyero zvavo zvekuchena. Kirasi
Kirasi D Kuchenesa Kamuri
Kirasi D Makamuri Akachena Anodawo kunzi kirasi 100,000 makamuri akachena. Chikamu chavo chechenje chinhambwe chakaderera, kubvumira huwandu hwezvikamu zvakakura kupfuura kana zvakaenzana ne 0.5um pa cubic metres kusvika 3,520,000 (static). Kirasi D Makamuri Akachena anowanzo shandisa zvakajairika Hapa mafirita uye ekutanga ekumanikidza kudzora kudzora uye kutenderera masisitimu ekudzora mamiriro emukati ekudzora nharaunda dzemuguta. Kirasi D Makamuri Akachena Anonyanya Kushandiswa Muzana Mugreen kugadzirwa kwemaindasitiri, chikafu chekudya uye kurongedza, kudhinda, kuchengetedzwa uye mamwe minda.
Mazinga akasiyana emakamuri akachena ane yavo chiyero chekushandisa, izvo zvinofanirwa kusarudzwa zvinoenderana nezvinodiwa chaizvo. Mune zvinoshandiswa zvinoshanda, kudzora kwezvakatipoteredza kwekamuri rakachena ibasa rakakosha, rinosanganisira kutarisisa kwekufunga kwezvinhu zvakawanda. Chete chesainzi uye chine musoro dhizaini uye mashandiro anogona kuve nechokwadi kuti hunhu uye kugadzikana kwenzvimbo yakachena yemumakamuri.
Kutumira Nguva: Mar-07-2024