Zvivako zvekuvaka
1. Madziro emakamuri akachena eGMP nemapanera edenga anowanzo gadzirwa nemapanera esandwich ane ukobvu hwe50mm, ayo ane chitarisiko chakanaka uye kuomarara kwakasimba. Makona eArc, magonhi, mafuremu emahwindo, nezvimwewo zvinowanzo gadzirwa nemaprofiles ealumina akakosha.
2. Pasi rinogona kugadzirwa nepasi rinozvienzanisa ne epoxy kana pasi repurasitiki rinodzivirira kupwanyika. Kana paine zvinodiwa zve anti-static, mhando ye anti-static inogona kusarudzwa.
3. Mapaipi emhepo neanodzosa mweya akagadzirwa nemapepa ezinc akabatana nekupisa uye akabatanidzwa nemapepa epurasitiki ePF foam anodzivirira moto ane kuchenesa kwakanaka uye kudzivirira kupisa.
4. Bhokisi rehepa rakagadzirwa nefuremu yesimbi yakaputirwa nehupfu, iyo yakanaka uye yakachena. Pureti yemesh yakaboorwa yakagadzirwa neplate yearuminiyamu yakapendwa, isingaori kana kunamira muguruva uye inofanira kucheneswa.
GMP clean room parameters
1. Nhamba yemhepo inofefetera: kirasi 100000 ≥ ka15; kirasi 10000 ≥ ka20; kirasi 1000 ≥ ka30.
2. Musiyano wekumanikidzwa: workshop huru nekamuri riri pedyo ≥ 5Pa
3. Avhareji yekumhanya kwemhepo: 0.3-0.5m/s pakirasi 10 uye kirasi 100 imba yakachena;
4. Tembiricha: >16℃ muchando; <26℃ muzhizha; kushanduka-shanduka ±2℃.
5. Hunyoro 45-65%; hunyoro mukamuri rakachena reGMP hunonyanya kudiwa hunenge 50%; hunyoro mukamuri rakachena remagetsi hwakakwira zvishoma kudzivirira kugadzirwa kwemagetsi asingachinji.
6. Ruzha ≤ 65dB (A); huwandu hwekuwedzera kwemhepo itsva i10%-30% yehuwandu hwese hwemhepo inopihwa; kupenya 300 Lux
Mitemo yekutarisira hutano
1. Kuti zvisapararire mukamuri rakachena reGMP, zvishandiso zvekamuri rakachena zvinofanirwa kutsaurirwa zvichienderana nehunhu hwechigadzirwa, zvinodiwa pakushanda, uye mwero wekuchena kwemhepo. Marara anofanira kuiswa mumabhegi eguruva oendeswa kunze.
2. Kuchenesa imba yakachena yeGMP kunofanira kuitwa usati waenda kubasa uye mushure mekunge basa rekugadzira rapera; kuchenesa kunofanira kuitwa apo sisitimu yemhepo inotonhodza imba yakachena iri kushanda; mushure mekunge basa rekuchenesa rapera, sisitimu yekuchenesa mhepo inotonhodza inofanira kuramba ichishanda kusvika huwandu hwekuchenesa hwataurwa hwadzorerwa. Nguva yekutanga kushanda kazhinji haisi pfupi pane nguva yekuzvichenesa yega yeimba yakachena yeGMP.
3. Mishonga inouraya utachiona inoshandiswa inofanira kutsiviwa nguva nenguva kudzivirira utachiona kuti husarambe nemishonga. Kana zvinhu zvikuru zvikaiswa mukamuri rakachena, zvinofanirwa kutanga zvacheneswa nemuchina wekuchenesa munzvimbo yakajairika, uye zvobva zvabvumirwa kupinda mukamuri rakachena kuti zviongororwezve nemuchina wekuchenesa mukamuri wakachena kana nzira yekupukuta;
4. Kana sisitimu yeGMP clean room isiri kushanda, zvinhu zvikuru hazvitenderwe kutamiswa mu clean room.
5. Kamuri rakachena reGMP rinofanira kucheneswa nemishonga inouraya utachiona uye kucheneswa, uye kucheneswa nemishonga inouraya utachiona nekupisa kwakaoma, kucheneswa nemishonga inouraya utachiona nekupisa kwakanyorova, kucheneswa nemwaranzi, kucheneswa negesi, uye kucheneswa nemishonga inouraya utachiona zvinogona kushandiswa.
6. Kuchenesa nemwaranzi kwakakodzera zvakanyanya kuchenesa zvinhu kana zvigadzirwa zvinonzwa kupisa, asi zvinofanirwa kuratidzwa kuti mwaranzi haina njodzi kuchinhu ichi.
7. Kuuraya utachiona nemwaranzi yeUltraviolet kune simba rekuuraya utachiona, asi pane matambudziko akawanda panguva yekushandiswa. Zvinhu zvakawanda zvakaita sekusimba, kuchena, hunyoro hwezvakatipoteredza uye daro remwenje weultraviolet zvinokanganisa simba rekuuraya utachiona. Pamusoro pezvo, simba rayo rekuuraya utachiona harisi rakakwirira uye harina kukodzera. Nezvikonzero izvi, kuuraya utachiona neultraviolet hakugamuchirwi neGMP yekunze nekuda kwenzvimbo inofambiswa nevanhu uye kune mhepo inoyerera.
8. Kuchenesa ultraviolet kunoda kuvhenekerwa kwenguva refu kwezvinhu zvakaratidzwa. Pakuvhenekerwa mukati meimba, kana chiyero chekuvhenekerwa chichifanira kusvika 99%, chiyero chekuvhenekerwa kwemabhakitiriya akajairika chingangoita 10000-30000uw.S/cm. Mwenje we ultraviolet we 15W uri 2m kubva pasi une simba rekuvhenekerwa kweinenge 8uw/cm, uye unofanirwa kuvhenekerwa kweinenge awa imwe. Mukati meawa imwe chete iyi, nzvimbo yakavhenekerwa haigone kupindwa, zvikasadaro ichakuvadzawo masero eganda revanhu nemhedzisiro inooneka yekenza.
Nguva yekutumira: Mbudzi-16-2023