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NDEZVIPI ZVIRI MUKATI ZVINOsanganisirwa muGMP CLEAN ROOM STANDARDS?

imba yakachena
gmp imba yakachena

Zvinhu zvekugadzira

1. GMP yakachena kamuri madziro uye sirin'i mapaneru anowanzo gadzirwa ne50mm gobvu masangweji mapaneru, ayo anoratidzirwa nekutaridzika kwakanaka uye kusimba kwakasimba. Arc makona, magonhi, mafaremu emahwindo, nezvimwe zvinowanzogadzirwa neakakosha alumina profiles.

2. Ivhu rinogona kugadzirwa ne epoxy self-leveling floor kana high-grade kupfeka-resistant plastic floor. Kana paine anti-static zvinodiwa, anti-static mhando inogona kusarudzwa.

3. Mhepo yemhepo uye mabheti ekudzoka anogadzirwa ne thermally bonded zinc sheets uye anonamirwa neflame-retardant PF foam plastiki mapepa ane kucheneswa kwakanaka uye kupisa kwemafuta.

4. Bhokisi rehepa rakagadzirwa nehupfu yakavharidzirwa simbi furemu, iyo yakanaka uye yakachena. Iyo punched mesh plate inogadzirwa nependi yealuminium ndiro, isingaite ngura kana kunamatira kuguruva uye inofanira kucheneswa.

GMP yakachena kamuri paramita

1. Nhamba yeventilations: kirasi 100000 ≥ 15 nguva; kirasi 10000 ≥ 20 nguva; kirasi 1000 ≥ 30 nguva.

2. Musiyano wekumanikidzwa: musangano mukuru kune kamuri yakatarisana ≥ 5Pa

3. Avhareji yemhepo yemhepo: 0.3-0.5m / s pakirasi 10 uye kirasi 100 imba yakachena;

4. Tembiricha: > 16 ℃ muchando; <26℃ muzhizha; kushanduka ±2℃.

5. Humidity 45-65%; iyo humidity muGMP yakachena kamuri inofarira kutenderedza 50%; humidity mukamuri yakachena yemagetsi yakakwira zvishoma kudzivirira kugadzirwa kwemagetsi akamira.

6. Noise ≤ 65dB (A); mweya mutsva wekuwedzera huwandu i10% -30% yehuwandu hwehuwandu hwekupa mweya; kuvhenekera 300 Lux

Utano hwekutarisira mitemo

1. Kuti udzivise kusvibiswa kwemuchinjika muGMP yakachena kamuri, maturusi ekamuri yakachena anofanirwa kutsaurirwa zvinoenderana nemaitiro echigadzirwa, zvinodiwa maitiro, uye mazinga ehutsanana hwemhepo. Marara anofanira kuiswa mumasaga eguruva uye obudiswa kunze.

2. Kucheneswa kwekamuri yeGMP yakachena kunofanirwa kuitwa usati waenda uye mushure mekuita basa rekugadzira; kuchenesa kunofanira kuitwa apo iyo air conditioning system yekamuri yakachena iri kushanda; mushure mekunge basa rekuchenesa rapera, iyo yekucheneswa air conditioning system inofanirwa kuramba ichishanda kusvika iyo yakatsanangurwa yehutsanana nhanho yadzorerwa. Iyo yekutanga-up yekuvhiya nguva kazhinji haina kupfupika pane yekuzvichenesa nguva yeGMP yakachena kamuri.

3. Mishonga inouraya utachiona hunoshandiswa inofanira kuchinjwa nguva nenguva kudzivirira utachiona kubva pakusaita zvinodhaka. Kana zvinhu zvihombe zvichiendeswa mukamuri rakachena, zvinofanirwa kucheneswa pakutanga nemuchina wekutsvaira munzvimbo yakajairika, uye wozobvumidzwa kupinda mukamuri rakachena kuti uwedzere kurapwa nekamuri yakachena yekutsvaira kana nzira yekupukuta;

4. Kana GMP yakachena kamuri system isiri kushanda, zvinhu zvakakura hazvibvumidzwe kutamirwa muimba yakachena.

5. GMP yakachena kamuri inofanira kuuraya utachiona uye sterilized, uye yakaoma kupisa sterilization, unyoro kupisa sterilization, mwaranzi sterilization, gasi kuuraya, uye disinfectant disinfection zvinogona kushandiswa.

6. Radiation sterilization inonyanya kukodzera kugadzirwa kwezvinhu zvinopisa zvinopisa kana zvigadzirwa, asi zvinofanirwa kuratidzwa kuti mwaranzi haina njodzi kune chigadzirwa.

7. Ultraviolet radiation disinfection ine imwe bactericidal effect, asi kune matambudziko akawanda panguva yekushandiswa. Zvakawanda zvinhu zvakaita sekusimba, kuchena, humidity kwezvakatipoteredza uye kureba kwemwenje we ultraviolet zvinokanganisa disinfection maitiro. Mukuwedzera, iyo disinfection effect haina kukwirira uye haina kukodzera. Nokuda kwezvikonzero izvi, ultraviolet disinfection haigamuchirwi neGMP yekunze nekuda kwenzvimbo iyo vanhu vanofamba uye kune kuyerera kwemhepo.

8. Ultraviolet sterilization inoda nguva refu irradiation yezvinhu zviri pachena. Pakuvheneka kwemukati, kana chiyero chesterilization chichidikanwa kuti chisvike 99%, iyo irradiation dose ye general bacteria inenge 10000-30000uw.S/cm. Rambi re 15W ultraviolet 2m kure nepasi rine simba rekuvheneka ringangoita 8uw/cm, uye rinoda kuvhenekerwa kweinenge awa. Mukati iyi 1 awa, nzvimbo ine irradiated haigoni kupinda, kana zvisina kudaro ichakuvadzawo masero eganda evanhu ane pachena carcinogenic effect.


Nguva yekutumira: Nov-16-2023
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