Puhaste ruumide nõuded on toodud standardis EVS-EN ISO 14644- 1-8:2000-2008

Standard koosneb 8 osast:

  1. Cleanrooms and associated controlled environments - Part 1: Classification of airborne particulate cleanliness for cleanrooms and clean zones
  2. Cleanrooms and associated controlled environments - Part 2: Specifications for testing and monitoring to prove continued compliance with ISO14644-1
  3. Cleanrooms and associated controlled environments - Part 3: Test methods
  4. Cleanrooms and associated controlled environments - Part 4: Design, help construction and start-up
  5. Cleanrooms and associated controlled environments - Part 5: Operations
  6. Cleanrooms and associated controlled environments - Part 6: Vocabulary
  7. Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, order gloveboxes, isolators and mini environments
  8. Cleanrooms and associated controlled environments - Part 8: Classification of airborne molecular contamination

Puhtaruumi klassifikatsioon

ISO 14644-1 järgi US FED STD 209E järgi GMP EU järgi* Maksimaalselt lubatud osakeste arv /m2
0,1µm 0,2µm 0,3µm 0,5µm 1,0µm 5,0µm
Klass 1 10 2
Klass 2 0 100 24 10 4
Klass 3 1 1 000 237 102 35 8
Klass 4 10 10 000 2 370 1 020 352 83
Klass 5 100 A/B 100 000 23 700 10 200 3 520 832 29
Klass 6 1 000 B/C 1 000 000 237 000 102 000 35 200 8 320 293
Klass 7 10 000 C/D 352 000 83 200 2 930
Klass 8 100 000 D 3 520 000 832 000 29 300
  • GMP EU ja ISO14644 ei ole üheselt võrreldavad. GMP mõõdab osakesi suurusega 0,5µm ja 5,0µm
Puhasruum ISO4 ISO5 ISO6 ISO7 ISO8
Filtritega kaetud ala % 90-100 50-70 20-30 7-15 4-5
Filtri efektiivsus 99,9997
ULPA
99,997
HEPA
99,997
HEPA
99,997
HEPA
99,97
HEPA

 

 Pakutavad tooted:

  1. Puhasteruumide kavandamine ja ehitamine ISO ja GMP järgi
  2. Puhtaruumi automaatika (osakeste loendajad, terviklahendused)
  3. Puhasteruumide valgustid
  4. Puhasteruumide FFU-d
  5. Puhasteruumide staatilised ja dünaamilised materjalilüüsid
  6. Õhulüüsid ja õhudushid