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  Helapet › Cleanroom Classifications

Cleanroom Classifications

ISO Class 5
(Class A/B, US-Class 100)
  • Sterile preparation - aseptic production
  • Media fill and transfer
ISO Class 6
(US-Class 1 000)
  • Sterile preparation - aseptic production
  • Background of class A
ISO Class 7
(Class C, US-Class 10 000)
  • Preparation of media before filtration
  • Media fill before sterilsation
ISO Class 8
(Class D, US-Class 100 000)
  • Preparation of products before endsterilsation
  • Handling of ingredients after cleaning process
  • Background of isolators
if needed slide table left for more...

Number of Particles per Cubic Metre

  Class 0.1micron 0.2micron 0.3micron 0.5micron 1micron 5micron
 ISO 1 10 2        
 ISO 2 100 24 10 4    
 ISO 3 1 000 237 102 35 8  
 ISO 4 10 000 2 370 1 020 352 83  
 ISO 5 100 000 23 700 10 200 3 520 832 29
 ISO 6 1 000 000 237 000 102 000 35 200 8 320 293
 ISO 7       352 000 83 200 2 930
 ISO 8       3 520 000 832 000 29 300
 ISO 9       35 200 000 8 320 000 293 000
Class 5 is expected to be free of particles >5micron acc. Annex 1 point 3 more strict than ISO 14644

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