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Cleanrooms

 

Frigomech undertakes cleanroom design, construction and validation for pharmaceutical manufacturing, medical devices, electronics,

food manufacturing and other special processes which require contamination controlled environments.

Using best quality materials and high efficiency HVAC equipment Frigomech cleanrooms successfully achieve desired

cleanliness classification and meet current Good Manufacturing Practices cGMP requirements.

Cleanrooms Cleanliness Classification

Maximum concentration limits (particles/m3 of air) for particles equal to and larger than the considered sizes below

ISO 14644-1 Class (N)

 

0.1 μm

0.2 μm

0.3 μm

0.5 μm

1 μm

5 μm

FED STD 20E

GMP

English

SI

Class 1

 

10

2

 

 

 

 

 

 

Class 2

 

100

24

10

4

 

 

 

 

Class 3

 

1.000

237

102

35

8

 

1

M1.5

Class 4

 

10.000

2.370

1.020

352

83

 

10

M2.5

Class 5

A/ B

100.000

23.700

10.200

3.520

832

29

100

M3.5

Class 6

-

1.000.000

237.000

102.000

35.200

8.320

293

1.000

M4.5

Class 7

C

 

 

 

325.000

83.200

2.930

10.000

M5.5

Class 8

D

 

 

 

3.520.000

832.000

29.300

100.000

M6.5

Class 9

 

 

 

 

35.200.000

8.320.000

293.000

 

 



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