V. Bougatsos SA is specialized in cleanroom design, construction and validation. We also hold international certification in cleanrooms from Cleanrooms Testing and Certification Board - international.
We construct cleanrooms for pharmaceutical applications (GRADE A,B,C,D), for electronic applications (ISO 3 - ISO 8), for aseptic food packaging (ISO5) or for medical or micro devices manufacturing.
Using best quality materials and high efficiency HVAC equipment V. Bougatsos SA cleanrooms successfully achieve desired cleanliness classification and meet current Good Manufacturing Practices cGMP requirements.
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Cleanrooms Cleanliness Classification |
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Maximum concentration limits (particles/m3 of air) for particles equal to and larger than the considered sizes below |
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ISO 14644-1 Class (N) |
0.1 μm |
0.2 μm |
0.3 μm |
0.5 μm |
1 μm |
5 μm |
FED STD 20E |
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| GMP |
English |
SI |
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Class 1 |
10 |
2 |
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Class 2 |
100 |
24 |
10 |
4 |
|
|
|
|
|
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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 |
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Class 6 |
- |
1.000.000 |
237.000 |
102.000 |
35.200 |
8.320 |
293 |
1.000 |
M4.5 |
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Class 7 |
C |
|
|
|
325.000 |
83.200 |
2.930 |
10.000 |
M5.5 |
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Class 8 |
D |
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|
|
3.520.000 |
832.000 |
29.300 |
100.000 |
M6.5 |
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Class 9 |
|
|
|
35.200.000 |
8.320.000 |
293.000 |
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