Download - Clean Room AS PER THE FDA
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Clean RoomClean Room
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Cleanroom Air Flow Principles
Air flow pattern for Turbulent Clean room
Air flow pattern for Laminar Flow Clean room
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Clean room Classifications
Clean rooms are classified according to the number and size of particles permitted per volume of air.
Ordinary room air is approximately class 1,000,000 or ISO 9
For example, an ISO class 5 clean room has at most 100,000 particles per m³
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US FED STD 209E Clean Room StandardsUS FED STD 209E Clean Room Standards
Class
maximum particles/ft³ISO
equivalent≥0.1 µm ≥0.2 µm ≥0.3 µm ≥0.5 µm ≥5 µm
1 35 7 3 1 ISO 3
10 350 75 30 10 ISO 4
100 750 300 100 ISO 5
1,000 1,000 7 ISO 6
10,000 10,000 70 ISO 7
100,000 100,000 700 ISO 8
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ISO 14644-1 clean room standards
Class
maximum particles/m³FED STD 209E
equivalent≥0.1 µm ≥0.2 µm ≥0.3 µm ≥0.5 µm ≥1 µm ≥5 µm
ISO 1 10 2
ISO 2 100 24 10 4
ISO 3 1,000 237 102 35 8 Class 1
ISO 4 10,000 2,370 1,020 352 83 Class 10
ISO 5 100,000 23,700 10,200 3,520 832 29 Class 100
ISO 6 1,000,000 237,000 102,000 35,200 8,320 293 Class 1000
ISO 7 352,000 83,200 2,930 Class 10,000
ISO 8 3,520,000 832,000 29,300 Class 100,000
ISO 9 35,200,000 8,320,000 293,000 Room air
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BS 5295 clean room standards
maximum particles/m³
Class ≥0.5 µm ≥1 µm ≥5 µm ≥10 µm ≥25 µm
Class 1 3,000
Class 2 300,000 2,000 30
Class 3 1,000,000 20,000 4,000 300
Class 4 200,000 40,000 4,000
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