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Clean Room AS PER THE FDA .....

Date post: 08-Nov-2014
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FDA FACILITY DESIGN AND AIR QUALITY STANDARDS
15
Clean Room Clean Room
Transcript
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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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