clean room as per the fda

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FDA FACILITY DESIGN AND AIR QUALITY STANDARDS

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Page 1: Clean Room AS PER THE FDA

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

Page 7: Clean Room AS PER THE FDA

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

Page 8: Clean Room AS PER THE FDA

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

Page 9: Clean Room AS PER THE FDA

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

Page 10: Clean Room AS PER THE FDA

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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