Clean Room Standards

US Federal Standard 209D

(1988)

Parameters

Class 100000

Particals / m3 (Ft3)

WHO

Class M6.5

Grade K

Class ISO 8

Grade D

Class 100000

Grade D

3500000/m3

3520000/m3

3500000/m3

3520000/m3

3500000/m3

700/ft3

24700/m3 (700/ft3)

2000/m3

29300/m3

20000/m3

29300/m3

20000/m3

20

20

20 - 48

20 - 48

20

NS

NLT 20

0.005 - 0.041 m/s

(1 - 8 ft/min)

Contact plates
(55mm)
cfu/plate
Glove print
5 fingers cfu/glove

Differential pressure
Clean air inlets cover as % of ceeling
area
inlets location
Filter location
return location
Velocity at clean air inlet
velocity at clean air return
Air lock
Area per occupant (m2)
Equipment in room
Room hight
recovery
cfm/person
Prefilters effciencies
HEPA eff
door size
filter preassure droop
Particle count test
Air pressure difference

Noise

ISPE

100000/ft3

Air sampler cfu/m3

Settle plates (90mm)
cfu/4hours

NS - Not specified

EU GGMP

5m

Differential pressure

Ceiling coverage ( Percentage)

BS EN ISO Standard

0.5m

Avarage air flow velocity

Ttest Parameters max.time interval

British Standard 5295:1989

3530000/m3
(100000/ft3)

Air changes

Limits for Microbial contamination

US Federal Standard 209E (1992)

Air flow
Installed filter leakage
Air flow visualization
Recovery
Containment Leak test

0.005 - 0.041 m/s

(1 - 8 ft/min)

0.005 - 0.041 m/s

(1 - 8 ft/min)

0.005 - 0.041 m/s

(1 - 8 ft/min)

0.005 - 0.041 m/s

(1 - 8 ft/min)

0.005 - 0.041 m/s

(1 - 8 ft/min)

0.005 - 0.041 m/s

(1 - 8 ft/min)

5 to 15 pascal
NS

5 to 15 pascal
100

NS
NS

5 to 15 pascal
100

NS
200

10 to 15 pascal
NS

10 to 15 pascal
NS

NS

50

NS

50

100

NS

NS

NS

NS

NS

NS

50

NS

NS

NS

NS

NS

NS

NS

NS

NS

NS

NS

NS

15 pascal

NS

NS

NS

NS

NS

NS

5-10%

NS

NS

NS

NS

NS

NS

Ceiling

NS

NS

Ceiling

NS

NS

NS

ceiling or AHU

NS

NS

NS

NS

NS

NS

Sidewall

NS

NS

Sidewall

NS

NS

NS

015-045 m/s

NS

NS

NS

NS

NS

NS

2.5m/s

NS

NS

NS

NS

NS

NS

upon requirement

NS

NS

NS

NS

NS

NS

NS

NS

NS

NS

NS

NS

50%

NS

NS

NS

NS
NS

NS
NS

NS
NS

2.25m
NS

NS
15-20 min

NS
NS

NS
NS

NS

NS

NS

NS

10 - 20

NS

NS

NS

NS

NS

85% less than 20 micron to

99.97 less than 5 micron

NS

NS

NS

NS

NS

NS

99.97 - 99.997

NS

NS

NS

NS

NS

NS

3ft wide and 7 ft hight

NS

NS

NS

NS
NS

NS
NS

NS
NS

NS
12 months

NS
NS

NS
NS

NS
12 months

NS
NS
NS
NS
NS
NS

NS
NS
NS
NS
NS
NS

NS
NS
NS
NS
NS
NS

6 months
12 months
24 months
24 months
24 months
24 months

NS
NS
NS
NS
NS
NS

NS
NS
NS
NS
NS
NS

6 months
12 months
24 months
24 months
24 months
24 months

NS
NS

5 - 15 %
NS

NS
NS

5 - 15 %
60 to 65 db

NS
NS

NS
NS

NS
NS