Sheet2

US
Federal
Standard
209D
(1988)

US
Federal
British
BS EN ISO
Standard Standard
EU GGMP
Standard
209E
5295:1989
(1992)

ISPE

WHO

100000

Particals / m3 (Ft3)

100000/ft3

NS

Air
Avarage air
change
flow velocity
s

700/ft3

Differential
pressure

Limits for
Microbial
contamination

5 to 15 pascal

NS

NS

NS NS

5 to 15 pascal
0.005 - 0.041
m/s
(1 - 8
NS
ft/min)

NS

NS

NS NS

NS

NS

NS NS

100 50

NS NS

M6.5
3530000/m3
(100000/ft3) NS

24700/m3
(700/ft3)
20 - 48

3500000/m3 NS

ISO 8

2000/m3

3520000/m3 832000/m3 29300/m3

3500000/m3 NS

100000

5 to 15 pascal

20000/m3

3520000/m3 832000/m3 29300/m3

3500000/m3 NS

Page 1

20000/m3

NLT 20

NS

200 100 50

10 to 15 pascal

NS

NS

NS NS

10 to 15 pascal

NS

NS

NS NS

Classification of cleanroom standards

Clean Room Standards
US Federal US Federal
British
Standard
Standard
Standard
209D (1988) 209E (1992) 5295:1989

Class

Class

Grade

BS EN ISO
Standard

Class

EU GGMP

Grade

ISPE

Class

WHO

Particals / m3 (Ft3)

Grade

0.5m0.5 1m1m 5m5m

m0.5m
1m
5m

1/ft3
10.0/m3
(0.283/ft3)
35/m3
35/m3
NS
NS
NS

NS

NS

NS
NS
8/m3
NS
NS
NS

NS
0/m3
NS
NS
NS
NS

NS

NS

NS

10/ft3
1000/m3
(28.3/ft3)
350/m3
352/m3
NS
NS
NS
100/ft3
3530/m3
(100/ft3)
3500/m3
3520/m3
3500/m3
3520/m3
3500/m3
1000/ft3
100000/m3
(2830/ft3)
35000/m3
35200/m3
NS
35200/m3
NS

NS

10000/ft3
353000/m3
(10000/ft3)
350000/m3
352000/m3
350000/m3
352000/m3
350000/m3

NS

100000/ft3
3530000/m3
(100000/ft3)
3500000/m3
3520000/m3
3500000/m3
3520000/m3
3500000/m3

M1
C
ISO 3
NS
NS
NS
10
M3
D
ISO 4
NS
NS
NS
100
M3.5
E/F
ISO 5
A/B
100
A& B
1000
M5
G/H
ISO 6
NS
1000
10000
M5.5
J
ISO 7
C
10000
100000
M6.5
K
ISO 8
D
100000

NS - Not specified

NS
NS
83/m3
NS
NS
NS
NS

NS
0/m3
NS
NS
NS
NS
NS

NS
NS
832/m3
NS
832/m3
NS
NS

NS
0/m3
29/m3
1/m3
29/m3
0
7/ft3
618/m3
(17.5/ft3)
200/m3
293/m3
NS
293/m3
NS

NS
NS
8320/m3
NS
8320/m3
NS

70/ft3
2470/m3
NS
(70/ft3)
NS
2000/m3
83200/m3 2930/m3
NS
2000/m3
83200/m3 2930/m3
NS
2000/m3
700/ft3
24700/m3
NS
(700/ft3)
NS
2000/m3
832000/m3 29300/m3
NS
20000/m3
832000/m3 29300/m3
NS
20000/m3

Avarage air flow

Air changes
velocity

Per/hr

360 - 540

0.305 - 0.457
m/s
- 90
m/s ((60
ft/min)
ft/min)
0.305 - 0.457
m/s
(60 - 90
ft/min)
0.305 - 0.457
m/s
(60 - 90
ft/min)

NS

300 - 540

NS

0.254 - 0.457
m/s (50 - 90
ft/min)

NS

NS

Differential
pressure

Pascal

5 to 15 pascal
5 to 15 pascal
NS
5 to 15 pascal

NS
NS
NS
NS
NS
NS

NS
NS
NS
NS
NS
NS

NS
NS
NS
NS
NS
NS

NS
NS
NS
NS
NS
NS

5 to 15 pascal

NS

NS

NS

NS

5 to 15 pascal
NS
5 to 15 pascal

NS
NS
NS
NS
NS
NS
NS

NS
NS
NS
NS
NS
NS
NS

NS
NS
NS
NS
NS
NS
NS

NS
NS
NS
NS
NS
NS
NS

5 to 15 pascal

NS
NS
<1
<1
NS
NS
NS

NS
NS
<1
<1
NS
NS
NS

NS
NS
<1
<1
NS
NS
NS

NS
NS
<1
<1
NS
NS
NS

NS
5 to 15 pascal
NS
10 to 15 pascal
NS

NS
NS
50
NS
NS
NS

NS
NS
25
NS
NS
NS

NS
NS
10
NS
NS
NS

NS
NS
NS
NS
NS
NS

5 to 15 pascal

NS

NS

NS

NS

NS
5 to 15 pascal
NS
10 to 15 pascal
10 to 15 pascal

NS
NS
100
100
NS
NS

NS
NS
50
50
NS
NS

NS
NS
25
25
NS
NS

NS
NS
NS
NS
NS
NS

5 to 15 pascal

NS

NS

NS

NS

5 to 15 pascal
NS
5 to 15 pascal
NS
10 to 15 pascal
10 to 15 pascal

NS
NS
100
200
NS
NS

NS
NS
50
100
NS
NS

NS
NS
NS
50
NS
NS

NS
NS
NS

NS

NS
5 to 15 pascal

240 - 480

0.254 - 0.457
m/s (50 - 90
ft/min)

NS
5 to 15 pascal
NS
10 to 15 pascal

NLT 20

150 - 240

NS

0.127 - 0.203
m/s (25 - 40
ft/min)
0.127 - 0.203
m/s (25 - 40
ft/min)
NS

60 - 90

0.051 - 0.076
m/s (10 - 15
ft/min)
0.051 - 0.076
m/s (10 - 15
ft/min)

NLT 20

20 - 48

NLT 20

0.005 - 0.041
m/s
(1 - 8
ft/min)

Contact
plates
Limits
for Microbial
Settle
plates contamination
Glove print
(55mm)
(90mm)
5 fingers
cfu/plate
cfu/2hours
cfu/glove
Contact
Settle plates
Glove print
plates
Air sampler (90mm)
5 fingers
(55mm)
cfu/m3
cfu/2hours
cfu/glove
cfu/plate
Settle plates
Glove print
Contact
(90mm)
5 fingers
plates
cfu/2hours
cfu/glove
(55mm)
NS
NS
NS
NS
cfu/plate

NS
NS