TECHNICAL
 Cleanroom standards

 DIVISIONS
 Cleanroom
 PPE (Safety)
 Equipment
 Furniture

 CLEANROOM
 
CLEANROOM STANDARDS

Quality standards and legislation continue to require an increasing range of processes to be carried out in clean, particle free conditions.
Research and development, manufacturing, assembly and packaging in many fields, require clean rooms which can be measured to meet appropriate atandards and most importantly can be shown to have been designed and constructed to provide and maintien these conditions throughout the useful life of the facility.
British Standards BS 5295 - Classes of environmental Cleanliness
Class of environmental cleanliness
Maximum permitted number of particles per cubic meter
(equal to or greater than, stated size)
Maximum floor area per sampling portion for cleanrooms (square metres)
0.3µm
0.5µm
5.0µm
10.0µm
25.0µm
C
100  
35  
0  
NS  
NS  
10
D
1,000  
350  
0  
NS  
NS  
10
E
10,000  
3,500  
0  
NS  
NS  
10
F
NS  
3,500  
0  
NS  
NS  
25
G
100,000  
35,000  
200  
0  
NS  
25
H
NS  
35,000  
200  
0  
NS  
25
J
NS  
350,000  
2,000  
450  
0  
25
K
NS  
3,500,000  
20,000  
4,500  
500  
50
L
NS  
NS  
200,000  
45,000  
5,000  
50
M
NS  
NS  
NS  
450,000  
50,000  
50

US Federal Standards 209D - Classes of environmental Cleanliness
Class of environmental cleanliness
Maximum permitted number of particles per cubic foot
(equal to or greater than, stated size)
0.1µm
0.2µm
0.3µm
0.4µm
5.0µm
1  
35
7.5
3
1  
NA
10  
350
75
30
10  
NA
100  
NA
750
300
100  
NA
1,00  
NA
NA
NA
1,00  
7
10,000  
NA
NA
NA
10,000  
70
100,000  
NA
NA
NA
100,000  
700

Comparison table of different cleanroom Standards.
USA
209E
EU GMP
In operation
BS 5295
UK
BS 5295
FRANCE
AFNOR
X44101
GERMANY
VDI. 2083
AUSTRALIA
AS 1386
Metric
Imperial
1  
M1.5
-
C
-
1
0.035  
10  
M2.5
-
D
-
2
0.35  
100  
M3.5
A
E or F
4,000  
3
3.5  
1,00  
M4.5
-
G or H
-
4
35  
10,000  
M5.5
B
J
400,000  
5
350  
100,000  
M6.5
C
K
4,000,000  
6
3,500  

ISO CLASSIFICATION - m³
ISO
Class
Maximum Concentration Limits (Particles/m³ of air) for Particles Equal to and Larger Than the Considered Sizes Shown Below
0.1µm
0.2µm
0.3µm
0.5µm
1µm
5µm
ISO Class 1
4  
2  
-
-
-
-
ISO Class 2
100  
24  
10  
4  
-
-
ISO Class 3
1 000  
237  
102  
35  
8  
-
ISO Class 4
10 000  
2 370  
1 020  
352  
83  
-
ISO Class 5
100 000  
23 700  
10 200  
3 520  
832  
29  
ISO Class 6
1 000 000  
237 000  
102 000  
35 200  
8 320  
293  
ISO Class 7
-
-
-
352 000  
83 200  
2 930  
ISO Class 8
-
-
-
3 520 000  
832 000  
29 300  
ISO Class 9
-
-
-
35 200 000  
8 320 000  
293 000  

ISO CLASSIFICATION - ft³ (EQUIVALENT)
ISO
Class
Maximum Concentration Limits (Particles/m³ of air) for Particles Equal to and Larger Than the Considered Sizes Shown Below
0.1µm
0.2µm
0.3µm
0.5µm
1µm
5µm
ISO Class 1
0.28  
0.07  
-
-
-
-
ISO Class 2
2.83  
0.67  
0.29  
0.1  
-
-
ISO Class 3
28.3  
6.71  
2.89  
0.99  
0.23  
-
ISO Class 4
283  
67.1  
28.9  
9.96  
2.35  
-
ISO Class 5
2 830  
671  
289  
99.6  
23.6  
0.82  
ISO Class 6
28 300  
6 711  
2 888  
996  
235.6  
8.3  
ISO Class 7
-
-
-
9 967  
2 356  
83  
ISO Class 8
-
-
-
99 675  
23 550  
830  
ISO Class 9
-
-
-
996 753  
235 596  
8297  


EU GMP- m³
Grade
Maximum Permitted Number of Particles/m³ Equal to or Greater Than
At Rest
In Operation
0.5µm
5µm
0.5µm
5µm
A
3 500  
0  
3 500  
0  
B
3 500  
0  
350 000  
2 000  
C
350 000  
2 000  
3 500 000  
20 000  
D
3 500 000  
20 000  
Not Defined  
Not Defined  

EU GMP- ft³ (EQUIVALENT)
Grade
Maximum Permitted Number of Particles/ft³ Equal to or Greater Than
At Rest
In Operation
0.5µm
5µm
0.5µm
5µm
A
99  
0  
99  
0  
B
99  
0  
9 911  
57  
C
9 911  
57  
99 108  
566  
D
99 108  
566  
Not Defined  
Not Defined  


AMERICAN FEDERAL STANDARD 209E- m³
Cleanliness Class
Class Limits with Maximum Number of Particles/m³
Imperial
Metric
0.1µm
0.2µm
0.3µm
0.5µm
5µm
M1
350  
75.7  
30.9  
10  
-
1  
M1.5
1 240  
265  
106  
35.3  
M2
3 500  
757  
309  
100  
-
10  
M2.5
12 400  
2 650  
1 060  
353  
-
M3
-
7 570  
3 090  
1 000  
-
100  
M3.5
-
26 500  
10 600  
3 530  
-
M4
-
75 700  
30 900  
10 000  
-
1 000  
M4.5
-
-
-
35 300  
247  
M5
-
-
-
100 000  
318  
10 000  
M5.5
-
-
-
353 000  
2 470  
M6
-
-
-
1 000 000  
6 180  
100 000  
M6.5
-
-
-
3 530 000  
24 700  
M7
-
-
-
10 000 000  
61 800  

AMERICAN FEDERAL STANDARD 209E- ft³ (EQUIVALENT)
Cleanliness Class
Class Limits with Maximum Number of Particles/ft³