Cleanroom-Classified
An ever increasing number of companies require a facility to provide an environment which enables the
control of their process, particularly important for today’s telecoms / net space, defence, food, pharma,
biotech and automotive industries. The ability to supply high quality, often ‘Box in Box’, type solutions has
become paramount for businesses to function profitably.
Classified clean rooms are very familiar to the pharmaceutical, electronic, semi-conductor and wafer-fab
industries, ranging from Class 100,000 up to Class 1 and are determined by the operation of the particular
room or process. Clean rooms are classified by the cleanlines of their air . The method most easily
understood most universally applied is based on ISO and cGMP Standards as given in the table.
Purity Classes for sterile zones
Clean rooms are designed to provide this by meeting purity classes of various degrees based on ISO and cGMP standards, as directed by the given applications
| Air Particle Count |
Maximum allowable particle count per M3 |
DIN
EN ISO
4644-1a) |
US
Fedral Standard
209 Si a) |
> 0.1 um |
> 0.2 um |
> 0.3 um |
> 0.5 um |
> 1.0 um |
> 5.0 um |
ISO
Class 1 |
|
10 |
2 |
|
|
|
|
ISO
Class 2 |
|
100 |
24 |
10 |
4 |
|
|
ISO
Class 3 |
M1.5
(1) b) |
1000
1240 |
237
265 |
102
106 |
35
35 |
8 |
|
ISO
Class 4 |
M2.5
(10) b) |
10000
12400 |
2370
2650 |
1020
1060 |
352
353 |
83 |
|
ISO
Class 5 |
M3.5
(100) b) |
100000 |
23700
26500 |
10200
10600 |
3520
3530
3500 |
832 |
29
0 |
ISO
Class 6 |
M4.5
(1000) b) |
1000000 |
237000 |
102000 |
35200
35200 |
8320 |
293
247 |
ISO
Class 7 |
M5.5
(10000) b) |
|
|
|
352000
353000
350000 |
83200 |
2930
2470
2000 |
ISO
Class 8 |
M1.5
(100000) b) |
|
|
|
3520000
3530000
3500000 |
832000 |
29300
24700
20000 |
ISO
Class 9 |
|
|
|
|
35200000 |
8320000 |
293000 |
a) Varies by status of operation, ideal conditions depicted
b) Class division in cubic feet
For Guidance
Class 1 and 10 (the highest specification) are generally used for integrated circuit and semi-conductor manufacture.
Class 100 (BS. 5295 equivalent classifications E and F) are often used by the electronics industry along with some applications within
pharmaceutical facilities.
Class 1,000 to 10,000 are used by manufacturers of the highest specification fibre optics, precision engineering, sterile packaging and
pharmaceutical manufacturing.
Class 100,000 is adequate for general component assembly and packaging.
|