Compressed air is one of the most frequently used energy sources. Besides, clean air is widely used for process needs. In the pharmaceutical industry, compressed air without proper purification may affect the equipment and lead to the failure of process parameters, resulting in the loss of product quality. That is why the qualification of compressed air is an essential process.
Compressed air qualification is documented evidence that such parameters as aerosol particle content, dew point, concentration of liquid water, content of vapor, oil aerosols and other contaminants are within limits and do not cause contamination of the product.
Dräger Aerotest, a gas detection instrument, is used for qualification.
Purity classes for compressed air
|
Class |
Particles |
Humidity |
Liquid water |
Oil |
|
|
Maximum number of particles per m3 |
Dew point, °С |
Concentration of liquid water, g/m3 |
Aerosol, liquid, vapor, mg/m3 |
||
|
0,5 < d ≤ 1,0 |
1,0 < d ≤ 5,0 |
||||
|
0 |
|
|
|
|
|
|
1 |
1 |
0 |
≤ -70 |
— |
≤ 0,01 |
|
2 |
1000 |
10 |
≤ -40 |
— |
≤ 0,10 |
|
3 |
10000 |
500 |
≤ -20 |
— |
≤ 1,00 |
|
4 |
Not specified |
1000 |
≤ +3 |
— |
≤ 5,00 |
|
5 |
Not specified |
20000 |
≤ +7 |
— |
— |
|
6 |
— |
— |
≤ +10 |
— |
— |
|
7 |
— |
— |
— |
≤ 0,5 |
— |
|
8 |
— |
— |
— |
0,5 < Cw ≤ 5,0 |
— |
|
9 |
— |
— |
— |
5,0 < Cw ≤ 10,0 |
— |
Compressed air qualification, stages:
-
DQ (Design qualification);
-
IQ (Installation qualification);
-
OQ (Operation qualification);
-
PQ (Performance qualification).
Qualification of compressed air and nitrogen, why to conduct?
Compressed air, nitrogen, and other gases that come into direct contact with the product or primary package should meet a certain purity class and should not affect the quality of manufactured products. In addition, compressed gas production and distribution systems belong to systems operating in continuous mode, which requires regular monitoring of critical functions and parameters and periodic re-qualification.