Compressed air qualification in the pharmaceutical industry is a critical process to ensure that the air used in manufacturing processes meets specific purity and quality standards. This is essential to prevent contamination of products and maintain product integrity.
The Objective of this protocol is:
To evaluate and qualify the compressed air generation and distribution system after the
installation of cartridge filter (0.01µ) on the outlet of compressed air Tank.
To establish a documented evidence to provide a high degree of assurance that the cartridge
filter (0.01µ) installed in the user points consistently produce prerequisite quality of
compressed air and complies with the specifications.
Acceptance Criteria:
The compressed air shall be checked for the following quality attributes
| S. No | Name of Parameter | Acceptance Criteria |
| 1 | Non –viable count | 0.5micron-3520 5.0 micron-29 |
| 2 | Presence of Water vapour | 5mg/metre3 for +3°c dew point and 0.01mg/meter3for -70°c |
| 3 | Presence of oil and mist | 0.1 mg /meter3 |
| 4 | Carbon monoxide content | 5ppm |
| 5 | Carbon dioxide content | 100ppm |
| 6 | Sulphur dioxide content | 0.5ppm |
| 7 | Hydrogen Sulphide content | 1ppm |
| 8 | Nitrogen oxide content | 0.5ppm |