Identifying difference between critical and non-critical parameters play an important role in the quality risk management process. The parameters which may affect product quality need to be identified as critical, clearly documented and be shown to be maintained within requirements.
Compressed air in most of the GMP production processes come into direct contact with the product, and as such needs to be identified as critical utility the variability of which has an impact on the product quality and therefore should be monitored or controlled.
Compressed air should be dry, clean and oil free and the quality should be confirmed.

We are able to provide testing of compressed air contaminants and purity classes, including critical parameters such as:

Qualification of compressed air (and other process or laboratory gases) in the pharmaceutical industry need to be followed by appropriate VALIDATION AND QUALIFICATION DOCUMENTATION.