Compressed Air / Breathing Air & Nitrogen Gas Validations

The Quality of Compressed Air/Breathing Air & Nitrogen Gas is important to ensure that product is safe. The most important parameters in specifying quality are: Carbon monoxide • Carbon dioxide • Oxygen Concentration • Total Hydrocarbon • Oil Mist • NVPC (Non-viable Particulate Count) • Dew Point • NO+NO2 • SO2 and Water Content. Pharmaceutical products is vital to assuring the quality and safety of those products. Compressed Air and Nitrogen Gas is a Critical Process Parameter (CPP) those variability has an impact on the Critical Quality Attribute (CQA) and therefore should be monitored and controlled to ensure the process procedures the desired quality.

An important international standard, ISO 8573-1, EP/BP/USP provides a variety of Purity Classes that can be incorporated into a robust quality assurance plan for this critical utility. Testing and monitoring of compressed air and other process gases such Nitrogen and Oxygen that come into direct contact with the product is vital to assuring the quality and safety of the product.