NITROGEN SYSTEM QUALIFICATION

Nitrogen System Qualification plays important role in pharmaceuticals. PSA (Pressure Swing Adsorption) Based Nitrogen Plant is to produce Nitrogen gas from Atmospheric compressed air. Air passes through Carbon Molecular Sieves (CMS) at a certain pressure, the moisture, Oxygen, and CO₂ are selectively adsorbed, and balance nitrogen comes out and collects in the receiver. Compressed air first collects in the air receiver at 7.0 kg/cm² pressure and then goes to the PSA module through the air filter module.  The air receiver has been provided to avoid air pressure fluctuation so that a constant flow & pressure will be available during plant operation.

Nitrogen System Qualification in Pharmaceuticals

One highly efficient air filter has been provided at the outlet of the air receiver to arrest dust particles from nitrogen gas before entering in PSA module. This is a specially designed composite bed-type PSA module having two towers filled with a special grade of Activated Alumina and a second generation of highly efficient Carbon Molecular Sieves (CMS) to produce 99.5% pure Nitrogen. As compressed air passed through the PSA module, moisture from compressed air is adsorbed in Alumina Bed and oxygen & carbon dioxide are selectively adsorbed in the CMS bed, balance Nitrogen is collected in the surge vessel at the outlet of the PSA Module. A surge Vessel is a vertical, cylindrical type vertical pressure vessel. A surge vessel has been provided to collect outlet nitrogen before being sent to the storage tank/user point.

One Oxygen analyzer connected to this vessel to measure oxygen impurity in the product nitrogen. Nitrogen from the surge vessel now goes to the user point through the flow meter and backpressure control valve at the required flow and pressure. To avoid impure high oxygen content in nitrogen on 3-way vent valve has been provided with an interlock of oxygen analyzer. In case oxygen content high as the purity limit nitrogen will vent out into the atmosphere till purity comes within the desired limit.

QUALIFICATION

1. Design Qualification
2. Installation Qualification
3. Operational Qualification
4. Performance Qualification Protocol
5. Performance Qualification Report

STANDARD OPERATING PROCEDURE

1. SOP for Operation of Nitrogen Plant
2. SOP for Chemical Analysis of Nitrogen
3. SOP for Cleaning and Operation of MCAS ECO Compressed Air Nitrogen Gas Sampler
4. SOP for Sampling and Sterility Testing of Nitrogen Gas & Compressed Air