Nitrogen is widely used in pharmaceutical manufacturing for inerting, product protection, purging, packaging, and environmental control. PrimeGMP ensures that nitrogen generation and distribution systems consistently meet pharmaceutical-grade purity, flow, and pressure requirements through complete lifecycle qualification.

Our Nitrogen Qualification Scope

1. Design Qualification (DQ)

• Review of URS, P&ID, OEM data sheets, and equipment specifications
• Verification of nitrogen generator type (PSA / Membrane / Cryogenic)
• Assessment of dryers, purification systems, filters, receivers, and piping
• Risk assessment as per ICH Q9
• Compliance check with ISO 8573, Ph. Eur., and USP purity requirements

2. Installation Qualification (IQ)

• Verification of equipment installation as per approved design
• Inspection of compressors, PSA towers/membrane modules, filters, and outlet lines
• Calibration of flow meters, pressure indicators, dew point meters, and oxygen analyzers
• Verification of valves, safety devices, alarm systems, and drain points
• Documentation review (material certificates, FAT/SAT, OEM manuals)

3. Operational Qualification (OQ)

• System start-up verification
• Oxygen concentration testing across the purification stages
• Dew point and moisture testing
• Pressure, flow, and load/unload performance checks
• Alarm, interlock, and auto-purge functionality testing
• Filter qualification (pre-filter, fine filter, sterile filter if applicable)

4. Performance Qualification (PQ)

Verification of nitrogen quality at all critical user points:

• Oxygen concentration (% O₂) testing
• Moisture / dew point testing
• Microbial testing (if nitrogen contacts product or critical surfaces)
• Particle count as per ISO 8573
• Oil aerosol / vapor testing (when applicable)
• Distribution line pressure stability checks
• Point-of-use mapping across the network

Purity tested against:

• ISO 8573-1
• USP Nitrogen
• Ph. Eur. Nitrogen

Documentation Provided

• DQ / IQ / OQ / PQ Protocols & Reports
• Oxygen, moisture, particle, and microbial test reports
• Calibration certificates
• Distribution point qualification sheets
• P&ID verification records
• SOPs for operation, monitoring, and maintenance
• Final Qualification Summary Report

Regulatory Standards We Follow

• ISO 8573-1 (air & nitrogen purity classification)
• USP Nitrogen Specifications
• Ph. Eur. Nitrogen Monograph
• WHO TRS 961 / 1019
• EU GMP Annex 1 & 15
• ISPE GPG – Utilities

Why Choose PrimeGMP for Nitrogen Qualification?

• Expertise in PSA, membrane, and cryogenic nitrogen systems
• Comprehensive point-of-use qualification
• Deep understanding of nitrogen applications in sterile & OSD manufacturing
• Accurate testing using calibrated, traceable instruments
• Fast execution with audit-ready documentation
• Support for troubleshooting oxygen/moisture deviations