Compressed air is a direct and indirect utility that impacts product quality in aseptic, sterile, OSD, and API manufacturing. PrimeGMP provides comprehensive qualification of compressed air generation and distribution systems to ensure air purity meets pharmaceutical-grade requirements and complies with regulatory expectations.

Our Compressed Air Qualification Scope

1. Design Qualification (DQ)

• Review of URS, P&ID, OEM technical documents
• Verification of compressor type (oil-free, oil-lubricated with filtration)
• Assessment of dryers (desiccant/refrigeration), filters, receivers, and piping
• Risk assessment as per ICH Q9
• Compliance check with ISO 8573 purity classes & GMP requirements

2. Installation Qualification (IQ)

• Verification of equipment installation as per design
• Inspection of compressors, dryers, filters, receiver tanks, and valves
• Verification of sterile filters for clean/sterile air applications
• Calibration of pressure, dew point, and flow sensors
• Documentation review (material certificates, FAT/SAT, manuals)

3. Operational Qualification (OQ)

• Verification of compressor performance parameters
• Testing of filters (pre, fine, sterile)
• Dew point measurement
• Verification of differential pressure & flow rate
• Alarm checks, moisture trap functions, auto-drain operation
• Oil carryover checks (where applicable)
• Load/unload cycle verification

4. Performance Qualification (PQ)

Full system performance testing under actual operating conditions:

• Microbial count test
• Non-viable particulate test
• Oil aerosol & oil vapor testing
• Moisture / dew point verification
• Filter integrity test (if sterile air)
• Pressure stability monitoring
• Point-of-use quality evaluation throughout distribution network

All testing is performed as per:

• ISO 8573-1 (air purity classes)
• ISO 8573-2/-4/-5/-7/-8 (oil, particles, moisture tests)

Documentation Provided

• DQ / IQ / OQ / PQ Protocols & Reports
• ISO 8573 Test Reports (Oil, Moisture, Particulates, Microbial)
• Calibration Certificates
• P&ID Verification Sheets
• Point-of-use Qualification Mapping
• SOPs for operation & maintenance
• Final Qualification Summary Report

Regulatory Standards We Follow

• ISO 8573-1: Air Purity Classification
• ISO 12500: Filter Testing
• WHO TRS 961 / 1019
• EU GMP Annex 1 & 15
• USFDA 21 CFR 210/211
• ISPE Good Practice Guide – Utilities

Why Choose PrimeGMP for Compressed Air Qualification?

• Comprehensive testing using calibrated, traceable instruments
• Deep experience with sterile & non-sterile environments
• Detailed point-of-use mapping across the distribution network
• Strong understanding of contamination control strategies
• Fully audit-ready documentation
• Practical troubleshooting during moisture/oil/particle failures