Compressed Air & Gases Testing
Ensuring Clean, Compliant & Contamination-Free Utility Gases
Compressed air and process gases come into direct or indirect contact with pharmaceutical products, manufacturing equipment, and packaging materials. Any contamination can impact product quality, patient safety, and regulatory compliance.
Cleanstep provides comprehensive testing of compressed air and process gases in accordance with international standards such as ISO 8573, EU GMP, USP, and industry best practices, ensuring your utility systems consistently meet quality requirements.
Standards We Follow:
- ISO 8573 Series
- EU GMP Annex 1
- USP Guidelines
- PIC/S Guidelines
- ISPE Good Practice Guides
Our Testing Capabilities
We perform qualification and monitoring of various pharmaceutical utility gases including:
- Compressed Air
- Nitrogen (N₂)
- Oxygen (O₂)
- Carbon Dioxide (CO₂)
- Clean Dry Air (CDA)
- Process Air
- Instrument Air
- Medical Gases
Parameters We Test
- Particle Contamination
- Oil Aerosol & Oil Vapour
- Moisture / Dew Point
- Microbiological Testing
- Viable & Non-Viable Contamination
- Pressure Dew Point
Typical Applications
We provide the services for (but not limited to)
- Manufacturing Lines
- Filling Machines
- Blow-Fill-Seal Systems
- Autoclaves
- CIP/SIP Systems
- Packaging Machines
- Tablet Compression Machines
- Fluid Bed Dryers
- Granulation Equipment
- Sterile Production Areas
- Clean Utilities Distribution Systems
Key Deliverables
Upon completion of testing, You receive:
- Approved Test Protocol (if applicable)
- Raw Data Records
- Instrument Calibration Certificates
- Sampling Location Layout
- ISO 8573 Test Results
- Microbiological Test Report (if applicable)
- Final Comprehensive Report
- Compliance Summary
- Recommendations for Corrective Actions (if required)
Why Choose Cleanstep?
- Advanced Testing Technology
- Experienced Validation Professionals
- Regulatory-Compliant & Audit-Ready Documentation
- Fast & Scalable Project Execution
- Comprehensive Utility Gas Qualification
- End-to-End Technical & Regulatory Support
Need Compressed Air & Process Gases Testing?
Partner with Cleanstep Pharma and Engineering Solutions for accurate, regulatory-compliant testing services. We ensure your utility gases meet ISO 8573 and GMP requirements through precise testing, audit-ready documentation, and efficient project execution.
