Compressed Air Qualification
Ensuring compressed air meets GMP standards
Compressed air in most GMP production processes comes into direct contact with products and must meet strict quality standards to ensure product safety and regulatory compliance.
Why This Service Matters
Compressed air quality is critical as contaminated air can directly impact product quality and patient safety. Regular qualification ensures compliance with required purity classes.
Parameters Tested
Pressure Measurement - System pressure verification and stability
Solid Particle Content - Particulate contamination assessment
Humidity Measurement - Water vapor content analysis
Oil Aerosol Content - Oil contamination detection
Microbial Testing - Bioburden assessment
Dew Point Measurement - Moisture content verification
Applications
Direct Product Contact ProcessesEquipment Operation and ControlPneumatic SystemsPackaging OperationsCleaning and Drying Processes
Air Quality Requirements
Dry
Low moisture content to prevent microbial growth
Clean
Free from particulate contamination
Oil-Free
No oil contamination from compressor systems