In pharmaceutical production, compressed air is a critical utility that can come into direct contact with drug products. Process air, aseptic filling, pneumatic conveying, instrumentation and equipment purging all depend on a reliable, validated supply of clean air.
Purity and quality requirements
Pharmaceutical plants typically specify ISO 8573-1 Class 1:2:1 or better, with Class 0 oil. The air must also be dry enough to prevent microbial growth, usually a pressure dew point of -40°C or lower for critical applications. Validation requires documented testing for particles, water and oil at the point of use.
Applications across the workflow
- Process air for spray drying, fermentation and mixing
- Aseptic filling and blister packaging machines
- Cleanroom instrumentation and valve actuation
- Vial and ampoule drying and line purging
Design and validation
Build the system with oil-free compression, adsorption drying and sterile-grade filtration. Route piping to avoid dead legs where condensate or microbes can collect. Include sampling points at critical use locations and document the system under GMP so air quality can be verified during audits.