Active pharmaceutical ingredient (API) plants use compressed air in chemical reactions, drying, material handling and containment systems. The air can contact the product directly, so it must meet validated purity standards under GMP.
Air quality
Specify ISO 8573-1 Class 1:2:1 or better with Class 0 oil, and a low dew point for moisture-sensitive intermediates. The system must be validated, with testing at the point of use and documentation for audits.
Key applications
- Reactor pressurisation and inerting
- Spray drying and fluid-bed drying
- Pneumatic conveying of powders
- Containment and cleanroom control
System design
Use oil-free compression with adsorption drying and sterile filtration, avoid dead legs, and provide sampling points at critical uses. Redundancy and continuous monitoring keep validated processes running during maintenance.