Pharmaceutical air without compromise.
The pharmaceutical and cosmetics industry demands compressed air quality without any compromise. Any direct or indirect contact with active ingredients, primary packaging or sterile production areas requires air that is completely free of oil, water and particles — in compliance with ISO 8573-1 class 0 and GMP Guide Annex 1.
What needs to be solved.
- 01Guarantee total absence of oil contamination across the entire compressed air chain, from compressor to point of use, under FDA and GMP audit.
- 02Maintain a low dew point (−40 °C or −70 °C) to prevent any condensation that could compromise sterility or active ingredient stability.
- 03Document complete traceability (IQ/OQ/PQ qualification, maintenance records, periodic validation) to pass regulatory inspections.
A concrete example.
A 380-employee soft-gel tablet manufacturing site combines two CZ-SLT-75V oil-free screw compressors in N+1 redundancy, a CZ-DRY-A200 adsorption dryer at −70 °C dew point, and three stages of ISO 8573-1 class 0 filtration. The air feeds directly the blow-molding machines, capping machines and primary packaging areas. Traceability is ensured by annual inspection reports and calibration certificates.
Our technical answer.
Combination of CEZIUM machines sized for this process. Technical details in the distributor pack.
Compliances attested.
Compliances are verified case by case according to the selected model and audit scope. Complete documentation provided with each machine.
Describe your process. We'll propose the right machine combination.
Reply from our technical team within 24 working hours. Free pre-study including sizing and budget estimate.