Cleanrooms are controlled contamination environments designed to maintain extremely low levels of airborne particles, with humidity, pressure, temperature, and particulate contamination continuously monitored.
Mangini Life Sciences designs and delivers cleanrooms in compliance with the applicable standards, creating tailor-made environments that meet specific production requirements, operational workflows and the level of control required by the process.
The primary objective is to prevent product contamination through particulate and microbiological control and the reduction of the cross-contamination risk.
Sectors
- Pharmaceuticals and Nutraceuticals
- Biomedical and Biotechnology
- Food and Veterinary
- Hospital pharmacy
- Laboratories and Biosafety
Key standards
- EU GMP Annex 1
- ISO 14644
- ISO 14698
- FDA, when applicable
Core technologies
- HVAC systems with high-efficiency HEPA / ULPA filtration
- Controlled airflow
- Differential pressures
- Particulate and microbiological control
- Design for material and personnel flows
- Cross-contamination risk reduction
