
Clean rooms
Particulate controls
- Particle counting and zone classification in accordance with standard 14 644 at rest
- Decontamination and recovery kinetics
- Tightness and integrity tests of filters, with and without aerosol generation
- Recovery time study in accordance with NF EN ISO 14644-3
Microbiological controls
- Surface contamination control contamination in accordance with GMP, standard 17141-1
- Airborne microbiological contamination control as per GMP, standard 17141-1
Airflow controls
- Airflow rates for supply and extraction, renewal rates, leak detection and measurements according to NF EN ISO 14644-3
- Temperature and humidity readings, pressure differentials according to NF EN ISO 14644-3
- Visualization and three-dimensional control of airflow, flow laminarity according to NF EN ISO 14644-3
- Filter integrity according to NF EN 1822 and NF EN ISO 14644-3
- Recovery time study according to NF EN ISO 14644-3
Chemical controls and other physical characteristics
- Efficiency tests on chemical filters
- Noise measurements (acoustic)
- Light intensity measurements
Qualification of Facilities and Environments
- Pharmaceutical qualification CQ, IQ, OQ, PQ
- Functional and value analyses
- Risk analyses such as FMECA, Ishikawa diagrams, OQ
- Reliability and maintainability analyses of installations and equipment