Accurate, compliant, and efficient validation processes
MCRT offers comprehensive cleanroom validation services to ensure that controlled environments meet regulatory and industry standards. We provide full DQ, IQ, OQ documentation tailored to specific cleanroom classification.
Particle measurements
- Filter integrity testing
- Classification of cleanroom environments
- Recovery time testing
- Clean up phase according to EU-GMP Annex 1
- Qualification according to VDI 2083 section 16
Measurement of environment parameters
- Temperature and humidity
- Air velocity
- Air volume and air changes
- Illumination
- Noise level
Differential pressure measurements
- Filter pressure drops
- Room pressure
- Pressure zones
- Pressure test filter tightness according to VDI 3803-4
Air-flow visualisation
- Air-flow visualisation with high purity water or fog and video documentation
Microbiological measurements (validation in certified laboratory)
- Surface test
- Air born biological test
Calibration services
- 3-point calibration for pressure sensors
- 1-point calibration for temperature and humidity sensors
Monitoring
- Maintenance and requalification of monitoring systems
Qualifications and documentation
- DQ – Design Qualification
- IQ – Installation Qualification
- OQ – Operational Qualification
Service and maintenance of HVAC systems
- Filter change
- Humidifier and dehumidifier
- Hygiene check according to VDI 2083
Training
- Fundamentals of cleanrooms
- Applications and industry use of cleanrooms
- Proper conduct and protocols within cleanroom environments
- Material flow, contamination control, and more