Validation

Renza Airflow Solutions is the leading cleanroom validation company. We perform measurements and maintenance on plenums, filter blow-out units and safe exchange filter houses, ensuring that everything is tested according to current standards such as Directive 7, Directive 11, ISO 14644 and GMP.

It goes without saying that Renza Airflow Solutions has measurements and validations performed by measurement technicians who have received thorough training in cleanroom validation. These are the measurements that can be performed Renza Airflow Solutions.

• RL7 measurement
• Air volumes
• Particle measurement
• Air speeds
• Temperature
• Relative humidity
• Filter integrity test
• Capturing flow profiles on film
• Pitot measurements in canals
• Light measurement
• Noise measurement
• Filter pressure
• Space prints
• Bacteriological and fungal measurement
• Oxygen measurement
• CO2 measurement

To determine the final classifications of the cleanroom, operating room, pharmacy, isolation room and CSA, the measurement of particle concentrations, among others, plays an important role. This is done through RL7 measurement, particle measurement and recovery measurement, among others. Relative humidity, temperature and room pressures are measured. We also do validations of fume cupboards and safety workbenches. Besides validation, maintenance is also carried out if required, such as re-tensioning the CG cloths, adjusting the air flow rates, replacing fluorescent tubes in the plenum, replacing fluorescent light fittings to sustainable LED lighting.

The results of the validation are stored in a comprehensive measurement report in which all values can be read including the calibration report, measurement protocols, inspection certificates, raw data and customised practical advice on how to get the most out of the equipment.

As much of the air validation is carried out via automated processes, the chance of incorrect measurements is very low, in addition a measurement report can be produced quickly, within a maximum of ten working days.

As an independent company, we perform validations with various measurements including the RL7 measurement, particle measurement and recovery measurement according to all applicable standards and guidelines.