High quality qualification services and complete dokumentation appropriate for GMP
High quality qualification services & complete, GMP-compliant documentation
bc-technology GmbH carries out qualifications and re-qualifications of technical cleanroom equipment and systems of all conventional directives. To this end, we define with our customers which statutory regulations, standards and directives are applicable to products and processes.
With our experienced employees and the use of state-of-the-art, calibrated measuring equipment,
bc-technology offers you the following measurements at the highest level:
- air flow rate measurement
- measurement of air exchange rate
- determination of room pressure
- filter integrity test
- differential pressure measurement on the filter
- cleanroom class determination
- sound level measurement
- recovery test
- temperature and humidity measurements
- measurement of the lighting strength
- determination of bacterial count
- flow visualisation
The measurements and correct documentation are carried out in accordance with EN ISO 14644 and VDI 2083. For pharmaceutical manufacturers, all necessary documentation is produced in compliance with GMP.
We carry out all measurements in an operating condition defined in advance ("at rest" or "in operation") and completely document all values in the approved test reports. The results are then evaluated with a special report.