– We offer individual and comprehensive measurements of the parameters of the ambient air and of the working environment.
– We hold the qualification and best practices, as well as advanced equipment, required for the validation (qualification) of cleanrooms, laminar flow zones, microbiological laboratories and engineering facilities.
– We provide individual measurements with particle counters and comprehensive evaluation (qualification) of cleanrooms according to ISO 14644-1, -2, -3 and EU GMP – Annex 1, which include one or more of the following tests:
- Airborne particle count for cleanroom classification, according to ISO 14644-1, 14644-2, 14644-3, Annex B.1 and/or EU GMP, Annex 1.
- Airflow test: airflow speed and volume of air, according to ISO 14644-3, Annex B.4
- Air pressure difference tests, according to ISO 14644-3, Annex B.5
- Installed filter system leakage test, according to ISO 14644-3, Annex B.6
- Airflow direction test and visualization, according to ISO 14644-3, Annex B.7
- Temperature and relative humidity tests, according to ISO 14644-3, Annex B.8 and B.9
- Recovery test, according to ISO 14644-3, Annex B.12
- Containment leak test, according to ISO 14644-3, Annex B.13
- Consultations on achieving and maintaining the cleanliness ISO classes and the critical parameters of cleanrooms and zones.
– We offer consultation and suport for the engineering and the implementation of ventilation and filter systems in cleanrooms.
– Our company is in the process of accreditation according to ISO / IEST 17025 for measurement.
– We have an individual approach for each case, depending on the needs and requirements of your projects.