Claan Room Validation

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.
  • Validation of air cleanliness clases according ISO 14644-1, ISO 14644-2 and 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
  • Tests according EN ISO 14644-3: temperature and humidity inside the clean room,
  • 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.
  • Tests of time for achievement of cleanliness class conditions (100:1),
  • Installed filter system leakage test, according to ISO 14644-3, Annex B.6
  • Differential pressure between rooms tests,
  • Visualisation of the air flow
  • Tests for airflow velocity and speed of air exchange
  • Tests of HEPA filters (DOP test) etc.

 

We are always ready to adapt your projects to comply with standards after instalation new climat, vantilation filtering and other systems.
Our engineering team are highly qualified and experienced engineers, using modern and reliable measuring equipment for validation of clean zones, zones with laminar flow, microbiological laboratories and engineering facilities.
We provide tests for gases and microbiological conditions in rooms.
Please, connect us if you need these services. We offer highly individual approach for each particular project according client's needs.