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Measuring the number of particles in the room and room classification

The purpose of the test is to measure the number of particles present in the area of measuring, and according to known concentration of particles place the clean area in one of the known cleanliness grade. Standards that are most frequently used in EU are: ISO 14644-1 and cGMP Annex1.

 Measuring number of particles

At measuring we place particle counter isokinetic probe at a predetermined measurement location and measure prescribed volume of air. Measuring locations have to be equally distributed over the clean area surface. After the measurement room is placed into the reached clean area class.

Measurements are performed with laser particle counters and special isokinetic probe, used to perform sampling of air in the predefined and marked places. Number of measuring places, number of repeated measurements and also time of sampling is defined in accordance with planed clean area class. In accordance with basic demands of standards, measurement spots as well as the time of sampling can be increased according to customer demands.

We use measuring equipment from renowned manufacturers Lighthouse, TSI.

All instruments are calibrated annually.

About Validation

In addition to manufacturing equipment for clean technology, Iskra Pio performs the validation of devices.

We validate
- clean rooms
- weighing booths
- sampling booths
- LAF rooms
- all kinds of safety
cabins (Class I, II,
III)

Validations are performed by a team of trained experts who use annually calibrated measuring devices.
After completing the validation, they also prepare a report (also in English), which is variable for inspection services.