FAQ - Conteo de partículas en producción farmacéutica y ciencias de la vida

Lasair II with Validation Documents for Cleanroom certification.

Pregunta
We are setting up a manufacturing facility which will have areas specified with particle concentaration limits as per ISO 8. The system is ready for validation. Which guidelines should be followed before starting the particle count tests.

Respuesta

Before starting the certification exercise ensure the room is clean, the HVAC has been running for a period of time to purge the ducting, this can be found by running a particle counter in the room in question for a period of time and ensure the baseline values do not change by more than x percent (x could be 5-10% based on external factors such as weather). Once this has been found and the room are deemed to be stable then run the ISO certification.

For more information, read Particle Monitoring Requirements in Pharmaceutical Cleanrooms.