FAQ - Pharmaceutical/Life Sciences Particle Counting

Question
Do we have to perform method validation if we were to use air particle counter for monitoring? Or can we just depend on the instrument's IQ/ OQ documentation + the calibration certificate?

Answer

Particle counters have been in use for several decades, so proof of method should not be required. The underlying technology is essentially unchanged; only the user interface and reliability has changed. Providing the particle counter has been validated as suitable for the purpose for which it is intended to be used (counting particles) and an SOP is followed for its use, then this is suitable for its employment. For continued compliance, the calibration certificate then proves that the counter meets all required conditions to count particles accurately.

For more information on this, including applicable graphs and images, read our paper Particle Monitoring Requirements in Pharmaceutical Cleanrooms.