8.2.17 For a pharmaceutical facility, based on a risk assessment, some of the typical HVAC system parameters that should be qualified may include:

- temperature

- relative humidity

- supply air quantities for all diffusers

- return air or exhaust air quantities

- room air change rates

- room pressures (pressure differentials)

- room airflow patterns

- unidirectional flow velocities

- containment system velocities

- HEPA filter penetration tests

- room particle counts

- room clean-up rates

- microbiological air and surface counts where appropriate

- operation of de-dusting

- warning/alarm systems where applicable.