Facility control and validation

Regulating authorities in sectors in which clean rooms are necessary require proof that the processes and equipment employed produce results that comply with applicable legislation. 

Obtaining this proof is generally referred to as Validation or Qualification and is the result of a number of checks performed on the facility:

• HEPA filter leak and integrity test.
• Filter pressure loss calculation.
• Air velocity test.
• Count of number of different-sized particles in suspension in the volume of air in the room.
• Renewals/hour calculation.
• Differential pressure measurements.
• Relative humidity and temperature.
• Lighting level.
• Noise level.
• Classification under at-rest conditions.

On successful completion, a validation certificate stating the results obtained is issued.

Validation is performed whenever there is a prolonged stoppage of the facility, the HEPA filters are changed or production quality needs to be checked.