Qualification of the cleanroom and other facilities.

All cleanroom facilities built according to current EN ISO 14644 standard have to be tested and approved in accordance with this standard. The following values are measured for all our cleanrooms:

– number of particles (determining ISO class)

– temperature

– humidity

– positive pressure

– ventilation rate (determining ISO class)

– noise level

Cleanrooms and facilities according to GMP have to be qualified and cleanroom processes have to be validated. Qualification is the documented evidence that the facility is suitable for the intended use.

This includes:

– specification and requirements sheets

– risk analysis

– qualification and validation master plans

– design qualification (DQ)

– installation qualification (IQ)

– operational qualification (OQ)

– performance qualification (PQ)

– microbiological tests and analyses

– calibration

– maintenance

– process validation

– cleaning validation

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