Cleanroom qualification

The cleanroom is a controlled environment in which the concentration of particles, microorganisms and other impurities is kept at an extremely low level. Such environments are essential in a wide range of industries, including pharmaceuticals, microelectronics, the food industry and medical technology. In these areas, even the slightest contamination can impair product quality, safety and performance.

Cleanroom qualification and requalification

Cleanroom qualification is the process of ensuring that a cleanroom meets the specified standards. It includes an assessment and monitoring of environmental conditions, including air quality, temperature, humidity and pressure differences.
A cleanroom qualification comprises three levels: (IQ, OQ, PQ) (as built, at rest, in operation).

For qualification purposes, we differentiate between physical and microbiological tests/measurements/sampling:

Particle measurement of the room or supply air
Air flow and air exchange rate
Uniformity of the air flow
Flow visualization
Differential pressure / displacement flow
Temperature and relative humidity
Sound pressure level
Filter leak test
Recovery time
Microbiological air analysis
Microbiological surface examination
Microbiological workplace testing
Compressed gas quality

Cleanroom requalification requires regular repetition and confirms that your production environment continues to maintain the required cleanliness standards. During requalification, the tests carried out when the cleanroom was commissioned serve as a database.

In accordance with the guidelines, we recommend that you schedule a regular review (e.g. 1x / 2x per year) to ensure that your qualifications are always up to date.

Changes to the production environment, e.g. due to structural changes or changes to the air conditioning system, require a new cleanroom qualification.

According to standards: