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:

  • DIN EN ISO 14644
  • EU GMP Guideline Annex 1
  • VDI 2083
  • DIN EN 17141
  • DIN 1946
  • ZLG document

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