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Cleanroom qualification

Not only can we help you with your initial cleanroom qualification, but we can also carry out any necessary re-qualifications. Our experienced service engineers provide professional support, carry out particle measurements in the cleanroom and other tests, and record the results. They can also provide fast, reliable maintenance and replacement of filter systems.

Request qualification

We are happy to carry out the qualification of your cleanroom. Qualification measurements are charged transparently per measurement point with no hidden costs.  Do you have any questions? Contact us, we will be happy to advise you!

Particle measurements

For your cleanroom classification, we perform particle measurements that determine the number and size of particles per cubic metre:
• Determination of the cleanroom class
• Recovery Test
• Integrity test / filter leak test

Flow measurements

Measurements and visualisations of airflows for cleanroom qualification:
• Measurement of air velocity
• Measurement of air volume flow
• Calculation of air exchange rate
• Proof of the uniformity of velocity
• Flow visualisations

Climate measurements

Some applications require temperature and humidity control. We can take the room measurements for you:
• Individual measurements temperature
• Individual measurements of relative room humidity

Other measurements

We can also help you measure and test your cleanroom further:
• Measurement of sound pressure level
• Measurement of illuminance
• Airborne germ measurement
• Area germ measurement
• Measurement of dissipative capacity of the floor
• Component testing

Pressure measurements

We demonstrate compliance with the specified pressure and pressure cascades for cleanroom qualification:
• Proof of differential pressure cascades
• Differential pressure measurement on filters


Cleanroom qualification ensures that the cleanroom meets its specific requirements. Qualification tests are carried out by our experienced service engineers in accordance with DIN EN ISO 14644 and EU GMP guidelines and recorded in detailed GMP documentation. All work steps, test procedures and readings are traceable for external inspection bodies.



Re-qualification is carried out to demonstrate that the cleanroom facility is still in a qualified state after modifications. Requalification is also required as part of periodic revalidation. Particle measurements for room qualification must be repeated every 6 or 12 months, depending on the zone.

Cleanroom qualification
Your advantages at a glance

  • Initial Qualification and Re-Qualification
  • According to EU GMP guidelines and  ISO 14644
  • GMP documentation
  • Transparent billing per measurement point
  • Expertise from experienced service engineers
  • Proportionate travel costs due to bundled assignments



Cleanroom qualification is a procedure for checking and documenting compliance with cleanroom classes in accordance with specific standards. The standards specify the requirements for particle concentration, air exchange rate, temperature, humidity and other parameters in a cleanroom. The most important standards for cleanroom qualification are ISO 14644-3, VDI 2083 and the GMP Annex 1 guideline.

The aim of a cleanroom qualification is to ensure that the cleanroom is suitable for the intended purpose and guarantees the desired quality of the products or processes. The qualification is documented proof that the cleanroom system is planned, built, installed and operated in accordance with user requirements and the applicable regulations.

The requalification of a cleanroom is carried out to check its performance and compliance with the specified standards for the cleanroom class. Requalification must be carried out at regular intervals to ensure that the cleanroom fulfills its function and does not cause contamination. The frequency of requalification depends on various factors, such as the type of activities in the cleanroom, the requirements of customers or authorities, the results of routine monitoring and changes to the system or equipment. We recommend that requalification is carried out at least once a year.

In ISO, it is usually sufficient to carry out and record a qualification in accordance with ISO 14644-3. The resulting qualification protocol then serves as documented proof. 
In the GMP area, the requirements are more stringent and the result of each test should be documented according to a predetermined procedure and released for the next step: 
DQ: Design Qualification = Design Qualification
IQ: Installation Qualification = Installation Qualification
OQ: Operational Qualification = Functional Qualification
PQ: Performance Qualification = Performance Qualification

The classification of a cleanroom into a specific class is based on precise particle measurements in the cleanroom, which record the concentration of particles in the air. These measurements are typically carried out using a laser particle counter to ensure that the number of particles in the air does not exceed the limits set for the relevant ISO or GMP classification. By strictly controlling and minimising these particles, a cleanroom will maintain its classification, which is essential for maintaining the required standards of cleanliness in sensitive production and research environments.

Why we are the right partner for you?

We are fit for the future.
Our family business is already in its second generation. So you can continue to count on us in the future and in the long term.

We work sustainably.
Over the years, we have trimmed our technology for maximum energy efficiency. Thanks to modularity, our systems are also sustainably designed for adaptations and expansions in the future.

We offer safety.
Our first priority is safety in terms of processes, people and the product. In each project, we seek the ideal balance between state-of-the-art technologies and proven engineering.