Cleanroom qualification
We are not only there for you during the initial cleanroom qualification , but also carry out the necessary requalifications. Our experienced service technicians offer you technical support, carry out particle measurements in the cleanroom and other tests and record the results.
We are happy to carry out the qualification of your cleanrooms. We not only qualify our own systems, but are also there for you for the qualification and requalification of cleanrooms from other providers. Qualification measurements are billed transparently per measuring point with no hidden costs.
Qualification and requalification
Our service - your benefits
- In accordance with EU GMP guidelines and DIN EU ISO 14644
- GMP documentation
- Transparent billing per measuring point
- Expertise from experienced service technicians
- Proportionate travel costs due to bundled assignments
Our service for you
Particle measurements in the cleanroom
As part of the qualification process, we carry out particle measurements in the cleanroom to determine the number and size of particles per cubic meter:
- Determination of the cleanroom class
- Recovery time measurement / recovery test
- Integrity test / filter leak test
- Clean-up measurement
Flow measurements
Measurements and visualizations of air flows for cleanroom qualification:
- Measurement of the air velocity
- Measurement of the air volume flow
- Calculation of the air exchange rate
- Proof of the uniformity of the speed
- Flow visualizations
Climate measurements
For some applications, temperature and room humidity must be controlled. We carry out the room measurements for you:
- Individual temperature measurements
- Individual measurements of relative room humidity
Pressure measurements
We demonstrate compliance with the specified pressure and pressure cascades for the qualification of cleanrooms:
- Verification of the differential pressure cascades
- Differential pressure measurement on the filters
Other measurements
We are also there for you for further measurements and tests in your cleanroom:
- Sound pressure level measurement
- Illuminance measurement
- Air germ measurement
- Area germ measurement
- Measurement of soil drainage capacity
- Component testing
Visualization of the air flow
We are happy to offer flow visualizations for your cleanroom.
Mist generators and video recordings are used to visualize and test the air flows within the cleanroom.
FAQ
Qualification
What is a cleanroom qualification?
Cleanroom qualification is a procedure for checking and documenting compliance with defined parameters. The parameters are designed based on the required quality for the product or personal protection and comfort. Standards such as ISO 14644 or VDI 2083 or GMP Annex 1 can be used as a basis for defining e.g. particle limit values, air exchange rates, recovery times etc.
Why is cleanroom qualification necessary?
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.
Why and how often must a requalification be carried out?
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 facility or equipment. We recommend that requalification is carried out at least once a year. Our overview shows the recommended intervals.
What standards are used for cleanroom qualification?
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
How does particle measurement in the cleanroom ensure the required cleanroom classification?
The classification of a cleanroom into a specific class is based on precise particle measurement in the cleanroom, which records 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 present in the air does not exceed the limits set for the relevant ISO or GMP classification. By strictly controlling and minimizing these particles, a cleanroom will meet its classification, which is essential for maintaining the required cleanliness standards in sensitive production and research environments.