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 specialist support, carry out particle measurements at Cleanroom and other tests, and record the results.
We are happy to carry out the qualification of your cleanrooms. 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 at Cleanroom, which 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
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 verify 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 at your Cleanroom:
- Sound pressure level measurement
- Illuminance measurement
- Air germ measurement
- Area germ measurement
- Measurement of soil drainage capacity
- Component testing
Air flow in the double glazing
To illustrate the air flow, we held a nebulizer to the overflow opening of a fully glazed external wall. The recirculated air flow moves upwards inside the walls to the FFUs, where the air is recirculated back into the Cleanroom. We are also happy to offer flow visualizations for your Cleanroom.
FAQ
Qualification
What is a cleanroom qualification?
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.
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 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 system or equipment. We recommend that requalification is carried out at least once a year.
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 is the required cleanroom classification ensured by particle measurement in Cleanroom?
The classification of a cleanroom into a specific class is based on precise particle measurement at Cleanroom, where the concentration of particles in the air is recorded. 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 an essential prerequisite for maintaining the required cleanliness standards in sensitive production and research environments.