What is a qualification?
The qualification of cleanrooms and controlled environments is an essential step in guaranteeing conditions that comply with the relevant standards. regulatory requirements and specific requirements hospitals, laboratories and the pharmaceutical industry.
The aim of qualification is to ensure that these rooms comply with current standards (ISO 14644, GMP, NF S90-351, etc.) through a series of tests, measurements and inspections.
Particle counting
Measurement of airborne particle concentrations to check compliance with air cleanliness classes
Air measurements
Control of air flows (unidirectional or not), speeds, flow rates and differential pressure to ensure proper air renewal and circulation.
Biocontamination control
Air and surface sampling to assess the presence of viable particles (bacteria, mold).
Air flow visualization
Use smoke to analyze the direction and laminarity of air flows, as well as the absence of dead zones or turbulence.
HEPA and ULPA filter integrity tests
Check filter efficiency to ensure optimum filtration
Measuring environmental parameters
Check temperature, humidity, brightness and noise levels.
Cleanroom qualification is based on a series of rigorous analyses and checks to ensure that facilities comply with current standards.
It guarantees control of contamination risks and optimization of environmental conditions for sensitive activities. Here are the main stages and services involved in qualification
Particle counting
Measurement of suspended particle concentrations to check compliance with air cleanliness classes.
Air measurements
Control of air flows (unidirectional or not), speeds, flow rates and differential pressure to ensure proper air renewal and circulation.
Biocontamination control
Air and surface sampling to assess the presence of viable particles (bacteria, mold).
HEPA and ULPA filter integrity tests
Check filter efficiency to ensure optimum filtration.
Air flow visualization
Use smoke to analyze the direction and laminarity of air flows, as well as the absence of dead zones or turbulence.
Measuring environmental parameters
Check temperature, humidity, brightness and noise levels.
Complementary service to our qualification service
Our commitment
Why choose Igienair?
By choosing IGIENAIR for your qualifications, you benefit from :
- Recognized expertise in controlled environments.
- Customized support, adapted to the specific requirements of your sector.
- State-of-the-art equipment and a qualified team to guarantee reliable, standard-compliant results.
- A pre-report immediately following the end of the intervention, followed by the final report within 24 hours.
French 
English