A cleanroom or other such controlled environment is designed and constructed to control the concentration of airborne particulates. Environmental factors which may need to be controlled are: airflow, differential pressure, microbes, temperature and relative humidity.
We understand the importance of your cleanroom conforming to regulatory standards including: ISO 14644:2015 and to the guidelines of agencies such as the MHRA and FDA.
All our engineers are CTCB-I qualified with a wealth of experience working within critical environments. At Crowthorne Group we want to ensure that any performance testing or maintenance within your cleanroom creates minimal disruption to your processes, production, and lab activities.
Crowthorne Group are independent from any designer, builder or equipment manufacturer, so there is no doubt that our testing, results and subsequent reports are completely unbiased.
Classifying your cleanroom
Facilities designed for pharmaceutical development or manufacturing, need to conform to either CGMP and/or ISO 14664:2015.
All cleanrooms have a classification which is determined by the concentration of airborne particles, ranging from 0.1μm to 5μm. Nanoparticles which are smaller than 0.1μm and macroparticles which are larger than 5μm are not covered within this range, however more information on these particle sizes is available upon request.
Cleanroom Validation Tests
Measuring the performance of your cleanroom or controlled environment is crucial when you need to regulate the level of airborne particulate contamination. Depending on your specific requirements, some or all of the following performance tests would form part of the annual or routine validation testing.
|Airborne particle concentrations (particle counting)||to ensure the concentration of particles is in line with the room’s classification|
|Pressure differential||to ensure the correct direction of airflow throughout the cleanroom|
|Airflow velocity||for unidirectional air supply (and extract?)|
|Airflow volume||for non-unidirectional air supply (and extract?)|
|Recovery rate||to ensure the integrity of HEPA filters using either dispersed oil particulate (DOP) or discrete particle count (DPC) testing|
|Filter leak testing||to review how quickly the facility recovers following a contamination release|
|Containment leak||to check the construction of the facility during high pressure works|
|Airflow visualisation||to ensure the movement of air is sufficient|
|Temperature & humidity||to/for…|
|Noise, light & vibration||levels to/for…|
|Compressed air testing||to/for…|
|Microbiological air sampling||to/for…|
Frequency of Services
|Perfomance test||Classification of Facility||Maximum Interval Between Tests|
|Airborne particle concentrations (particle counting)||< ISO Class 5||6 months|
|Airborne particle concentrations (particle counting)||> ISO Class 5||12 months|
|Pressure differential||All classes||Continuously monitored|
|In situ filter leak/integrity (DOP testing)||< ISO Class 5||Item #1|
|In situ filter leak/integrity (DOP testing)||> ISO Class 5||12 months|
|Airflow velocities in unidirectional airflow||All Classes||6 months|
|Airflow volume supply in non-unidirectional airflow||All classes||12 months1|
Additional performance tests such as airflow visualisation, particle deposition rates, recovery rate and containment leak should be undertaken during commissioning and every 4 years thereafter, unless significant changes have been made to the airflow system or facility. Temperature and humidity are measured as required, subject to the requirements of the cleanroom user.