A cleanroom or other such controlled environment is designed and constructed to control the concentration of airborne particulates, at Crowthorne we work to test, service and classify your cleanroom.
We understand the importance of your cleanroom conforming to regulatory standards including: ISO 14644:2015 and to the guidelines of agencies such as the Medicines and Healthcare Products Regulatory Agency (MHRA) and the Food and Drug Administration (FDA).
At Crowthorne we want to ensure that any performance testing or maintenance within your cleanroom creates minimal disruption to your processes, production, and lab activities. To that end, all our engineers are Cleanroom Testing and Certification Board (CTCB-I) qualified and have a wealth of experience working within critical environments.
Crowthorne are independent from any designer, builder or equipment manufacturer, so you can be in no doubt that our testing, results and subsequent reports are completely unbiased.
Classifying your cleanroom
We understand the various cleanroom classifications and can advise on yours.
- 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)||Ensures the concentration of particles is in line with room classification|
|Pressure differential||Ensures the correct direction of airflow throughout the cleanroom|
|Airflow velocity||Ensures adequate air velocity to maintain correct pressure within the facility|
|Airflow volume||Ensures correct airflow volume as specified within relevant standard|
|Recovery rate||Ensures integrity of HEPA filters using either dispersed oil particulate (DOP) or discrete particle count (DPC) testing|
|Filter leak testing||Review how quickly the facility recovers following a contamination release|
|Containment leak||Check the construction of the facility during high pressure works|
|Airflow visualisation||Ensure the movement of air is satisfactory using smoke to visualise|
|Temperature & humidity||Ensures correct temperature and levels of humidity|
|Noise, light & vibration||Ensures correct noise, light and vibration levels as per relevant standard or on site operating procedures|
|Compressed air testing|
|Microbiological air sampling|
Frequency of Services
|Performance 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|
|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.