We specialise in cleanroom validation for MHRA licensed facilities and offer a complete range of performance tests including:
Airflow volume flow measurement and air change rate calculation
Unidirectional airflow velocity measurement
HEPA filter integrity testing (DOP and Particle Count)
Room differential pressure measurement
Non-viable airborne particulate monitoring
Clean-up recovery test
Temperature and humidity monitoring and uniformity mapping
Containment and induction leak test
Our professionally qualified test engineers are able to offer comprehensive cleanroom validation to the requirements of all current standards and guidelines including:
Federal Standard 209E
Other corporate SOPs
We take pride in producing professional, well structured reports to ensure your audits are trouble free.
Our reporting format is completely flexible and will include:
Concise summary of results.
Defined acceptance criteria for each test conducted.
Detailed, site specific test methods.
Layout drawings of the facility indicating location of test measurements.
Test certification with full results and raw data collected.
Calibration certificates for all test equipment used.
Report conclusion and recommendations.
Reports can be compiled, quality checked and issued whilst on site to speed the validation and approval process.
Our cleanroom validation teams can work shift patterns through the night if necessary to ensure minimum plant downtime. We use the latest, high flow particle counting equipment and statistical analysis software to reduce sampling times.
Achieving cleanroom certification is made far easier and much more certain when included as part of a regular, ongoing clean room maintenance schedule. Tecomak can provide a full maintenance, repair and upgrade service including scheduled maintenance visits and emergency call out. A scheduled maintenance programme ensures any problems are picked up and rectified at an early stage, ensuring GMP cleanroom compliance as well as keeping your facility up and running.
Comprehensive Clean Room Services
Clean Room Decontamination
Clean Room Certification
Clean Room Maintenance
Clean Room Ventilation
Clean Room Testing
Airflow Visualisation – Airflow Design in Clean Rooms
Hydrogen Peroxide Decontamination