Tecomak has been providing validation and maintenance solutions to the Pharmaceutical and BioTech Industry for 15 years, including cleanroom services.

  • 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
  • Airflow visualisation
  • 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:

  • ISO 14644

  • EU GMP
  • IEST-RP-CC006.3
  • Federal Standard 209E
  • Other corporate SOPs

Our Documentation:

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.

Minimising Production Downtime:

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.

Combined Validation and Maintenance

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.