Cleanroom Certification and Testing
Cleanrooms are rooms designed, constructed, and operated to control the concentration of airborne particulates within the room. Control of airborne particulate concentrations is accomplished using engineering controls such as HEPA-filters and airflow design parameters, including unidirectional and non-unidirectional airflow. Cleanrooms may also incorporate additional design considerations such as hazardous particulate containment, temperature/humidity control, and electrostatic discharge (ESD) protection. To verify that a cleanroom facility is performing within operational limits and applicable cleanroom classifications, routine certification must be performed in accordance with client, industry, and regulatory specifications.
Our cleanroom certification services include electronic documentation created with eData, TSS' proprietary, 21 CFR Part 11– compliant data collection software. Cleanroom testing documentation is delivered at the conclusion of service. An optional formal summary report detailing all test procedures, associated diagrams, results, and comprehensive conclusions may be included and customized to suit your quality documentation needs.
As one of the top cleanroom certification companies, all cleanroom performance testing is performed by our highly qualified technicians in accordance with current good manufacturing practices [cGMP], Institute of Environmental Sciences Technologies [IEST], International Organization for Standardization [ISO], and any applicable customer design specifications.
Our primary cleanroom services for testing and certification include:
- Airflow volume and velocity measurments – ensures both unidirectional and non-unidirectional flow areas are properly balanced and unidirectional zones maintain proper airflow patterns
- Room air exchange rate [RAER] – confirms that proper ventilation rates are achieved
- Room differential pressure testing – verifies room differential pressures meet design requirements
- HEPA filter integrity testing – detects defects or damage in the filter media and verifies proper installation by identifying bypass leakage.
- Nonviable particle counting – conducted per ISO 14644 or EU Annex 1, reporting airborne particulate concentrations at specified particle sizes, cleanliness class limit/grades, and operational states.
- Temperature and relative humidity measurement – confirms whether HVAC controls are functioning properly and uniformly
Optional tests include:
- Airflow visualization studies – qualitatively verifies airflow patterns using a neutrally buoyant visible medium
- Viable environmental monitoring [EM] – performed in both air and on surfaces to detect bacterial and/or fungal contamination
- Compressed air and gas testing – evaluates system suitability for cleanroom environments, including nonviable and viable particulate, total hydrocarbon (oil), and dew point testing
- Lighting, vibration, and sound testing – performed against design specifications to support operator comfort and functionality
- Room recovery testing – determines whether an area can return to a specified cleanliness level following non-routine exposure events
Additional testing may be performed as specified by client requirements and/or applicable ISO or IEST guidelines.
Make TSS your first call for all your cleanroom facility testing, cleanroom certification, biological safety cabinet validation, compressed gas system testing, and controlled environment needs. CONTACT US ONLINE or call 866-280-3114 to discuss your specific regulatory compliance needs and to schedule service.
With every service call, TSS offers you
- Responsive service to minimize downtime
- Customized documentation and technical writing services
- Online access to your equipment inventory and certification
- The assurance of an ISO 9001-certified business
