Cleanroom Certification and Testing
Cleanrooms are rooms designed, constructed, and operated to control the concentration of airborne particulates within the room. The control of airborne particulate concentrations can be accomplished using engineering controls such as HEPA-filters and airflow design parameters such as unidirectional and non-unidirectional airflow. Cleanrooms can also incorporate additional design considerations such as hazardous particulate containment, temperature/humidity control, and electrostatic discharge (ESD) protection. To verify a cleanroom is performing within operational limits, a certification must be routinely performed to ensure 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 of the testing performed may be included and customized to suit your quality documentation needs.
As one of the top cleanroom certification companies, all cleanroom 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 testing and certification services include:
- Airflow volume/velocity readings – ensures both unidirectional and non-unidirectional flow areas are properly balanced and unidirectional zones are maintaining proper airflow patterns
- Room air exchange rate [RAER] – confirms a proper ventilation rate is being achieved
- Room differential pressure testing – verifies room differential pressures meet design requirements
- HEPA filter testing – detects any defects or damage in the filter media and ensures filters are properly installed by detecting bypass leakage.
- Non-viable particle counting – conducted per ISO 14644 or EU Annex 1, reports the concentration of airborne particulates at a specified size, class limit/grade, and operational status.
- Temperature/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 determine if any bacterial and/or fungal contamination is present
- Compressed air and gas testing – ensures compressed air and gas systems meet the requirements of the controlled environment, testing includes: non-viable and viable particulate, total hydrocarbon (oil), and dew point determination
- Lighting, vibration, and sound tests – performed to design specifications to ensure worker comfort
- Room recovery testing – performed to determine whether an area is adequately capable of returning to a specified cleanliness level after non-routine exposure events
- TSS can perform additional testing as specified by client and/or ISO/IEST guidelines
Make TSS your first call for all your cleanroom testing, cleanroom certification, compressed gas system testing, and controlled environment needs. CONTACT US ONLINE or call 800-877-7742 to discuss your specific 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
