Cleanroom Testing and Certification

Cleanrooms, by definition, are designed to control airborne particulate and environmental conditions. Cleanrooms can be positive or negative pressure environments that sweep a specified area with HEPA filtered air. Critical pharmaceutical, microbiological, and nanotechnological areas require adherence to exacting performance requirements. TSS’ certification programs verify that your facilities perform to appropriate international standards and client specifications. Included with all testing is complete documentation of the test results and certification of the rooms and devices tested. An optional, customized formal report detailing test procedures, test results, and comprehensive conclusions of the testing performed can be included to suit your needs. All cleanroom testing is performed in accordance and compliant with Current Good Manufacturing Practices [cGMP], Institute of Environmental Sciences Technologies [IEST], and International Organization for Standardization [ISO].

Our primary cleanroom testing battery includes:

• Airflow volume and velocity readings - assures that both unidirectional and non-unidirectional flow areas are properly balanced and unidirectional zones are maintaining proper air patterns
• Room air exchange rates - states if the area is meeting its design airflow
• HEPA filter integrity testing - tests HEPA filters and system for leaks
• Non-viable particle counting - reports the amount of airborne particulate of a specified size in the clean zone
• Temperature / relative humidity testing - examines whether the air HVAC controls are functioning properly and uniformly
• Pressure cascade monitoring - verifies that room differential pressures are operating according to design

Optional tests include:

• Air balancing - adjusts airflow in the air handling systems to achieve design airflow, room air exchange rates, and pressure cascade
• Airflow visualization testing – qualitatively verifies airflow direction using a source of visible fog
• Viable environmental monitoring [EM] - samples both the air and surface for microbe enumeration and identification
• Compressed gas testing [compressed dry air (CDA) testing] – assures that the compressed gas sources meet the requirements of the controlled environment for contamination and microorganisms
• Lighting, vibration, and sound tests – assures worker comfort
• All other special tests from the ISO/IEST guidelines

Make TSS your first call for all your controlled environment needs. Contact us at 1.800.877.7742, or directly at our nearest regional office, to discuss your specific needs and to schedule services.

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 most comprehensive quality system in the industry

Contact your regional TSS office today!