Cleanroom Certification &
Environmental Testing Services

Comprehensive testing performed in accordance with current industry standards and regulatory requirements, including USP <797>, USP <800>, ISO 14644-1, IEST-RP-CC035, ANSI/AIHA Z9.5, and NSF/ANSI 49.

HEPA Filter Testing

We perform comprehensive HEPA filter testing across a wide range of installations, including:

  • Filter integrity (aerosol leak) testing

  • Airflow velocity measurements

  • Airflow uniformity analysis

All testing is conducted in accordance with IEST-RP-CC035 to ensure proper filtration performance and compliance.

Room Pressure & Airflow Analysis

We evaluate and verify environmental controls within cleanrooms by:

  • Measuring and adjusting room pressure differentials to maintain proper cascading pressure relationships

  • Ensuring directional airflow meets regulatory requirements

  • Calculating air changes per hour (ACH) to confirm minimum ventilation rates

All work is performed to meet the requirements of USP <797> and USP <800>.

Cleanroom Classification

We perform cleanroom and controlled environment classification in accordance with ISO 14644-1, including:

  • Airborne particle counting

  • Determination of ISO classification levels

  • Verification of compliance for cleanrooms, clean areas, and controlled environments

Primary Engineering Control Certification

We test and certify critical airflow equipment to ensure performance and containment:

  • Laminar Flow Hoods (LAFWs): Airflow velocity, HEPA filter integrity, and unidirectional airflow verification in alignment with ISO 14644-1

  • Fume Hoods: Face velocity and airflow performance testing in accordance with ANSI/AIHA Z9.5 using non-tracer gas methods

  • Biological Safety Cabinets (BSCs): Full certification including inflow/downflow velocity, HEPA filter integrity, and containment testing per NSF/ANSI 49

Viable Environmental Monitoring

We conduct microbial (viable) environmental monitoring to evaluate cleanroom contamination control:

  • Air and surface sampling using validated growth media

  • Sampling performed in accordance with established SOPs

  • Incubation and analysis for colony-forming units (CFUs)

  • Documentation and evaluation against action levels defined by USP <797>

Ready to schedule your certification?

Every facility is different. Contact us to discuss your testing needs and we'll put together the right plan for you.

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