The Challenge

The FDA’s BSL-3 laboratory at the Federal Research Center is required to meet the CDC’s Federal Select Agent Program requirement to have the facility’s design, operational parameters and procedures verified annually. FDA has the profound responsibility to maintain the BSL-3 facility that stores and works with high-risk pathogens as this laboratory serves as a vital hub for the United States public health preparedness.

The Solution

In a proactive move to underscore the FDA’s unwavering commitment to biosafety and biosecurity standards, World BioHazTec was enlisted to verify the safety compliance of their BSL-3 laboratory. Leveraging our specialized equipment, we conducted verification testing during off-peak business hours to minimize any disruption to ongoing operations.

Our team of engineers conducted a thorough physical inspection of the facilities, identifying safety hazards and pinpointing areas of non-compliance. We then put the laboratory’s secondary containment integrity to the test by evaluating spatial pressure relationships and conducting directional airflow challenges. Throughout the process, we closely monitored HVAC failure responses using our state-of-the-art equipment. All data collected was analyzed by our team of engineers to ensure compliance with regulatory standards.

The Result

World BioHazTec successfully tested the facility over a two-day period. World BioHazTec certified the BSL-3 laboratory per the requirements set forth by the Centers for Disease Control and Prevention (CDC), and National Institutes of Health (NIH) so that research can be performed safely and infectious agents can be contained.