The Forensic Chemistry Center (FCC) serves as the FDA’s premier national forensic laboratory for method development, research, and analyses related to criminal, regulatory, and counter terrorism investigations. The BSL-3 laboratory is available for the safe analysis of unknown, high-risk samples. CRC was selected to evaluate the BSL-3 laboratory’s true ability to meet system reliability and operational requirements based upon the following guidelines:
- World Health Organization’s Laboratory Biosafety Manual, 3rd Edition
- Centers for Disease Control (CDC) and the National Institutes of Health’s (NIH) Biosafety in Microbiological and Biomedical Laboratories Guidelines (BMBL), 5th Edition
- NIH BSL-3 Laboratory Certification Requirements and Checklist
Our professionals conducted a thorough inspection of the BSL-3 laboratory’s engineering systems and validated these controls. To achieve certification CRC conducted directional airflow challenges to address airflow reversals. The operation of the Building Automation System (BAS) was witnessed. HVAC and exhaust systems failure responses were tested. The emergency power system was tested under load conditions and effects on the ventilation system was recorded. Noise levels were evaluated. Bioseals were evaluated and tested. Lighting levels were measured. Accuracy of differential pressure monitors was tested. A thermal imaging assessment for penetrations was conducted. Airflow and airflow patterns were observed and measured and spatial pressure relationships were recorded. Laboratory operations and equipment were evaluated. Inspection of the mechanical equipment operation was made. HEPA filtration caissons and their certification reports were evaluated.
The final component of the certification required an assessment of the safety management system. A risk analysis of laboratory engineering controls was performed. Documentation and record keeping was verified. Safety design features and controls were evaluated. Upon completion of CRC’s assessment, we provided a Certification Assessment Report and Certificates of Compliance to the FDA which included quality improvements and suggestions so that the BSL-3 laboratory can exceed the regulatory guidelines.