U.S. FOOD AND DRUG ADMINISTRATION
FORENSIC CHEMISTRY CENTER
Cincinnati, Ohio, USA
We are your partner in
achieving groundbreaking
research while practicing
safe science.
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. World BioHazTec 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
Centers for Disease Control (CDC) and the National Institutes of Health’s (NIH) Biosafety in Microbiological and Biomedical Laboratories Guidelines (BMBL)
NIH BSL-3 Laboratory Certification Requirements and Checklist
75,000
Gross Square Feet
BSL-3
Containment Level
Project Details
Our professionals conducted a thorough inspection of the BSL-3 laboratory’s engineering systems and validated these controls. To achieve certification World BioHazTec 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 World BioHazTec’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.
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 World BioHazTec’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.
Headquarters
5105 Rae Court NE
Rio Rancho, NM 87144
5105 Rae Court NE
Rio Rancho, NM 87144
East Coast Headquarters
329 Steedman Point Road
Pasadena, MD 21122
329 Steedman Point Road
Pasadena, MD 21122
Phone: (202) 247-0589
Email: info@worldbiohaztec.com
Email: info@worldbiohaztec.com