The Challenge

During the SARS-CO-V2 pandemic, Pfizer realized the need for its first BSL-3 laboratory in the United States. The project required design, construction, and commissioning of a BSL-3 laboratory in nine months during a global pandemic. The usual time for this work under normal circumstances is approximately two years.

The Solution

A design-build model was implemented to fast-track the design and construction of the laboratory. World BioHazTec participated in the Detailed Design Phase as a BSL-3 Subject Matter Expert. We leveraged our design experience to recommend cost effective solutions to avoid or resolve design issues prior to or during the construction and commissioning phases. We worked with Pfizer, architects/engineers and key contractors to review the design/construction documents and schematics. Acceptable commissioning criteria were discussed, including critical component verification, HVAC failure scenarios, and the impact of each BSL-3 module based upon humidity, airflow, and temperature. We identified proper conditions to pass commissioning and validation testing of facility systems. We also assisted in the development of the schedule and critical path milestones.

World BioHazTec oversaw all phases of the design and construction processes and executed the commissioning of this facility. The culmination of this process was the testing of the engineering controls of the laboratory to maintain containment under various failure conditions. The construction process proceeded with a focus on a high level of aseptic finishes, sealing the containment envelope and a robust HVAC System to consistently provide directional airflow.

As the commissioning phase proceeded, we developed the BSL-3 Biosafety Manual and SOPs for Pfizer within eight weeks as compared to the usual minimum of approximately six months. Through rigorous planning and collaboration, we tasked a project manager and two biosafety professionals to have weekly meetings with the biosafety officer to discuss protocols around biosafety, biosecurity, and biorisk. World BioHazTec generated site specific SOPs and protocols that were reviewed and approved by Pfizer.

The Result

World BioHazTec commissioned the BSL-3 Vaccine Laboratory within the nine-month deadline. The laboratory meets and exceeds the high containment laboratory BSL-3 acceptance criteria as put forth by the U.S. Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH) and the ANSI/ASSP Z9.14-2020 Standard.

World BioHazTec continues to provide certification of this and all containment laboratories at Pfizer.