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The Critical Role of a Commissioning Agent in BSL-3 Laboratory Design and Operation

January 22, 2025

The commissioning agent plays a vital role in ensuring the BSL-3 laboratory operates safely, effectively and meets the design intent. This subject matter expert is responsible for rigorously challenging a new or renovated laboratory’s critical MEP systems and other containment features.

A commissioning agent’s expertise goes beyond just testing equipment; they ensure that all systems work together as intended under real-world operating conditions. By simulating potential failures through Integrated Systems Functional Performance Tests (ISFPTs), conducting performance verification tests, and ensuring compliance with biosafety standards, the commissioning agent confirms that the facility is ready for safe operation.

It is ideal to involve the BSL-3 commissioning agent as early as possible in the programming/design phases of the laboratory. Early engagement ensures that critical building systems and operational requirements are seamlessly integrated into the design, reducing the likelihood of costly modifications or delays later in the project. As a rule of thumb, the commissioning agent should consist of a multidisciplinary team of engineers and biosafety professionals. This combination of expertise ensures not only a deep understanding of critical building systems, such as HVAC, pressure controls, and decontamination systems, but also the ability to translate scientific and biosafety requirements into practical, effective design solutions. By incorporating their insights from the outset, the project team can align the laboratory’s design with its functional and safety goals, paving the way for a smooth commissioning process and long-term operational success.

The commissioning process involves detailed documentation, culminating in a comprehensive report that extends beyond a simple compilation of test results. This report includes ISFPT (Integrated Systems Functional Performance Testing) sheets, detailed risk assessments, graphical depictions of directional airflow and laboratory layout, validation checklists, calibration verification, differential pressure readings under normal and abnormal conditions, annotated photographs, quality improvement recommendations, and certificates for the equipment used during data collection. Serving as both a record of compliance and a valuable resource, the report provides critical guidance for future maintenance, certification/recertification, and continuous quality improvement.

Choosing an experienced commissioning agent is essential to the success of your BSL-3 laboratory project. The ideal candidate should have a strong background in biosafety, engineering, and regulatory compliance, along with a proven track record of commissioning high-containment facilities. Collaborating with a knowledgeable third-party commissioning agent ensures that your laboratory is not only operationally sound but also fully compliant with all relevant guidelines and regulations.

It’s important to select a commissioning agent who routinely visits BSL-3 laboratories for annual HVAC verification and validation testing. This hands-on experience provides critical insights into how laboratories operate over time, which can be applied during design, construction, and of course commissioning. A seasoned commissioning agent understands these lessons learned to optimize your laboratory’s functionality, safety and sustainability. Their expertise ensures your facility is built to meet both current and future demands.

Investing in the right BSL-3 commissioning expert is a crucial step toward achieving a successfully laboratory project, ensuring that the facility meets its design intent, safeguarding both personnel and the environment while supporting the laboratory’s research objectives. To learn more about World BioHazTec’s commissioning approach, contact us for a free consultation.



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