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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Celebrating 30 Years of Excellence: World BioHazTec’s Journey in Biosafety and Biosecurity
For three decades, World BioHazTec has been at the forefront of biosafety and biosecurity consulting, helping countless organizations meet rigorous standards and create safer laboratory environments. What started as a small, specialized consulting firm has evolved into a global leader known for its innovative solutions, expert guidance, and unwavering commitment to protecting both people and the planet. As we celebrate our 30-year milestone, we’d like to reflect on how we got here and share what’s on the horizon. A Legacy of Expertise and Innovation When World BioHazTec opened its doors 30 years ago, biosafety was still an emerging field. Laboratories and research facilities often grappled with a patchwork of safety guidelines and minimal oversight. Recognizing a need for clear, consistent standards, we set out to develop comprehensive consulting services that would empower organizations to reach the highest level of safety and regulatory compliance. Over time, we’ve embraced technology-driven solutions—from advanced laboratory design tools to sophisticated HVAC diagnostics—that continue to shape the future of biosafety. Guiding the Evolution of Biosafety Standards and Regulations Our influence extends beyond day-to-day consulting projects, as we actively participate in shaping and refining industry guidelines. Over the years, World BioHazTec has consulted on and contributed to the development and review of essential biosafety standards and regulations, such as the Biosafety in Microbiological and Biomedical Laboratories (BMBL), the National Institutes of Health Design Requirements Manual, ANSI/ASSP Z9.14-2020, and the NIH BSL-3 Laboratory Certification Requirements and Checklist. We have also been involved in reviewing the CEN Workshop Agreement 15793: Laboratory Biorisk Management Standard which has been converted to ISO 35001:2019, as well as advising on the Singapore Standard Biorisk Management and the Singapore Biological Agents and Toxins Act. Our deep familiarity with these regulations—and our hands-on industry experience—ensures that the solutions we provide keep laboratories worldwide at the cutting edge of safety and compliance. Driving Global Impact Over the past 30 years, World BioHazTec has established a strong global presence by addressing operational challenges in BSL-2 and BSL-3 laboratories, utilizing in-country resources, and training local personnel to manage biosafety and preventative maintenance effectively. We’ve expanded our reach by opening offices in Singapore and Latin America, where we’ve delivered impactful results. Highlights include becoming the first Ministry of Health-approved facility certifier for BSL-3 and ABSL-3 laboratories in Singapore, certifying the country’s first BSL-3 laboratory under the Biological Agents and Toxins Act, and consulting on the design and construction of Singapore’s first BSL-4 laboratory. In Latin America, we are currently consulting on the design of a BSL-3/BSL-4 cabinet lab in Chile—the first of its kind in the region—and have delivered significant biosafety training by partnering with the Organization of American States to enhance biosafety practices throughout Latin America. In Brazil, we contributed to the design of the nation’s first BSL-4 laboratory, showcasing our expertise in high-containment facilities. Additionally, we’ve engaged with the biosafety community by attending inaugural conferences in Singapore, Indonesia, Korea, the Philippines, and Malaysia. This extensive experience underscores our capability to collaborate on addressing administrative and engineering control challenges in these regions. Collaborative Approach and Trusted Partnerships One key to our longevity has been building strong relationships with clients and collaborators. Over the last 30 years, we’ve partnered with leading academic institutions, research hospitals, and private corporations, supporting them through complex projects. By listening carefully to each organization’s needs—whether it’s a university seeking a new lab layout or a multinational company aiming to comply with evolving regulations—we tailor our solutions to deliver measurable, sustainable results. Our team of engineers, biosafety professionals, scientists, and project managers works closely with every client to ensure transparency, effective communication, and long-term success. Looking Forward While our journey so far has been remarkable, we know that the future holds even more possibilities for growth and innovation. Emerging infectious diseases, evolving regulatory frameworks, and the expansion of high-containment research facilities underscore the ongoing need for diligent, effective biosafety measures. World BioHazTec is dedicated to staying on the cutting edge of this field, combining our decades of experience with new technologies and best practices to safeguard the well-being of lab personnel, surrounding communities, and the environment. Thank You for 30 Years As we commemorate this special anniversary, we want to extend our heartfelt thanks to everyone who has been part of our story: our dedicated employees, loyal clients, and industry partners. Your trust and collaboration have fueled our passion and helped us grow into the organization we are today. We look forward to continuing this journey together—providing top-tier biosafety and biosecurity consulting, adapting to new challenges, and making the world a safer place for groundbreaking research. Here’s to the next 30 years of innovation, collaboration, and excellence in biosafety. We’re excited to see where this path leads, and we invite you to stay tuned for the next chapter in World BioHazTec’s story. If you have any questions or want to learn more about our services and projects, feel free to contact us. We’d love to hear from you!
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The Critical Role of a Commissioning Agent in BSL-3 Laboratory Design and Operation
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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Outsourcing Training for Work in Critical Environments
When managing a high-containment facility, such as a BSL-3 lab, safety is paramount. Training staff to handle biological hazards properly and operate within stringent protocols can literally be a matter of life and death. A critical question many organizations face is whether to develop training programs in-house or outsource this training to a specialized provider. We’ll explore barriers to in-house development and delivery of quality training and why outsourcing your training for high-consequence workplaces could be the best option for your organization. What are your barriers to faster learning design and development? A recent survey conducted by the Association for Talent Development (ATD), which has supported instructional developers of employee training programs worldwide for over 80 years, identified eight top barriers to faster learning design and development.[1] The top three barriers are: Adapted from DeFelice, R. 2021. ATD Blog. Rounding out the top eight barriers include lack of availability of Subject Matter Experts (SMEs) or stakeholders at 37%. In our experience, SMEs and stakeholders have many hats they wear, and their time is limited. Often, SMEs are outside of the organization and pose an additional expense to the development of in-house training, initially and annual updates to the curriculum. World BioHazTec uses the Successive Approximation Model (SAM) approach to instructional design. SAM is a three-phase process: Preparation Phase, Iterative Design Phase, and Iterative Development Phase.[2] SMEs and stakeholders are brought in at the initial outlining phase and then only as needed for review. Because this is an iterative process, by the time the final phase is reached, SMEs and stakeholders have agreed to the plans and there should be very few revisions, or scope creep, to the design and plans. This saves time for these busy professionals and reduces costs by managing time and scope. Limited learning infrastructure—such as access to dedicated systems, authoring tools, and networks—accounts for 35% of the barriers. Authoring tools and resources, such as licensed images, add to the expense. Additionally, online self-paced (asynchronous) learning modules require authoring tools to create interactive content with feedback, as well as a learning management system to deliver the modules effectively. The final three barriers are a lack of learning and development skills within the talent development team (25%), lack of accountability (when the talent development team or SMEs do not fulfill responsibilities or meet deadlines) (23%), and insufficient leadership or management support (19%). These barriers indicate that staff are often occupied with other duties, with training development frequently becoming a lower priority. How much extra time does your staff have? Developing in-house training programs takes time—far more than many organizations realize. According to ATD in its most recent survey, creating one hour of new classroom training can take anywhere from 112 to 367 hours to develop.[3] That means developing just a half-day session could consume weeks of work by several employees. Time that could be better spent on other critical functions of your lab. Also, think of the breadth of knowledge and skills required to operate and maintain a high-containment laboratory, both for inside and outside, from construction to cybersecurity, from environmental protection to personal safety. Biosafety professionals not only require training in performing their jobs safely, they are also involved in risk assessments and compliance with applicable regulations daily, and appropriate emergency response. Frequently, the biosafety professional is called upon to participate in the planning, design, and validation of a new biocontainment laboratory or renovation of an existing facility. “Biosafety professionals should have a foundation in all aspects of working in and around a high-containment laboratory and develop skills to ask questions in specific terms and have the confidence to question the answers.” -World BioHazTec Course Development Guide. [Internal Communication] Developing meaningful, high-quality training that addresses all necessary components typically requires more SMEs and stakeholders than a single facility may have available for training development. Outsourcing training development strengthens course quality by bringing together SMEs with various expertise for only the time that is necessary under the management of a proven training development team. Also, the development team can use resources already developed to tailor to the specific needs of your facility and staff, which saves time and resources. If you’re thinking of transitioning your existing training into an online format, the time investment can be even greater. Converting a course into effective web-based training requires expertise in instructional design, an investment in e-learning tools, an understanding of e-learning platforms, and the ability to ensure that virtual training still delivers the same level of engagement and effectiveness as in-person sessions. Just as with any training, online training and learning management systems must be monitored regularly and reports generated to stakeholders. Outsourcing this process to specialists not only saves your team countless hours but also ensures the training is designed by professionals with experience in biosafety, biosecurity, and online learning. A Fresh Perspective and Unbiased Assessment One of the key benefits of outsourcing your BSL-3 training is gaining access to an external team of experts who can offer a fresh perspective. When organizations develop their own training programs, there’s often a risk of becoming too close to the material, potentially missing gaps or risks that an SME might spot, offering a fresh perspective. An external provider can objectively assess your current protocols, highlight potential areas for improvement, and suggest best practices based on up-to-date industry standards. “Things change quickly …, so job responsibilities must evolve. If companies evolve their strategy and expect employees to expand their skill sets, offering a team continuous learning will help prevent them from falling behind.” [2] In high-stakes environments like BSL-3 labs, where even minor oversights can have serious consequences, having an unbiased third-party review can add an additional layer of safety. Expert consultants are experienced in tailoring their training programs to meet both your specific operational needs and strict regulatory requirements, ensuring your staff is fully equipped to handle emergencies and day-to-day challenges. CEUs and Professional Development Incentives Professional development is also a tool for employee retention. “About 80 percent of employees rank professional development and continuous learning as high priorities when job hunting. And 94 percent of employees say if an employer invested more in learning and development, they would stay longer at an organization.” [3] Another significant advantage of outsourcing BSL-3 training is the ability to offer Continuing Education Units (CEUs). If your training provider is accredited, they can award CEUs to participants which can be used to maintain certification with professional organizations. This ensures your team remains compliant with the latest industry developments and ongoing certification requirements. It also provides an added incentive for staff to engage in the training. CEUs enhance the perceived value of the training, as they provide tangible career benefits to employees. By outsourcing, you can integrate this offering into your program without the burden of navigating the lengthy accreditation process yourself. Outsourcing Offers Expertise, Efficiency, and Compliance The decision to outsource BSL-3 training boils down to efficiency and safety. By partnering with an experienced external provider, you’re investing in expert insights, saving substantial time, and ensuring your team has access to accredited, top-tier training. Not only does this free up your internal resources, but it also offers peace of mind knowing your staff is receiving the most current and comprehensive training available. So, should you outsource your BSL-3 training? For most organizations, the answer is a resounding yes. World BioHazTec provides extensive professional development training. Schedule a free consultation to learn more about our customized training offerings. [1] DeFelice, R. 2021. ATD Blog. Retrieved from https://www.td.org/content/atd-blog/how-long-does-it-take-to-develop-training-new-question-new-answers [2] Allen, M. (2012). Leaving ADDIE for SAM – An agile model for developing the best learning experiences. Washington DC: American Society for Training and Development. [3] Based on survey average module length of 23 minutes, the variance was 43 to 141 hours with an average of 67 hours. These results were used to calculate times to develop a one-hour module. [4] Rozensweig, F. 2022. Retrieved from https://www.td.org/atd-blog/shift-from-onboarding-to-everboarding. [5] Rosenzweig, F. 2022. ATD blog. Retrieved from https://www.td.org/content/atd-blog/shift-from-onboarding-to-everboarding
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