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World BioHazTec has been a leader in biosafety and biosecurity since its inception in 1995. Over the years, we have successfully completed numerous groundbreaking projects and received prestigious awards, showcasing our dedication to excellence and innovation.

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Design Pitfalls in Biocontainment Laboratories: Lessons from Real Projects

Building a biocontainment laboratory—whether BSL-3, ABSL-3 or ACL-3, is a highly specialized process that requires careful planning and coordination. When design decisions are made without early input from Subject Matter Experts (SMEs), critical issues often surface late in the project, leading to costly changes and delays. Below are examples of common challenges identified during design reviews and commissioning phases. These illustrate why early integration of biosafety and engineering expertise is essential. Example 1: Missing Containment Features In one recent project, a design review uncovered a critical oversight. The Basis of Design (BOD)—the document outlining the institution’s requirements for the laboratory—specified that the facility would support research involving avian influenza. However, the design did not include provisions for a shower-out protocol or the necessary plumbing infrastructure to accommodate a future effluent decontamination system, both of which may be required by evolving regulations. This omission significantly limited the laboratory’s operational capabilities, restricting it to work with agents that do not require a shower-out process. Ultimately, substantial redesign was needed to bring the project back into alignment with the BOD and ensure long-term compliance and flexibility. Other issues included: In a BSL-3 setting, undefined personnel pathways and workflows create unclear boundary separations, increasing the risk of containment breaches, procedural confusion, and noncompliance biosafety requirements. Insufficient clearance for biosafety cabinets (BSCs) in isolation spaces. Doors swinging against intended airflow direction. Use of inappropriate sealing materials for penetrations. Inclusion of a fume hood for chemical work instead of a Class II Type B2 BSC. Incomplete risk assessment during early design phases. Insufficient attention to maintenance access and laboratory equipment placement. Structural limitations in the room envelope made it unable to safely tolerate deep negative pressure conditions. Impact: These oversights affected containment integrity and workflow efficiency, requiring structural changes late in the process. Example 2: Airflow and Equipment Integration During commissioning of a facility under construction, several design gaps were identified: A BOD change required upgrading the Class II BSC from Type A2 to Type B2, but the existing exhaust fan curves could not support the increased airflow demand. Lack of exhaust ducting over the autoclave chambers to manage heat and connecting to the BSL-3 exhaust ductwork. Freezer placement in a concentrated area not accounted for in the air distribution. Provision for decontaminating large equipment before removal. Autoclave bioseal ordered for the wrong side with the master control on the wrong side. Impact: These issues prolonged commissioning, delayed the project schedule, and resulted in substantial change-order claims. Example 3: HVAC and Containment Compliance In another case, evaluation of arthropod containment labs revealed: Omission of supply and/or exhaust air in anterooms. Misinterpretation of containment guidelines led to improper combining of BSL-2 and BSL-3 exhaust ductwork. Non-airtight ceiling access doors and introducing unaccounted infiltration affecting directional airflow. HVAC airflow reversals during failure testing created unacceptable containment risks. Impact: These deficiencies increased the risk of containment loss, with airflow reversals posing the greatest safety threat and pest intrusion creating major USDA compliance concerns. Top 6 Design Principles for Biocontainment Labs To avoid these pitfalls, consider these foundational principles during the earliest stages of design: 1.Define the Research Capabilities of the Laboratory Clearly defining laboratory intent in the Basis of Design is essential to ensure the facility is engineered to meet its functional, safety, and regulatory requirements. 2. Define Containment Boundaries Clearly Establishing primary, secondary, and tertiary barriers in relation to workflow early ensures the laboratory’s containment strategy is clear, coordinated, and integrated into the design from the start. This prevents costly redesigns, reduces construction risk, and supports reliable, compliant biocontainment performance. 3. Plan for Directional Airflow and Pressure Differentials Ensure airflow moves from clean to contaminated areas, with validated pressure relationships and redundancy in HVAC systems. 4. Integrate Equipment into Design Account for biosafety cabinets, autoclaves, and other critical equipment in spatial layouts and airflow calculations to ensure sufficient make-up air and proper cooling and heat-load dissipation. 5. Design for Maintenance and Decontamination Include provisions for safe removal and decontamination of large equipment and keep serviceable maintenance items outside of containment where possible. 6. Follow Risk-Based Guidelines and Standards Align with Biosafety in Microbiological and Biomedical Laboratories (BMBL), NIH Design Requirements Manual, WHO Laboratory Biosafety Manual and other relevant standards to ensure compliance and operational safety from the start. The Bottom Line Early engagement with World BioHazTec’s SMEs ensures: Compliance from the start with WHO, CDC, NIH, ANSI/ASSP Z9.14-2014 and other applicable guidelines. Cost savings by avoiding late-stage redesigns. Operational efficiency through risk-based design and redundancy planning. Don’t wait until commissioning to discover design flaws. Partner with World BioHazTec early and build a laboratory that meets the highest standards of safety and functionality. Ready to start your project right? Contact us for a free consultation.

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Celebrating Leadership: Kerstin Haskell Receives the 2025 Diane Fleming Leadership Award

Leadership in the biosafety and biosecurity community is more than a title—it’s a commitment to mentoring, collaboration, and advancing the profession. Each year, ABSA International honors an individual who exemplify these values through the Diane Fleming Leadership Award. In 2025, that honor goes to World BioHazTec’s President: Kerstin Haskell. Why Kerstin? Kerstin embodies the spirit of Diane Fleming through visionary leadership, cross-sector collaboration, and a dedication to strengthening the biosafety profession. As President of the Chesapeake Area Biological Safety Association (ChABSA) from 2024 to 2025, Kerstin reinvigorated the organization—inspiring membership, motivating council, and establishing a sustainable operational model. Her leadership didn’t stop there. Kerstin forged partnerships with organizations previously unengaged with biosafety, demonstrating her ability to translate biosafety’s value to broader audiences. One of her most notable achievements? Securing a gubernatorial proclamation from Maryland Governor Wes Moore, declaring June 4, 2025, as Biosafety Day—a first-of-its-kind recognition at the state level. This milestone required persistent outreach and collaboration with key stakeholders, including the Maryland Department of Commerce, the Maryland Tech Council, and the Universities at Shady Grove. Kerstin’s ability to communicate biosafety’s impact in ways that resonate with decision-makers was instrumental in making this happen. A Leader Who Inspires Kerstin’s leadership style fosters trust, collaboration, and genuine connection. She creates an environment where members feel valued and engaged—bringing not only professionalism but also a sense of fun to meetings. Her approach reflects the core values of ABSA International and the Diane Fleming Award: service, collaboration, and impact. Quote to Remember “Serving on an ABSA International affiliate leadership team is not a burden—it’s an honor. Yes, the work is real, but it is absolutely possible to do this work with joy, humor, and a sense of purpose.” — Kerstin Haskell Acknowledging the Team In her acceptance remarks, Kerstin emphasized that leadership is never the work of one person. She credited the ChABSA Council for their dedication and contributions: Tracey Brown, Treasurer – Integrity and accountability Matt Fischer, Secretary – Clarity and continuity Bruce Donato – Attention to detail for symposium success Ron McNeil – Fresh energy and ideas as a first-year counselor Jamie Pope, David Harbourt, Sharon Altmann – Innovative technical programs and academic partnerships Elizabeth Bramhall, Current President – Dynamic speaker scheduling and networking opportunities Together, they created a culture of learning, laughter, and trust—proving that leadership can be both impactful and joyful. Congratulations, Kerstin! This award is a testament to what servant leadership can accomplish. Kerstin’s achievements inspire all of us to lead with vision, collaboration, and heart.

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The BMBL vs. the NIH DRM: Intent Meets Design

When planning or operating a biocontainment laboratory, two cornerstone documents are frequently referenced: the Biosafety in Microbiological and Biomedical Laboratories (BMBL) and the NIH Design Requirements Manual (NIH DRM). While often mentioned together, they serve distinct purposes. The BMBL defines the intent and biosafety principles, while the NIH DRM translates that intent into specific design and construction requirements. Together, they ensure laboratories are both conceptually sound and technically compliant. A Brief History The BMBL was first published in 1984 as a collaborative effort between the CDC and NIH to provide standardized biosafety guidance across U.S. research laboratories. Now in its 6th Edition, the BMBL has become the gold standard reference for biosafety practices worldwide. The NIH DRM, on the other hand, originated as a facility design guide for NIH projects and has since evolved into a detailed, regularly updated manual that sets design and engineering expectations for biomedical research laboratories. While the BMBL grew out of biosafety practice and policy, the DRM emerged from the need to ensure consistency and safety in laboratory infrastructure. The BMBL: Defining Intent The BMBL (now in its 6th Edition) sets out the “what” and “why” of biosafety. It outlines the risk-based principles and operational expectations needed to protect laboratory workers, the community, and the environment. For example, the BMBL states that: Laboratories must maintain negative pressure relative to adjacent spaces. Surfaces should be smooth, impervious, and easy to clean. Engineering controls and safety equipment must be certified and tested annually. These requirements establish goals, but they do not prescribe exact dimensions, tolerances, or engineering solutions. The NIH DRM: Defining Design The NIH DRM, on the other hand, provides the “how.” It offers detailed technical specifications for architects, engineers, and commissioning agents to follow when designing, constructing, or certifying biomedical research facilities. Where the BMBL requires negative pressure, the DRM might specify: The exact pressure differential values (e.g., - 0.05” w.g.). Systems and components parameters performance requirements. What type of engineering controls and monitoring systems must be installed. This level of specificity makes the DRM indispensable in turning biosafety principles into verifiable design criteria. Compliance and NIH Funding It is also important to note that institutions receiving NIH funding for biomedical research facilities are generally required to follow the NIH DRM. For example, organizations awarded construction or renovation grants under the NIH often must demonstrate compliance with DRM requirements as part of their project scope. In these cases, adherence to the DRM is not optional — it is a condition of funding, ensuring that federally supported facilities meet uniform standards for biosafety, containment, and long-term sustainability. Three Examples: BMBL Intent vs. NIH DRM Design Directional Airflow and Pressure Differentials BMBL: Requires negative pressure relative to adjacent areas and directional airflow to prevent contamination spread. NIH DRM: Specifies exact differential pressure setpoints, monitoring devices, alarm requirements, redundancy requirements, and expected systems response during failures conditions. Materials and Finishes BMBL: States that surfaces must be sealed, non-porous, and resistant to chemicals to allow for easy cleaning and decontamination. NIH DRM: Details acceptable materials (e.g., epoxy resin flooring), minimum coving heights, sealant specifications, inspection procedures, and how penetrations should be sealed to maintain integrity. Monitoring, Alarms, and Verification BMBL: Requires laboratories to have visible indicators for directional airflow, alarms for ventilation system failures, and annual certification of HEPA filters. NIH DRM: Defines commissioning requirements to verify if the design intent has been met and containment has not been compromised during commissioning and re-verification cycles. Why Both Are Necessary The BMBL provides the vision and principles: ensuring biosafety practices are risk-based, adaptable, and grounded in scientific intent. The NIH DRM provides the execution details: ensuring that those principles are realized in the built environment through specific engineering and architectural standards. One without the other creates gaps: relying only on the BMBL risks inconsistent design interpretations, while relying only on the DRM risks treating biosafety as a checklist without context. Together, they create a balanced framework that protects people, research, and the environment. Closing Thoughts For private institutions, government, universities, or any organization preparing to open or operate a BSL-3 facility, understanding the interplay between the BMBL and the NIH DRM is essential. The BMBL tells us what must be true and why it matters. The NIH DRM tells us how to build, test, and verify so that intent becomes reality. Aligning both is the key to safe, compliant, and sustainable laboratory operations. For more information or to discuss how these principles apply to your facility, contact World BioHazTec today to schedule a free consultation with our biosafety and biocontainment experts. References Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition. Centers for Disease Control and Prevention; National Institutes of Health. June 2020. https://stacks.cdc.gov/view/cdc/97733?utm NIH Design Requirements Manual — LIVE Version. Office of Research Facilities. August 2024. https://orf.od.nih.gov/TechnicalResources/Pages/DesignRequirementsManual.aspx

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World BioHazTec is an Accredited Provider (AP) of the International Association for Continuing Education and Training (IACET). As an IACET Accredited Provider, World BioHazTec offers IACET CEUs for its learning events that comply with the ANSI/IACET Continuing Education and Training Information.

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