Industry Insights

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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A laptop sitting on the floor next to a BSL-3 lab door

Why Cracking the Door Gets BSL-3 Airflow Wrong

What the BMBL, NIH DRM, and ANSI/ASSP Standards Actually Say About Directional Airflow Questions about directional airflow in BSL‑3 laboratories sometimes arise during government oversight, particularly when qualitative techniques such as smoke visualization are used. To evaluate these situations correctly, observations must align with established biosafety guidance and recognized engineering standards, rather than informal or non‑representative test conditions (BMBL, 6th ed.; NIH DRM; ANSI/ASSP Z9.14). Taken together, the Biosafety in Microbiological and Biomedical Laboratories (BMBL), the NIH Design Requirements Manual (DRM), and ANSI/ASSP laboratory ventilation standards all emphasize the same foundational principle: directional airflow is an engineered pressure condition that must be verified quantitatively and under normal operating conditions (BMBL, 6th ed.; NIH DRM §6.6; ANSI/ASSP Z9.14). Directional Airflow Is a Pressure‑Control Function The BMBL defines directional airflow in terms of pressure differentials, requiring BSL‑3 laboratories to be maintained at negative pressure relative to adjoining spaces so that airflow moves inward toward areas of higher risk (BMBL, 6th ed.). The NIH Design Requirements Manual reinforces this requirement by translating biosafety goals into enforceable engineering criteria. The DRM specifies that BSL‑3 laboratories must incorporate pressure cascades, continuous differential pressure monitoring, and alarmed systems to confirm airflow direction on an ongoing basis (NIH DRM §6.6, Mechanical Systems). Both documents treat directional airflow as a measurable HVAC performance parameter, not something inferred from short‑term visual observations (BMBL, 6th ed.; NIH DRM). Why Standards‑Based Engineering Rejects the “Cracked Door” Test ANSI/ASSP laboratory ventilation standards provide additional clarity regarding acceptable testing methods. ANSI/ASSP Z9.14 establishes that airflow performance must be evaluated using appropriate instruments and under representative operating conditions, particularly in laboratories designed with pressure control systems (ANSI/ASSP Z9.14). When calibrated pressure instrumentation is present, Z9.14 identifies differential pressure measurement as the primary indicator of directional airflow and cautions against drawing conclusions from conditions that defeat the designed airflow regime (ANSI/ASSP Z9.14). Cracking a door during testing introduces a large, uncontrolled opening that collapses the pressure differential, creates turbulence, and invalidates the engineered pressure cascade—conditions explicitly inconsistent with how laboratory ventilation systems are designed to be assessed (ANSI/ASSP Z9.14; NIH DRM §6.6). BSL‑3 Laboratories Are Leaky by Design Across biosafety guidance and engineering standards, there is a shared recognition that BSL‑3 laboratories are not airtight. The BMBL describes containment as a function of primary and secondary barriers working together to minimize release, not as the elimination of all leakage (BMBL, 6th ed.). Doors, frames, and penetrations are expected to have small leak paths, which are accounted for in design. The NIH DRM similarly assumes leakage and relies on negative pressure maintenance to ensure that air moves inward through these paths rather than outward (NIH DRM §6.6). ANSI/ASSP standards align with this approach, emphasizing pressure relationships as the controlling mechanism for airflow direction (ANSI/ASSP Z9.14). Containment is therefore achieved through controlled inward airflow, not by seal tightness. Normal Operating Conditions Matter BSL‑3 laboratory doors are required to be self‑closing and self‑latching, ensuring that performance is evaluated with doors either fully closed and latched or fully open briefly during passage (BMBL, 6th ed.). Neither the BMBL nor the NIH DRM recognizes a partially open, held door as a valid operating condition for assessing containment performance (BMBL, 6th ed.; NIH DRM §6.6). ANSI/ASSP Z9.14 similarly emphasizes that testing must reflect how the space is designed to operate, not artificial configurations introduced for convenience (ANSI/ASSP Z9.14). Airflow behavior observed under non‑representative conditions cannot be reliably correlated to system performance. Unified Message Across All Standards Viewed together, the guidance is unequivocal: The BMBL defines the biosafety objective: inward directional airflow achieved through negative pressure (BMBL, 6th ed.). The NIH DRM defines how that objective is engineered, monitored, and verified (NIH DRM §6.6). ANSI/ASSP Z9.14 defines how airflow performance should be evaluated using accepted ventilation engineering practice (ANSI/ASSP Z9.14). None of these authorities support determining loss of containment based on smoke behavior observed during a cracked‑door test. Final Takeaway Directional airflow in BSL‑3 laboratories is an engineered pressure condition, not a visual effect. The BMBL, NIH Design Requirements Manual, and ANSI/ASSP laboratory ventilation standards all reinforce that quantitative pressure verification under normal operating conditions is the correct and defensible method for assessing airflow performance (BMBL, 6th ed.; NIH DRM §6.6; ANSI/ASSP Z9.14). Smoke visualization may serve as a supplemental diagnostic tool, but it cannot override calibrated pressure data or be used under conditions that undermine system design intent. Alignment with these standards supports clear, consistent, and technically defensible evaluations of containment performance. Works Cited American National Standards Institute (ANSI) / American Society of Safety Professionals (ASSP). ANSI/ASSP Z9.14-2020 – Testing and Performance-Verification Methodologies for Biosafety Level 3 (BSL-3) and Animal Biosafety Level 3 (ABSL-3) Ventilation Systems. Centers for Disease Control and Prevention (CDC) & National Institutes of Health (NIH). Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition. U.S. Department of Health and Human Services, June 2020. Available at: https://www.cdc.gov/labs/bmbl/index.html National Institutes of Health (NIH), Office of Research Facilities (ORF). NIH Design Requirements Manual for Biomedical Laboratories and Animal Research Facilities (DRM). Current Edition, Sections 6.6 and 7 (Mechanical Systems; Biosafety Level‑3 Requirements). Available at: https://orf.od.nih.gov/TechnicalResources/Pages/Design-Requirements-Manual.aspx National Institutes of Health (NIH), Office of Research Facilities. BSL‑3 and ABSL‑3 HVAC System Requirements. NIH ORF Technical Guidance Documents and DRM Interpretive Publications.

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What This Award Represents—and Why Biosafety Matters

By: Kerstin Haskell, MBA. President, World BioHazTec. I remember exactly where I was when I got the call. I was sitting in an airport, waiting for my flight home from Iceland after attending a conference in Germany. I was exhausted, jet-lagged, and only half paying attention to my phone when it rang. “Check your email!” said Carol Traum, our Executive Vice President. “Congratulations!” said Ted Traum, our Principal. “What are you talking about?” I asked. I was tired. “The award! You got it!” “Wait,” I said, suddenly more awake. “I’m going to meet the Governor?” That was the moment I learned I had been selected to receive the World Trade Center Institute Maryland International Business Leadership Award. It Started with a Conversation, Not a Campaign Like most meaningful recognition, this did not begin with a campaign or an application package. It started with a phone call from Brian Castleberry at the Maryland Department of Commerce—an exceptional partner who had helped bring Biosafety Day to Maryland the year before. He asked a few straightforward questions about our exports that year. “I’m putting you in for an award,” he said. “Oh, okay,” I replied, and rattled off some numbers. At the time, it didn’t feel momentous. In hindsight, it was one of those quiet inflection points that leadership careers are built on. Showing Up as a Team When the interview invitation arrived, the timing could not have been better. Dan Yoong, World BioHazTec’s Managing Director for Asia, the Middle East, and Africa, was already in the U.S. preparing for the ABSA International Conference. There was no question—Dan needed to be part of that interview. If we were being asked to speak about global impact, public health, and international collaboration, then he was a living example of that work. His wife joined us as well, as we were driving straight from the interview in Baltimore to Raleigh, North Carolina, for the conference. I will never forget that room—nearly fifteen people gathered around a conference table, introducing themselves. When it was Dan’s wife’s turn, she smiled and said, “I’m the boss of him,” pointing directly at Dan. The room immediately burst into laughter. Any nervousness disappeared. From there, we spoke openly and proudly about biosafety, engineering, partnership, and what it takes to build a company that crosses borders while remaining deeply rooted in Maryland. A Night That Felt Bigger Than One Person The awards ceremony at the M&T Bank Exchange was unforgettable. The room glowed with dramatic purple and blue hues, and for a moment, everything felt quietly surreal. Sitting to my left was my mentor, RADM Deborah Wilson, PhD, CBSP, RBP (ret.), with her husband, Tom, by her side. On my right was my husband, Jake. At our table were my parents, Ted and Carol Traum, long-time leaders and partners in World BioHazTec, alongside COO Juan Osorio and his wife Nathalie, and Lia Vizzotti, CEO of World BioHazTec Latin America. As I looked around the room, what struck me most was the scale. There were nearly 400 people in attendance—leaders from business, government, academia, and industry. Many of them had likely never heard the word biosafety before that evening. And yet, the work represented in that room—and far beyond it—depends on it. That realization stayed with me. Biosafety should not be a niche term known only to scientists and engineers. It should be recognized and embraced by C-suite executives, policymakers, investors, and institutional leaders as a foundational element of responsible innovation, public health preparedness, and economic resilience. If biosafety is invisible, it is vulnerable. If it is understood, it becomes integrated into decision-making at the highest levels. That sense of responsibility made the night feel larger than any single recognition. The People Who Brought Us Here That feeling deepened as women approached me throughout the evening—congratulating me, thanking me, and noting that I was the only woman among the six award recipients that year. Each time, I proudly introduced them to RADM Wilson and shared just how instrumental she has been in bringing so many of us together. From Ted’s early brainstorming sessions with RADM Wilson, to Juan Osorio—whom we met through colleagues in RADM Wilson’s orbit who recognized both his talent and the growing need for leadership in biocontainment engineering—to Lia Vizzotti, whom we met during a WHO-supported training session RADM Wilson helped organize, the throughline was RADM Wilson. She had an extraordinary ability to see what was needed and to connect people at exactly the right moment. We never forget that. Seeing Our Story on the Screen I will admit, I was nervous when the program began introducing each honoree and playing short videos about their work. I didn’t know what to expect when World BioHazTec appeared on the screen. You can watch the video here. What I saw was emotional, grounded, and deeply reflective of what our team has built over decades. When the video ended and I stood, the applause was immense—and humbling. A Conversation with the Governor When I met Governor Wes Moore, I thanked him for issuing Maryland’s Biosafety Day Proclamation—and, admittedly, asked whether we might be able to have another one. I asked him to connect me with his team so we could talk more about biosafety, its economic impact, and why Maryland is uniquely positioned as a global hub for high- and maximum-containment laboratories. We are a dense, interconnected community doing work that matters far beyond our borders. He was gracious, engaged, and genuinely curious. After confirming it was allowed, my husband stepped up to the stage. As we stood with Governor Wes Moore, he handed his phone to a woman nearby and asked, “Would you mind taking our picture?” I quickly interjected, “Jake, she is probably the CEO of some big company.” She laughed and replied, “Actually, I am the CEO of BWI Airport,” and graciously took our photo with the Governor. What This Award Represents This award is an honor—but more importantly, it is a responsibility. It reflects the collective work of World BioHazTec’s global team, the mentors who shaped us, the partners who trusted us, and Maryland’s leadership in biosafety and public health. The work continues, and we are proud to carry it forward—together. My hope is that leaders across industry, government, and policy will engage with biosafety not as a compliance obligation, but as a strategic responsibility that protects people, strengthens innovation, and safeguards our collective future.

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Elevating Biocontainment Certification: World BioHazTec’s Engineering Approach

Ensuring the performance and safety of BSL-3 and ABSL-3 laboratories requires more than a checklist. It demands an engineering-based methodology that anticipates risk, verifies containment performance under both normal and abnormal operating conditions of critical laboratory systems, and delivers clear findings with actionable, technically sound recommendations to support facility leadership decision-making. At World BioHazTec, we have built our certification approach on that principle, combining deep technical rigor, licensed engineering oversight, and structured, decision-ready reporting. Expert-Led Certification, Not Technicians High-containment laboratories operate at a level of complexity where engineering judgment and field experience are critical. For that reason, we do not deploy technicians. Your facility is evaluated onsite by senior Subject Matter Experts (SMEs) who have assessed more than 200 biocontainment laboratories, contributed to biosafety guideline development, and presented internationally on certification practices and performance verification. This SME-led model ensures that subtle performance anomalies are accurately interpreted, risk assessments reflect operational realities, and recommendations are technically robust and strategically applicable to operations, maintenance, and Environmental Health and Safety (EHS) leadership. Engineered Assurance with PE Oversight World BioHazTec certification reports are reviewed and signed by a licensed Professional Engineer (PE). This provides technical authority, professional accountability, and regulatory defensibility to the findings and recommendations, giving stakeholders confidence that the report meets rigorous engineering standards. Comprehensive Methodology, Beyond the Baseline Baseline certification includes: Document review Interior inspection Differential pressure verification during normal/abnormal laboratory operation Verification of calibration of installed instrumentation Performance testing under normal operating conditions Performance testing under critical system failure scenarios Quantitative directional airflow verification Functional alarms confirmation World BioHazTec goes beyond the baseline by including: Exterior building inspection Thermal imaging Differential pressure trend analysis SME-led risk assessment Structured quality improvement recommendations Remote notification system verification One-year expert access Decision-Ready Reporting Our reports are structured to support executive and operational decision-making. Data related to pressures, airflow behavior, and alarm performance are presented alongside engineering interpretation, risk analysis, and clearly defined corrective and preventive actions. Fail-Forward: Proactive Failure Scenario Testing World BioHazTec conducts controlled failure scenario testing during laboratory operation to strengthen system reliability, not merely to record pass/fail results. Airflow behavior under upset conditions is thoroughly documented, with SME-led evaluations guiding risk-based corrective actions. Independence from BAS-Generated Graphs World BioHazTec does not rely solely on Building Automation System (BAS) trend graphs. BAS trend logs may be limited by server bandwidth restrictions or legacy system constraints, which can obscure or oversimplify critical airflow behavior or differential pressure relationships between areas, variables essential for containment integrity. Instead, we use certified and calibrated instruments to obtain independent measurements, ensuring that the data presented is precise, high-resolution, and fully representative of actual critical system performance. This approach provides engineering-grade documentation that stands independently of automation system limitations. Report Clarity and Usability Clear communication is essential in high-containment facilities, where decisions impact safety, operations, and long-term system reliability. Our reports are intentionally designed to be precise, structured, and easy to navigate. We focus on relevant information presented clearly and directly. We avoid excessive narrative, redundant data, and confusing diagrams. Each report follows a logical structure that directs the reader to key findings. Data is presented using clear photographs, defined graphs, and well-labeled diagrams that quickly identify what is functioning properly, what requires attention, and what actions are recommended. This clarity ensures documentation that is technically rigorous, practical, and ready for audits, internal reviews, and operational planning. Lifecycle Partnership, Not a One-Time Event High-containment environments evolve as equipment ages, operations change, and research requirements shift. Our one-year complimentary expert access ensures continued technical support beyond the certification visit. Why This Matters for BSL-3 / ABSL-3 Facilities A comprehensive certification approach provides: · Greater system reliability · Clear documentation for audits and regulatory compliance · Early identification of vulnerabilities · Trend analysis to support maintenance and upgrade planning · Stronger technical support for leadership decisions Beyond Compliance: The World BioHazTec Philosophy Compliance is the starting point. Our goal is engineered assurance, ensuring that the facility performs as intended, especially during off-normal events. Ready to learn more? Contact us for a free consultation.

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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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