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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decorative presentation slide that says "From legal Work to Biosafety: My Journey Into the World of Safe Science"

From Legal Work to Biosafety: My Journey into the World of Safe Science

By: Tracey Ann Brown, Training Program Manager A recent celebrity death brought back memories of my time as a paralegal involved in a pioneering Texas workers’ compensation death benefits case that relied on DNA analysis. At the time, Texas lacked a DNA analysis laboratory recognized as reliable by the courts to determine paternity, so the technology was still in its early stages and often debated in the news. Though this story isn’t about that specific case, it highlights my journey into the world of biosafety and biosecurity. As I managed proper collection and ensured the chain of custody of specimens to a North Carolina lab, I had the privilege of working closely with the analyst in charge of DNA sequencing. Those who know me know I will ask questions! The analyst patiently guided me through the intricacies of DNA analysis and its impact. Back then, receiving results from DNA analysis was a lengthy process. Imagine being a teenager who has just lost a parent, and then waiting over a month to learn if you have a half-sibling. In Texas, death benefits extend through age 21 as long as the child remains enrolled in college. There was a lot at stake for someone with their entire life in front of them. Fortunately, thanks to safe research and the hard work of dedicated scientists, the waiting period for DNA results has significantly shortened. This was not the first or last time a scientist took the time to educate me on complex, groundbreaking scientific advancements. These interactions deepened my appreciation for the importance of science in uncovering truth and emphasized the necessity of ensuring safety in research and discovery. I have been further intrigued about how the safe practices and procedures that are carried out strengthen the validity of scientific results. I admire how scientists take the time to follow these processes as part of their craft. That one analyst in North Carolina may not realize how their expertise, patience and time set off a ripple effect that ultimately established the foundation for my career in biosafety and biosecurity. About The Author: Tracey Ann Brown has been developing training programs for government institutions including the National Institutes of Health, Department of Labor, Department of Energy, and the U.S. Food and Drug Administration. Notably, Ms. Brown ensures that World BioHazTec’s training programs adhere to the rigorous standards set by the International Accreditors for Continuing Education and Training (IACET). Before entering the life sciences sector, Ms. Brown gained substantial experience as a paralegal and investigator, focusing on occupational health and safety cases, including complex healthcare workplace transmission litigation in Federal court.

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Selecting BSL-3 Supply Air Duct Material and Decontamination

When considering the material for BSL-3 supply air ducts, the primary objective of biosafety design is to ensure a continuous duct path from the room’s supply diffusers and exhaust outlets (including biological safety cabinets [BSCs]) to ideally an airtight valve in the supply and exhaust ductwork, respectively. This sealed duct section not only maintains the concentration of decontamination gas or vapor required for efficacy but also prevents any leakage of the decontamination agent into surrounding rooms. We advocate for two options while advising against two other alternatives. Selection should be based upon a risk assessment of your facility’s ductwork design. Option 1: Welded Stainless Steel Ductwork In the context of BSL-3 facilities, employing welded stainless steel ductwork for both exhaust and supply systems is recommended. This ductwork extends from the BSL-3 laboratory to the airtight isolation damper of the HEPA caisson inlet and the low leakage shut-off control air valve or isolation valve. These supply and exhaust ductwork sections are referred to as “decon duct sections” to distinguish them from ductwork sections where the decon agent is not held for decontamination efficacy. During the decontamination process, the closure of only these two airtight valves is necessary, aligning with current design practices. This approach provides the necessary airtight duct sections for the supply and exhaust decon duct sections. In terms of operational ease, the preparation for decontamination is streamlined through a dedicated button on the Building Automation System (BAS) interface. However, even with the implementation of welded stainless steel ductwork, it remains imperative to conduct integrity testing of the duct decon sections during the commissioning phase. This precaution is essential as the risk of potential welding pin holes in the ductwork hinges upon the proficiency of the welder involved. Option 2: Galvanized Ductwork With Sealed Joints An alternative to Option 1 is round galvanized steel ductwork with press fit joints, where all duct joints are sealed with duct mastic to ensure airtightness. Rectangular or square ductwork can be flanged with neoprene gaskets. Like Option 1, readiness for decontamination requires closing the two airtight valves. It’s advisable to conduct an integrity testing during commissioning. Additionally, this design entails an annual visual examination of duct connections to detect any breaks or deterioration in the mastic at ductwork joints. The risk of ductwork mastic failure hinges on the meticulousness of the mastic application process. Option 3: Supply Spiral Galvanized and Welded Stainless Steel Flexible Ductwork (Not Recommended) We discourage the use of galvanized and welded seam stainless steel spiral flexible ductwork for the decontamination section. Welding may not be feasible due to the gauge of the metal. Option 4: Non-Metal Flexible (Not Recommended) This approach is discouraged. While some engineers have devised their own modifications, replicating the custom duct seal raises concerns particularly when dealing with a carcinogenic decontamination agent. Some material options offer unique benefits and considerations, ensuring the effectiveness and safety of BSL-3 laboratory decontamination operations. Option 3 and Option 4 should be avoided. Contact World BioHazTec to schedule a free 30-minute consultation or send us an email. You are a conversation away from starting down a successful pathway to meet BSL-3 facility compliance.

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The 5 Strategic Advantages of Certifying Your BSL-3 Facility

Biosafety Level 3 (BSL-3) incidents are rare, yet their repercussions are monumental. Operating at BSL-3 demands meticulous protocols and unwavering risk mitigation. While rare, any lapses can have far-reaching and potentially devastating consequences. In this article, we explore the significance of BSL-3 certification. Even though it may not be mandatory in your country, it proves to be a vital strategic move. 1. Professional Accountability In a Biosafety Level 3 (BSL-3) facility, professional accountability emerges as the first compelling intention. Activities in a BSL-3 facility include the propagation of high-risk pathogens and long-term storage. This entails a profound responsibility. Researchers operating within BSL-3 facilities are accountable for ensuring not only their safety but also the safety of their colleagues, the community, and the environment. Certification acts as a tangible manifestation of this commitment, demonstrating to stakeholders and regulatory bodies that the organization embraces the gravity of their work. Beyond biosafety, BSL-3 certification also underscores the importance of stringent biosecurity measures, ensuring the safeguarding of these pathogens against unauthorized access and potential misuse. By obtaining BSL-3 certification, operators signal their dedication to maintaining the highest standards of both biosafety and biosecurity, fostering a culture of responsibility and accountability within the facility and beyond. 2. Public Health Preparedness Biosafety Level 3 (BSL-3) facilities play an indispensable role in public health preparedness. When a pandemic strikes, BSL-3 facilities stand at the forefront of the fight, equipped with the expertise and infrastructure necessary to handle and analyze high-risk pathogens. These facilities serve as vital hubs for research, diagnostics, and the development of therapeutic interventions. BSL-3 certification, in this context, becomes a strategic asset, signifying a commitment to being at the forefront of global health emergencies. It positions the facility to swiftly and effectively respond to emerging threats, contributing significantly to public health resilience and preparedness on a global scale. When the real test of a pandemic arrives, a certified BSL-3 laboratory signifies a prepared laboratory, with competent professionals adeptly executing their roles, ensuring a prompt and effective response to safeguard public health. 3. Creating a Safe and Secure Culture In a certified BSL-3 facility, a dedicated commitment to establishing a culture of biosafety and biosecurity is evident. This certification stands as a tangible testament to the management’s unwavering dedication to continuously enhancing biosafety and biosecurity measures. It mirrors a proactive approach towards nurturing a workplace culture that places the well-being of its staff and the integrity of its operations at the forefront. The certification process mandates rigorous adherence to standards, promoting continuous training and evaluation. This level of commitment resonates with the laboratory personnel, instilling confidence that their management is wholeheartedly invested in cultivating an environment where biosafety and biosecurity take precedence. 4. Safety Equals Quality A certified BSL-3 facility not only prioritizes safety and security but also indirectly contributes to the overall quality of results. Taking reference from the World Health Organization’s Handbook on Laboratory Quality Management System, laboratory safety is a cornerstone for establishing robust laboratory practices. By fostering a culture of strict adherence to biosafety protocols, certified BSL-3 facilities systematically integrate quality management principles into their daily operations. This meticulous approach not only safeguards the well-being of personnel but also ensures the integrity of laboratory processes. As safety practices become ingrained in the laboratory’s ethos following international quality management principles, the probability of errors and contamination diminishes, leading to consistently high-quality research outcomes. In essence, the commitment to safety in a certified BSL-3 facility reinforces the crucial connection between safety practices and the reliability of scientific results. 5. International Collaboration Opportunities A certified BSL-3 facility, known for its adherence to rigorous safety and security standards, builds credibility and trust within the scientific community. Collaborators and funding agencies, especially those from different countries, are more likely to engage with a facility that is recognized for its commitment to maintaining high-quality, safe, and secure research environments. BSL-3 facilities that demonstrate adherence to internationally recognized certification standards also make themselves attractive partners for collaborations assuring that research will be conducted in a secure environment, minimizing the likelihood of accidents or incidents. Conclusion In the pursuit of scientific excellence, BSL-3 certification emerges not merely as a commitment to safety but as a strategic gateway to collaborative possibilities. A certified BSL-3 facility, fortified by rigorous safety and security standards, amplifies credibility within the scientific community and encourages collaboration on a global scale. Let World BioHazTec be your strategic partner in preparing your facility to meet our certification requirements, widely acknowledged as the gold standard in BSL-3 certification. Contact World BioHazTec (WBHT) to schedule a free 30-minute consultation or send us an email. You are a conversation away from starting down a successful pathway to meet BSL-3 facility compliance.

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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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