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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Ensuring Biorisk Management in BSL-3 Labs: Can ISO 35001:2019 Stand Alone?

ISO 35001:2019, “Biorisk Management for Laboratories and Other Related Organizations,” was introduced to address the unique challenges of managing biological risks. This standard focuses on establishing, implementing, maintaining, and enhancing biorisk management systems. It aims to identify, evaluate, and mitigate biological hazards, promoting a secure workplace and compliance with regulatory requirements. While it offers a solid foundation for biorisk management across various biosafety levels, its applicability in high-containment environments like BSL-3 labs warrants a closer examination. Understanding ISO 35001:2019 ISO 35001 provides a universal framework for biorisk management across Biosafety Levels (BSL 1-4). It emphasizes foundational principles but lacks site-specific or technical requirements, especially critical for BSL-3 and BSL-4 facilities. Applying ISO 35001 to BSL-3 Environments BSL-3 laboratories handle infectious agents that pose significant health risks. These labs must adhere to stringent safety protocols to prevent accidental exposure and ensure biosecurity. However, ISO 35001’s general guidelines need to be adapted to meet the specific demands of BSL-3 environments. Example: Risk Assessment Requirements ISO 35001:2019, Section 6.1.2, mandates that organizations conduct a risk assessment to identify and evaluate risks associated with biological agents. However, it does not specify the methodology—whether a 3×3 or 5×5 matrix should be used or if the assessment should be activity-based or agent-based. The approach to risk assessment can vary widely across countries and organizations, with some methods proving more effective than others. To align with best practices, organizations should consider industry standards, consult with experts, and continuously review and refine their risk assessment processes. Example: Maintenance of Facilities and Equipment ISO 35001:2019, Section 7.1.2, requires the maintenance of facilities and equipment to prevent failures and accidents. In BSL-3 environments, this involves specific engineering controls, such as inward-directed airflow and certified biological safety cabinets (BSCs). Mechanical failures, such as airflow reversals, can create hazardous conditions. Therefore, regular certification and proper maintenance of BSCs and HEPA filters are crucial. Example: Emergency Response Procedures ISO 35001:2019, Section 8.2.1, mandates the establishment of procedures to respond to emergencies involving biological agents. For BSL-3 facilities, this includes detailed protocols for spill response, training personnel in using personal protective equipment (PPE), and effective decontamination methods. Thorough documentation of incidents and corrective actions ensures ongoing compliance and preparedness. Certifying to the ISO 35001 Standard Certification to ISO 35001 signifies a commitment to global biorisk management standards. This involves integrating the standard’s components with various publications, including legislation, standards, and guidelines. The rigor of certification requirements varies, with BSL-3 facilities facing more stringent demands. The expertise of the auditing firm is crucial in this process. At World BioHazTec, we have been certifying and verifying BSL-3 and BSL-4 facilities for 29 years. Our auditors are experienced practitioners who have contributed to national standards and international guidelines. As recognized certifiers by the Singapore Ministry of Health, we emphasize practical and site-specific solutions for high-containment laboratories. Take the Next Step in Ensuring BSL-3 Compliance Ready to enhance your biorisk management systems? Schedule a free 30-minute consultation with our experts at World BioHazTec or email us for more information. Let’s work together to ensure your BSL-3 facility meets the highest standards of safety and security.

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BSL-3 laboratory with walls that have wall cladding

Enhancing the Reliability of BSL-3 Laboratory Walls with Wall Cladding

More and more BSL-3 laboratory owners are selecting wall cladding for their wall system. When designing and constructing BSL-3 laboratories, ensuring the durability and reliability of the wall cladding is paramount. Wall cladding, with advanced fiber-reinforced polymer (FRP) technology, offers a promising solution for these high-stakes environments. However, addressing potential detachment issues and ensuring the cladding can withstand the unique challenges of BSL-3 labs is crucial. Here’s a detailed guide on how to enhance the reliability of BSL-3 walls with wall cladding. Avoid Detachment Issues Surface Preparation One of the primary causes of cladding detachment is improper surface preparation. To mitigate this risk, it’s essential to: Clean and Prime: Ensure that the substrate surface is thoroughly cleaned to remove any contaminants that might interfere with adhesion. Applying a primer that is compatible with both the substrate and the cladding material can significantly enhance adhesion. Control Moisture Content: High moisture levels in the substrate can compromise adhesive effectiveness. Specifying a maximum allowable moisture content for application can prevent detachment due to moisture-related issues. Application Techniques Proper application techniques are vital for ensuring secure attachment of the cladding material. Consider the following: Adhesive Application Guidelines: Provide detailed guidelines for applying adhesives and tapes, including recommended environmental conditions such as temperature and humidity. Clear instructions on curing times for adhesives will help minimize installation errors. Qualified Installers: Specify that the installation should be carried out by a contractor recommended by the manufacturer. Additionally, the installer should have experience with similar installations (World BioHazTec recommends more than 3) to ensure they are familiar with best practices. Substrate Compatibility Different substrates may require different approaches to ensure optimal adhesion. It’s important to: Evaluate Compatibility: Assess the compatibility of the cladding material with various substrates such as wallboard, concrete, and metal. Specify any necessary primers or adhesives to enhance adhesion based on the substrate type. Consideration of Environmental Forces Negative Pressure Gradients BSL-3 laboratories operate under negative pressure to prevent the escape of hazardous materials. This unique environment can exert significant forces on wall cladding: Calculate Maximum Force: Determine the maximum force exerted on the cladding due to negative pressure gradients. This should consider the largest potential pressure differential between the inside and outside of the laboratory. Apply a Safety Factor: Incorporate a safety factor to account for variations and uncertainties in pressure gradients. This ensures that the cladding material can withstand unexpected forces without detachment. Verification of Performance Reference Verification Ensuring that the cladding material has a proven track record in similar environments is essential: Request References: Require bidders to provide references of BSL-3 laboratories where their cladding materials have been successfully used. Include detailed contact information and installation dates. Verify Performance: Contact the provided references to verify the performance and durability of the cladding material in real-world BSL-3 environments. Seam Validation Seam integrity is crucial for maintaining the negative pressure environment in BSL-3 labs: Leak Testing: Specify the use of an air leak tester to validate the integrity of wall seams. This ensures there are no air leaks that could compromise the negative pressure environment. Warranty Given the critical nature of BSL-3 laboratories, a robust warranty is essential: Extended Warranty: A one-year warranty for materials is insufficient. Specify a warranty that covers both materials and workmanship for a minimum of ten years. This provides assurance that the cladding material will perform reliably over the long term. Conclusion By addressing these key considerations, you can enhance the reliability and performance of wall cladding in BSL-3 laboratories. Ensuring proper surface preparation, application techniques, substrate compatibility, and accounting for environmental forces are crucial steps. Additionally, verifying performance through references and seam validation, along with an extended warranty, will help ensure that the cladding material meets the rigorous demands of BSL-3 environments. World BioHazTec provides our clients details about the intricate design of BSL-3, ABSL-3, BSL-3ag, BSL-4 and ABSL-4 labs. To learn more about how we can strengthen your design team, 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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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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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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