Industry Insights

Council Rock Consulting, Inc. d/b/a World BioHazTec Becomes an IACET Accredited Provider

Prestigious Accreditation Demonstrates Commitment to High-Quality Adult Learning May 1, 2023 – The International Accreditors for Continuing Education and Training (IACET) has awarded Council Rock Consulting, Inc. (CRC) d/b/a World BioHazTec (WBHT) the prestigious Accredited Provider accreditation. IACET Accredited Providers are the only organizations approved to offer IACET Continuing Education Units (CEUs). The accreditation period extends for five years, and includes all programs offered or created during that time. “CRC and WBHT are proud of our education programs which educate biosafety professionals each year in critical environment safety, and maintenance and operations skills so that our clients can maintain relevancy in today’s world,” stated Kerstin Haskell, President. Kerstin added, “Our accreditation with IACET is a demonstration of our commitment to quality adult education and high standards for all our programs. We are very pleased to join such a prestigious organization as well as an elite group of organizations that offer excellent continuing education and training programs.” “We are pleased to recognize and celebrate the achievement of CRC and WBHT as an Accredited Provider,” stated Randy Bowman, interim President & CEO of IACET. Bowman added, “CRC and WBHT proudly joins nearly 600 organizations around the globe that have matriculated through a rigorous peer-reviewed process by experts in continuing education, thereby ensuring the highest possible standards are met.” Example course offerings include: Biosafety Principles, Select Agents and Toxins, Aerosol Hazards Decontamination and Sterilization; Autoclaves and Biosafety Cabinets Engineering for the Biosafety Professional Part I Engineering for the Biosafety Professional Part II Risk Assessment and Working With Institutional Biosafety Committees Biosafety Standard Operating Procedures Effluent Decontamination Systems and Waste High-Containment Laboratory Design Review BSL-3 Operations and Maintenance for Sustainability CRC and WBHT develop site-specific courses in collaboration with you to meet your learners’ needs. To achieve Accredited Provider accreditation, CRC and WHBT completed a rigorous application process and successfully demonstrated adherence to the ANSI/IACET 2018-1 Standard for Continuing Education and Training by addressing the design, development, administration, and evaluation of its programs. CRC and WBHT has pledged its continued compliance with the Standard and is now authorized to use the IACET name and Accredited Provider logo on promotional course material. In addition, CRC and WBHT are now linked to the IACET website and is recognized as offering the highest quality continuing education and training programs. CRC dba WBHT works on special, meaningful projects that promote safety and health for the constantly changing world. Taking on challenges requires flexibility, creativity, and technical knowledge. WBHT is one of the first movers in the biocontainment industry to provide biosafety and biosecurity consulting that focuses on creating a safe and conducive work environment for the scientific industry. The mission of WBHT’s continuing education and training program is to support our client organizations by developing programs unique to their needs to promote workplace safety and health, safe facility operations, continuity of operations, and professional development to meet the client’s organizational goals. About IACET: The International Accreditors for Continuing Education and Training (IACET) is a non-profit association dedicated to quality continuing education and training programs. IACET is the only standard-setting organization approved by the American National Standards Institute (ANSI) for continuing education and training. The ANSI/IACET 2018-1 Standard for Continuing Education and Training is the core of thousands of educational programs worldwide. For more information, please visit www.iacet.org or call 703-763-0705.

Does BSL-3 Laboratory Accreditation Exist?

More and more laboratories are built every day in countries throughout the world. Having high and maximum bio-containment laboratory capabilities is a great investment and aims for the betterment of public health. When the laboratory program, operations, and the laboratory facility is being planned, the first question you want to ask is, “What national regulations and guidelines will this laboratory meet to ensure compliance?” Identifying the laboratory standards will impact your laboratory design, biorisk management system, human resources, operations, and safety culture. Organizations want the best biosafety laboratory culture possible and want to prove that they meet or exceed in-country standards. Post COVID-19, it is highly recommended that a laboratory meet a higher quality standard. World BioHazTec has been asked numerous times if a client’s high or maximum containment laboratory (BSL-3, ABSL-3, ACL-3, BSL-3Ag, BSL-4, ABSL-4) can meet an accreditation that is formally provided by an institution. At this time, there is no formal accreditation offered for biocontainment laboratories that verifies containment, capabilities, and quality, and that tests engineering and administrative controls. There are several focused accreditation programs that can be considered. Ultimately, you want a laboratory where risk can be measured as low. Guidance to attain a low-risk laboratory is achieved through meeting high or maximum containment laboratory biosafety standards such as the World Health Organization (WHO), Laboratory Biosafety Manual, Fourth Edition; CDC/NIH Biosafety in Microbiological and Biomedical Laboratories, Sixth Edition (BMBL); and NIH Design Requirements Manual. Most important is knowing the intent of these standards in their implementation. This is the first step in the process. As some organizations have prescriptive standards for accreditation, those need to be identified next. The following is a sample list of organizations with accreditation programs. ABSA International (The Association for Biosafety and Biosecurity) A laboratory accreditation program has been closed. AAALAC International AAALAC International provides accreditation for organizations that use animals in research, teaching, or testing. An active animal care and use program is required to achieve accreditation. This accreditation does not apply to standard non-animal BSL-3 laboratories. Clinical Laboratory Improvement Amendments Managed by the U.S. Centers for Disease Control and Prevention (CDC), these regulations include meeting federal standards applicable to U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. This certification supports clinical laboratory quality. Canadian Counsel on Health Service Accreditation (CCHSA). Accreditation of medical laboratories in Canada is regulated by provincial health authorities. Out of the ten provinces of Canada, five have provincial accreditation bodies, while in the other five provinces, medical laboratories are accredited by the Canadian Counsel on Health Service Accreditation (CCHSA). The Joint Commission International The laboratory accreditation is designed for clinical laboratories that are typically found in hospitals. High and maximum containment laboratories do not meet these criteria for accreditation due to their complex nature of design and operations. If you evaluate the standards and guidelines applicable to high and maximum containment laboratories, you will discover that specific language is used which does not include the word, “Accreditation.” The World Health Organization, Laboratory Biosafety Manual, Fourth Edition does not mention accreditation but offers the following definition for certification: “Certification: A third-party testimony based on a structured assessment and formal documentation confirming that a system, person or piece of equipment conforms to specified requirements, for example, to a certain standard.” (Page xi) The WHO goes on to state in Section 7.7.2 Audits and inspections (internal and external): “Many laboratories implement a cooperative inspection programme where laboratory personnel are directly responsible for periodic self-audits (self-assessments) coupled with a less frequent, but more in-depth, evaluation with the biosafety officer and/or members of the biosafety committee. In some cases, laboratories may also have external audits and/or inspections, for example, as part of a certification process, under the national regulatory framework, or in an international mentoring programme. These assessments can provide information on the effectiveness of a biosafety programme, and the results can be analysed to identify weaknesses that may need to be addressed.” (Page 82) The CDC/NIH Biosafety in Microbiological and Biomedical Laboratories, Sixth Edition (BMBL) notes: “The BSL-3 facility design, operational parameters are verified and documented prior to operation. Facilities are tested annually or after significant modification to ensure operational parameters are met. Verification criteria are modified as necessary by operational experience.” (Page 51) The NIH Design Requirements Manual (DRM) does not acknowledge accreditation but does provide guidance on “Critical Facility Risk Assessment and Certification” in Section 1.14: “Certification is the systematic review of all safety features, design elements, operational modes and processes associated with a critical facility (e.g., patient care, pharmaceutical preparation, biocontainment) to validate that all facility controls and required practices (engineering controls, personal protective equipment, building and system integrity, standard operating procedures (SOPs), administrative controls such as documentation and record retention systems) are in place to minimize, to the greatest extent possible, the risks associated with operations… Certification should be conducted before initial operation and subsequently on an annual schedule or after a program change, renovation or replacement of any engineering controls that may affect the operating environment of the facility.” (Page 90) The aforementioned standards use words such as “certification,” “audit,” and “verification.” Accreditation is not mentioned. The ISO 35001: Biorisk management for laboratories and other related organizations define a process to identify, assess, control, and monitor the risks associated with hazardous biological materials. However, the International Organization for Standardization (ISO) does not provide an accreditation, certification, or audit for meeting this standard. It is the responsibility of each institution to determine if they will perform an internal certification that includes a detailed and documented risk assessment of their biosafety laboratory and program by challenging the engineering and administrative controls. Alternatively, as the WHO suggests, the institution can rely on a third-party private company to conduct the certification. If the institution trusts this responsibility to a third-party, then it is recommended to check the firm’s credentials and the professional(s)’ experience conducting the audit. Key questions for consideration include: Does the certifier have proven experience certifying high and maximum containment laboratories that were also inspected and approved by a government body (e.g., CDC, NIH, USDA, Canada Health, Appropriate Country Ministry of Health)? Many times, government agencies will be present to witness a certification or review the certification report. If the certifier’s documentation and report are reviewed and approved by a government agency, this demonstrates a high level of competence. Is the certifier properly insured? Professional liability insurance should be requested and verified. An insurance company will do their research on a certifier. They do not want to support a company or person(s) that do not have the credentials or experience. Insurance companies are vigilant in evaluating risk. If a certifier does not have professional liability insurance, then they have not been evaluated by a professional to deem them qualified enough to perform the work required in a high or maximum containment laboratory. Does the certifier use their own certified equipment? Engineering controls for a laboratory should be challenged. Relying on the Building Automation System to identify potential airflow issues puts the institution at risk. Certification equipment verifies if the Building Automation System is working appropriately. Ask the certifier how many differential pressure meters they possess. If they have only one or two meters, the certification testing can take days to complete. If the certifier insists on relying on just the Building Automation System, then “let buyer beware”. Ask if the equipment is calibrated to a national or international standard and request copies of each meter’s certificate of calibration to be included in the certification report. Make sure the certificates’ dates of calibration are within the certification period prescribed by the equipment’s manufacturer. Although accreditation is an important aspect that is a part of many industries, it has not been introduced into the field of biosafety. However, certification has been utilized for decades and offers an alternative that will meet the objectives set forth in accreditation programs. Certification is more encompassing as it challenges quality processes such as administrative controls and the laboratory engineering controls. The certification process documents laboratory capabilities, risk reductions, and laboratory compliance with standards and, if applicable, accreditation programs. Lastly, certification is based upon the testing of engineering systems and documents their performance during normal and failure conditions. This is of utmost importance to ensure the containment of pathogens. To learn more about our certification process, please visit our website. You can also book a free 30-minute consultation here or send us an email.

scientist working in a laboratory and using a pipette to transfer solutions

Twenty Considerations for a Successful BSL-3/ABSL-3 Laboratory Design

The pathway to a successful Biosafety Level 3 (BSL-3) and Animal Biosafety Level 3 (ABSL-3) laboratory project lies in the approach and attention to detail during the design process. The following are twenty suggestions for achieving a research program-driven design: 1. Team approach: Completing a BSL-3/ABSL-3 project is a team effort. It involves the creativity of the designer, the forthcoming of the users, the wisdom of the regulator, the ingenuity of the contractor, the experience of the BSL-3/ABSL-3 laboratory certifier, and the restraint of the financier. Developing a design that meets the needs of the research program and then following that plan is a team effort. The team needs to include the Principal Investigator and Biosafety Officer who focus the team on the intended use of the laboratory now, tomorrow, and in the future. The team needs to be aware of the project budget and operating maintenance costs associated with each major design decision. The financier not only needs to be vigilant about projected construction costs but needs to be cognizant of the impact of design decisions on operating costs. Time spent in planning and analysis is money saved in design and construction. Projecting operating and maintenance costs provides for a sustainable design. 2. Checklists: Developing checklists for compliance with applicable guidelines and regulatory requirements, facility standards, biosafety policies and practices, and equipment preferences will identify issues that the designer needs to address. These are tools for ensuring that the design will meet the needs and concerns of the users, stakeholders, regulators, and certifiers. If you have received grants, make sure that your BSL-3/ABSL-3 laboratory is compliant with these guidelines and regulatory requirements as well. The following are key US guidelines and regulations to consider: Biosafety in Microbiological and Biomedical Laboratories (BMBL) CDC/NIH publication, 6th Edition – November 2020 Design Requirements Manual, Division of Technical Resources, The National Institutes of Health, Revised Version 812A 2012, 200 ANSI/ASSP Z9.14-2020, Testing and Performance-Verification Methodologies for Ventilation Systems For Biosafety Level 3 (BSL-3) And Animal Biosafety Level 3 (ABSL-3) NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) – April 2019 CDC/USDA Select Agent Policy Statements 3. Pathways drawings: Architectural drawings should show the pathways for personnel, materials, and waste. They should also include emergency exit pathways and gathering points. This analysis will unearth inefficiencies and bottlenecks which can be resolved as part of the design process. 4. Decontamination provisions: Typically, laboratories are surface-decontaminated. Gaseous/vapor decontamination is infrequently utilized. Defining when and how often a laboratory will need gaseous/vapor decontamination is necessary to determine if there is a need to purchase decontamination equipment or if contract services will defray this type of capital investment. A decision to own decontamination equipment is not only a capital investment decision, but it is also an operational decision which requires funds for annual training and validation of the decontamination system. The users need to decide the method of decontamination so the designer can develop provisions in the design. 5. Adequate storage space: Provisions for storage in the anteroom should include space for PPE storage and maintenance (charging of power packs), waste containers, sign-in books, storage/securing of personal items, toweling, hand-washing soap, cleaning materials, and hanging of lab coats where applicable. Space for storage of the autoclave cart needs to be provided. Laboratory storage should be limited to what is needed for the research program. Shelving should be fixed or be the friction-lock adjustable shelving type. Adjustable shelving with hole-type adjustments are pest management and decontamination issues. Cardboard should not be stored in the laboratory, therefore provisions for plastic containers should be considered for storing loose items. 6. Cleanability of surfaces: Ceilings, walls, and floors need to be smooth and cleanable. Design details need to address how surfaces mate together, how they are sealed and finished, specify type of caulk, its color (for maintenance and inspection), and shrinkage requirements. Performance standards for acceptability of caulked joints need to be defined. Surfaces need to be selected for their resistance to chemicals, organic solvents, acids, alkalis, and most importantly, to surface decontamination disinfectants and gas/vapor decontamination processes. 7. Casework: Surface decontamination is the primary method by which most labs are decontaminated. Selecting wall-hung counters and moveable casework to facilitate cleaning should be considered. 8. Doors and frames: Doors need to be self-closing. Doors for change rooms need to provide privacy. Laboratory doors need to have vision panels so one can see if anyone is on the other side of the door. Door frames need to be rigid so the airflow around the door remains constant with door usage. Hardware needs to be filed so there are no sharp edges which can cut a person and/or their PPE on entry into the laboratory. 9. Penetrations: Sealing of penetrations is important from energy consumption, air pressure differential, HEPA filtration, pest management, and decontamination perspectives. The design must provide details for sealing penetrations and performance standards for acceptability of sealing work. Sprinklers often present a challenge if they are not pendant type. 10. Room airflow distribution: Placement of diffusers and exhaust grilles can affect the airflow of the biosafety cabinet and can cause indoor air quality issues. A reflected ceiling plan must take into account the location of the biosafety cabinet and sedentary work stations in relationship to placement of diffusers. The engineer should work closely with the architect in coordinating these locations and selecting the supply airflow terminal devices. Diffusers, exhaust grilles, and exhaust inlets of caging are penetrations in the ceiling and need to be sealed. These details need to be provided in the reflected ceiling plan and in drawing details. 11. Directional airflow: Directional airflow must be designed so that under any laboratory condition the air does not reverse. A drawing should be developed which shows the pressure differentials at each door. The designed airflow balance needs to create directional airflow measured by pressure differentials at each containment barrier door. The design of the laboratory needs to take into consideration building effects from elevators, stack effects, adjoining independent HVAC/exhaust systems, and loading docks. In an HVAC/exhaust system failure scenario, building effects can reverse the airflow in containment if not addressed in the design process. Deep negative conditions can be programmed out using the Building Automation System (BAS). 12. HEPA filtration: If the program or regulations require exhaust HEPA filtration then consideration needs to be given to either central or local HEPA filtration. Local HEPA filtration is either at the exhaust intake or in the branch duct from the exhaust intake at the room level. The issues with room level HEPA exhaust are decontamination and testing of the HEPA filter costs. With local HEPA filtration, the issue is the number of units that need to be tested annually. This cost needs to be evaluated against the cost of decontamination and testing of a central HEPA filtration unit. 13. Redundancy: Unless there is a Class III cabinet being used for aerosol experiments, two redundant exhaust fans is all that is necessary for a BSL-3/ABSL-3 laboratory. These fans perform best during failure scenarios if they are operated together at reduced speed. Redundant air handling units are typically reserved for containment laboratory facilities housing animals. Air pressure differential gages at the entry to the anteroom and at the entry to the laboratory provide laboratory personnel the assurance that the laboratory is working properly. Redundant HEPA filtration units are only necessary if an animal laboratory needs to operate continuously. Laboratories can be tested and inspected while in operation, therefore not requiring an annual shutdown. 14. Maintenance provisions: Space for maintenance of equipment, removal/replacement of components, and decontamination of system components need to be provided as design details. Control exhaust valves are of particular concern and their placement is a decontamination/maintenance issue if they are upstream of the HEPA filter. 15. Sinks: In order to prevent aerosols generated by the water impacting the sink bottom, the designer needs to consider specifying deep well sinks in combination with controlling water pressure. Selection of hands-free devices for faucet operation (elongated wall attached foot pedals, infrared sensor, rod-operated valve, knee valve, or floor pedal) should be based on maintenance requirements as well as the experience of the facility’s maintenance personnel. Regardless of the designer’s choice, the faucet should not have handles of any type which personnel could touch. If a hose bib is attached to the faucet, it should have a hose attached which does not extend below the sink’s rim if not protected by a backflow preventer. Backflow preventers are usually required on laboratory faucets and are recommended provided that they will be maintained. 16. Gas cylinders: Gases should be piped into the laboratory as part of the design. Piping penetrations should be sealed around the pipe. Escutcheon plates are not recommended. Provisions for bottled gases should be made outside the laboratory so bottles can be changed from outside of containment. 17. Lighting and sound levels: Proper lighting levels are necessary for performing tasks, data entry, and cleaning. Energy-efficient lighting technology should be the basis of the lighting design. Light-emitting diode (LED) is today's most energy-efficient lighting system. A lighting consultant can select the proper color temperature and light fixture photometric data to achieve the needed light levels for the tasks to be performed throughout the space. Lighting levels need to be evaluated for security camera selection. Glare on biosafety cabinets needs to be minimized. Provisions for emergency lighting for securing research materials and safe egress are required. Alarm strobing lights in animal facilities need to consider their placement and effect on animal research. Limitations on noise should be part of the design criteria. The noise criteria levels specified by the designer should account for ventilation noise, and owner-specified equipment noise such as biosafety cabinets, freezers, and centrifuges. 18. Communications and security: Design of wiring for communication and security devices needs to have the same detail as for electrical wiring devices. Penetrations need to be sealed and devices caulked to be smooth and cleanable. Provisions for computer stations that are ergonomically designed and placed in close proximity to the data generation point is a time-saving design element. Another consideration is the placement of the computer’s fan so it doesn’t cause a disturbance to the biosafety cabinet. Also, the cords for the computer, monitor, keyboard, and other peripherals need to be harnessed so they are not draped on the floor and can be easily cleaned. The design must address the biosafety vulnerabilities of the facility. A multi-disciplinary approach (biosafety professional, security professional, facilities director, human resources representative, and an executive management representative) should view security from a holistic perspective. 19. Circuit breakers: Electrical panels should be located outside of containment so maintenance personnel do not need to enter containment. Additionally, the receptacles within containment need to be marked with breaker identification so in the event of a tripped breaker the researcher can direct the maintenance personnel from within containment to which breaker needs resetting. 20. Emergency power: Choices for emergency power systems are usually left to the designer. The users need to provide direction as to their emergency power needs, either total or partial emergency power. Consideration should be given to a dedicated emergency generator for the laboratory rather than utilizing the building emergency generator for reliability reasons. Reliability rules when specifying the automatic transfer switch. With emergency power you can, on larger campuses, have redundancy but a transfer switch is a single failure point. Regardless of these choices, the equipment serving the room-level equipment including HVAC control components may need uninterruptible power supplies. A holistic approach is recommended for selection of an emergency power system that also accounts for shutting down or not shutting down the entire building to test the containment laboratory within the building. Testing disruptions cannot be tolerated in some instances because of other 24/7 critical functions which cannot not be interrupted. In analyzing the final design, emphasis needs to be placed on the details. Constant referral to the research program requirements, containment guidelines, lessons learned, project construction and operating budgets, and the completeness of the design documents are essential to a successful design that meets the users and the stakeholders’ needs and provides sustainability. Efforts spent in design by an integrated team of users, professionals, and stakeholders will culminate in a safe, sustainable, and secure research facility. Are you planning to build or renovate a BSL-3/ABSL-3 laboratory? No matter what project phase you are in, 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 containment compliance and sustainability!

5 Key Takeaways from the ISO 35001:2019 Lead Auditor Course

Since its launch in 2019, ISO 35001 has gained significant global interest, particularly among organizations seeking to strengthen biosafety and biosecurity risk management in the workplace. Learning from Dr. Stefan Wagener of Biorisk Management International (BRMI) during this course was both intensive and enriching. Representing our teams across Asia, North America, and Latin America, here are five key takeaways from the course. Enhancing Our Value as Certifiers and Consultants At World BioHazTec, we serve our clients in both certification and consulting roles, though never simultaneously—a critical principle emphasized in this course. As lead auditors, we must assess every clause of ISO 35001, as none can be excluded. With limited time on-site and hundreds of mandatory "shall" requirements, how do we efficiently gather evidence? Learning to think like a lead auditor not only strengthens our audit process but also enhances the quality of our consulting services. A Hands-On, Interactive Learning Experience ISO 35001 sets a high bar, and so does this course—daily individual and group exercises, quizzes and a final exam demand full attention and deep engagement. Fortunately, Stefan Wagener and the team at BRMI ensure the material is far from dry or overly technical. Through interactive exercises, real-world case studies, and engaging discussions, participants gain hands-on experience applying ISO 35001 principles. What made this experience even more valuable was the diverse perspectives in the room. With attendees from around the world—biosafety professionals, biosecurity experts, scientists, and engineers—discussions often revealed different interpretations shaped by cultural and regulatory contexts. This collaborative learning environment made the course dynamic and insightful, while also providing practical strategies for auditing clients from various industries. ISO 35001:2019 Requires Serious Commitment Adopting ISO 35001 is not just a box-checking exercise—it demands a long-term commitment from organizations. Successful implementation requires: ✅ Strong leadership support to drive adoption ✅ Comprehensive training to ensure conformity ✅ Adequate financial resources for a sustainable biorisk management system Without these elements, achieving and maintaining conformity becomes incredibly challenging. However, ISO 35001 incorporates a structured "Plan, Do, Check, Act" approach to biorisk management, ultimately strengthening an organization’s biosafety culture and moves biorisk management to the system level. The Course is Designed for Subject Matter Experts (SMEs) ISO 35001 follows a familiar clause-based framework, but its specialized focus on a biorisk management system sets it apart from other ISO standards and requires an upfront knowledge of laboratory biosafety and biosecurity, As our instructor pointed out, it’s easier for a biosafety SME to learn auditing than for an ISO 9001 auditor to transition into ISO 35001 auditing. For biosafety practitioners, this course provides the necessary structure, tools, and knowledge to successfully conduct both internal and external ISO 35001 audits. If you’re already working in biosafety or biosecurity, this training will significantly enhance your auditing capabilities. Before Learning ISO 35001:2019, You Need to Understand ISO 19011 ISO 35001 does not stand alone—it relies heavily on ISO 19011, the global guideline for auditing management systems. ISO 19011 provides the principles, procedures, and competency requirements for auditors across various fields, including quality, environmental, safety, and information security. A solid understanding of ISO 19011 is essential for conducting effective and structured ISO 35001 audits. At World BioHazTec, we have long adhered to these principles as certifiers. Applying ISO 19011’s systematic approach has allowed us to continuously improve our audit processes and enhance our team’s competencies. Final Thoughts The ISO 35001:2019 Lead Auditor Course is an intensive yet high-value training program designed for biosafety and biosecurity professionals looking to deepen their expertise in biorisk management system implementation and auditing. This course goes beyond theory, offering real-world applications of ISO 35001 while fostering global collaboration among industry experts. For those looking to elevate their knowledge of biorisk management systems, this BRMI course is an investment worth making—but be prepared for a challenging, rewarding, and highly engaging experience! Learn more about how World BioHazTec can assist you with your biorisk management system.

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!

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.

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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