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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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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!

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Looking for a BSL-2 Laboratory Space?

Five things to consider when scoping out a BSL-2  lab space to keep your workers safe. More and more commercial building landlords set aside laboratory space to lease. When scoping out possible options for existing laboratory space, beyond the research experiment, you need to consider worker safety. Being risk averse is a good practice when walking through potential laboratory spaces for your next research project. Here are 5 things to consider when scoping out a BSL-2 laboratory. 1. Establish Your Criteria Through Safety Guidelines Safety in a laboratory is paramount! There are guidelines available to you that can serve as your criteria or provide a checklist to ensure that when evaluating a space, it “checks the boxes.” When looking for a new home, most people have their “dealbreakers” (e.g., must have 3 bedrooms and a walk-in pantry) versus their “bonuses” (e.g., pool and wood-burning fireplace). The same idea can be applied when looking at a potential BSL-2 laboratory space. What are your dealbreakers? Establishing your safety guidelines before you even call a landlord to inquire about a space is a good way to communicate what kind of laboratory space is needed. The Biosafety in Microbiological and Biomedical Laboratories (BMBL) published by the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) provides guidance on the laboratory space requirements. The World Health Organization (WHO)’s Laboratory Biosafety Manual is another source that will guide you how to approach your laboratory with a balanced risk assessment. Please be informed, the BMBL is a guideline and not a regulation. If a laboratory space does not meet all of the statements within the guidelines, you can conduct a risk assessment to evaluate the potential risk and impact to your research, workers and the surrounding environment. A workaround solution such as an administrative control can provide an easy resolution. Workaround administrative control solutions will require training and monitoring so factor that into your decision-making. Preplanning will expedite decision-making and protect your most valuable personnel as well as the tenants who share the building. If you are an employer or landlord and in need of a space evaluation, risk assessment or a second opinion if whether a space or building qualifies for a biological containment laboratory, contact us for more information. 2. Adequate Inward Directional Airflow Inward directional airflow that does not recirculate outside of the BSL-2 laboratory is highly recommended by the BMBL to ensure that sufficient air is being drawn into the BSL-2 laboratory and to prevent aerosol transmission from the laboratory into another part of the building. Inward directional airflow draws air into the laboratory from the “clean” areas (e.g., corridor outside of a laboratory) and toward “potentially contaminated” areas (e.g., a biological safety cabinet [BSC]). Although not a requirement, the BMBL and WHO Laboratory Biosafety Manual recommends that a BSL-2 laboratory has inward directional airflow. The rationale is to eliminate the risk of others in the building from being exposed to the biological and/or chemical materials that could be released into the space inadvertently. Verification of directional airflow can be accomplished and documented by a Testing and Air Balance (TAB) Report or by an engineer’s testing and certification. A pressure differential target value is at least .05 In. H2O (15 Pascals) which approximates 100 CFM passing through the crack area of the entry door. Ask the landlord for a TAB Report so you can verify if there is directional airflow. Not sure where to start or how to read a TAB Report? Contact us and we can help you. 3. Biological Safety Cabinet (BSC) Placement The BSC is a key area where your manipulations will occur in the BSL-2 laboratory. When walking through the laboratory, consider where the BSC will be placed. You want to make sure that people walking by do not disrupt the air inflow into the BSC. Rule of thumb is to place the BSC away from doors and common pathways within the laboratory. If you have limited options, put a demarcation line on the floor (red tape works well) as a visual aid as to where not to walk. Train and periodically observe your laboratory personnel to ensure they do not cross the demarcation line when walking past the BSC. Ideally, the BSC should be placed as far as possible from the entryway. The objective of directional airflow is to draw air from the “clean” areas toward the potentially contaminated areas. The BSC is the most potentially contaminated space within the laboratory. Having your BSC placed far from the entryway reduces the risk of exposure and minimizes BSC airflow disruption. One last point about BSCs and their required annual testing. There needs to be at least 12 inches between the HEPA filter of a Class II type A2 BSC for scanning the HEPA filter. Make sure to check floor-to-ceiling clearance for the height of the BSC you will be using. Although BSC stands are adjustable, you do not want to have the BSC so low that it impacts the worker’s ergonomics. BSC heights are generally about 8 feet so you will need at least a floor-to-ceiling height of 9 feet. 4. Look Down At The Floor Slips, trips, falls and spills are always a great risk in the workplace. The BSL-2 laboratory floor should be smooth, slip-resistant flooring. Sealed flooring is recommended. Watch out for manufactured floors with grooves or grouted floors that cannot be easily cleaned. We suggest verifying that the flooring material is chemical resistant and antimicrobial. Carpets and rugs are unacceptable. 5. Let This Sink In You would be surprised how many times our experts evaluated laboratories that do not have sinks at the entry/exit ways. Good laboratory practice is to wash your hands before leaving the laboratory to minimize potential contamination of door hardware. Ideally, the sink should be located close to the laboratory exit so that after doffing PPE, the worker can wash their hands. 6. It Doesn’t Hurt To Ask Surprise! We have a 6th tip. Discuss with the landlord and document what needs to be installed, repaired, or replaced before you take occupancy. Any annual maintenance items should also be discussed (e.g.,  filter changes, lighting relamping, etc.) and discuss deliveries to the facility (e.g., laboratory samples, bottled gasses, etc.). This effort will pay off in the future with you being a long-term tenant and establishing an amicable tenant and landlord relationship. Next Steps Are you interested in scoping out a biological containment (BSL-2 or BSL-3) laboratory? Consider inviting one of World BioHazTec’s experts along. We can evaluate the space and perform a risk assessment to determine if the containment laboratory space can accommodate your laboratory needs. Our services can include any or all needs for reviewing the TAB Report, assisting with equipment placement and evaluating the overall layout of the laboratory. Our report will provide you and the landlord a basis for discussion on lease modifications and tenant upgrades to move forward with leasing the space.

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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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Accredited Auditing Organization

World BioHazTec is recognized under the Auditing Organisation (AO) scheme by the Singapore Accreditation Council (SAC) to perform the following services:
• Certification of BSL-2, BSL-3, and ABSL-3 facilities worldwide*
• Engineering Verification
• Gap Analysis
*For BSL-3/ABSL-3 facilities in Singapore, World BioHazTec is the Auditing Organization, accredited by the SAC.