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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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Pressure Decay Testing and Why It is Important in BSL-4 Laboratory Annual Verification Testing

What is Pressure Decay Testing? Pressure decay testing is a systematic procedure to validate room construction to determine if the laboratory’s containment barrier defined by walls, floors, ceilings, penetrations, and other construction features meet the required integrity to prevent leakage of unfiltered air from the BSL-4 containment space. Pressure decay testing is the most reliable method to prove that a BSL-4 laboratory room’s envelope is airtight. The National Institutes of Health, which oversees the operation of the BSL-4 laboratories located in Fort Detrick, Maryland, and Hamilton, Montana, indicates that the standard BSL-4 pressure testing method is to negatively pressurize the room to 2 InH2O, and then measure the pressure decay. The requirement for a BSL-4 laboratory is to maintain a pressure higher than 1 InH2O after 20 minutes (Memarzadeh, 2009). This quantifiable test can pinpoint issues with  critical equipment in a BSL-4 laboratory including: Air distribution valves Isolation dampers and actuators Isolation dampers bioseals APR doors gaskets Barrier autoclaves gaskets and seals Breathing air system lines Laboratory vents Why is Pressure Decay Testing Important? Pressure decay testing provides an acceptable level of quality for annual verification testing of BSL-3 Ag and BSL-4 laboratories. The complex design and operation of these facilities minimize the potential risk of an aerosolized pathogen to staff, the general population, and the surrounding environment. The pressure decay test verifies that there is no air leakage. Air leakage can compromise research studies through cross-contamination of multiple pathogens. How to Prepare for Pressure Decay Testing? The following steps must occur before conducting a pressure decay test: Verify the facility’s HVAC system is operational and commissioned. Verify the building automation system (BAS) is operational. Provisions for setting up testing equipment are available (pressure transducer enclosures, decontamination ports, etc.) Use either testing vacuum pump or exhaust system to negatively pressurize the system up to 2.00 InH2O. Check all potential sources of leakage for audible or identifiable leakage. To the extent practical, eliminate/minimize potential sources of heat generation so that the space stays at a relatively constant temperature throughout the testing (lights, freezers, motors, etc.) Isolate the affected areas from pressure fluctuations that will affect the testing. Monitor room Differential Pressures (DP) with static conditions (no airflow or pressurization air) to ensure that there are no external effects that will invalidate the results. All plumbing fixtures and floor drain traps are filled with water. If previously identified, all construction deficiencies have been rectified and completed. Ensure no visible damage is apparent to the room under test. All conduit, wiring, and electrical boxes have been epoxy-sealed. All epoxy coatings (if epoxy coatings are present) are in place and free of visible defects. Seamless flooring is in place and free of visible defects. Check valves and isolation valves are in place and operational. Dunk tanks (if installed) are filled. Autoclaves are operational and have their seal barriers in place. APR doors are functional and interface to BAS, and door access control systems are operational. Room temperatures are measured and data logged. Changes in temperature cause changes in pressure. Atmospheric pressure is measured using an instrument with an accuracy of 0.01 In. Hg. which is equivalent to 33.86 Pa or .136 InH2O. A pressure decay test form has been generated. It has been confirmed that room and general laboratory conditions are acceptable for testing the laboratory. The subject test area should be isolated and then allowed to stand for 20 minutes before commencing the test. Acceptance Criteria The room passes the pressure decay test if the residual pressure at the end of the 20-minute period is -1.00 InH2O or more negative (50% of the initial room’s pressure value) under steady state conditions for temperature and barometric pressure. Each pressure zone within maximum containment (BSL-4) must pass two consecutive pressure decay tests. If Pressure Decay Testing Is Not Feasible If annual pressure decay testing is not feasible for some rooms, then another option would be conducting a smoke saturation test. A smoke saturation test is a qualitative test, but it will help the users to identify possible issues with the containment envelope. The maximum containment engineering/maintenance team will need to command the laboratory into maintenance or decontamination mode. The surrounding areas will be more negative; therefore, if there is a leak or issue during the testing, the maximum containment team will be able to identify it. The challenge with this method is that it is only recommended if the rooms are decontaminated. Another option (a little bit messy and more time-consuming) is the use of a soap solution on critical areas. This test is the least accurate option because it will only test perimeter barrier components. The laboratory will require decontamination prior to testing. “Light Pressure Decay Test” If there is a decontamination or maintenance mode for the facility, you can run what we call a “light pressure decay test.” Before a decontamination process begins, you need to make sure the laboratory is airtight. The light pressure decay test is typically conducted from the BAS for testing and running trends. No additional testing equipment is used. This is a non-invasive procedure. What About BSL-3 Laboratories? BSL-3 laboratories can be pressure decay tested depending on the laboratory’s envelope construction system, calculated room’s leakage rate, and room’s isolation capabilities. Pressure decay testing on BSL-3 laboratories is more challenging since, by concept, these types of laboratories are considered “leaky labs” (infiltration of air is required). However, with the implementation of good room isolation standard operating procedures, the pressure decay test can be achieved with no issues. Recommendations Pressure decay testing is a team effort. Our recommendations to have a successful pressure decay test include: Make sure to get involved with experienced staff and a third-party consultant such as World BioHazTec from the beginning. Pressure decay testing is a critical testing procedure that requires experience and knowledge of BSL-4 and BSL-3 laboratories. Pressure decay testing should not be rushed. It requires coordination and is a team effort that involves the biosafety officer, Responsible Official, Alternate Responsible Official, facility director, facility personnel, and contractors. Differential pressure meters and test equipment calibration must be current and traceable to NIST. Check and double-check items which could inadvertently affect the testing outcome. If room or atmospheric conditions are not stable, such as a thunderstorm, do not hesitate to reschedule the test. If you would like to learn more about pressure decay testing, contact World BioHazTec for a free consultation or send us an email. Works Cited Farhad Memarzadeh (2009, September 15). Pressure and Temperature Correction for BSL4-Pressure Decay Test. (O. o. National Institutes of Health, Producer) Retrieved 2023, from Pressure and Temperature Correction for BSL4-Pressure Decay Test: https://orf.od.nih.gov/TechnicalResources/Bioenvironmental/Documents/PressureandTemperatureCorrectionforBSL4_508.pdf

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N+1 Redundancy in BSL-3 and ABSL-3 Laboratories

Redundancy is a “must” for BSL-3 and ABSL-3 laboratories. Although the Biosafety in Microbiological and Biomedical Laboratories, 6th Edition (BMBL) and the World Health Organization Biosafety Manual, 4th Edition (WHO) do not specifically mention N+1 critical equipment for BSL-3 or ABSL-3 laboratories (BMBL) or “heightened laboratories” (WHO), they both specify: BMBL: “Loss of directional airflow may compromise safe laboratory operation.” – Page 16 WHO: “Laboratory ventilation where provided…should ensure airflows do not compromise safe working.” – Page 33 What is N+1 Redundancy? N+1 redundancy is a risk reduction strategy used in critical containment environments such as BSL-3, ABSL-3, BSL-3Ag, BSL-4 or ABSL-4 laboratories to ensure operational reliability and containment during failure of system components to reduce risks to personnel, animal health, the public and the environment. Building systems are made up of many components (e.g., fans, pumps, motors, variable frequency drives, control air valves, damper actuators, etc.). “N” refers to the component necessary for the system to operate. For systems that are critical to maintain containment, directional airflow, electrical power, water, fire protection, etc., an engineer provides an additional component N+1, or additional components N+2, etc., to reduce the risk of interruption of the building service serving the laboratory.  These redundant components are capable of handling the full load of the building system in the event one of its primary components fails. This means that even if one of the primary components fails “N”, the redundant component “+1” takes over. This is not unique to our industry. For instance, commercial jet airliner engines are redundant. Jet airliners are designed so that if there is a loss of one engine, the other engine takes over (N+1 redundancy). Likewise in the biocontainment industry, the electrical supply to the BSL-3 laboratory has N+1 redundancy.  The “N” represents the utility that normally supplies electricity to your facility. The “+1” would be the redundant power supply (e.g., emergency generator, uninterruptible power supply, flywheel) that can provide enough power to run the entire or a portion of the building systems which serve the laboratory. Just like a commercial jet airliner, the laboratory will be able to operate until corrective action can be taken. This is extremely important for containment and especially for animal facilities as the animals will suffer if the building systems are not restored. Personnel can leave the laboratory while animals cannot.  Deciding to what extent you provide redundant components (N+1, N+2, or N+3, etc.) requires a risk assessment. What Does the BMBL and WHO Say? The BMBL states, “A ducted mechanical air ventilation system is required. This system provides sustained directional airflow by drawing air into the laboratory from ‘clean’ areas toward ‘potentially contaminated’ areas. The laboratory is designed such that under failure conditions the airflow will not be reversed at the containment barrier”. The key words here are “under failure conditions.” The BMBL and WHO guidelines rely on the best tool we have in biocontainment: “risk assessment.” Risk Assessment for N+1 Redundancy Some factors we need to consider for N+1 redundancy when conducting a risk assessment are (among others): BSL-3 laboratory location (isolated, building, city, campus, etc.) Research protocol and volume of samples or biological material to be used Budget BSL-3 laboratory size Design intent and acceptance criteria Capability for ease of annual testing of HVAC and electrical systems When World BioHazTec consults on the design of containment laboratories located at universities, research campuses and public health laboratories, meeting the N+1 redundancy provision is a group decision with input from the biosafety officer, users, facilities management, designers and cost estimators to reduce risk to an acceptable level. The resultant design needs to be reviewed for performance criteria, especially for the timing of the transfer from the failed component to the redundant component. This is particularly important for the electrical and HVAC components’ sequence of operation to restore the system to full operation parameters.  The restoration of a system with the redundant component is a critical operation which needs to be observed and documented to show there was not an airflow reversal caused by the redundant component taking over.  A robust sequence of operation and programming,  supported by a strong biosafety program which addresses system failure events, reduces risk and documents performance. For more information about N+1 redundancy, risk assessment and laboratory design, contact World BioHazTec for a free consultation, or send us an email.

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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.

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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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