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Incident Reduction in BSL-3 and BSL-4 Laboratories
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Practices that improve biosecurity during material transfers.
This document details how biosecurity professionals, laboratory owners, architects, planning and engineering teams, and purchasing managers can strengthen the security of BSL-3 and BSL-4 facilities. Historical data from previously reported incidents in research laboratories reveal the need for better solutions for material transfers. This document provides important procedural recommendations for managers and employees on methods to improve biosecurity in BSL-3 and BSL-4 areas.
When containment does not work.
The transfer of materials in and out of contained areas represents a fundamental challenge for BSL-3 and BSL-4 facilities, due to the risks attributed to confinement. Infectious disease research conducted in BSL-3 and BSL-4 facilities requires a greater degree of containment to prevent occupational hazards. These can affect the facility and the surrounding community. The threat associated with incidents when containment is broken is particularly dangerous at BSL-4 facilities. BSL-4 facilities contain known viruses, such as Ebola, Zika, and others, that pose pandemic risks and currently have no treatments or vaccines. Although several biosecurity protocols have been implemented
To prevent the number of incidents at research institutes, contamination problems continue to pose a risk. Between June and July 2014, the U.S. Centers for Disease Control and Prevention (CDC) reported three biosecurity incidents, the first of which was partially due to “a mechanical malfunction in an autoclave.” Following a self-imposed moratorium on the external transfer of infectious agents, intended to allow time for complex biosecurity procedures, the CDC reported another incident that involved the potential transfer of live Ebola virus to a BSL-2 facility in December of the same year. Additionally, in 2014, the National Institutes of Health reported the discovery of previously forgotten vials containing smallpox virus that were in an unauthorized cold storage area. Another institution that sets the bar for biological safety is the U.S. Army Medical Research Institute of Infectious (USAMRIID) which, in 2015, reported 18 incidents with BSL-3 laboratories and 51 incidents with BSL-4 facilities, one of which involved a Potential Biological Exposure (PBE). High-risk biosecurity breaches like these emphasize the reality that incidents can happen anywhere. Accidents at any infectious disease facility raise concerns about biosafety procedures because contamination or exposure to pathogens affects more than just research. The impact of procedural flaws extends far beyond the laboratory to potentially affect humans, animals and agriculture. The situation with these incidents of violation, however, is not always sufficiently recognized in the mass media or brought into the public consciousness to its fullest extent. The importance of biosafety procedures and the optimized specification of autoclaves is not overemphasized. The problems are much more widespread than properly perceived.
Elimination of poor performance.
Both new and old equipment can cause containment and contamination problems. However, older technologies that often require manual processes increase flow control and throughput problems; in addition to putting at risk the security measures used to protect research and the environment. Manual opening of doors on older autoclaves models, for example, can compromise operator safety, especially when the absence of interlocking devices allows operators to open doors before a cycle is complete. Such human error releases pathogens that have not been deactivated. Outdated equipment also requires frequent maintenance to ensure performance and avoid downtime. While shutdowns are a huge problem for all research facilities, they can be particularly damaging to vivariums. The creation of animal waste and the need for decontaminated water and food are continuous processes in this environment. The impact of a maintenance shutdown can be minimized by a preventive method, which anticipates component wear, leverages statistical information from other facilities, and benefits from the proficiency of specialized technicians. In addition, this service is performed on a previously defined day and time, where there is less impact on the interruption of laboratory processes. Regardless of the time of use, autoclaves that are not correctly specified compromise the environment and the integrity of the research, especially in cases where animals or specimens are introduced to other pathogens that interfere with the testing of vaccines and treatments. If users do not have the necessary training to ensure an adequate specification, the risk of acquiring equipment that does not meet biosafety levels 3 and 4 is great. Autoclaves must be thoroughly specified within a strict targeted standard according to their final application. If this does not occur, research and biosafety in general will be compromised.
Importance of community support.
While new facilities typically benefit from new technologies, they still face challenges. Community support and public understanding are essential to the successful construction of BSL-3 and BSL-4 facilities. Without this support, many of these facilities do not receive the necessary approval to carry out the full range of research they were built to manage. In 1985, the Australian Animal Health Laboratory (AAHL), which is part of the Common Wealth Scientific and Industrial Research Organisation (CSIRO), opened in Geelong, Australia. Although the BSL-4 facility was originally built for diagnosis and production of foot-and-mouth disease vaccines, opposition from local farmers prevented any research into the matter from being set up. A similar example is that of the National Emerging Infectious Diseases Laboratory (NEIDL) at Boston University. Construction of the university’s medical campus was completed in the fall of 2008 and although the BSL-4 facility received the necessary approvals from government agencies, public controversy led them into a contentious fight that, according to the university’s newspaper, has kept much of the lab closed. Opposition was so strong that in March 2014, an ordinance was created to ensure that all BSL-4 research was banned from the city of Boston. Although this was rejected two months later, since 2016 the laboratory has remained closed for this type of operation. To persuade the public to take a stand in favor of BSL-3 and BSL-4 facilities, particularly in areas with a higher risk of pathogenic and epidemiological diseases, it is important, therefore, that the leadership of these facilities communicate openly with the community prior to the construction of a new facility. At the same time, leadership must do everything possible to reduce or eliminate the possibility of incidents. Undoubtedly, biosecurity can be improved by choosing the right autoclave, designed for the sterilization and decontamination of materials inside and outside the confinement area.
What an autoclave must have.
All BSL-3 and BSL-4 facilities are required to use autoclaves or other decommissioning method as a standard procedure to ensure decontamination of all material prior to disposal. According to the CDC “a method for decontamination of all laboratory waste should be available, preferably at the facility itself.” Facilities operating at the BSL-4 level must additionally have double-door or “barrier” autoclaves, with automatic control, for the transfer of materials between areas. The CDC also determines that these doors must have interlocking devices that prevent opening from the outside, if the cycle is one of decontamination. The use of door locks for flow control is a method that ensures the complete decontamination of materials and also prevents accidents. Both new and existing facilities should have a double-door autoclave, designed to anticipate eventualities and handle procedures that aim to reduce the possibility of incidents. Many factors must be considered in the early planning stages to ensure long-term biosecurity. An experienced architect and planning team must weigh the cost-effectiveness of designing a pass-through transfer system from scratch. Solutions may include tailoring some project needs, to purchasing autoclaves that have been specifically field-tested for years to meet all requirements and objectives. Key features of an autoclave: The most effective autoclave model for BSL-3 and BSL-4 installations is one with a pass-through configuration, which provides flow control for material transfers between containment areas. In BSL-3 and BSL-4 areas, sterilizers must have an integrated containment barrier or biological seal, welded to the autoclave chamber, with a seal in the masonry walls, to create an internal transfer channel between the areas. This seal must be tested, verified and must ensure the safety of the operator and the environment by eliminating the risks of cross-contamination within the facility. Autoclaves with a containment barrier or biological seal must meet defined criteria and meet a number of other requirements specific to BSL-3 and BSL-4 installations. For example, the doors of these equipment models must have a watertight pressurized sealing seal. Watertight seals eliminate cross-contamination and protect processes and operators by making it impossible to open doors simultaneously.
For most applications, moist heat is the most effective agent for microbial deactivation. When materials sensitive to moist heat need to be transferred into the lab, pass-through autoclaves are particularly useful as they can be adapted according to procedures and processes to allow materials to pass through without initiating a sterilization cycle. This facilitates the transport of live animals to containment areas. Autoclaves can also be retrofitted with hydrogen peroxide gas generators (H202) for decontamination of electronics, samples, and high-temperature-sensitive items. The value of a brand: When an autoclave purchase process is opened, considering a trusted brand with historically recognized performance will accelerate the procurement process and deliver the benefits of containment solutions developed across the global biosafety system. For facilities that specialize in pathogens or materials that cannot be processed in existing autoclave models, working with a recognized experienced global company offers significant advantages. An experienced consultant can assist in determining the new autoclave, so that it meets the specific needs of the processes. This consultancy forms partnerships that are mutually beneficial in the pursuit of technological innovations, while encouraging valuable support to the general public and the creation of a satisfactory performance story that can serve to demonstrate the biosafety of a laboratory. The reputation of the autoclave manufacturer that will be chosen is a critical point in efforts to ensure a common understanding of processes and safety measures to protect personnel and the environment. Companies must have a documented portfolio of successful installations related to new construction, retrofits, standard installations, and customized products for highly specific projects and applications. Equipment manufacturers must offer extensive research and development expertise. Professionals must conduct extensive testing and provide ongoing support services after installation and commissioning. To ensure proper maintenance, you need a manufacturer with a global reach and trained technicians ready for a quick response. This is a critical factor in compliance requirements: selecting the right autoclave for a specific application is only the first step in ensuring good performance and not just a consideration.
Solving inefficient performance processes.
It is equally important to include frequent performance testing as part of regular laboratory procedures. While almost all facilities perform daily leak testing, many do not evaluate the overall performance of the autoclave. Frequent performance testing is the only way to measure the level of inactivation of organisms. Monitoring through chemical and biological indicators is also essential to verify that the time and temperature are as initially parameterized. These tests are vital methods for verifying desired decontamination or sterilization results. While these tests can add costs to the process, they provide a return on investment and are much less costly than incidents caused by some poorly performed shutdown. The performance of the laboratory team is also an important component in the effectiveness of sterilization procedures. When the autoclave is running its process correctly, incomplete decontamination can still occur as a result of inappropriate loading, due to human error. While Bowie-Dick test cycles ensure that the autoclave is able to effectively remove air from the products and the chamber itself, incorrectly positioned loads can prevent this from occurring. Laboratory waste is typically packaged in autoclaving bags and problems with ineffective deactivation can occur if temperature and time parameters are not met.
The conclusion.
Double-door autoclaves with containment barrier or integrated biological seal ensure the safe transfer of materials in and out of containment zones, as well as appropriate flow control within the facility. A properly designed material transfer area ensures a one-way process flow and ensures that the two doors of a pass-through autoclave are never opened simultaneously. This limits the possibility of environmental contamination caused by the release of pathogens still present in an incomplete sterilization cycle. A pass-through autoclave greatly reduces the risk associated with transfers of laboratory materials in BSL-3 and BSL-4 facilities, but only when it has proper design and quality equipment. It is important to understand, however, that an effective autoclave is only part of the solution. It is equally important to establish a preventive performance plan to control all sources of contamination and follow proper maintenance. Ultimately, facility owners are important factors when associated with the use of autoclaves as contamination barriers. They must develop a laboratory management plan to make these transfers more effective, through risk assessment and planning. When making purchasing decisions, the history of the product and the manufacturer’s performance should be considered. The manufacturer should also offer a track record of success, advanced operational training, best practices, and continuing education.
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