This is the first in a series of two articles about implementing design solutions for multi-pathogen, multi-use, multi-protocol biocontainment facilities. This article discusses biosafety and program management considerations and strategic planning issues.

“Most BSL-3 and BSL-4 facilities struggle with overhead costs, equipment that is dedicated specifically for small programs, and insufficient flexibility,” says Uwe Ulex Mueller-Doblies, head of biosecurity, biocontainment, and animal services at the Institute of Animal Health (IAH) in the United Kingdom. “There is either too little space or too much space for a particular program element.”

As a result, financial backers are seeking more value for their money by scaling up facilities, merging multiple programs into one facility, sharing expensive equipment, and making buildings flexible enough to accommodate future changes. There are two obvious downsides to merging programs and bolstering flexibility. First, building sufficient flexibility into a facility requires substantial upfront costs. Secondly, bringing a critical mass of scientists together to share equipment and to collaborate on research increases the likelihood that something will go wrong since more people are involved.

However, Mueller-Doblies believes the positive results far outweigh the two negatives and produce a better value for the money. For instance, multi-use facilities provide higher levels of integration, accommodate larger research programs, achieve a critical mass of science with multiple smaller programs, and require lower overhead costs for maintenance, utilities, and other services.

Biosafety and Program Management Considerations

Biosafety issues should be at the top of the priority list when designing a multi-use facility. It is important to ensure that research taking place in a common area has the same regulatory requirements for quality standards, animal housing, and containment to prevent human and environmental hazards.

The first step is to consider the pathogen portfolio and the types of Select Agents that may be used in the labs. Co-location of different programs is an option, but care must be taken to match different safety cultures and to respect the requirements of various researchers working in close proximity.

“Most importantly, you have to agree on common rules that will work in that particular facility in order to protect your barriers,” says Mueller-Doblies. “You must decide whether to use shared spaces or dedicated spaces. Do you use things in parallel or do you have tidal use of highly specified equipment where you say, ‘I can alternate between BSL-3 and BSL-2 because the space around that piece of equipment meets the higher containment requirements, and different protocols are applied depending on the hygiene status of the space.’ Facility down-time and service resources also must be taken into account.”

A systematic design approach is best since large facilities typically house a range of species and handle a variety of pathogens that require varying containment levels from SPF to BSL-3, BSL-3Ag, or BSL-4. It is helpful to sort the biosafety drivers into four categories: hosts, pathogens, protocols, and scale. Restricting the number of pathogens, which are a primary driver, eases numerous complications, such as the type of decontamination that may be required. While chemical disinfection may be satisfactory in some instances, thermal decontamination may be required in others. Foot and mouth disease is a prime example&emdash;it can be destroyed by heat, but chemical disinfectant is also sufficient.

Knowing the type of animals that will be housed in a facility today and in the future is critical to proper design. This information dictates what type of containment is necessary. Protocols are determined by the type of research and diagnostics—such as molecular, cellular, analytical, immunology, pathogenesis, drug testing, or epidemiology—that will take place in the facility. Scale pertains to the complexity of the research, whether it is short-term or long-term work, and whether the volume of research is constant or fluctuating. If there is a big fluctuation, the necessary accommodations must be made to address subsequent changes in costs.

There are four major factors that serve as biosafety drivers, including legal constraints, staff considerations, risks, and quality standards. Legal issues focus on human safety, environmental and veterinary safety, as well as regulations on genetically modified organisms. Staff considerations must address interaction and comfort of individuals working in the facility, quarantine implications, and functionality.

“The risks are not only pure science. There are a lot of perception issues, politics, and, of course, there are other considerations like what is the natural disease distribution,” notes Mueller-Doblies. “The quality drivers must also be satisfied and the most important message is to accept that procedures are the weakest link in the containment. Engineering solutions are 100 times more reliable than any procedure will ever be.”

Focus on the weak procedures and then build your floor plan around them. This will result in common, robust barrier procedures. Mueller-Doblies recommends limiting the number of different procedures that are required to maintain barriers so that individuals working in the facility will understand the correct actions that should be taken. Design the facility around enough space for barrier procedures and design modular barriers to prompt the same protocols.

Strategic Planning Issues

There are various business drivers that demonstrate why a multi-pathogen facility makes sense.

“We have to future-proof the facilities today,” suggests Randy Kray, director of high containment planning and design for CUH2A Inc. in Atlanta. “We may be designing for one or two research programs today, but they might be completely different even by the time the facility opens. We need to understand the justification beyond the current program in terms of why it is important to build in this extra flexibility.”

Additional costs are incurred as part of the program complexity and the need to accommodate multiple users. Room fit-out costs increase for multiple-use flexibility because the design must be based upon broader uses rather than simply right-sizing the rooms for a single type of research. Movable partition systems are a good design choice, but are more expensive than traditional room configurations. Blended room configurations are necessary to provide additional program space.

The engineering costs also increase in order to provide more flexible use of space for animal research and animal holding. Designing for more than one program and more than one pathogen requires barriers to prevent contamination. The isolation requirements increase the amount of protocol space and the number of barriers that are necessary.

“It’s important to discuss barriers and protocols because they are the key to success in designing these facilities,” says Kray. “A major benefit from these investments is that you have a simpler system to manage. You are managing and maintaining one facility instead of many locations. For someone who has hundreds of employees or who is managing very large programs, that is a real benefit.”

Other benefits include a better utilization of program space as opposed to having unused areas of a facility. The infrastructure is too expensive and the research is too important to have facilities that are not being used to their maximum capability. Multi-use facilities make it easier for researchers to collaborate and share core services and expensive equipment, such as MRIs and PET Scans. It is cost-prohibitive to duplicate an expensive infrastructure multiple times to support numerous programs. Sharing equipment and services also facilitates more interaction and collaboration across many disciplines and groups of researchers.

Multi-Use and Flexibility Costs

There is a direct connection between multi-use facilities and the need for flexibility. Greater flexibility equates to a higher multi-user cost. Expenses start to accumulate with the addition of extra anterooms, fumigation airlocks, and autoclaves to isolate different programs. Taking the necessary steps to control temperature, humidity, and lighting to accommodate multiple species can be expensive. The most appropriate finishes and plumbing must be selected for each of the areas.

“You can significantly increase the cost of your program space. However, if the facility is scaled up and achieves a higher utilization by combining programs and having multiple users, then it is gaining significant returns from these investments, and there is potentially significant savings in the sharing of non-productive support space costs, which are almost a fixed cost regardless of the size of your program space,” says Kray. “They tend to be more quantum than incremental. You need them whether you have a small or a large program and they can add up. You want to find the right balance between the cost of the non-productive, non-scientific space and necessary functions, increasing the amount of productivity and utilization of your facility.”

Maximizing the amount of program space results in a lower capital cost per room. It is even more important to create a multi-user facility when considering basic economics and the impact on the annual capital depreciation cost per room.

By Tracy Carbasho

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