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Gary Broberg, founder and chief executive officer of Boston-based Practical Applications Inc. (PAI), can’t tell you everything you might want to know about two of the contracts he’s proudest of landing. The reasons have to do with homeland security: PAI was selected to design and build wastewater biocontainment systems for two new “level 3” biosafety laboratories. In those labs, researchers will study dangerous infectious diseases that can be transmitted through the air, such as tuberculosis, SARS, and influenza. Lab levels range from 1 to 4. In the most secure, level 4, researchers study Ebola and anthrax.
The labs are part of an aggressive biodefense research program that the National Institutes of Health (NIH) launched in 2002. As part of the federal government’s homeland security efforts, the NIH National Institute of Allergy and Infectious Diseases (NIAID) developed a strategic plan for biodefense research that confirmed “a pressing need to focus research efforts on agents that pose the greatest risks to civilian populations in the event of a bioterrorist attack.” The panel also “concluded that there is a critical need for facilities in which research can be conducted on new drugs, vaccines, and diagnostics that would serve to protect the general population from bioterrorism.”
Accordingly, NIAID is funding construction of two national, level-4 labs and thirteen regional, level-3 labs. It’s also funding major alterations to and renovations of five existing labs.
Mother Nature Is A Terrorist, Too
And while the original thrust was anti-terrorist, in the prevailing political sense, the threat of avian flu reminds us that Mother Nature can be a terrorist, too. A May 20, 2004, article in The New England Journal of Medicine, “Biomedical Research—An Integral Component of National Security,” puts it chillingly: “The challenge of bioterrorism will be with us indefinitely. It is difficult to assess the probability of future deliberate releases of microbes or their products, but the potential consequences of such attacks are enormous. Furthermore, we will certainly face naturally occurring emerging and resurging infectious diseases, and the potential for devastation associated with such diseases as pandemic influenza or SARS may surpass that associated with bioterrorism. The research agenda of the NIAID and the NIH is designed to prepare for and provide protection against both types of threats ... it is imperative that we move ahead ... as rapidly as possible. To do otherwise would be extremely risky and, in many respects, unconscionable.”
NIH’s budget signals the seriousness of this initiative: For fiscal year 2000, its budget for biodefense research was $43 million; for fiscal year 2006, $1.78 billion. Following Sept. 11, 2001, through fiscal year 2005, NIH spent $883 million on construction of biosafety labs, with extramural grants alone totaling $521 million. NIH plans to provide extramural grants of $29.7 million in fiscal year 2006 and $25 million in fiscal year 2007. Universities housing the new NIH labs contribute $1 for each $3 they receive from NIH, further boosting spending. Other federal agencies are pursuing biodefense agendas, too.
The Wastewater Industry And Biodefense
The urgency and gravity of this mission place a special burden on the parties who carry it out: the federal government, universities, and their contractors. NIAID says, “These laboratory facilities will be designed and built using the strictest federal standards and incorporating multiple layers of safety and security to protect laboratory workers and the surrounding environment.”
In level-3 labs, in which potentially lethal agents can be transmitted through the air, researchers perform lab manipulations in a gas-tight enclosure. Other safety features include clothing decontamination, sealed windows, and specialized ventilation systems.
Safety features also include systems for handling solid, gas, and liquid wastes. Those wastes will contain disease pathogens that must be killed before the wastes are disposed of. This escalates the function of wastewater systems from treatment to biological kill.
Of course, conventional wastewater systems are the unsung heroes of public health: They generally perform so admirably that they’re taken for granted. But how do you ensure that biokill systems can be taken for granted—and that they’ll be not only safe and reliable but easy to operate and maintain? Who can perform this demanding work?
Broberg recalls that before the biodefense initiative, the only US facilities with large-scale, central biocontainment labs were the Centers for Disease Control (CDC) and the US Army’s Fort Detrick. In universities, bench-scale research has largely prevailed: Quantities are measured in milliliters; beakers are used; pathogens are killed in a glove box. “Under the sink” wastewater systems are adequate. This has the merit of simplicity and economy, but it severely limits the number and kinds of experiments that can be conducted. It has also limited the market for designing and building large central biocontainment labs. Few companies have gained the necessary experience.
Now that the federal government is radically scaling up biodefense research—as Broberg puts it, “before, they were tinkering”—it’s relying heavily on university partners. The universities and their architects and engineering firms must identify qualified bidders and invite them to bid. Broberg explains that, for wastewater biokill, only three US firms are qualified: WR2, Progressive Recovery, and PAI.
PAI’s Conventional Line Of Business
When Broberg founded PAI in 1993, he could not have imagined that he would one day be competing in a “homeland security” market; that concept had not yet entered American public discourse. His company made its reputation in the conventional process water and wastewater treatment business, by pooling the expertise of scientists, engineers, regulatory compliance specialists, and technicians to offer a range of systems and services.
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| This control panel is part of the transfer pump and heat exchanger in PAI's biokill system. |
Its business is concentrated in the Boston area, where regulatory mandates created a market for treatment systems that reduce the pH levels of wastewater discharged to Boston Harbor. A more recent market driver is the growing number of biotech companies in the Boston area that need high-purity water for their labs.
Significantly, PAI isn’t an equipment vendor. Rather, it consults closely with each client, tailoring solutions to specific needs, to optimize each system, and then purchasing mechanical, plumbing, and electrical components. Its systems employ sophisticated sensors and controls that provide a simple, intuitive user-interface. PAI fabricates the control panels in its UL-listed control panel assembly shop in the EDIC Marine Industrial Park in Boston. In its South Boston facility, PAI welds and assembles components, to deliver turnkey systems that have been “skid-mounted” (assembled as fully as possible before delivery). Because PAI can’t perform work onsite for customers whose employees are union members, skid-mounting minimizes problems in the field.
Beyond hardware, PAI supports its clients’ operations by helping them obtain permits and maintain regulatory compliance through self-monitoring, sampling, analysis, and reporting. It trains wastewater system operators. It provides continuous emergency on-call service and routine repair and maintenance services. That’s to say, it understands the wastewater business inside and out.
PAI has suffered its ups and downs, but in 2005, revenues reached $2.7 million, and the work keeps coming in.
PAI’s Leap To Biodefense
PAI’s qualifications for biodefense contracting rest in part on work it did in 1999 to design and build a large wastewater biodecontamination system for the Massachusetts Biological Laboratories tetanus facility in Jamaica Plain. It also designed and built two 500-gallon reactor biodecontamination systems for Aga Khan University Hospital in Karachi, Pakistan, and three biodecontamination systems for US corporations.
When PAI was first invited to bid on biodefense contracts, in 2004, it was by far the smallest firm in the field, with only 11 employees (it now has 15-16). So far, it’s batting two-for-three: Its bid on the contract for a level-4 system for the national lab at the University of Texas was not successful, but it won contracts for level-3 systems at the University of Pittsburgh and Duke University. It’s now waiting to learn if its bid on a level-4 system for Boston University was successful.
Biodefense is sensitive work, and PAI’s contracts came complete with confidentiality clauses that Broberg and his staff scrupulously honor. Without disclosing confidential information or proprietary information, they described their work for U Pitt and Duke.
A Biokill Engineering Primer
Broberg explains that all biokill systems must perform to the same safety standards, but each must satisfy a different set of variables. Design must take into account the lab’s biosafety level, the kinds of biological agents and the forms they take, solids load and type, pollutants other than biological agents, wastewater flow rate, and utility requirements.
Pathogens can be killed by chemicals, heat, or a combination thereof, he adds. NIH’s baseline approach to level-3 biocontainment employs chemicals. Chemicals kill what’s on the surface, so for wastestreams taking the form of simple cellular solids, chemicals work well. But chemicals can’t penetrate to the interior of a solid, so wastes that contain soft tissues in which pathogens may be embedded require heat, which can penetrate. While steam-kill systems are effective with a wider variety of waste materials, they’re also more complex and therefore costly.
In addition to the wastestream’s biological content, its “geometry” must be understood. For example, pieces of lab equipment could break; the tip of a pipette could cause a valve to fail; a rubber stopper could accidentally enter the system and obstruct a line. The system must be designed to handle the unexpected. And not only are entire biosafety labs sealed and workers garbed in protective clothing; everything within the labs that a pathogen might contact must be sealed, to prevent worker exposure and contamination of anything in the surrounding environment, including worker’s clothing and other equipment.
Every move lab workers make must be thought through and planned.
Moreover, the system must be designed so that maintenance can be performed safely and the system can be shut down safely. Every surface that pathogens might contact will have to be decontaminated, so every surface workers touch and every item they might remove from the lab, and exactly how they should remove it, must be thought through and planned for in advance.
The validation of the system is its performance, Broberg emphasizes, and it can only perform for the wastestream it’s designed for. NIH requires the lab owner to validate that pathogens entering the wastestream are those the system was designed to destroy. The lab owner must also test wastewater samples to verify that it’s sterilized.
The Steam-Kill System For U Pitt
PAI won its first biosafety contract in January 2005, from mechanical contractor, McKamish, Inc., of Pittsburgh, PA. The base contract was for $645,000 to design and build a biokill system for the level-3 Regional Biocontainment Laboratory at U Pitt’s Bioscience Tower III. Options and engineering services purchased subsequently could bring the total close to $1 million.
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| One of several control panels attached to the three main tanks in the PAI biokill system.. |
Because Pitt will be working with tissue, it opted for a thermal system. As Joshua Jondro, the PAI engineer who served as project manager observes, “Time and temperature kill most bacteria. The variables are how high the temperature is and how much time is allowed.” The engineering challenge was to design a system that could kill a broad range of pathogens as quickly as possible, within budget and within the physical constraints of available lab space, which is expensive.
Applying its expertise in wastewater and chemical engineering, PAI developed the design in consultation with its client’s engineer, the Boston-based firm of Bard, Rao + Athanas Consulting Engineers LLC, defining and refining specifications and modifying the way lab space was configured, to accommodate the system. PAI also contributed its expertise in handling solids in waste streams to the task of characterizing Pitt’s waste stream.
Engineering Breakthroughs
Ten years ago, Broberg recalls, to biodecontaminate wastewater produced by bench-scale research, “the conventional lab practice was basically to put whatever had to be decontaminated into an autoclave”—a steam sterilizer. For its own large, central-lab system, the CDC basically tripled the size of its autoclave.
For Pitt, PAI—long accustomed to tailoring systems to clients’ specific needs, and with the benefit of what it had learned from prior contracts—took a radically different approach. Rather than scaling up, it proceeded to rethink the entire biokill system, to determine how to optimize performance. It examined the nature of the wastestream and problems known to arise in other wastewater processes, how best to handle solids, heat transfer to and within various waste forms, containment, throughput, size, controls, and automation. “How can we make this simpler? Better? How can we design a unit with a smaller footprint?” were the questions.
PAI fundamentally rethought the entire system and came up with one that’s faster, smaller, simpler, less costly.
The result is a unique proprietary design for mixing steam with wastewater that accelerates how the heat in the steam is transferred to the wastewater mixture, including the biological material it contains. CDC’s conventional method takes hours; PAI’s takes minutes—and because it uses less steam and is more efficient, it uses less energy. CDC’s system stratifies contents in a tank, which produces cold spots; PAI’s mixes the waste to avoid cold spots, accelerating the rate at which heat is transferred to biosolids suspended in the wastewater—and thus the kill rate.
This sharply reduces not only the time it takes to complete a decontamination cycle but the size of the tanks required for treatment, which in turn cuts equipment costs and minimizes the cubic feet of lab space needed. High wastewater-volume throughput relative to tank volume results in a system that is physically smaller by half than conventional CDC designs yet exceeds throughput requirements, yields better performance, and can handle more complex wastestreams. Overall, it’s unique, simple, robust, and compact—and reduces costs.
PAI’s pending bid on the level-4 biocontainment system at Boston University would employ steam and a design similar to the one for Pitt.
Physical Components
Designed to handle up to 21,000 gallons of laboratory wastewater per day, PAI’s system will collect wastewater in two sealed plastic tanks that together hold 6,500-gallons. From there wastewater will be transferred to one of three 1,500-gallon stainless steel, “steam kill” tanks in which live steam will be injected and mixed with wastewater at temperatures above 250°F and at maximum pressure of 30 psi.
All critical systems are automated. A state-of-the-art SCADA (Supervisory Control and Data Acquisition) system permits real-time monitoring. The SCADA system is based on an Allen-Bradley SL/C505 programmable logic controller; it communicates with a color touch screen and a Honeywell Color Recorder. The SCADA system will ensure that the system will only perform if all conditions necessary to kill pathogens are in place: notably, that a high-enough temperature is being maintained and that waste and wastewater are properly mixed. It will also document all necessary conditions, so system performance can be verified. An alarm system will sound remotely if anything goes wrong, and the system will automatically shut down if any conditions are out-of-spec.
After biological material has been destroyed, the wastewater will be cooled via a heat exchanger. Effluent will be monitored for temperature and flow and discharged into a pH neutralization system, from which it will be discharged to a municipal sanitary system.
At that point, the wastewater will have reacquired its “civilian” identity.
To Fortify Safety
But wait: Not only are pathogens potentially dangerous; steam is, too. As Jondro points out, “If a steam system over-pressurizes, you’re sitting on a bomb.” To minimize the risks posed by the dual dangers of potentially lethal pathogens and live steam under pressure, and to minimize PAI’s insurance liability, PAI enlisted a nationally recognized expert in process safety and hazard analysis, Ronald J. Willey, professor of chemical engineering at Northeastern University. Willey is first vice chair of the Safety and Health Division of the American Society of Chemical Engineers and a member of SACHE, an AIChE-Center for Chemical Process Safety committee devoted to the integration of process safety into chemical engineering education.
His assignment for PAI: subject the system design to a rigorous hazard analysis. Willey “brought fantastic insight to reviewing PAI’s system from a safety standpoint,” Broberg says, “compiling about 60 pages of what-if analyses and recommendations.” Working toward one goal—protecting the public’s safety, worker safety, and equipment—Willey applied HAZOPS (hazard and operability studies) analyses to examine what might go wrong and to determine how to prevent or mitigate it.
HAZOPS employs a multidisciplinary approach, and ideally someone with experience operating a system helps troubleshoot it. But PAI had designed a first-of-its-kind system that had never been operated. Willey therefore drew from what’s been learned from hazard analyses of a host of processes that operate with steam or related systems. Applying fundamental principles, he and PAI staff generated a host of what-ifs “to perturb the system.”
“We took every event we could think of,” he says, “and asked what could happen if some parameter or variable exceeds or falls below its threshold. What are the consequences to the public, to workers, to equipment?” Key words were over, under, less than, more than. “We took each flow line,” he recalls, “water flow, steam flow; waste lines, air lines; lines going into the system, lines going out; vessels.” What might cause the component to fail? Could its failure cause the system to fail? How could failure be prevented? How could it be mitigated?
For example, what if a valve leaks? What if a pressure sensor fails and the backup sensor fails and the unit overpressurizes? What if dirt gets into the system and prevents a valve from closing tightly? What if that pipette tip lodges somewhere? What if there’s a fire? An explosion? Sabotage? Where are redundant safety features needed? As Willey puts it, how can you ensure that, whatever happens, “the system itself will remain in control and no one will be harmed and no untreated waste will be discharged?”
The consequence of this analysis is that extensive safety features have been designed right into PAI’s system. Of course, Willey adds, it’s necessary to run the system to determine if anything has been missed. And of course there’s no end to what-ifs; it’s a truism that worst-case scenarios are limited only by our imaginations; not all risks can be eliminated. But the residual risks are small compared with the huge risks that biodefense research is intended to minimize.
Fabrication, Assembly, And Delivery
To fabricate the system for Pitt, PAI procured three ASME-rated, stainless steel tanks from JD Cousins Inc., in Buffalo, NY. The tanks have a special coating to prolong their life. The two plastic tanks come from ME Baker Co., of Cambridge, MA, and Plastic Concepts, of Billerica, MA. Other components are unique plumbing and piping systems, medium-pressure steam, welded stainless steel piping, welded polypropylene piping, pressure vessels, and automatic valves. To minimize start-up issues and liability risks should equipment fail, PAI went beyond the minimum QA for fabrication and assembly required by its contract. The system was tested with water at PAI’s South Boston facility. The steam test will occur when the entire system is fully tested at Pitt.
The system was shipped in November 2005, with PAI’s engineering staff providing technical guidance as needed for final installation. The unit came in on budget, and installation went smoothly thanks to testing and assembly PAI had performed in Boston. The system is ahead of schedule to support the laboratory operations. The plan is to start the system up toward the end of 2006, test it, then shut it down until lab construction is complete, around the start of 2007. PAI will train the system operators and provide a manual on operations and maintenance. The system comes with a 1-year warranty and is designed for a 10-year service life.
Chemical Kill for Duke
In August 2005 PAI won a $93,200 contract from mechanical contractor John J. Kirlin, of Rockville, MD, to design and build a biokill system for the level-3 Regional Biocontainment Laboratory at Duke University’s Global Health Research Building.
Because Duke’s research will be conducted at the cellular level, not on tissue, chemicals can be used to kill pathogens. The system PAI is designing will handle up to 33,000 gallons of wastewater per day and will employ two identical 700-gallon reactors, for 100% redundancy. Concentrated sodium hypochlorite will be the main decontamination agent. The system will feature the same SCADA system as Pitt’s. Effluent will be measured for pH, flow, and total chlorine.
Opportunities For Future Business
More contracts for biosafety labs will be issued, and Broberg hopes to bid on some. Moreover, that 10-year lifespan means PAI’s systems will wear out long before the threats posed by bioterrorists and Mother Nature vanish. This niche market will be around for years to come, and PAI may one day be refurbishing or replacing the systems it’s designing and building now.
Will other companies enter this market, or will it remain the province of three firms, similar to the pattern in the aerospace and major-weapon-systems industries? Whatever the market configuration, it’s vital that core biosafety expertise be preserved and perpetuated.
And as Broberg observes, that expertise can be further strengthened: As biosafety systems come online, there will be opportunities for players in the field to learn from each other’s work. CDC is one obvious source of expertise: CDC staff served on teams that reviewed proposals for biokill systems and offered suggestions for modifying some design elements. Broberg hopes CDC will take a leadership role in promoting direct exchanges that can further advance the state of the art.
Meanwhile, as researchers race to protect us from potentially deadly, sometimes mutating, pathogens, the wastewater industry will be making—in the face of the most extreme demands ever placed on it — another of its quiet, indispensable contributions to the common good.
CHRISTINE VAN LENTEN is a New York City-based freelance writer
OW - July/August 2006 |
