Few industries can draw a direct correlation between success and their facilities. But in pharmaceutical, biotech and medical research operations, there is a close connection between the capabilities of one's laboratory and the quality of work. Consistent, reliable system operation is crucial to the integrity of research—and to the corporate profits that discoveries can create.
Few industries can draw a direct correlation between success and their facilities. But in pharmaceutical, biotech and medical research operations, there is a close connection between the capabilities of one's laboratory and the quality of work. Consistent, reliable system operation is crucial to the integrity of research—and to the corporate profits that discoveries can create. Additionally, as wonder-drug stakes continue to rise, research facilities are becoming a major lure for the world-class researchers that top public and private organizations are seeking to attract.
But quality comes at a cost. Today's research labs are expensive, high-performance spaces that place significant demands on virtually every engineering discipline: an air-handling system can play a crucial role in preventing bio-contamination; backup generators can ensure the operation of refrigeration units preserving rare cell cultures; and advanced security systems can provide vital protection from both terrorists and corporate spies. For systems designers, such requirements can make these assignments both fascinating and frustrating.
On the subject of market intelligence, engineers are seeing varying levels of activity in this design-intense sector, with many biotech and pharmaceutical clients facing challenges in their respective fields. Industry participants say biotech companies doing the advanced research on which many new medical treatments are based are having greater difficulty attracting investors than they did just a few years ago.
"The venture capitalists have started to perform more rigorous reviews on the stability of biotech companies," says Donald Procz, P.E., senior vice president of Syska Hennessy Group's San Diego-based Science and Technology Group. "If you don't have a blockbuster opportunity, they aren't giving the money out. Five years ago, there was a lot more money floating speculatively."
On the pharmaceutical client side, a raft of mergers over the last few years has slowed facilities work, as new parent companies have taken time to evaluate market strategies. However, Procz says, his firm is beginning to see infrastructure upgrades and even some program modification emerging as a result of this strategic planning.
Research hospitals, especially those affiliated with colleges and universities, are another bright spot, according to other industry observers.
"That's a market that's been strong and will continue to be strong," says Bill Beckman, P.E., president and CEO of Maitland, Fla.-based GRG Consulting Engineers. His firm recently completed work on a 375,000-sq.-ft. addition to the H. Lee Moffitt Cancer Center and Research Institute located on the University of South Florida's Tampa campus. The facility, named to the National Cancer Institute's elite list of comprehensive cancer centers in 2001, had maxed out its research capacity. The addition, according to hospital officials, will give the facility room for up to 40 more scientists.
The Moffitt project illustrates the competitive pressures now motivating many research construction efforts. Private industry, including major pharmaceutical manufacturers, has become a major funding source for nonprofit research organizations, and the researchers able to attract this private funding have become recruiting targets for the nonprofits. Top-of-the-line facilities are required to attract these valuable players.
"If you build it, they will come," says Tim Pennock, P.E., project manager and lead commissioning agent at GRG. "There's a vicious cycle of one-upsmanship."
Adaptability to changing research directions is one of the key characteristics of today's R&D facilities, a design approach Pennock calls "brutally flexible." In the Moffitt center, this means ductwork that is looped and manifolded to allow for easier changes as air delivery and exhaust requirements shift.
To plan this kind of flexibility into the HVAC design, engineers first must understand whether facility needs are air- or load-driven, Beckman says. In air-driven environments, such as vent-hood areas that can require up to 16 air changes per hour, flexibility can mean sizing ductwork and air handlers to serve the maximum number of vent hoods the space can include—even if it's only partially occupied to start. Load-driven areas, like those housing electron microscopes or large refrigeration units, may not need the same ventilation but could require added chilled-water supply capacity.
Clients are also requiring flexible plumbing designs. In some cases, labs are becoming completely modular and mobile with cabinets, counters—and even sinks—mounted on wheels, so they can be re-configured as needs change. In these cases, engineers are creating multiple plumbing docking stations incorporating quick-connect supply and waste hookups.
Gerald Williams, P.E., a senior mechanical engineer at Burns & McDonnell's St. Louis office, sees this flexibility go hand in hand with more open floor plans. Such designs allow easier communication between the varied scientific disciplines involved in any given drug's development.
One example Williams cites is a recent project combining two laboratory spaces into a single, large facility to allow greater collaboration as drug development moves, potentially, from initial development into human testing. Motivating researchers to mingle is also a goal of common-area design, Williams adds.
"We're also designing casual-encounter spaces," he says, "to try to encourage some of those interactions that are so important to discovery."
And clients aren't just hoping for more discoveries with these more open environments, notes Procz. They're also hoping for faster product development.
"A big driver is speed to market—how quickly you can move the new discoveries through the sciences in your organization," he says, noting how drug development can progress from chemistry through to biology and physiology. "We're seeing a lot of our clients looking at collaborative approaches so they see the same result in a shorter period."
At the Moffitt Center, this interest in connecting previously disparate functions was addressed with a bridge that connects research areas to the adjoining treatment areas. In this way, experimental drugs can easily be transported from laboratory bench to patient bedside, where computers also allow easy access to research data.
Increased security concerns are another driver, especially in retrofit work, notes Williams. The Centers for Disease Control and Prevention, he says, has been pushing laboratories working with exotic agents to upgrade their facilities in the wake of the Sept. 11, 2001, terrorist attacks and the anthrax attacks that followed. Such projects can mean addressing air-handling designs to create negative-pressure zones where required, as well as adding chemical-shower facilities with attached kill tanks to treat wastes, among other requirements.
Burns & McDonnell recently completed one such assignment for the County of San Diego, Williams says. That lab's location, on the Pacific coastline and the U.S./Mexico border, potentially puts it on the front lines of a biological attack, so authorities wanted the facility to be prepared to handle a range of dangerous materials.
Of course, increasing sophistication means a significant growth in critical loads. Backup protection for fume hoods and other ventilation equipment has long been considered essential so that the negative pressure protecting personnel from dangerous fumes is maintained. Now, rising use of electronics in labs is adding to power demands.
"One of the things we're seeing now is a lot more computers in the lab spaces," Williams says. "And robots, doing the kinds of work that used to be done by lab technicians."
The need for backup power protection is also being driven by cold, hard dollars—represented by research samples locked up in-80°C freezers, called stability chambers. "They're incredibly critical," says Williams. "Because if you lose that chamber, you lose months or years of research."
Similar care is devoted to the planning of vivariums, where research animals can represent a significant investment in both dollars and intellectual capital.
"These mice are almost genetic duplicates of each other," says GRG's Pennock. "So they're very sensitive to bright lights and loud noises. If they start dying, 15 years of research might go down."
To protect the animals, and the health of workers in surrounding spaces, very strict air-pressure settings are maintained. Additionally, these facilities can incorporate diurnal lighting patterns to mimic the natural night-and-day cycles the animals may never experience firsthand. Significant pro-visions are made for backup power to ensure these operations continue through interruptions and outages. In some cases, even the backup power has fallback protection. "Everything is backed up," Pennock says. "Every single thing."
Sustainability becoming important
Despite the significant power demands present in today's labs, engineers shouldn't get the impression that lab managers don't care about energy efficiency. In fact, many are seeing increased concerns regarding environmental impact from their clients.
"A lot of our clients are becoming more focused on sustainable design," notes Syska Hennessy Group's Procz, who ties this interest to a growing recognition of the need to reduce research-employee turnover. "Life-cycle costs need to be thought about, and the largest cost of a facility over its life cycle is the salaries of the folks who work there."
Burns & McDonnell's Williams is seeing similar interest in working conditions from their clients.
"There's a real push to improve the indoor environment," he says. "If we can increase productivity by improving that environment, that goes right to the bottom line."
From an architectural standpoint, this emphasis is resulting in more interior windows and vision panels to bring outdoor light in, along with improved indirect lighting and the use of low-VOC materials.
But these efforts are also addressing system efficiency, looking at new ways to improve the performance of, for example, ventilation and fume-hood systems. One approach Williams' group has studied is separating general room exhaust from fume-hood exhaust so that the room's exhaust air can be used with a heat-recovery device to pretreat the incoming air supply. Williams also encourages clients to consider newer, more efficient low-flow fume hoods.
"A typical fume hood uses as much energy as three houses. There's a whole new generation of fume hoods out there that are designed to work with low air flows," he says, noting reductions down to 60 ft. per min., as opposed to the standard 100 ft. per min. "It's a huge reduction in the amount of energy used."
The bottom line
Being able to outline such potential savings is crucial for engineers working in this challenging sector, experts say. Owners are often forced to make difficult decisions when confronted with the behind-the-scenes requirements their ambitious building programs demand.
"The infrastructure can sometimes be up to 50% of the building cost," says GRG's Pennock, who notes the limiting impact such costs can have on project plans. "Ninety-nine percent of the time, program and budget don't match. At a lot of colleges and universities, the budget is the budget."
So, for GRG, this means putting a lot of up-front planning into these project to ensure unexpected conflicts don't arise among the many interdependent systems once construction is underway. This includes significant benchmarking of both costs and programs among comparable facilities.
"Engineers have to be really strong in documenting what the M/E/P costs are up front," he says. "Once the machinery gets moving, it's hard to change direction."
A competing challenge to this need for planning, though, is the growing need for speed. Especially among pharmaceutical companies, the high-stakes demand to get new products into patients' medicine cabinets is also pressuring the professionals designing and building research and manufacturing facilities.
"[Being] the first to market with a drug could mean a difference of millions of dollars," says Williams. "Sometimes, the schedule is so critical that it's the overriding factor on a project."
However, Williams remains optimistic about the opportunities he believes the R&D arena will continue to offer engineers, as new discoveries emerge to treat the ailments of an aging population.
"It's an exciting field, and it's somewhat resistant to some of the ups and downs of other areas in the building industry," he says. "I think we're going to see a lot more pharmaceutical work. With the new genomics, they can use a sharpshooter approach. And as Baby Boomers age, there's going to be a lot more need."
Commissioning for Success
Commissioning is becoming a more important factor in successful building design with the growing sophistication of today's facilities. Ensuring integrated system performance is even more important with research laboratories because of the potential impact system failure could have on occupants' safety and the owner's bottom line. Although design engineers may not carry out commissioning functions, they need to consider them in both their cost estimates and schedules, experts say.
Simply put, the function of commissioning is to ensure a building's performance matches the criteria to which it was designed, so that airflow rates and electrical supplies, among many other requirements, match design specifications. But when done thoroughly, commissioning is much more than simply testing individual systems. Instead, systems intended to operate together are observed and tested together. For example, smoke-detection and air-handling systems might be brought online along with a backup generator to see how all three might hold up under actual conditions.
Susan Kessler, P.E., an associate partner at Syska Hennessy Group's New York office, has outlined the responsibilities of consulting engineers in the commissioning process for others at her firm. Although clients will generally contract with a separate commissioning agent, engineers need to ensure their specifications and documentation can support that professional's efforts, she says. Engineers also need to consider how contractor requirements could affect project costs.
"The engineer's spec buys the contractor's time," Kessler says. "You have to buy time for meetings, you have to buy time for sending documents, you have to buy time for operating manuals. If you leave something out, it's a change order."
For pharmaceutical companies, commissioning reports can become the foundation for further validation efforts, a legally required process for any facility producing food or drugs for human consumption. Validation is a quality-control process intended to ensure product consistency over time. It involves regular audits and reports to certify, among other things, that building systems are performing to established criteria. A thorough commissioning, Kessler says, not only establishes compliance with criteria at outset, it also provides procedures and guidelines to maintain that performance over time.