In the pharmaceutical industry, stringent manufacturing standards and regulations ensure the efficacy and safety of products. But the rules in one subset of this industry—vaccines—are in their own class. It follows, then, that the demands on building teams who work on vaccine manufacturing facility projects are among the toughest of any category of construction.
After all, vaccines are substances given to healthy people to prevent future illnesses, points out Craig Johnson, head of global engineering and maintenance for Sanofi Pasteur. They must not be a delivery method for spreading disease, and lax operating conditions could violate that imperative. Vaccines contain complex biological ingredients that require tightly controlled production environments which sets them apart from facilities that make medicines using chemical compounds.
“Building a state-of-the-art vaccine manufacturing facility is incredibly complex as compared to something like a food-processing plant or a pharmaceutical tablets and capsules facility,” Johnson says. He has spent most of his 23-year career in building and maintaining vaccine production plants.
These facilities contain intricate, specialized production systems and extensive building infrastructure. Because a facility’s manufacturing equipment is its most critical component, vaccine plant projects begin with a design from the inside out. The production systems come first, so the design of the building itself is less challenging, Johnson says.
Sourcing manufacturing system components is a key step in developing the design, as this equipment is highly specialized with a limited number of vendors. “You might have just a few suppliers for certain process equipment,” Johnson says. It can be a challenge to make sure that certain parts are available, particularly if you have an ambitious timeline.
The heart of a vaccine manufacturing facility is the clean room manufacturing space. In addition to creating an environment with purified air, designers have to pay close attention to the materials used on all surfaces. The materials used for walls, floors, doors, and ceilings must be nonporous, cleanable, and not a breeding ground for contaminants. Like the process equipment, these materials must often be procured from specialized vendors.
Most clean room components, including wall and ceiling panels, are prefabricated. Much of the design has to be completed before placing orders for these components because features such as wall and ceiling holes for light fixtures and switches are created at the prefabrication plant. “You don’t want to do a lot of field retrofitting,” Johnson says. Altering building components not only complicates construction, it also risks degrading clean room standards if not performed correctly.
The labor required in vaccine plant projects is just as specialized as the building components. Relatively few construction management companies have experience building vaccine plants, so it’s critical to find one with the capacity to meet a tight project schedule.
Sometimes that requires working with a company that hasn’t completed a vaccine plant project before. “You might find somebody who is familiar with about 90 percent of the necessary work,” Johnson says. In some cases, Johnson has filled the knowledge gap by bringing in professionals from other parts of the world. “They help share knowledge of construction processes that the subcontractors are not familiar with,” he says.
Finding subcontractors grounded in construction techniques particular to vaccine plants is especially tough in less developed parts of Asia and Latin America. Construction practices in those places can be much different than in the developed world. For example, in some parts of Asia it is common to use scaffolding that does not meet US safety standards, Johnson says. “We’ll help subcontractors get the proper construction safety equipment,” Johnson says about such cases.
Vaccine manufacturing plants can run well over
$50 million in construction costs and take two to five years from design to completion. During the course of the project, market conditions can change, which might require the project to significantly change production capacity of the manufacturing facility. Thus, those on the project team have to be able to adapt to design changes on the fly.
“You have to cultivate a culture of acceptance of change,” Johnson emphasizes. It’s easier to find people who can deliver exactly what’s in the original plans, but to succeed in this niche they have to be flexible enough to reschedule work sequencing, find ways to reconfigure systems after they have been designed or are partially built, and make any number of other adjustments
At any time, Johnson may have several multimillion-dollar projects underway. In order to keep on top of things, Johnson has to go on site frequently. “You spend a lot of time in airports,” he says. He’s quick to point out, too, that his well-seasoned, highly capable team is critical to success. “It takes a great deal of work to build a strong execution team,” he says. “Success cannot depend solely on me.”
Though the demands are great, so too is the professional satisfaction from a job well done. “I can’t imagine a more exciting challenge than building a factory to make medicine that prevents a disease,” Johnson says.
Photo: Sophie Dennehy