Designing a new or expanded manufacturing facility with a new or modified process requires two sets of knowledge—that of process-flow architects and that of the manufacturing production experts.
Together, process-flow architects and manufacturers possess key components of the knowledge required to find a better process. A manufacturer understands the process flow of a current facility, has adapted it over the years to better fit the existing facility and site constraints, knows what will and won’t work in an existing facility and, perhaps most importantly, understands the imperatives of the current market for its product.
A process-flow architect possesses an overview of how manufacturing processes in different industries have maximized quality and efficiency. A process-flow architect can, for instance, pluck an idea from a plastics manufacturing process and plug it into a pharmaceutical process.
At the beginning of a project, however, neither side has a comprehensive understanding of what knowledge or insights the other can offer to this specific project.
Designing a more efficient manufacturing process begins with each side telling the other enough about what it knows to create a common body of knowledge that can be shaped and molded—by both sides—into a new and improved process and product.
While all of this may seem like common sense, it is difficult for manufacturers and process-flow architects to generate a mutually beneficial planning relationship.
It is similar to the situation that a home-seller and homebuyer find themselves in. The seller resents the comments that the prospective buyer makes about repainting or adding a room here and changing that room there. The prospective buyer views the homeowner as a small thinker.
It is natural for different people or different groups of people with different ideas and priorities to feel like adversaries when first thrown together. But if the home-seller finds a way to like the prospective buyer’s ideas and if the prospective buyer focuses on what it likes about the existing house, both sides are much more likely to find common ground and, perhaps, a sales contract.
The same dynamic can improve the results from process-flow architects and manufacturers. Both sides must identify the common goal—of an improved process—and resist the natural resentments that can crop up, and to focus on answering each other’s questions until someone has an insight that makes everyone shout, “That’s it!”
What If You Cut A Hole In The Ceiling?
Consider the case of a pharmaceutical manufacturer working through the question of how to increase the production of tablets. The existing production process uses forklifts to deliver powder to a compactor, which compresses the powder into a solid ribbon of material that could be processed into tablets.
In discussions with the process-flow architects, the manufacturing team indicated that the key to increasing production was to move more powder into the compactor. The forklifts couldn’t keep up. Adding more forklifts wouldn’t work because the existing floor did not have enough space to permit more traffic.
“What about an addition?” asked the architects. The manufacturer had already considered that option in detail. One area of the plant offered plenty of space for the addition, but it was so far away from the production line that followed the compactor that the time required to transport the material wouldn’t produce a measurable improvement.
The expansion would have to go in near the existing compactor, but that option raised structural issues related to supporting walls and the second floor area of the plant.
Both the architectural team and the manufacturing team worked the options over, searching for the answer to what had become the key question: How do you design an addition to the building in the area of the compactor?
Finally someone asked, “Can we cut a hole in the ceiling?”
That question unleashed more questions and the ultimate answers. As it turned out, the floor above the compactor had been abandoned some time ago. There was nothing up there. A vertical expansion could include a tall lift system that would raise a product-filled tote and dispense it directly into the compactor feed tube.
The lift could be designed to eliminate the time-consuming docking and maneuvering that the current compactor assembly required of the forklifts. The forklifts could feed more powder to a larger compactor, which could in turn feed enough ribbon to the final production line to increase production as necessary.
The concept posed several challenges. The most significant challenge involved removing a portion of the existing roof, reinforcing the roof framing and constructing a roof penthouse to accommodate the new, higher equipment.
Lesser but still significant challenges included determining the most cost-effective approach to the suite renovation that would still accommodate the equipment; coordinating the equipment suppliers during design as equipment design and assembly occurred simultaneously; and maintaining production operations during the renovation, which would have to be carried out in an adjacent space.
These challenges all required close coordination between the construction phasing and production phasing. At the same time, the architects worked to keep the owners fully informed about the complex design solution. This was essential because the owner could not be expected to visualize what the renovation would look like and how it would function from the construction documents. The architects continually elicited questions from the owner and provided explanations to ensure that the owner understood and approved of what was being built.
Adding a New And Potent Powder Product, Safely
Regulations also wield great influence over the design of a plant. FDA, for instance, requires that manufacturing lines producing injectables meet an ISO-5 cleanliness standard, which affects the HVAC design by requiring more air changes than normal. ISO-5 also requires specialized packaging procedures handled by people wearing personal protective equipment (PPE).
One manufacturer recently satisfied these regulations while incorporating a new, potentially dangerous product into an existing manufacturing facility.
The simplest solution, from a logistical point of view, was to expand through the back wall of the plant. Behind the wall, however, were offices and a primary connecting corridor, which could not be moved efficiently.
The plant manufactures a pharmaceutical product by formulating and batching ingredients. So the plant managers and employees were familiar with batching work.
With the back wall of the plant eliminated as an option, the architects had to figure out how to fit the new process into a limited space on the already crowded manufacturing plant floor.
A downdraft booth seemed like the solution, but that would require coming to terms with three challenges. First and most importantly, the design would have to control the cost of construction—downdraft booths can be prohibitively expensive to purchase and install.
Once again, the concept required a lot of discussion to ensure that the owner had a complete understanding of a complex concept that design drawings probably couldn’t convey in satisfactory detail to people unaccustomed to reading plans. By the time construction began, the architects and the owners had been through many more review meetings than would be expected for a relatively small project. The architects were also careful to involve the owners and other stakeholders as construction proceeded.
Second, the design would have to control the cost of heating, ventilating and cooling the space—downdraft booths require 100 percent air changes all the time.
Third came the problem of where to put the booth within the existing facility. The new facility had to be big enough to do its job and small enough to hold down costs and stay out of the way of existing processes.
The plant already contained a half-dozen dispensing suites, and one or two could be converted to a suite for potent drug dispensing without requiring major modifications to the other suites to maintain the original production lines.
Still, the booth would have to be small yet allow sufficient space for dressing rooms and airlock entries for employees plus the airlock intake areas for the product.
The architects whittled the booth itself down to an 8- x 8- x 10-foot box. The small booth made it possible to accommodate the support spaces for employees and materials, while limiting the expense of the HVAC system and its operating costs.
As with any plant renovation, the work had to be carried out without interrupting plant operations. In the end, simplicity and efficiency was the key to the design of the downdraft booth.
Indeed, simplicity and efficiency are always the keys to designing successful pharmaceutical plants, which typically rank among the most sophisticated manufacturing facilities in the world. They cost thousands of dollars per square foot to construct. The simpler the process, the smaller the plant and lower the cost.
While pharmaceutical plants must embrace practical design considerations over aesthetic desires, they are in the truest architectural sense the result of form following function or process flow, and then going with the flow.
About the Author
Alan A. Liddy, AIA, NCARB, PMP, is a Senior Project Manager at SSOE Group (www.ssoe.com), an international engineering, procurement, and construction management firm.With 23 years of experience, Alan specializes in pharmaceutical and nutraceutical projects. He can be reached in SSOE’s Raleigh-Durham, North Carolina office at 919.361.9606 or [email protected].
