Facility Design: Finding the Flow
Designing a new pharmaceutical manufacturing facility requires that architects and manufacturers collaborate to improve process flow.
By Alan A. Liddy, AIA, NCARB, PMP, SSOE Group
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 Alan.Liddy@ssoe.com.