By Mike Lennon, Senior Process Architect.

You have decided you’re going to renovate or expand your pharmaceutical manufacturing facility. You have developed a conceptual plan and now, during the detailed design phase, you will need to make a critical decision about the quality of the facility of which you will be operating. One of the most important decisions you will make on this project revolves around the materials of construction - specifically, the built environment surrounding your process.

Each project type presents its own design challenges, whether it is a generic solid dosage plant, a BSL-3 biologics manufacturing facility, or a medical device assembly plant. There are also some common challenges shared between them all such as the availability of skilled labor, existing site/building conditions, and above all the project budget. One specific design challenge is to determine which relatively common two options for wall and ceiling construction types should be used when building a cleanroom environment. This blog explores how your specific project might drive your decision in either direction.

Modular cleanroom wall and ceiling systems typically include a “sandwich” panel construction with an aluminum honeycomb core between galvanized steel outer sheets. Panel faces which are exposed to the cleanroom environment are typically finished with a white hygienic coating such as PVC and are cold welded together for a monolithic air tight environment.

Modular Panel Pros:

• Panels are designed to interlock during installation to create a completely closed environment with very little air leakage/infiltration.
• Field finishing is not required. No joint compound sanding, priming or painting.
• Wall system base typically provides a solid backer for an integral floor base, usually a weak point in the wall assembly.
• Walk-on ceiling systems can create an interstitial space above production areas which cuts down on shutdown requirements during regular maintenance.
• Most modular cleanroom systems either provide or can integrate clean room doors and hardware saving on field coordination. Doors show up on site prepped for installation.

Modular Panel Cons:

• Larger upfront capital investment for wall and ceiling systems.
• Longer lead-times for design time, fabrication and a detailed submittal creation.
• Modular panels are less adaptable for field modification/changes.
• Building structure must be substantial enough to carry the load of optional walk-on ceiling systems.

Metal stud construction with wallboard such as gypsum or fiberglass composite is totally field fabricated and installed on site. Metal studs are measured, cut, aligned and fastened in place followed up with a wallboard installation, joint compound, and several coats of paint or supplemental finished surface. An acoustical ceiling can be suspended in place in lieu of the wall board type, consisting of an aluminum grid frame and ceiling tiles of varying materials.

Metal Stud Pros:

• Lower upfront capital investment for the materials.
• Materials are typically readily available for delivery to the site.
• Field modifications /changes can usually be accommodated easily and quickly.
• There is a deep knowledge base for the means and methods of construction amongst many contractors.

Metal Stud Cons:

• Project quality will rely mostly on field fabrications rather than factory controlled environments.
• Paper-based gypsum board has the potential to harbor fungus growth such as mold.
• Working with wall board panels creates particulate which could migrate into sensitive process equipment during installation.
• Harsh cleanroom cleaning chemicals can damage wall boards without proper protection and precautions.

With the increased availability of modular type systems, many of the challenges associated with the heavily field fabricated traditional techniques are mitigated. As the industry moves many process unit operations to a modular approach, so can building projects push the boundaries of construction systems toward a cleaner, simpler approach to building cleanrooms.

Historically production facilities have been designed and built using traditional construction materials and methods. Over the years, IPS has seen in increase in the use of modular cleanroom systems in most project sectors including biologics manufacturing, oral solid dosage facilities, medical device, and many others. As the building industry has shifted so have regulatory agencies with an expectation of a high level of cleanliness, accessibility and visibility into your facility and a better understanding of the built environment required to run a leading edge plant.

If your project involves the regular visibility of regulators or clients, will need to be flexibility for future alternate configurations, or is slated to be the center for excellence for your industry or sector, then implementing modular cleanroom systems is well suited to meet the needs of your project.