When designing a new cleanroom—be it for USP compliance or to improve compounding efficiency—one of the first decisions is whether to install a modular design or the more traditional stick-built compounding facility. Because cleanroom construction has historically been stick-built, this continues to be the most common choice for new cleanroom installations, accounting for 85% of total cleanroom installation worldwide. The remaining 15% is the modular/prefabricated type.1 At first glance, standard off-the-shelf, prefabricated modular units may appear more cost-effective. However, once customization due to regulatory requirements comes into play, the total cost between the two methods may be similar. Also, bear in mind that due to economies of scale, the larger the room, the lower the cost per square foot. This article explores how the specific requirements of your project might drive your decision in either direction.
The first step is to decide which option—a traditional stick build, a modular build, or a hybrid of both—is the best fit for the organization. No one solution is better than another as each offers a variety of features; thus, the best fit ultimately depends on the individual needs of the facility.
There are a few key areas to consider before making a decision:
Each sterile compounding facility project presents unique design challenges. Nevertheless, there are some common considerations, including project budget, existing facility conditions, and the availability of skilled labor to perform the work. It is important to have a complete understanding of the different construction options before committing to a final design.
Traditional Stick-Built Compounding Facilities
Traditional stick-built construction with wallboard, such as gypsum or fiberglass composite, is field-fabricated and installed onsite. The build begins with the construction of the stud structure, which may be metal or wood. Wallboard is then attached to the studs and a joint compound is applied and smoothed by sanding. Finally, either several coats of epoxy paint are applied or a supplemental finished surface, such as polyvinyl chloride (PVCu) wall cladding, is installed. An acoustic ceiling is typical, consisting of an aluminum-grid frame with ceiling tiles of varying materials or epoxy-painted wallboard. There are both positive and negative attributes to this type of construction, which should be examined closely.
Traditional Stick Build Pros
Traditional Stick Build Cons
Modular Compounding Facilities
The wall and ceiling systems for modular compounding facilities typically have a lightweight core composed of an aluminum honeycomb or foam inserted between galvanized steel or fiberglass outer sheets. The wall options are either glass panels that sit in aluminum frames or panel faces exposed to the compounding environment that are generally finished with a white, hygienic coating such as PVCu and are cold-welded together to create a monolithic, air-tight environment. Like stick-built cleanrooms, there are both advantages and disadvantages to this construction approach.
Modular Panel Pros
Modular Panel Cons
Review all applicable regulations with the manufacturer. Like stick-built construction, the modular units must meet local code requirements as well as USP and board of pharmacy requirements. To accomplish this, there are specific approaches that must be avoided in modular construction; for example:
Hybrid Compounding Facilities
A third option is a blended or hybrid design that utilizes stick-built ceilings, sides, and flooring with modular frames and viewing windows or panels. These hybrid compounding facilities may decrease the costs associated with modular builds, particularly if the foundation already exists for the stick-built segments.
Ongoing Maintenance Costs
While initial construction and installation costs are primary concerns when building a cleanroom, another item to consider is the cost of maintaining and repairing the physical structure after installation. Both types of cleanroom designs—stick-built and modular—will require ongoing upkeep; neither option provides zero preventative maintenance.
It is important to establish who will be responsible for providing any required services post-construction. Traditional stick-built facilities will need preventative maintenance and damage mitigation. It is best practice to look to local contractors with cleanroom experience to manage repairs and maintenance. Due to its specialized nature, modular construction maintenance may need to be conducted by the primary installation company. When preventative maintenance and repair from damage or deterioration is limited to one company’s staff and materials, it may be more costly and not as readily available, leading to more downtime. Further, some replacement parts may be unavailable years down the road due to the age of the modular build.
Undertaking a cleanroom construction project can certainly seem daunting at the outset; however, there are many resources available to answer any questions that may arise throughout the process. It is quite likely that neighboring facilities have recently taken on similar installations and can serve as a font of information. State boards of pharmacy are an excellent resource for identifying issues that should be avoided. Finally, consider engaging with a consultant who is familiar with design, operational functionality, and regulatory compliance when building new compounding facilities. They often provide a unique, outside perspective and have direct experience with the challenges your pharmacy may face. Ultimately, it is pharmacy’s responsibility to ensure the selected company is familiar with USP <797> and USP <800> standards for 503A facilities, or FDA cGMP regulations for 503B facilities. Including your contractor in the design process and reviewing the construction documents prior to completion will provide the best outcome.
Mark Bodnar is the director of special projects for Kastango Consulting Group. He has over 40 years’ experience in sterile compounding, covering hospital, home infusion therapy, and LTC as well as FDA-regulated outsourcing facilities. Mark performs construction document reviews to ensure regulatory compliance and recommends best practices for sterile compounding facilities. He is also a peer reviewer for gap analysis, facility design development, and other related documents.