Modular Systems Vs. Stick Built:
Getting The Most Out Of Your Pharmacy Cleanroom Investment
As healthcare facilities begin to plan out a new pharmacy cleanroom, there are to two major options that are commonly considered. These options include Modular Systems and Stick Built. These options are decided based on: end-user preferences, compliance benefits, and of course, budget. Within this article, we analyze these two approaches and weigh the true costs over the long-term. In addition, we explore common ground and the ability to custom blend the two approaches through ProPharma Cleanrooms' hybrid approach.
Modular Systems
In modular system installs, the walls and ceiling are manufactured, packed for shipment, and delivered to the project site. They are then assembled based on design and layout. Wall systems can include a variety of different materials such as: aluminum or glass. For example; ProPharma Cleanrooms wall panels are manufactured with an aluminum honeycomb core under an aluminum facesheet with a baked enamel finish.
Ceilings in the modular systems tend to be a ceiling grid system comprised of cleanroom grade tiles and/or panels. ProPharma Cleanrooms utilizes a cleanroom grade Armstrong Ceiling System with gasketed grid and thick cleanroom grade tiles that are smooth to the touch.
Modular systems offer a lot of flexibility to create a cleanroom environment essentially anywhere (given appropriate HVAC connections, etc..), however, they tend cost higher due to the higher grade materials used in the installation and the convenience of the install.
As flexible as modular systems may be, there are situations where space allotment will not support a modular “box within a box” and the pharmacy may lose valuable square footage if this route is selected.
Stick Built
The leading alternative for the past few decades is commonly called stick built construction, which generally involves construction of cleanroom spaces using steel-studded structure (the sticks) covered in gypsum wallboard. Ceilings in stick built cleanrooms can vary using a ceiling grid system, or more, commonly, a "hard" ceiling which is made of the same gypsum wall board as the walls. Under the current USP General Chapter <797>, this approach with an epoxy paint is acceptable as the minimum build-out standards to meet compliance. Stick built construction is often perceived as more affordable given the simplicity of the techniques involved and material costs, overall. Those perceptions, however, may not take account of long-term durability and the associated costs of maintenance.
The Dirty Truth of Drywall
As contractors know the distinct advantages of drywall (cheap, easy to store, and simple to cut to any shape), the inherent disadvantages of drywall (especially to a pharmaceutical cleanroom grade environment) are oftentimes overlooked. It is messy to work with, easily punctured, and can easily absorb and retain moisture.
Drywall is a simple product made of gypsum rock sandwiched between sheets of paper. It crumbles when cut, and it swells when wet.
In damp environments, drywall becomes something far worse: a welcoming home to mold and other microorganisms. Gypsum naturally draws in and retains moisture, while the cellulose and starch used in drywall covering becomes, in essence, a growth medium for spores. The makings of a regulatory nightmare for pharmacy practices.
Mold growth is not just unsightly, it is potentially dangerous. A case in the early 2000s saw several children die due to exposure from a recurring mold infestation at a children’s hospital in Washington State. It is decidedly the opposite of a controllable environment in which these ISO rated environments must maintain.
Since the early 2000's USP has continually improved its design and engineering standards to reduce the potential for microorganism growth along with enhanced cleaning efforts and chemicals. Drywall is less forgiving to these harsh chemical cleaners. Without the proper grade epoxy paint, the coated enamel will wipe off and begin to affect the wall’s integrity.
Drywall is also less tolerant of bumps and knocks. If a wall is hit and punctured during equipment and furnishings install or during the weekly/monthly cleaning process, the drywall particles will be exposed to the environment required patching and re-painting. This is a risk that will remain throughout the life of the stick built cleanroom, and something to be factored as its on-going maintenance.
Getting The Most Out of Your Investment
One of the most important considerations in pharmaceutical cleanroom applications is that materials used are to be non-absorptive, non-shedding, and non-reactive. This is required to ensure the safety, quality, and integrity of the drug product. Additionally, it is critical that materials selected stand up to the harsh cleaning chemicals required by USP on a daily, weekly, and monthly basis.
Modular systems check all of those boxes and do not require the on-going repairs/maintenance that the stick built alternative requires. Each time a stick built cleanroom must go down for patches, re-painting, and repairs; compounding operations must stop and teams are required to clean prior to start-up costing the facility resources and money each time.
Additionally, should the standards be revised in future years, eliminating painted drywall from the acceptable build-out approach, your facility is not stuck having to re-do all those effort to once again meet compliance.
Common Ground - The Hybrid Approach
Not all pharmacy practices want to go 100% modular. Sometimes space isn't feasible to fit a "box within a box". Yet one thing is clear, pharmacy clinicians prefer the benefits of lasting systems and staying well within regulatory compliance.
ProPharma Cleanrooms custom solutions offer a unique approach to flexibly incorporate the benefits of modular systems within stick built environments. ProPharma Cleanrooms' aluminum honeycomb core wall system if offered in two different sizes: 1/4" thick and 1-3/4" thick panels.
The 1/4" panels offer the ability to cover or skin any gypsum wallboard from an existing wall or perhaps newly built wall giving it the durable and cleanable features necessary to last the life of the cleanroom and be easily maintained to never break the seal of sterility within the environment.
The 1-3/4" modular wall panel can be its own partition wall allowing the ability to add electrical and data runs to compounding equipment and incorporate viewing windows for monitoring within the environment. Again, giving the walls the smooth and durable finish to be easily maintained.
In many cases, ProPharma Cleanrooms will work in cooperation with the facility to cover any existing or newly constructed "stick built" walls that make the perimeter "box" of the cleanroom suite with the 1/4" panels. Then, all partition walls separating respective ISO rated rooms and compounding areas will be comprised of the modular 1-3/4" panels.
This hybrid approach grants further flexibility in the build-out of the cleanroom environment and meets the needs of facilities that prefer not to go 100% modular or lack the space to install a full modular box within their allotted space. All while making an easily cleanable environment that will outlast any standard stick bult environment.
About ProPharma Cleanrooms
ProPharma Cleanrooms' team of experts brings more than 40 years of cleanroom construction experience and regulatory knowledge. As a result, our turn-key, configurable, and custom solutions represent decades of know-how and continued improvement.
ProPharma Cleanrooms turn-key services and cleanroom components are best-in-class. Our regulatory team carefully designs each suite to exceed standards of compliance while staying fully functional for current operations and future growth. Find out more about our full service offerings.