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By Mike De Lisio, PCCA North American Sales Director
Over the last four years, we have encountered more and more pharmacies who approach PCCA for help with cleanroom design for nonsterile and sterile compounding. The uniqueness of every project has been an incredible learning experience. Since every pharmacy’s layout is different, the use of modular-wall systems ensures a customized installation as well the incorporation of the very best materials used to comply with all regulations.
A modular-wall system allows you to keep existing walls within your current laboratory and use wall cladding (overlay) that provides seamless internal walls and coved corners within the confines of the lab space. You can also enclose a space within your lab with additional walls that are erected as part of the build-out. With an overall emphasis on maintaining sanitary conditions, a seamless wall design with soft, angular coving allows any pharmacy to mitigate risk and approach nonsterile or sterile compounding with improved confidence. Cleaning protocols and the validation of a pharmacy’s procedures are immediately improved in a well-designed laboratory. To help you think about considerations for your next cleanroom build-out, here are some important factors to consider.
Starting from the ground up, the application of a levelled, nonporous floor is vital to the room’s integrity. We have completed successful installations with a poured epoxy surface that is extremely durable and easy to clean. This is a great flooring option. It’s also important to include horizontal floor coving that provides a simple and neat finish. Coving resembles internal crescent shapes that smoothly transition wall-to-wall corners as well as where the walls meet the floor and ceiling. A seamless vinyl surface is another flooring option that ensures compliance with relevant regulations.
Coving that transitions between walls, floor and ceiling facilitate cleaning protocols and help with compliance.
While a modular-wall cleanroom system can include cladding existing walls and erecting additional ones, the planning and installation process does not end there. You can choose solid walls, walls with windows or half-glass panels to improve aesthetics while maintaining cleanroom integrity. It’s also ideal to have horizontal and vertical coving as mentioned above. This allows for a smooth finish and results in easier implementation of appropriate cleaning procedures for the floor, walls and ceiling. Overall, this simple design feature removes any 90° angles within the modular-wall system and facilitates all cleaning protocols and further reduces the risk of insanitary conditions.
As the project finishes, it’s important that installers use pharmaceutical-grade silicone along all wall seams and coving to also maintain the integrity of the room’s pressure. Most nonsterile cleanrooms are designed to maintain a negative-pressure environment to prevent aerosolized powders or fumes from escaping. From a sterile perspective, proper sealing can provide a positive-pressure environment that prevents ambient air from entering the facility, thus maintaining sterile air to protect all products compounded within that specific area.
Also on The PCCA Blog : Important Considerations for Cleanroom Design
To finish enclosing your cleanroom, you can use a T-grid ceiling that is stabilized from your current structure. This ceiling type allows for panels to be easily removed for maintenance and to be adjusted to your pharmacy needs. A fully customizable ceiling allows the pharmacy to choose a desired height of each modular chamber between eight and 10 feet. The panels should also be seamless, and they can be integrated within a full LED lighting system that provides a brightly lit area with a long life span.
Ceiling tiles within a T-grid system can also be customized for all HVAC accommodations with specific air-return grills and/or HEPA filters if necessary. It’s also best to have all HEPA filters come equipped with a smoke-test port that allows pharmacy personnel to test the functionality of the cleanroom from within the lab itself, without removing any fan filters or other components. This is an extremely important factor to consider given the testing and validation performed to ensure that the HEPA filter is functioning at full capacity.
The ceiling of a modular cleanroom can be customized for optimal height, lighting and ventilation.
With looming regulatory changes and an overall focus on implementing the best solution for your lab, we have been grateful to partner with the Nicos Group for all lab renovations in recent years. Nicos offers expertise within the CGMP area and has been building extensive sterile modular cleanrooms for decades. They have taken this approach to large pharmaceutical manufacturers and scaled it down for compounding pharmacies, but the quality of materials and installation is the same. Importantly, they provide suitable and customizable options for all of the cleanroom considerations discussed above.
If you choose PCCA and Nicos for your next cleanroom build-out, we will work with general contractors, mechanical engineers, electricians and plumbers to ensure a smooth installation. Further customizations, such as the inclusion of pass-through chambers, automatic self-closing doors, and seamless electrical receptacles and data ports are also options we can provide. Upon completing the final design, we also identify the location of your equipment and fixtures that may require further wall reinforcement, all at no additional charge.
Also on The PCCA Blog: Why PCCA Chose Nicos, and Why You Should Too
If you are choosing to renovate your facility, do not underestimate the benefits of a modular-wall system for all types of compounding. They offer peace of mind, high-quality materials and the flexibility to accommodate your needs. We also encourage you to connect with your financial advisor since a fully modular cleanroom is considered a fixed asset and may be depreciated over time, thus providing many potential tax advantages. If you have any questions about building a new modular cleanroom in your pharmacy, please contact us at 800.331.2498.
Want more information on building a new cleanroom? Listen to Mike and his colleague, Sebastian Denison, RPh, FAARM (candidate), discuss it on PCCA’s podcast, The Mortar & Pestle: Getting Started on Your New Cleanroom
Mike De Lisio, PCCA’s North American Sales Director, is a graduate of the John Molson Business School at Concordia University in Montreal, Canada, where he majored in management of information systems and minored in marketing and consumer behavior. Having worked in the compounding industry for 18 years, Mike has served as a key account manager, national sales manager and managing director of PCCA Canada, and currently is responsible for PCCA’s recruiting, customer service, and inside and outside sales functions for both Canada and the United States.
This article originally appeared in PCCA’s members-only magazine, the Apothagram.