Demand Booms for Modular Cleanrooms: G-CON Delivers
José Negrón is a process architect at G-CON, a manufacturer of prefabricated modular cleanrooms.
José Negrón is a process architect at G-CON, a manufacturer of prefabricated modular cleanrooms, which the company calls PODS. His role involves a combination of engineering and architecture. At the beginning of a project, his goal is to fully understand all the steps of the client’s production process, “starting from how they get raw materials into their warehouse; how they check the quality of the materials; every step of their production line; the flow of people and materials through the process; all the way to the finished product going out the door.” With that understanding, Negrón can design a POD layout that best serves the client’s processes and equipment.
The PODs structures are made by welding aluminum members. Some extrusions are patented aluminum shapes that provide higher load bearing capacity than typical extrusions.
The PODs are fit-out at the factory with the necessary architectural components, in addition to the mechanical, electrical, automation and fire protection systems.
Product Design
Cleanrooms often have smaller rooms adjacent to them, called airlocks. Airlocks are used for people to gown-up, or for materials to go in or out. These actions take place in the airlocks so the proper environmental conditions can be maintained inside the cleanroom. Depending on the process, some airlocks are bi-directional, and some are uni-directional.
The superstructure of each cleanroom POD is made of aluminum, which is strong, light, and corrosion-resistant, all significant advantages over steel and wood construction. G-CON builds each POD frame in their fabrication shop. “The PODs are then combined with pre-assembled architectural and mechanical systems,” Negrón says.
“Fresh outside air is pre-conditioned with a make-up air unit to remove particulates and to get the temperature and humidity within a certain range,” Negrón explains. “Within each POD, there’s a dedicated HVAC system that receives the pre-treated air and pushes it through a number of filters. The final HEPA [High Efficiency Particulate Air] filters are in the cleanroom ceiling.”
Once the air flows into the cleanroom and reaches the floor, low wall return chases remove it from the room. “Any particulate matter that might be in the air goes down to the floor and out through the low wall returns,” Negrón adds. This airflow ensures no particulates accumulate in the corners of the cleanrooms. Coving where the walls meet the floor and ceiling also help achieve this.
Strict Requirements
In the pharmaceutical industry G-CON serves, there are different regulatory requirements for various aspects of a client’s processes. For example, air cleanliness and room classification requirements will vary depending on a client’s manufacturing processes.
In addition, many clients have very specific, rigorous cleaning protocols for every surface of the cleanroom, including the floor, walls, and ceiling. The materials for the interior surfaces must be able to withstand the cleaning chemicals used and the cleaning frequency.
In many cases, G-CON’s clients need to be able to prove to regulatory agencies that their products — such as vaccines — have been manufactured within strict environmental parameters. This means they must collect data on air temperature, relative humidity, air pressure, and other factors. “The data needs to be digitally collected, saved, and protected in such a way that nobody can tamper with it,” Negrón explains. “So, if someone from the regulatory agency asks for the data regarding a specific batch of vaccines manufactured at a certain time on a certain date, all that data is available.”
Modular Manufacturing Advantages
Building in a controlled, indoor environment means that it’s much more feasible to keep the product clean during construction. “Before shipping, we have a list of tests we perform on each POD in the factory. After they’re tested, the PODs are prepared and shrink-wrapped for shipping and delivery,” Negrón says. Once the cleanroom PODs are installed at the client’s facility, G-CON cleans them again. “For commissioning, we test the POD systems once more.” The client then does the final sanitization prior to operation.
SubPODs are joined together with clean corridors that lead to airlocks, pass-through boxes and other material transfer elements.
Negrón says that more and more clients are turning to prefabricated modular cleanrooms “because of the high quality, cost certainty, predictable schedules, and the ability to deliver projects much faster than traditional construction.”
Another advantage of POD cleanrooms is that they can be used temporarily and then re-located. Clients can use the cleanrooms for as long as they need them and then re-deploy them for another use or sell them. With traditional stick-built cleanrooms, the building expenses are sunk costs because the cleanrooms can’t be moved or re-sold as independent units if they’re no longer needed. Also, a small manufacturer can begin operating with one cleanroom POD and add more as the company grows and requires additional capacity — because each POD is completely self-contained.
Depending on the client’s process, subPODs can be joined together to form a POD cluster. Projects vary from 1 to 14 plus subPODs. Interconnecting the PODs allows clients to have great layout flexibility.
Greater Demand and Increasing Standardization
The demand for cleanrooms has been very high over the past couple of years. “When COVID hit, some clients put projects on hold. But we were also inundated with new requests for cleanrooms, to support the global COVID response, including vaccine manufacturing,” Negrón says.
This increased demand has resulted in rapid growth for G-CON, including greater manufacturing footprint, capacity, and head count. At the same time, G-CON is moving towards more standardization of its POD systems to further reduce the time and cost for delivering cleanroom facilities. The company recently released a catalog of standardized POD designs. These standard models can address the needs of cell and gene therapy companies, or can handle fill-finish. (Fill-finish is the final step of filling, labeling, and packaging vials of medications before they’re distributed.) The idea is that the standardized PODs will provide enough variety and flexibility for clients to mix and match, while also providing the speed advantages of standardization. “Standard PODs can be ready for delivery in three months, whereas if a client requires custom POD designs, it might take six months to a year to deliver the PODs, depending on the project size,” Negrón says.
World of Modular Presentation
The main focus of Negrón’s World of Modular presentation is to show how G-CON delivers projects faster than regular construction methods, helping companies take drugs and therapies to market faster, saving patients’ lives. Cleanrooms must adhere to strict standards imposed by regulatory bodies such as the FDA, and Negrón will talk about how the manufacturing process for cleanrooms differs from ordinary modular prefabrication.
About the Author: Zena Ryder is a freelance writer, specializing in writing about construction and for construction companies. You can find her at Zena, Freelance Writer or on LinkedIn.
More from Modular Advantage
How Rebel Concept Harnesses AI as a Design Tool to Improve the DFMA Process
“The complexity of projects and the size of project are so large, and the technology is so complicated that AI would do it so much faster than we are,” says Kris Droszcz, CEO at Rebel Concept. “Everybody’s struggling to control the manufacturing processes according to the design. And I think that’s what AI will do.”
One Answer from AI Can Provide Innumerable Opportunities, says Stack Modular’s Jim Dunn
The Stack AI Engine is not fully functional yet, but it offers an unlimited number of productivity benefits. Currently, the company is using AI for cost estimates, most recently for a project out in California.
GrayWolf: Building the Future of Modular Data Centers to Power the AI Revolution
The growth of artificial intelligence (AI) and cloud-based applications has created an urgent need for data centers capable of managing massive amounts of data. As businesses across industries increasingly rely on digital infrastructure to power their AI tools, the demand for data centers has skyrocketed.
Artificial Intelligence: Yes, it is a Construction Game-Changer
Much like other sectors of the economy, AI is reshaping construction, revolutionizing how projects are planned and executed across the country. While it is obvious that AI cannot do certain things by itself, like laying bricks, paving roads, or shingling roofs, its impact stands to be both massive and positive.
The Potential and Possibilities of AI for Offsite
AI is everywhere. Many industries have incorporated AI into business as usual with new organizational structures and new dependencies to be more efficient and to automate repetitive tasks. Offsite construction will not be immune to AI’s ubiquity. The technology offers unique benefits to the offsite building process.
Moving from AI Hype to an AI Advantage
Learning about AI will help you see past the overinflated hype and identify the opportunities specific to your own business. Learning about AI is like peeling an onion – each layer reveals something new, and occasionally it might make your eyes water. But in the end, you’ll have all the ingredients you need to cook up some real innovation in your organization.
The Blueprint for Smart and Ethical AI Integration in Your Business
The journey toward smart and ethical AI integration involves crafting a strategic vision that aligns AI’s transformative potential with your organizational goals. True success with AI is measured by its capacity to enhance human capabilities, foster sustainable growth, and generate value for all stakeholders while actively avoiding ethical pitfalls and harmful risks.
Five Factors for Success When Shifting Your Business to Modular
As labor, competitive and cost factors push more contractors and developers to embrace the opportunity to go modular as a first choice and not a last resort, it’s become clear that adopting this new model requires more than just a willingness to make it happen. Here are five factors to consider as your company moves to a modular construction model:
UniCool-Edge: Optimized Cooling Solutions for Modular and Edge Data Centers
In an industry where efficiency, scalability, and security are crucial, the UniCool-Edge™ system is a revolutionary solution for modular data center manufacturers. By offering external mounting for maximum space utilization, energy-efficient cooling, and pre-commissioned reliability, UniCool-Edge helps manufacturers stay ahead in the rapidly evolving AI-driven data center market. As edge data centers continue to expand, solutions like UniCool-Edge will play a vital role in supporting the next generation of modular data centers and their data center infrastructure.
Building Skills in a Virtual World: Immersive Training for the Modern Workforce
As both the hardware and software for developing and deploying XR applications continue to become more affordable, the investment in this technology as a training tool is increasingly appealing. XR also offers several other benefits, including performing potentially hazardous tasks in a safe environment and acquiring new skills without the immediate need for physical materials.