Modular construction, preassembled modules, and independent structures offer advantages for cleanroom users.
Based on discussions with consultants, cleanroom manufacturers, flooring companies, engineers, and architects, as well as customers that use modular cleanrooms, the authors highlight the following cleanroom facility trends.
Offsite work. The largest trend in the cleanroom industry seems to be the movement towards doing more work offsite. There has been an industry-wide shift that can be observed in various ways throughout the cleanroom industry, one of which is modular construction. The overall goal here is clear-to do more work at the manufacturing site where efficiency and quality can be better controlled. Panels are manufactured with factory-installed utilities, which are pre-wired and pre-cut, as shown in Figure 1. Installation time is also greatly reduced. When the panels arrive onsite, the construction process is much smoother and cleaner (e.g., minimal dust, no cutting or drilling) with minimal or no disruption to the customer’s activities, which results in cost savings for the customer and minimizes or completely eliminates downtime.
Figure 1. Three-dimensional model of a pre-cut and pre-wired cleanroom panel. All figures are courtesy of Mecart Cleanrooms.
Figure 1. Three-dimensional model of a pre-cut and pre-wired cleanroom panel. All figures are courtesy of Mecart Cleanrooms.
Pre-assembled modules and PODs. Offsite construction has manifested itself in a wide variety of formats. Another trend is the movement towards PODs or other forms of modular buildings, where the cleanrooms are pre-assembled offsite and then integrated into the facility onsite. These types of cleanrooms are self-contained and autonomous. Their reinforced structure allows the modules to be lifted and transported (see Figure 2).
Figure 2. The reinforced structure of self-contained cleanrooms allows the modules to be lifted and transported.
Figure 2. The reinforced structure of self-contained cleanrooms allows the modules to be lifted and transported.
Additionally, completely mobile cleanrooms are now a reality: a trailer shows up, electricity is hooked up, the water is connected, and the cleanroom is quickly functional. This method allows customers to set up a cleanroom very easily when additional capacity is needed, in case of an emergency, or in circumstances where a more permanent structure is being built but cleanroom capacity is needed immediately.
Structure independent from the main building. Another significant trend is the movement towards cleanrooms that are not only freestanding, but also detached from the main building roof structure. These totally “isolated” cleanrooms offer more flexibility than traditional stick-built cleanrooms. Because no part of the cleanroom structure is attached to the main building, the rooms are more adaptable to future needs and are also generally quicker to install. The benefits are even greater for cleanrooms that are not attached to the building’s roof. Many modern roofs are designed more for aesthetics than structure. A modern heating, ventilation, and air conditioning (HVAC) system plus a cleanroom ceiling can have a load bearing demand of 21–30 pounds per square foot. This load is often more than a modern roof can handle (especially a metal roof). Companies are forced to reroof large sections of their facility to meet the cleanroom and the associated HVAC requirements, which can cost hundreds of thousands of dollars depending on the size. A modular cleanroom with a self-supported roof can eliminate this load on the main facility’s roof, and thus eliminate the cost of roof enhancements.
Lead time reduction. Probably the most important factor in the trend toward modular construction is reducing the turnaround time. Companies can no longer wait years for a cleanroom to be designed, engineered, manufactured, installed, and finally commissioned/validated. Customers want the whole cycle to be completed within a year and often even quicker depending on their product cycles and time-to-market. They can’t afford to wait too long for the cleanroom to be functional.
Easy future reconfiguration with no shut down. Customers and manufacturers are looking for increased flexibility in cleanroom construction. This trend is generating an increase in the popularity of modular cleanrooms. Customers would like to have the ability to have a smaller cleanroom today, but be able to add more rooms or change configurations a year (or even a month) later. They don’t want this conversion process to take several months or years and cannot afford lengthy shutdowns. They also don’t want to have to tear down everything. Rather, they expect cleanrooms to be reconfigured in days or weeks with minimal shutdowns/interruptions to current operations (a few hours, or at most a few days).
Functionality and aesthetics. Companies are looking for cleanrooms that are functional, easy to maintain, and aesthetically pleasing. In some cases, these objectives may compete with each other and compromises may have to be made. However, customers want it all. With respect to functionality, they want rooms with built-in utilities that are easily accessible and easy to change out/maintain. Modern facilities have electrical and local area networks built into their walls (with no exposed wiring conduits), multiple access points for gases or deionized water, and integrated process piping, for example. Electrical and mechanical utilities should also be easily accessible for cleaning and maintenance tasks. The aesthetic look and feel of the facility is also a key element to demonstrate that quality is a company value. Cleanrooms are often used as showrooms for clients and investors.
Easy cleaning and maintenance. For cleanrooms, ease of maintenance is key. Modern rooms need to be easy to maintain and clean (for daily maintenance as well as periodic maintenance), and materials used in the construction of the room need to be robust. Many companies request stronger walls that are impervious to day-to-day abuse and can resist a wider variety of cleaning and disinfecting processes. When maintenance is performed, downtime needs to be minimized or eliminated entirely, as shutdowns can cost several million dollars per day in some cases. For example, maintenance, such as servicing lights, can be done from the roof without entering the cleanroom, thus preserving the clean environment (see Figure 3). If a shutdown is unavoidable, the cleanroom needs to get back to specifications very quickly so that production or research can continue.
Figure 3. Maintenance, such as servicing lights, can be done from the roof without entering the cleanroom, thus preserving the clean environment.
Figure 3. Maintenance, such as servicing lights, can be done from the roof without entering the cleanroom, thus preserving the clean environment.
Completely turnkey, less intermediates. Finally, due to the increased reliance on their cleanrooms, companies are looking for integrated solutions for their cleanroom needs. They want true turnkey solutions, where a single provider takes care of everything from design to manufacturing to installation. With larger customers, they are seeking partnerships or consortiums that can handle all of their needs. In a perfect world, these partnership companies can help them find suitable land or buildings, take care of all of the process engineering, complete a full facility buildout (including the cleanroom, of course), source equipment, work on permits, and other activities. Customers need to have a strong trust relationship with the partner and need to be convinced that this partner is doing everything in their power to work on the customer’s behalf in all phases of the project.
Charles Lipeles is vice-president of US Operations for Mecart Cleanrooms, a Canadian manufacturer of modular cleanrooms, clipeles@mecart.com, tel: 1-866-463-2278; Patrice Genois is vice-president and general manager, Mecart Cleanrooms.
The Solution Lies with SOLBIOTE™: Achieving Sustainability, a Growing Focus in Biopharma
October 28th 2024The nexus between biopharmaceuticals and sustainability is seemingly far apart, however, it is increasingly recognized as an inevitable challenge. It is encouraged to take a sustainable approach to reducing the environmental impact of the production and supply of medicines while improving people's health; delivering the well-being of people and the planet. Yosuke Shimojo (Technical Value Support Section Manager, Nagase Viita) will unveil how SOLBIOTE™, a portfolio of injectable-grade saccharide excipients, would be a key for the biopharmaceutical development and achieving sustainability for a better future of the industry.