Increasingly, manufacturers want standard facility designs of their GMP manufacturing facilities so they can be replicated elsewhere in the world, but this approach comes with unique considerations.
When a pharmaceutical manufacturer planned to expand its operations into Asia, the company hoped to accelerate the process by leveraging a standard facility design. But the manufacturer almost overlooked an important detail: In Asia, it is customary for workers to swap outdoor shoes for indoor shoes. Therefore, the entrance needed to be designed with appropriate space and furniture for changing and storing shoes.
This illustrates one potential challenge that comes with using a standard facility design. While performing the main design work upfront seems like it would allow manufacturers to quickly “copy and paste” their successes in other countries, it’ is never quite that simple. There are still numerous benefits to leveraging standard facility design for a company’s expanding global footprint—as long as you take into account local infrastructure, logistics, and culture.
The benefits of standard facility design
Standardized facility design for global deployment offers cost and time savings as well as operational advantages.
Having a set of workable blueprints in a company’s back pocket is a huge advantage when it comes to quickly building production capacity. From programming to design, approvals, selections, detailing and documentation, a project team can save months on the design schedule. Similarly, fewer RFIs and submittals during construction, as well as streamlined commissioning, qualification, and validation processes all contribute toward cost and time savings. Whether it is to run multiple manufacturing sites to serve local patient populations for personalized medicine or autologous therapies, or to quickly ramp up production capacity in response to epidemics or pandemics, standard facility designs are the key to consistent, reliable, rapid deployment.
Consistent operations pave the way for easy cross-training and interoperability. Once management understands how a facility is laid out, operated, and maintained, they can conduct training at a global level. Employees can be relocated as needed to turn on a facility or lend a hand during production surges. This is especially handy during times of crisis, such as the pandemic, when there are new challenges to recruitment and onboarding.
Design considerations for standard facility design
Standardization holds a lot of promise—but it’s important to be realistic. It would be nearly impossible to simply replicate an entire facility and drop it into another country. Codes and regulations, utilities, logistics, and cultural norms vary by region, so it is important to design for adaptability. Otherwise, rigidity becomes a breaking point. Here are some specific design considerations I’ve come across in recent projects.
Utilities pose challenges to standardized systems. Unlike in most of North America and Europe, where tap water is drinkable, the national infrastructure of less developed countries could result in an inconsistent supply and quality of water. If that’s the case in your new facility’s location, you may need to add a pre-filtration step to improve water quality prior to WFI generation. Furthermore, regulatory requirements vary by region. China, for instance, requires WFI to be produced via distillation—a process requiring a bigger footprint and a more expensive system than membrane-based reverse osmosis (RO) system.
Also, power availability and reliability vary by region, which necessitates different systems and capacities of backup generators and battery storage. While the operational load is driven by equipment and remains consistent, the supporting power system’s type and capacity should be determined based on local available infrastructure. When designing facilities for global needs, consider both the quality and reliability of available water and power.
Supply chain and warehouse sizing
Local supply chain issues impact warehouse sizing and strategy. While just-in-time delivery may allow for smaller facility warehouses in some regions, it’s not the right solution elsewhere. In some areas, such as those vulnerable to weather disruption, natural disasters, or civil unrest, manufacturers should consider holding higher volumes of inventory. Other factors such as value and availability of land, transportation infrastructure, and presence of third-party warehousing service providers also play a role in determining the size and strategy of warehousing operations.
Today, an increasing number of facilities employ single-use technology, thereby producing huge amounts of contaminated solid waste that needs to be hauled away. But who does this and where does it go? In the US, there is an ecosystem to support this with entire companies whose sole job is to take away all the plastic waste and, in some cases, decontaminate it and recycle it.
In undeveloped countries without landfills or where garbage is simply burned, a manufacturer may face issues managing input and output. The process of deciding between stainless steel systems and single-use technology is complicated and nuanced. So, a design team needs to holistically evaluate the life cycle cost of equipment and components, including environmental costs and impact, when considering a standard facility design.
Regulations require gowns used in cleanroom operations to be dedicated, clean, non-particle shedding garments. Of course, this aspect of cGMP manufacturing heavily depends on the availability of suppliers and service providers. While some facilities may hire a laundry service or opt for single-use gowns, other facilities located in an area with limited third-party service provider options may need to build out a full on-site laundry facility.
Gowning and locker rooms
As a general rule of cGMP manufacturing, cleanroom operators need to remove all street clothes down to their underwear before donning a facility uniform and then layering on PPE as needed. Cultural views around hygiene, modesty, and gender segregation vary throughout the world.
In Korea, there is a cultural perception that shoes are dirty, so they are removed when entering a building, which needs to be addressed in the standard facility design to avoid a bottleneck at the entrance.
Then there is the issue of unisex locker rooms. In the US, it is becoming more common for facilities to have unisex locker rooms with private individual change rooms. But in other countries, this setup would not be considered proper. Therefore, designers need to be prepared to offer an alternative design with gender-segregated locker rooms.
Some cultures prefer hot foods to be eaten in groups, while others prefer cold sandwiches on the go. Some cultures eat a lot of meat, while still others eat very little. Various meal preferences translate into different refrigeration, heating, and storage requirements. A cafeteria that doesn’t meet the cultural cooking needs of a country is not an ideal cafeteria. A practical standard facility design needs to be generic enough that it can flex to accommodate local dining customs.
A modular standardized solution
One innovative solution in the global deployment of facilities is the use of ISO shipping containers. In this extreme version of prefabrication, preassembly, modularization, and offsite fabrication (PPMOF), containers with standardized dimensions can be manufactured and easily be shipped on cargo ships, trains, or trucks. Facilities can combine multiple containers to build out entire sections of their facility. For example, a skid of mechanical utilities can be assembled and then shipped, with the connection points hooked up on site.
With this lean construction strategy, shipping containers can be used as building blocks in designing and laying out a facility. Some companies may choose one or two vendors to create all of these containers before shipping them across the ocean. This PPMOF approach circumvents any labor shortages or lack of quality supplies. For example, if the labor market in the final country does not have the technical prowess to design and build cleanrooms, these can be built inside shipping containers and sent over.
The use of ISO shipping containers accelerates speed-to-market. Shifting from onsite construction to shop floor conditions means that operations can run 24/7. For example, unlike onsite conditions—which naturally come with inescapable constraints—it is possible to add additional labor to speed things up.
Undoubtedly, standard facility design will gain steam as companies expand further, faster. This design philosophy has so much to offer: speed-to-market, cost control, and streamlined training opportunities. To be truly successful, however, companies must build flexibility into their designs. By working with a team of seasoned professionals, companies can find the sweet spot of pre-planning and adaptability.
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