Process architecture is a specialized area of architecture that leverages design principles with process expertise and regulatory knowledge. Here’s why it’s essential for life sciences facilities.
Efficient, compliant operationsProcess architecture plays a critical role in optimizing your facility design.
What is process architecture?
Highly technical facilities require highly specialized design teams. When those facilities are home to complex drug manufacturing processes on which patients’ lives may depend, design teams need even deeper knowledge to get every detail exactly right. That’s where process architecture plays a vital role.
In the life science industry, process architecture focuses on the design of highly technical spaces that comply with cGMP regulations, protect the health and safety of occupants, drive businesses forward, and inspire workforces toward a shared objective—delivering safe therapies as efficiently as possible to the patients who need them.
Focused on the art of designing spaces that protect occupants’ health, safety, and welfare (HSW) while improving productivity and generating business value.
Specializes in building codes, building systems, hazardous materials, fire protection, accessibility, sustainability, etc.
Focused on the equipment, technologies, and processes that drive safe and reliable cGMP manufacturing operations.
Specializes in cGMP process design and regulatory requirements.
Focused on layering architecture and cGMP process design together to deliver a safe, integrated, and high-performing drug manufacturing facility.
Specializes in architectural and cGMP-related regulations, and the way those regulations work together to support a safe drug manufacturing operation.
For example, a process architect would work closely with the process engineer designing an efficient and compliant cell therapy manufacturing operation to ensure that the space in which the process takes place has an optimal layout, segregation strategy, finishes, and lighting. This enables more efficient and productive cGMP spaces.
Why should you include process architecture in your next capital project?
Your project will benefit from deeper technical expertise.
Experts in process architecture are licensed architects who have developed a specialization in cGMP manufacturing through extensive experience. With these experts on your project delivery team, you gain:
Built-in regulatory compliance
Process architects have a thorough understanding of the regulations that govern drug manufacturing around the world, including U.S. Food and Drug Administration’s Code of Federal Regulations, European Medicines Agency’s Eudralex, and more.
From this perspective, process architects will help ensure that your facility complies with the law governing cGMP facilities.
But more importantly, process architecture is all about understanding the fundamental “why” behind cGMP requirements, and applying appropriate solutions based on the needs and attributes of your particular product, process, and facility.
As such, process architects will also ensure that your facility reflects the intent behind regulatory requirements, in a way that’s optimal for your unique situation.
A facility designed for efficient cGMP manufacturing
Your manufacturing facility is a complex network of functional adjacencies and operational activities. Through the lens of process architecture, your project team can develop graceful solutions to help that network function smoothly.
Some of these solutions contribute to your facility’s spatial efficiency, such as stacking mechanical units directly above the cleanrooms they serve for more direct duct routing. Other solutions might support process efficiency. In a scenario where manufacturers anticipate frequent product sample collection, for example, a pass-through chamber between the production hallway and the QC sample receipt room could ensure efficient sample transfer.
Multiplied across the scope of your whole operation, solutions like these can have a significant impact on your facility’s efficiency. By adding process architecture to your delivery team’s capabilities, you’ll be positioned to find those solutions early and maximize their impact over the long term.
What role does process architecture play on a project delivery team?
In general terms, process architecture has a significant impact on three critical areas; safety, business success, and employee wellness.
1. Process architecture connects the goal of delivering a safe product with the art and science of designing a safe building.
Experts in process architecture are, first and foremost, registered (licensed) architects who have pledged to protect the health, safety and welfare (HSW) of the public. Think of that pledge as the process architect’s compass, and the cGMP facility as the environment in which they are experienced navigators.
In practice, this combination of architectural integrity and cGMP considerations means that process architects are especially qualified to advocate for the safety of two key groups:
Every detail inside a facility that could impact a drug product’s safety and purity needs the meticulous attention of a specialist team. It’s the process architect’s role to make sure that happens. From day one, they assess each design decision from the context of contamination control and patient safety, ensuring that no detail goes overlooked.
That means understanding and influencing the facility’s design from its highest levels (such as its room classifications, cGMP flows, and functional adjacencies) to its most granular details (such as the wall coatings inside a cleanroom, or the hardware for door interlock). Large or minute, complex or deceptively simple, every one of these details contributes to the safety of patients who rely on the facility’s output—and every one of them could benefit from the expert guidance of a process architect.
The safety of building occupants
Any environment in which potent materials, flammable solvents, and other hazardous chemicals are processed must contend with high-stakes health and safety considerations. This is especially true for manufacturers with antibody-drug conjugates (ADCs) in their pipeline, as well as those handling oligonucleotides, peptides, or the lipid nanoparticle (LNP) step in the mRNA manufacturing process.
Process architects have the specialized knowledge necessary to keep operators safe in these environments. They understand the stringent requirements in play when a space is classified as a hazardous occupancy (H-occupancy), and they can help project teams design appropriate fire-resistive assemblies, fire protection strategies, secondary containment, means of egress, safety stations, and more.
2. Process architecture supports your business case.
It takes a long history of diverse project work to shape a qualified process architect. For owners, that means a process architect draws from that extensive first-hand experience—the good and the lessons learned—to help deliver major business advantages.
Improved ROI on your capital spending
In order to get more bang for your capital bucks—that is, to maximize your use of every square foot in your facility—you need design solutions that elegantly balance both time and throughput considerations.
Process architects are especially good partners in this respect. They design your facility with the most efficient ratio of production targets versus available space possible, resulting in a highly utilized cGMP manufacturing operation.
Your brand, brought to life
A facility’s success from a business point of view isn’t only about the bottom-line. It’s also about how that facility establishes or elevates a company’s brand and reputation in the eyes of its stakeholders, its employees, and its end consumers. Here, too, process architects play a key role.
While thinking through the facility from a scientific and functional point of view, process architects are also considering the experience of being in that facility: What do you want employees, visitors, investors, and others to feel when they walk inside? What will your facility say about your priorities as a company—especially to the people who spend their workday between its walls?
Process architects achieve these brand-level goals through spatial design within the specific constraints—and opportunities—of a cGMP manufacturing facility. They know, for example, how and where to use glass walls to establish line-of-sight between manufacturing and administrative areas without impacting sensitive production areas, or which finishes are appropriate for maintaining cleanability while giving staff a pleasant experience of their environment.
These details can have a cascading effect on your facility’s business performance in terms of attracting and retaining top-performing staff, demonstrating success to investors, and building company-wide support for your overall mission.
A more sustainable facility
When implementing sustainable designs and strategies, many project teams focus on familiar concepts like energy or water conservation. These initiatives are important, but with the right expertise on board project teams could go much further, helping even the most energy-intensive facilities reduce their impact on the environment and increase their overall efficiency.
Process architecture is the missing piece. It encompasses both a high-level perspective on sustainable design and a ground-level approach, resulting in a building that maximizes sustainability from multiple angles, as advocated by the LEED rating system.
3. Process architecture advocates for your employees.
By helping to design a cGMP manufacturing environment that is not only safe and functional but inviting, comfortable, and tailored for the specific needs of its end users, process architecture greatly impacts the lives of employees in several ways.
Today more than ever, drug manufacturers recognize the link between investing in more human-focused workplaces that promote health and the need to attract talent, reduce absenteeism, and improve productivity. This investment is also a signal of respect and recognition for the hard work that their employees take on every day.
With these priorities in mind, initiatives like WELL certification are gaining momentum across all industries, including the life sciences, incentivizing companies to consider the positive impacts of natural light, movement, nourishment, sound control, and other factors. Process architects deeply understand these concepts and design them into the drug manufacturing environment, bolstering employees’ health and wellness in meaningful ways.
A drug manufacturing facility presents unique ergonomic situations. For example, employees may be required to repeat the same motions throughout their workday, stand for long periods over a biosafety cabinet, or lift chemical drums and other bulk materials. Without proper interventions, these scenarios could cause real physical harm.
Process architects can help mitigate that harm by planning for healthy ergonomics throughout the facility. For example, they can eliminate or reduce the need to physically transport solution totes by locating solution prep, hold, and point-of-use areas adjacent to one another. They can also recommend and appropriately design lifting devices for operations that require repetitive or heavy material handling activities.
What is an example of process architecture?
Process architecture brings value to the delivery of any cGMP manufacturing facility, but here are a few examples where it’s especially beneficial:
Like a Swiss army knife, the multimodal facility gives manufacturers the ability to run different process platforms within the same facility, either through segregation via scheduling or segregation via room boundaries.
This strategy has the potential to greatly improve speed and flexibility for drug manufacturers with multiple products in their pipeline. But multimodal manufacturing comes with elevated risks related to segregation, cleaning and decontamination, and equipment turnover.
A process architect brings an end-to-end, holistic perspective to this multimodal design exercise. They have experience with every tool in that Swiss army knife, and they understand how each sub-component fits together. This means they help project teams take advantage of critical commonalities between process platforms and balance risks associated with multimodal manufacturing operations.
Aseptic and sterile facilities
Manufacturers need facilities that comply with agency regulations, and they also need efficient facilities that deliver on their business case. It takes specialized knowledge to meet those two criteria when it comes to designing for aseptic and sterile manufacturing. The regulations governing these manufacturing facilities are necessarily rigorous, and the level of sophistication involved can hamper efficiency.
Process architects working in the life science industry have the skills and technical experience to apply the rigorous requirements of aseptic manufacturing while also helping to optimize and streamline the facility as a whole.
Cell therapy facilities
The processes involved in manufacturing cell-based therapies are typically done on a very small scale, especially when autologous (patient-specific) therapies are involved.
This presents unique challenges, from choosing a site that’s appropriate for cell therapy manufacturing to planning a future scale-out strategy that won’t impact ongoing operations. Given the volume of traffic and material flow involved in this type of facility, maintaining a therapy’s chain of identity and chain of custody (COI and COC) as it moves through the manufacturing process is also a particular challenge—one that could have a major impact on patients’ lives.
Process architects have the experience to think through and solve these challenges early in the facility’s design stage, helping manufacturers determine the best cell therapy manufacturing approach for their particular project and overseeing its implementation.
Large-scale stainless steel facilities
Though they require more upfront investment to build, stainless steel facilities generally cost less to operate than facilities designed for single-use technologies, and they’re capable of higher-volume production—10,000L or more, in some cases.
For that reason, many biopharmaceutical manufacturers are choosing this route. With that choice comes a few important considerations, though—and a strong case for process architecture.
One important consideration is the sheer size of some stainless steel equipment. It’s not unusual for a vessel to span multiple floors; a stacked process space is necessary in such cases, giving operators access to the top of the vessel as well as the ports and outlet connections located near the bottom. Process architects know how to design a facility featuring these types of process spaces, as well as the intricate network of hard pipe connections required to support them.
Another factor impacting the efficiency of a stainless steel facility is its cleaning flow. Portable stainless steel equipment requires cleaning and sterilization, which typically means planning an equipment wash suite as well as appropriate flows of portable equipment to and from the wash suite. It also means planning for safety showers, eye wash stations, containment curbs, and other features that will keep operators safe from the caustic cleaning solutions. Here, too, process architects ensure that the project team has considered every factor, and that your large-scale stainless steel facility will operate safely and efficiently, long into the future.
The bottom line
Process architecture helps project delivery teams establish conditions for safe therapies, efficient cGMP manufacturing spaces, and strong business performance.
Behind every drug therapy is a complex manufacturing facility—the result of a large, multidisciplinary project delivery effort, often involving hundreds of people, several months or years, and a large financial investment.
To get the most from that investment and position your next facility for success from the perspective of your business, your employees, and—most of all—the patients who rely on your products, include a process architect with expertise in cGMP manufacturing on that delivery team. They are agile critical thinkers, capable of approaching novel challenges with innovative solutions that fit the business need while protecting patient safety.
By seeing your project through the lens of process architecture, these experts will help you lay the groundwork for a smoother delivery experience and a facility that is compliant, safe, and efficient.
Reach out to our team of process architects to learn more about how they can support your next capital project.