How will an operator describe the pharmaceutical production facility in which they work 10 years from now?
They likely won’t mention fixed equipment or long runs. Instead, they’ll describe mobile process equipment whirling from one production area to another, as one small batch ends and another begins. They’ll mention they always have a tablet on hand. And they’ll use an augmented reality (AR) headset to provide digital work instructions and confirm proper connections are made.
This is the facility of the future. It can make you more competitive with lower capital costs, more efficient production and faster startups. And it can help you better serve patients by creating more targeted medicines and getting life-saving drugs to market faster.
So, what exactly is the facility of the future?
It’s open. Mobile equipment and materials can be wheeled in and out of production areas. As this happens, the production system can confirm that equipment is connected in the right place and that the right product is being made.
It’s connected. Systems are linked and can talk to each other. And information can guide workers through production and equipment-setup steps.
And most importantly, it’s agile. Modular equipment and single-use technology can create “plug and play” operations that reduce changeover times and support smaller batches. Pretested and validated equipment can drastically reduce startup times. And reduced cleaning demands can shorten product changeover times moving from one personalized batch to the next, resulting in increased production and profitability.
Where today’s facilities fall short
To understand why a facility of the future is business critical, you need only look at how the industry is changing.
Cellular biology and gene therapy advancements have opened the door for smaller-volume and more personalized drugs. As a result, biotech manufacturing is shifting from bulk production to multiproduct facilities. These facilities require complicated batching, frequent changeovers and meticulous tracking.
There’s also a shift underway from large, global facilities to smaller, localized operations. This is helping bring API production to more cost-effective locations, allowing the industry to make personalized medicines closer to those who need them.
Finally, the need to get to market faster at competitive costs, while maintaining compliance and data integrity, is more critical now than it ever has been. Manufacturers need greater process management, smarter operations and more efficient R&D operations to accelerate regulatory approval and production. Facilities of the future bring much lower capital costs. While a large scale, traditional, biotech greenfield facility might cost between $500 million to $1 billion to build and get into production, a single-use facility typically ranges from $80 million to $200 million. And because less equipment means less installation work, start-up time is faster.
All these demands are creating the need for a more agile and connected approach to production — one where mobile equipment can be easily swapped in and out to make more products with shorter lifecycles; and one where information is used to not only help manage this activity but also make operations more efficient.
Today, most facilities aren’t designed for this style of operation. The main culprit? Aging distributed control system (DCS) technology.
The case for a modern DCS
Traditional DCS systems are built on proprietary technology. It can be costly and difficult to integrate them with other production and business systems, which in turn restricts agility and responsiveness.
Traditional DCS systems also often use outdated protocols. These protocols can create a flood of alarms and errors when workers disconnect equipment, making them unsuitable for plug-and-play operations. Some systems do use closed proprietary protocols that allow disconnections, but they can come with complex physical design criteria.
A modern, information-enabled DCS addresses these challenges. It uses open, unmodified Ethernet to seamlessly connect equipment. And it uses a common data structure to achieve two-way communications across your organization and give workers real-time insights in a single, consistent format.
A modern DCS can also help manage certain aspects of mobile operations to reduce human error and improve efficiency. For example, it can enable controls only for equipment that is docked in the correct location. It can also support the scanning of materials and other components, so workers can verify they’re being used with the right equipment.
When used with single-use equipment and technology, a modern DCS allows you to create more modular, flexible and information-driven operations. This is where the benefits of the facility of the future come to life.
Greater flexibility
A modular design concept can help you produce smaller batches, better utilize assets and get to market faster.
Think of production like a ballroom dance. You have an open area with minimal segregation and no fixed equipment. In this space, mobile equipment and materials all enter and exit based on demand.
Reactors are wheeled into position and connected with disposable tubing. The intermediate can be transferred back into a tote and sent into a centrifuge or depth filtration. And downstream, media is hard-piped through ultrafiltration, defiltration and chromatography columns.
A modern DCS helps you achieve this “dance” and reduces missteps throughout. For example, mobile mixing tanks and bioreactors can have many possible configurations and connections. A modern DCS can help streamline connecting and disconnecting equipment and provides workers with one interface to manage the process.
Empowered workforce
Fixed screens aren’t practical in a facility of the future. Workers need tablets or mobile screens to carry with them as they follow production from one area to another.
Thin client technology makes mobile visualization possible. And it can help to reduce human errors when using mobile equipment.
Thin client technology also uses software to centrally configure and deliver content to visualization sources like mobile devices. Some thin client software platforms have location-based content delivery to mobile devices. This is critical in the facility of the future. Why? Because it allows operators to only access screens and applications in physical areas where they’re working.
For example, an operator standing in front of a mixing tank can receive control of it from the software. But if they walk away, they will only retain visualization of the tank. They can’t control it. This can keep the operator informed of how the asset is running and help to reduce the risk of erroneous operation.
Additionally, as training resources are tightened, visualization technologies like AR can help. Training workers in an AR environment allows them to learn about and interact with production assets without disrupting production. If equipment fails, a technician can access diagnostics and work instructions in an AR environment to get it back up and running faster.
AR can also be using during operation to improve compliance. Operators in the facility of the future using smart glasses with AR could see an overlay of the single-use tubing connections in their field of vision. Instead of looking at a work instruction and trying to determine connection points, the connection points would illuminate as the operator looked at the equipment with the glasses. And the software would verify that the tubing connections are correct prior to allowing the system to move to the next step. Additionally, smart glasses could allow the operator to dynamically follow the process and interact with it using voice commands and gestures.
Compliance driven
Smaller batch sizes and faster changeovers may seem challenging given today’s compliance burdens. But the right manufacturing execution system (MES) can help your facility of the future be both agile and compliant.
An integrated MES that automates tasks, collects data in-process and delivers analytics can provide relief from lengthy compliance activities. In fact, instead of weeks of review, a facility of the future can achieve real-time release without quarantining product.
What should you look for in an MES? Make sure it can seamlessly integrate from your ERP system to your plant floor. It should also have these key attributes:
- An electronic batch record (EBR) capability that collects product genealogy, uses review by exception and connects with your serialization system
- Role-based recipe management that optimizes each stage of a recipe lifecycle, from creation to qualification
- Data-integrity features to help prevent documentation or human errors that can result in wasted product, contamination or recalls
One pharma manufacturer recently proved the power of MES in one of its facilities. The company developed a new approach to making an in-demand drug. It included using an MES that digitized paper records and automated document management.
By making production 100 percent paperless, the company reduced the risk of human error, like incorrect data entry. The company also calculated it would save five to 10 percent on labor costs by eliminating manual data recording. Finally, a more efficient batch-review process is expected to reduce supervisory and QA batch product review by up to 75 percent and cut management-review-cycle time by 50 percent.
In addition to an MES, scalable analytics tools can also help you improve your performance while achieving compliance. These tools collect raw data from a variety of sources and turn it into useful information to drive better decisions from the edge to the enterprise.
For example, a single processing line or inspection system can produce multiple terabytes of data daily. Extracting insights like temperature deviations and refrigeration exposure times from this data can help you minimize how long batches are held.
Securing a smarter facility
The facility of the future reimagines production to create a tremendous competitive advantage. But its more connected nature requires that you make security a priority.
Security approaches must go beyond traditional IT systems or an industrial DMZ. Pharma manufacturers need to address risk across an attack continuum.
Where do you start? Consider building a security strategy around the five functions of the NIST Cybersecurity Framework. As NIST puts it, these functions “represent the five primary pillars for a successful and holistic cybersecurity program.” They can also prepare you for the global security requirements in IEC 62443.
The five functions include:
- Identify: Understand your attack surface and asset vulnerabilities.
- Protect: Implement measures to safeguard your control systems.
- Detect: Vigilantly monitor risks and detect when threats bypass your protection measures.
- Respond: Develop a plan to immediately respond to security incidents and minimize damage.
- Recover: Quickly recover and return to production with root-cause incident investigation to follow.
The facility of tomorrow, today
The facility of the future is optimized to help pharma manufacturers compete tomorrow. But it’s already being proven around the world today. The right design approach — one that’s built for seamless connectivity and fluid information and that uses mobile equipment, single-use technologies and a modern DCS — can help you quickly deploy this game-changing facility.
