Emersons Patnaik: Todays Realities Shape a Vision of Pharmas Future Facilities
The interactive wall flickers to life as the production manager walks into his office. It reads his wireless badge and displays an urgent request to expand production of the new vaccine: a custom order is needed for an outbreak in Central Africa. The manager brings up a graph showing current production trends and overlays it with displays of critical resources and other operational attributes, then zooms in on a potential bottleneck. Agreeing with the system's recommendations for increasing titer and utilizing some hidden capacity, he issues instructions to the on-duty operator, who he can see on the plant-floor display is already moving toward the area needing his attention.
This scenario isn’t science fiction. It’s a vision of pharmaceutical or biotech plant operations in the year 2020—a vision based on technologies already emerging in response to today's industry trends.
Two Directions, One Challenge
In coming years scientific, economic, and political factors will continue driving producers toward the "macro" and "micro" ends of the production scale—and technology will continue evolving to meet the needs of each.
On one hand, expiring patents and governmental pressures for lower cost drugs will result in widespread production of generics. Cost-effective large-scale generic production will demand greater reliance on initiatives like Process Analytic Technology (PAT) that focus on delivering required quality continuously during production rather than testing it in after the fact. A major benefit will be the assurance that products are being made right the first time, every time. Resulting increases in throughput and decreased unit costs will also help meet financial objectives.
In other instances, production will go small-scale—even micro-batches of a liter or less—as manufacturers tailor medications for different regions, specific illnesses, or certain age groups, or even individuals. Small batch production in single-use equipment will enable flexibility and agility to quickly meet changing demands, while requiring ways to maintain consistent quality when every batch is different from the one before.
One result of both trends will be an explosion of data. Whether it's a continuous stream of quality data or thousands of individual micro-batch records, the data must be collected, integrated, put in context, made available and understandable, and preserved to meet regulatory or process-improvement needs.
Fortunately, tools and approaches for collecting, integrating, and managing data from across the operation are emerging and will become more sophisticated in the next 10 years. Managers and others will be able to quickly and easily access correlated data on everything from equipment availability to quality monitoring to lot comparisons and use the information to solve production issues—all in a matter of seconds.
This easy access to integrated information will enable personnel to be more productive. Imagine a worker on the plant floor being able to instantly correlate increasing vessel-fill times with rising pump-bearing temperatures, then identify the best time to schedule bearing replacement so customer deliveries are unaffected. This type of insight has historically required offline analysis by experts from multiple domains—but not in the plant of the future.
Human-Centered Information
Data not only has to be acquired, integrated, and managed; it also has to be usable. What good is a system that tells you something is wrong with your equipment or process, if operators or maintenance personnel can’t find the information they need or don’t know how to act on it?
That’s why the plant of the future will use human-centered technology that eliminates unnecessary work, removes complexity, and guides decision-making. Information will be made available to the people who need it, when they need it, and in a way that makes it easy to visualize situations and take recommended actions.
Studies of pharmaceutical operations by our Human Centered Design Institute have shown the importance of how employees interact with technology, especially as they work and communicate across organizational lines. The plant of the future will meet these needs with better data presentation and guidance to streamline important and frequently performed tasks.
In fact, this human centered design approach is already being adapted to automation projects and plant operations. "Electronic marshalling" eliminates traditional engineering tasks so plants can be brought online faster. Intuitively designed "device dashboards" also give workers an instant view of the critical information they need to evaluate and manage each field device. Similar techniques are being used in automation-system user interfaces.
Information Where It’s Needed
Not only will the plant of the future bring needed information to individuals, but reliable and secure data communications will also deliver that information wherever it's needed—even when the information source and user are both in a dynamic environment.
For example, flexible production lines with portable or single-use vessels could make maintaining traditional wired connections between sensors and the control system prohibitively expensive. And workers whose specialized skills and diminishing numbers keep them moving from task to task won't always be near a traditional control-system workstation.
Wireless technology will solve many of these problems. WirelessHART self-organizing networks, for example, are already being used to communicate measurement and diagnostic data from devices in remote, hard to reach, and hazardous areas and are starting to be deployed for control applications.
In the plant of the future, portable and single-use equipment will be added or moved wherever it's needed. Authorized equipment will be automatically incorporated into the wireless network and configured in the control system for the batches to be produced.
Wireless networks will also bring mobile workers the information they need on handheld PCs or other portable devices, enhancing critical collaboration between control room, maintenance, and operations personnel. And wireless tracking systems will quickly locate equipment, material, and personnel as they move through the plant.
These wireless applications will be greatly expanded in the future. Flexible, lowest-cost manufacturing will demand integration of field device networks, control networks, plant networks, and business networks so that all individuals have ready access to the information they need to do their jobs.
The Future Begins Here
These are only a few aspects of the plant of the future. For example, single-use vessels and sensors will reduce the need for cleaning cycles and systems, which will in turn reduce power, water, and space requirements. Scalable control and information systems will help shorten delays between research and full production. Flexible production lines will enable plants to respond quickly as opportunities change. The list goes on.
Creating a vision like this is the first step toward achieving it. Just as important, plans and investments made to lay a foundation for that future also pay off in the near term. Finding better ways to manage data, make it usable, and deliver it where it's needed can help meet today's requirements for cost containment, product quality, and—above all—patient safety.
Because some things never change.
