The life sciences industry is in a transformational period adjusting to new trends and influences. As the number of blockbuster drugs decreases, many facilities are transitioning from dedicated to multi-product manufacturing facilities, requiring shorter production runs with faster change-overs.
At the same time, many unit operations are switching from batch to continuous production which requires smaller equipment and more flexibility for product change-overs.
In addition, the number of new therapies progressing through the development process continues to grow, driving new production processes and change-overs of existing production lines. Governments are providing incentives (or in some cases mandates) to have local production facilities instead of shipping from centralized locations.
As companies adapt to these changes, they also want to have the flexibility to utilize equipment from a wide variety of suppliers while minimizing the effort required to integrate different systems that are provided on the different skids.
Responding to these trends puts pressure on plant design, equipment set up, and utilization to enable more flexible and faster production. By focusing on a modular manufacturing strategy, organizations position themselves well for successful present and future operations.
Among its many strengths, modular manufacturing enables facilities to use equipment from different suppliers, to switch production skids in and out, or to move process equipment within a facility without extensive integration updates and without major schedule impacts.
Through modular manufacturing, facilities can avoid significant change management, thus minimizing documentation, testing, and overall validation efforts while still maintaining required production performance.
These advances are possible because a modular manufacturing strategy enables equipment to be installed, connected, disconnected, and moved, while supporting the equipment’s related control, quality, recipe, connectivity, and equipment status—without having to reprogram.
In short, modular manufacturing is possible when machine intelligence is pushed down in the hierarchy so that equipment possesses the operating capabilities, quality processing, equipment status, as well as integration and connectivity requirements needed to operate in today’s manufacturing environment.
Enabling a Modular Manufacturing Strategy
Modular manufacturing is enabled by the adoption of smart skids, which means that much of the automation, quality control, and equipment status are implemented and maintained on each skid, and each skid then supports the ability to tell the overall manufacturing system what capabilities it has and how to connect to it.
The main elements of a smart skid include:
- Distributing the measurement, automation, and quality control onto each skid or piece of equipment that is movable.
- Making it easy to connect/disconnect/move that equipment within an overall system.
- Providing performance capabilities and readiness-to-serve status so that a manufacturing system will be able to know the current status of the inventory of skids, including disconnected skids.
- Having connectivity capabilities such that an overall manufacturing system recognizes a new or moved piece of equipment and easily supports any required management of change for adding or deleting skids and equipment from the facility.
This approach combines operational, quality, and maintenance applications into a single solution at a modular level. Inline analytical measurements are connected directly to the skid controller for closed-loop quality control on critical quality attributes. Electronic operational sequences are embedded as part of normal operations.
The skid monitors itself for problems with the equipment or instrumentation, reports problems, and troubleshoots events.
These individual smart skids (for example, Figure 1) can be plugged easily into a manufacturing system. The manufacturing system recognizes that a new module is plugged into the overall system and reads the standardized module description containing the required module type information.
This information is then integrated into the existing structure of the manufacturing system. Standard communication protocols such as OPC UA and Ethernet IP support the communication infrastructure.
The manufacturing system provides the skid with recipe information telling it the appropriate parameters for what is being manufactured, while the skid provides information back about what is being produced, the status of the process, and the status of equipment on the skid.
Modular Techniques Simplify Product Lifecycle Management
Modular manufacturing can improve the cost effectiveness of moving a product from the lab to production. A key assumption here is that a company has adopted standardized production modules and equipment, which many life sciences companies actively are doing.
Then development work done in research and discovery can utilize the same manufacturing modules as in clinical or commercial production.
With this kind of modular manufacturing in place, a company can delay the capital investment decision for a new therapy (Figure 2). The time required and the associated scale-up risk to bring a new therapy into production using standardized modular components is significantly less than a traditional approach.
Therefore, a company can wait until they have a much higher degree of confidence in the efficacy of the therapy before starting the required capital investment.
Easing Day-to-Day Manufacturing and Operations
Modular manufacturing greatly simplifies adding to or exchanging equipment in product lines since all information remains in place in the equipment itself.
There are two main scenarios: 1) mobile equipment that moves as part of an existing process, and 2) changing out production skids in the existing “ballroom” of the production floor to change over to a different product run.
Without the advances of modular manufacturing, moving mobile equipment can cause problems. There typically are one or more physical connections from the skid to the manufacturing system.
Disconnecting them, moving the equipment, and then reconnecting them can cause system errors, alarms, and confusion about how to handle the “missing old inputs” as well as the “new inputs.” How the skid is accessed, whether through a local panel or through a system workstation, also can be affected.
Similarly, if a new product run requires changing the current manufacturing process to add, for example, an extra filtration step, adding that filtration skid can be a long change management process.
Someone in automation engineering typically needs to make changes to add the new skid into the existing system. Connections to the overall system and other skids need to be defined, established, and tested. The existing user interface(s) must be updated. Licensing may need to be expanded. The reverse of this is true if you are taking a skid out of production.
By leveraging a modular manufacturing strategy, a facility can much more quickly adapt to changing set-ups with minimal impact on manufacturing systems as the integration set up and testing are significantly reduced.
Managing Data to Enable Modular Manufacturing
Modular manufacturing brings strong benefits to a facility, but to achieve the highest efficiencies, manufacturing systems must work together seamlessly so that the effort to create the modular environment is manageable.
For example, automatic connections between a manufacturing execution system (MES) and a distributed control system (DCS) are the key to make this modular capability function seamlessly.
When designed from the start to work together, the DCS and MES are easier to integrate without the customization typically required. Additionally, connected systems make regulatory compliance concerns, such as data integrity, easier to manage as both systems can automatically track changes made and ensure information is properly accessed and used.
Flexible automation systems are required for a modular manufacturing strategy. Smaller scale and more flexible production means that capital project spending for new therapies can be deferred.
Furthermore, existing operations are more efficient as it is easier to utilize mobile equipment and easier to change the facility over for the next product in the schedule.
While there still is significant work to be done to prove the goals of a modular manufacturing strategy, great strides are being made with individual user companies and key industry standards groups and consortia.
Teams in both the NAMUR Module Type Package and BioPhorum Plug & Play currently are working to verify the possibilities.
About the Author
Bob Lenich is Global Life Sciences Director at Emerson.