Known as “CP3,” Purdue University’s Center for Particulate Products and Processes in West Lafayette, IN operates a particle, powder, and compact characterization laboratory and a continuous solids processing pilot plant in a quest to boost the quality of particulate products and lower manufacturing costs.
Dhananjay Pai, laboratory manager of CP3, will discuss the center’s research activities in pharmaceutical continuous manufacturing at this year’s International Powder & Bulk Solids Conference & Exhibition at the Donald E. Stephens Convention Center in Rosemont IL on Thurs., April 26. Known as the “Powder Show,” the event on April 24-26 is North America’s largest gathering for power and bulk solids technology.
Managing Editor of Powder & Bulk Solids John S. Forrester caught up with Pai prior to his Powder Show appearance to learn more about the center’s work and its view on continuous tableting.
Powder & Bulk Solids: Why is there a need to research particulate-related products and processes? What major problems is the center trying to solve?
Pai: Facilities that handle particulates have been shown to face longer start up times and lower operating efficiencies than those that handle fluids. In some cases, facilities have even failed to open due to particulate flow handling issues! Although particulates are commonplace in industry, most engineers, especially those in the U.S., have had little training on how to design systems involving particulates. In addition, there are fewer modeling tools available for modeling particle-related processes than those used for fluid systems. The Purdue Center for Particulate Products and Processes (CP3) mission is to provide the knowledge, tools, and trained workforce needed to effectively design and manufacture particulate products. The CP3 conducts research investigating the manufacture and application of a wide variety of particulate materials, such as pharmaceuticals, agricultural products, energetic materials, chemicals, thermal pastes, and food products. We're particularly interested in how to better design and control particle-related manufacturing unit operations and how to design particulate-based products with prescribed functionality.
Powder & Bulk Solids: Describe CP3’S research in continuous tableting – What role does the center play in advancing knowledge in this area?
Pai: The pharmaceutical continuous manufacturing pilot plant within CP3 comprises of direct compression and dry granulation lines with PAT tools measuring product quality at critical points and a distributed control system controlling each equipment. Research on continuous tableting focuses on aspects such as data reconciliation, model-based advanced process controls, sensor network accuracy for real-time release testing (RTRT) and development of material property based models. In particular, the center has led the effort on integrating sensor networks for implementing advanced process control. Although continuous manufacturing is widely implemented in many industries, the stringent regulatory environment for pharmaceuticals necessitates introduction of robust technologies that ensure product quality. In this context, the research contribution of CP3 group is of particular importance.
Powder & Bulk Solids: What is fueling interest (within academia, industry) in continuous tableting?
Pai: For industry, adoption of continuous tableting would result in faster and more efficient drug product development process. It would also allow for real-time product quality monitoring and process control resulting in significant reduction of off specification product. The FDA has been strongly encouraging industry to engage with its Emerging Technology Team (ETT), which assists companies interested in adopting continuous tableting. Academia is focused on addressing knowledge gaps in continuous tableting, along with introduction of new PAT technologies and implementing advanced control strategies. Both industry and academia are actively engaged with each other in order to advance continuous tableting efforts.
Powder & Bulk Solids: Where does the global pharmaceutical industry stand on adoption of continuous tableting? In the U.S.?
Pai: In 2015, US FDA approved the first ever drug product made by continuous manufacturing. Since then, the FDA has approved two other drug products. Each of the US and Europe based major prescription drug product companies have invested in continuous manufacturing in terms of research, development, manufacturing or combinations thereof. In our experience, there is a large interest from the generic drug companies in adopting continuous tableting as well, due to manufacturing being significant component of manufacturing costs.
Powder & Bulk Solids: How does the center keep track of the latest technology for particulate processes?
Pai: Members of the CP3 actively collaborate with engineers and scientists from other U.S. and international academic and industrial institutions. Through these interactions, along with attendance at workshops, conferences, and trade shows and reviewing academic and trade journals, we are able to stay up to date on the latest developments in the field of particulate science and technology.
Powder & Bulk Solids: What role do corporate partners/sponsors play in CP3? What sorts of equipment has the center received from its sponsors?
Pai: We have CP3 partners and sponsors from both government and industrial sources. Our industrial collaborations are particularly rewarding since these interactions provide us with relevant research problems while giving companies the opportunity to learn about the latest research tools and results, and see our students, who are potential future employees, in action. These industrial collaborations are usually well structured, with clear milestones, deliverables, and frequent interactions.
We’ve had a number of equipment donations/loans in recent years, including two pharmaceutical tablet presses, twin screw granulator/extruder, roll compactor, powder and liquid rheometer and modeling and controls software. These donations get significant use since our Particle, Powder, and Compact Characterization Laboratory and Continuous Solids Processing Plant are used by many faculty and students in both research and coursework.
To learn more about CP3, visit https://engineering.purdue.edu/CP3