Continuous manufacturing pilot plant of pharmaceutical solid dosage forms located at Purdue University's FLEX lab.

Credit: David Sixon

Purdue University is one of two universities in the country that has a continuous manufacturing pilot plant of pharmaceutical solid dosage forms, said Marcial Gonzalez, training program leader and Associate Professor of Mechanical Engineering. The sessions will help the FDA learn to inspect and review the manufacturing of new drugs coming onto the market.

“That’s why the FDA recognizes they should be training inspectors and reviewers," he said. " So they can judge a new drug application and see if the industry has implemented its manufacturing process correctly.”

Purdue University’s Continuous Solids Processing Pilot Plant and Particle, Powder, and Compact Characterization Laboratory are located at the Center for Particulate Products and Processes (CP3), where students can study, design, and manufacture pharmaceutical tablets and other particulate products on an industrial scale.

Training will also be conducted by Paul Mort (Professor of Materials Engineering), Zoltan Nagy (Arvind Varma Professor of Chemical Engineering), and Rex Reklaitis (Burton and Kathryn Gedge Distinguished Professor of Chemical Engineering). The training team also includes a research scientist, undergraduate and graduate as well as postdoctoral students.