José Luis Santos is guest speaker at the Pharmaceutical Technology Keynote Series on Oral Solid Dosage Manufacturing - Continuous Manufacturing Roundtable: Best Practices for Implementation
Date: April 17
Time: 11:30 AM - 12:30 PM
Place: INTERPHEX Innovation Stage
The pharmaceutical industry has made progress in implementing continuous manufacturing for oral solid-dosage drugs. Commercial processes have been approved, and process understanding is growing. This expert panel will discuss the current capabilities, ongoing challenges, and best practices for configuring equipment, optimizing startup and changeover, handling cleaning and maintenance, and other equipment and system implementation issues.
Savitha Panikar is guest speaker at the Pharmaceutical Technology Keynote Series on Continuous OSD: Designing a Controls Model
Date: April 17
Time: 4:15 PM - 5:00 PM
Place: Technical Conference Stage 2, Booth 1177, Exhibit Hall
Continuous processing holds the promise of revolutionizing our approach to manufacturing and quality, but that promise is based on having a fully developed process model and integrated control system. Making that leap from locally automated stand-alone equipment to integrated production lines can be daunting. This is a hands-on, detailed introduction to how continuous oral solid dosage (OSD) lines are developed and operated. We will illustrate a hypothetical OSD system, describe the process equipment, and select process automation technology (PAT) to help us measure critical quality attributes. We will also discuss what product characteristics we need to study in order to understand the feedback from our PAT and process measurements, and how Statistical Design of Experiment (DOE) helps us collect the information we need in only a few days of experimentation. Finally, we will discuss monitoring the critical process parameters (CPP), and how this effects production and batch records. We will detail how feedback and feed-forward loops help the continuous OSD line react to variations in raw materials in a way that increases quality, and how this can enable our industry to achieve real-time release (RTR) in the near future.