Events/Educational Seminars

2018 IFPAC Annual Meeting /PAT Implementation for Drug Product Development and Manufacturing

Tuesday, February 13th, 2018
Tuesday AM-III, 7:50 AM - 12:00 PM, White Flint Amphitheater
Bethesda North Marriott, N. Bethesda, Maryland (Washington, D.C.) USA

Session Title:
PAT Implementation for Drug Product Development and Manufacturing
Chairs: Tim Stevens and Martin Warman

Paper Presentation Title 1:
Real Time RTD Models for Dynamic Processes based on Numerical Integration for Continuous Manufacturing and Advanced Process Control (APC) including MPC

Presenters/Co-Authors:
Brian Sauerborn, Control Systems Engineer, QbD Process Technologies, Inc.
Eric Jayjock, Director of Continuous Manufacturing, Patheon
Paul Brodbeck, Chief Technologist, QbD Process Technologies, Inc.

Abstract:
Tracking the lot history of raw materials within a product is required by the FDA and is also important for optimizing the efficiency of a continuous OSD plant. Raw material lot tracking for traditional batch processes is inherent, but for continuous processes containing multiple lots it is much more difficult. One of the current methods is to operate under constant process conditions and to measure the length of time it takes for a step change to propagate through a process unit, defining a Residence Time Distribution (RTD) model. While accurate under constant processing conditions, dynamic changes inherent to continuous processes may upset the accuracy for one or more materials of such models. In this presentation, we will discuss a new approach that takes the RTD model method one step further for use in dynamic processes. The approach we will discuss uses numerical integration of parameter driven mass balance equations to get a second by second material analysis of every process unit. This approach has the flexibility to be expanded upon to fit any future design and the accuracy to track lots from raw material to final product. In addition the RTDs can be used for real-time Advanced Process Control (APC) for feedforward and feedback. Two cases will be presented showing the use of RTD feedforward for a Model Predictive Control (MPC) for level and feedback for LIW feeders for disturbance minimization.

Paper Presentation Title 2:
Plant Development using PAT-Automation and Control Perspective

Presenter/Author:
Paul Brodbeck, Chief Technologist, QbD Process Technologies, Inc.


2018 IFPAC Annual Meeting
International Forum for Process Analytical Technology
February 11-14, 2018 | Bethesda North Marriott
N. Bethesda, Maryland (Washington, D.C.) USA

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