(565b) Use of Process Analytical Technology (PAT) in Advanced Manufacturing Process Monitoring and Control: Scientific Considerations and Regulatory Challenges

Significant scientific advancement made in PAT tool design and process analysis has resulted in the increasing use of PAT during process development. However, the actual implementation of PAT in a manufacturing setting has lagged despite its potential for advanced manufacturing process monitoring and control. In this presentation, we will discuss some of the scientific considerations and regulatory challenges when evaluating a PAT system for process monitoring and control for the manufacturing setting. Some aspects will be discussed are:

1) Identification of critical process parameters or critical quality attributes for monitoring and control purpose;

2) Risk-based strategy for identifying measurement interface between process analyzer and process stream and data acquisition frequency;

3) Model building framework, pros and cons of each modeling methods for process monitoring and control 4) Incorporating the PAT monitoring and control as part of control strategy for manufacturing.

Several examples will be included to highlight the use of PAT for advanced manufacturing process monitoring and control, in the spirit of facilitating broad adaptation of PAT in advanced manufacturing for robust manufacturing and product quality.