The material residence time distribution in a continuous manufacturing process can be utilized to develop, design and justify the process control strategy. This paper successfully demonstrates using both major and minor formulation component step changes to determine the system response using either Near Infrared Spectroscopy or process parameters. These options provide development flexibility to determine the system's material residence time earlier in the development process and more cost effectively.

• Eli Lilly and Company

• PAT
• Oral solid dose

1. continuous manufacturing
2. Drug product
3. oral solid dose
4. pat
5. Research Article
6. residence time distribution
7. Soft sensors