Implementation of real-time and in-line feedback control for a fluid bed granulation process

Area of Science:

• Pharmaceutical Manufacturing
• Chemical Engineering
• Process Control

Background:

• Process Analytical Technology (PAT) enhances pharmaceutical production by monitoring Critical Quality Attributes (CQAs).
• Fluid bed granulation is a key pharmaceutical process requiring precise control over particle characteristics.

Purpose of the Study:

• To develop and evaluate the first PAT-based feedback control system for fluid bed granulation.
• To demonstrate real-time control of particle size and ensure consistent product quality.

Main Methods:

• Implemented a feedback control system utilizing in-line spatial filtering technique (SFT) for real-time particle size measurement.
• Defined a target particle size post-binder spraying and established a control strategy with loop tuning.
• Investigated system robustness by varying process and formulation parameters.

Main Results:

• Successfully demonstrated the functionality of the PAT feedback control system by adapting target particle size.
• Showcased the system's ability to maintain a predefined particle size despite variations in spray rates and binder concentrations.
• Validated the compensation of process and formulation parameter effects through feedback control.

Conclusions:

• The developed PAT-based feedback control system offers an advanced approach for quality assurance in fluid bed granulation.
• The system ensures consistent product quality by actively controlling particle size within a specified range.
• This technology enhances the reliability and understanding of pharmaceutical manufacturing processes.