Digital design of an integrated purification system for continuous pharmaceutical manufacturing

Area of Science:

• Pharmaceutical Engineering
• Process Systems Engineering
• Chemical Engineering

Background:

• Continuous manufacturing offers intensified processes for pharmaceutical production.
• Integrated processing steps like crystallization, filtration, and drying are key to efficiency.
• Digital design and modeling tools are crucial for optimizing complex pharmaceutical processes.

Purpose of the Study:

• To develop dynamic models for continuous crystallization, filtration, deliquoring, washing, and drying.
• To enable the digital design and simulation of an integrated continuous two-stage crystallization and filtration-drying carousel system.
• To investigate the impact of model uncertainty on optimal operating conditions.

Main Methods:

• Development of dynamic models within the open-source pharmaceutical modeling tool PharmaPy.
• Simulation of an integrated continuous two-stage crystallization and filtration-drying carousel system.
• Analysis of improved crystallization design on downstream operations and process efficiency.

Main Results:

• Improved crystallization design enhances critical material attributes, boosting filtration and drying efficiency.
• Digital design of the integrated process achieves higher productivity while meeting quality constraints.
• PharmaPy facilitates systematic process development, including design space identification and robust operation optimization.

Conclusions:

• PharmaPy enables the digital design and optimization of intensified continuous pharmaceutical manufacturing systems.
• Optimized process design leads to enhanced productivity and tailored product attributes.
• The developed models support improved process understanding and robust operational strategies.