(568a) Solvent Change and Process Optimization to Improve Sustainability of Spray Drying Particle Formation Process

Material isolation via spray drying is an energy-intensive process. As one of the final steps, it significantly impacts key Critical Quality Attributes (CQAs) of the product, including residual solvent content, particle size distribution, and particle microstructure, all of which influence the product's bioavailability and stability. Adjusting process parameters (e.g., temperature) or feed properties (e.g., type of solvent) poses substantial quality and regulatory challenges. This makes changes aimed at improving the process's sustainability both complex and sensitive.

In this presentation, two industrial-scale case studies will be discussed to explore process changes that enhance sustainability:

A) Solvent Substitution: Dichloromethane, the primary solvent, was replaced with a greener alternative.

B) Energy Optimization: The condenser's operating temperature was optimized to reduce overall energy consumption and improve energy utilization.

Both cases will delve into the intricate correlations among Critical Material Attributes (CMAs), Critical Process Parameters (CPPs), and Critical Quality Attributes (CQAs), as well as their impact on product quality. The presentation will also outline the workflow for implementing process changes, covering steps from laboratory development to manufacturing and post-approval regulatory updates. Additionally, improvements in economic metrics (e.g., Return on Investment) and sustainability outcomes will be highlighted.