Advancing Pharmaceutical Manufacturing: Real-Time Tablet Quality Monitoring with Terahertz Technology
The pharmaceutical industry faces ongoing pressure to enhance manufacturing efficiency, improve quality control, and meet evolving regulatory expectations driven by initiatives like Process Analytical Technology (PAT), Quality by Design (QbD), and Real-Time Release Testing (RTRT). Traditional methods for testing critical physical properties of tablets – such as height, porosity, and mass – are often offline, destructive, and too slow for effective real-time process control.
Our research focuses on addressing these challenges using Terahertz Time-Domain Spectroscopy (THz-TDS). This non-destructive technique offers a unique capability for rapid, simultaneous measurement of multiple tablet attributes crucial for quality and performance. As demonstrated in our recent work developing automated sampling interfaces and robust data analysis algorithms, THz-TDS can be integrated directly into the manufacturing line, moving quality assessment closer to the process.
By providing real-time insights into tablet quality, THz-TDS can enable tighter process control, potentially reducing batch variability and the risk of failures. This rich data stream supports modern manufacturing paradigms, including continuous processing and provides a pathway towards realising the goals of Real-Time Release Testing.
We understand that adopting novel technology in a regulated environment requires careful consideration of practical implementation. Our work therefore also addresses crucial aspects like ensuring data integrity compatible with ALCOA principles, system validation, and lifecycle management, including strategies for ongoing model verification and adaptation to potential process changes. With demonstrated accuracy comparable to standard methods, THz-TDS presents a compelling, validated opportunity to modernise pharmaceutical tablet manufacturing, enhance quality assurance, and meet the demands of next-generation process control.