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A modern strategy for digital real-time release testing in continuous tablet manufacturing.

Selma Celikovic¹, Jakob Rehrl², Rúben Martins Fraga²

¹Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13/2, 8010 Graz, Austria; Institute of Automation and Control, Graz University of Technology, Inffeldgasse 21b, 8010 Graz, Austria.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V

|March 26, 2025

Summary

This study introduces a digital real-time release testing (RTRT) strategy for pharmaceutical manufacturing, using advanced process monitoring and material tracking to ensure product quality and safety.

Keywords:

Continuous Tablet Manufacturing Digital Quality Control Digitalization Material Tracking Process Analytical Technology (PAT)Real-Time Release Testing (RTRT)Soft Sensors

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Area of Science:

Pharmaceutical Manufacturing
Process Analytical Technology (PAT)
Quality Control

Background:

Traditional pharmaceutical quality control relies on off-line testing, which is inefficient.
There's a growing need for advanced methods to reduce environmental impact and enhance patient safety.
Process monitoring tools like PAT are crucial for real-time quality assessment.

Purpose of the Study:

To develop and demonstrate a digital real-time release testing (RTRT) strategy.
To align real-time process data with specific product quality attributes.
To enable comprehensive digital tracking of product quality throughout manufacturing.

Main Methods:

Application of process analytical technology (PAT) and soft sensors for real-time monitoring.
Development of residence time distribution (RTD) models and material tracking algorithms.
Implementation and validation on the ConsiGma™-25 industrial manufacturing line.

Main Results:

A digital RTRT strategy was successfully designed and demonstrated.
Full digital availability of product quality information, including critical quality attributes (CQAs).
Process data was effectively aligned with specific product quantities (single tablets).

Conclusions:

The proposed digital RTRT strategy enhances pharmaceutical quality control.
It enables real-time quality assessment and data availability, improving safety and efficiency.
The strategy was validated against traditional off-line methods, confirming its reliability.