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

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.