Laser triangulation as a fast and reliable method for determining ribbon solid fraction; focus on accuracy,...

Area of Science:

• Pharmaceutical Technology
• Process Analytical Technology (PAT)

Background:

• Roller compaction and dry granulation are key pharmaceutical manufacturing processes.
• Ribbon solid fraction is a critical quality attribute impacting final product performance.
• Current methods for measuring ribbon solid fraction have limitations, necessitating novel at-line monitoring solutions for continuous manufacturing.

Purpose of the Study:

• To evaluate a novel laser triangulation device for at-line measurement of ribbon solid fraction during roller compaction.
• To compare the performance of the laser triangulation device against established methods like X-ray micro-computed tomography and powder volume displacement.
• To assess the accuracy, precision, and total measurement time of the laser triangulation device.

Main Methods:

• A novel laser triangulation device was employed for at-line process monitoring.
• Comparative analysis was conducted against X-ray micro-computed tomography and powder-based volume displacement.
• Statistical evaluation methods were used to assess accuracy, precision, and measurement time.

Main Results:

• The laser triangulation device demonstrated high accuracy and precision in measuring ribbon solid fraction.
• It achieved the shortest total measurement time compared to X-ray micro-computed tomography and powder volume displacement.
• The device proved suitable for at-line process analytical technology application in roller compaction.

Conclusions:

• The laser triangulation device is a viable and effective tool for at-line monitoring of ribbon solid fraction in roller compaction.
• Its speed and accuracy support its implementation in continuous manufacturing environments.
• This technology can overcome limitations of traditional end-product testing, enhancing process control and product quality.