Real-time monitoring of the moisture content in different type of dryers by NIR spectroscopy as a PA

The Process Analytical Technology (PAT) and Quality by Design (QbD) initiatives have been of interest for pharmaceutical manufacturing in the last years. Implementation of PAT/QbD approach involves monitoring and controlling critical process parameters that influence the critical quality attributes of the product. One of the prime processes in pharmaceutical solid dosage form is granulation and drying process. With the PAT and QbD initiatives, the FDA aims to increase efficiency of the pharmaceutical production by real-time process analysis and control. Near Infrared spectroscopy (NIRS) is well accepted as a potential PAT analyzer due to its rapid and nondestructive technique that additionally requires no sample preparation. 

Metrohm is well-established in determining the moisture content by Karl Fischer titration in every conceivable type of product. To provide advance solutions for pharmaceutical customers, Metrohm now is moving forward, bringing NIRS to help customers to optimize the use of raw materials and to consistently run production closer to target specifications with time- and cost-saving analytical techniques.

During this webinar, we will be showing the use of NIR in the process that allows for monitoring low levels of residual moisture and other process constituents to yield better process control and endpoint determination. Additionally, we will be focusing on:

• Developing robust and precise method
• Minimizing implementation efforts

Ensuring calibration model transferability between analyzers.