Christian Opel
In-Process and At-Line Quality Control in Drug Production
photo: Christian Opel May 2020;
source: private
My PhD project deals with the use of Near Infrared Spectroscopy (NIRS) for monitoring and improving mixing operations in a pharmaceutical process chain.
A proper mixing of all blending components in solid dosage form manufacturing is a key step to ensure the uniform distribution of active pharmaceutical ingredients (APIs) and excipients among dosage units like tablets. The content uniformity of APIs and blend uniformity of excipients enables patient safety by assuring the correct dose, drug release profile and other important quality parameters like mechanical properties, shelf life stability, uniform taste and color.
Thus, a suitable monitoring of mixing operations, especially for product development, transfer and scale up is necessary. This also complies with the FDA initiative regarding the use of process analytical technology (PAT) for quality assurance and process understanding. Recently, NIR spectroscopy gained rising attention in the field of monitoring mixing operations.
In the present project, NIR spectroscopy is used to fully characterise and monitor blending operations at different scales, revealing time dependent quantitative and qualitative blending information like precise prediction of API and excipient concentrations and blend homogeneity. Furthermore, the critical quality attribute (CQA) water content is measured in real time.