Micromeritics Predictive Material Science Solutions for the Identification and Control of Critical Quality Attributes
Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control. Achieving QbD requires an in-depth understanding of physicochemical properties.
Early identification of Critical Quality Attributes (CQA) of excipients and active pharmaceutical ingredients (API) and their impact on a formulation is a key component of QbD. Micromeritics’ instruments and contract analytical services offer solutions for the early identification of CQA’s, continuous process monitoring, and verification, which are the foundation of QbD. Historically, particle size has been the dominant physical characteristic control parameter for release. But now, properties such as surface morphology, porosity, particle shape, density, and surface energy are additionally utilized as predictive tools to reduce possible manufacturing failures by predicting scale-up effects on the final product.