Characterization and control of (foreign) particulate matter is a major issue in the development and quality control of pharmaceuticals, medical devices and ATMPs throughout the product life cycle.
While increasing regulatory expectations with regards to the characterization of subvisible and submicron particulates pose challenges for product and formulation development, visible particulates as major or even critical quality defects may constitute direct patient health risks and therefore remain one of the main causes of product recalls from the market.
This webinar will address some of the issues around particulate matter. We will discuss what guidance is available for testing and why regulators now expect manufacturers to move away from simple counting techniques to apply multiple and where possible orthogonal methods to quantify and also characterize particulates in drug products.
We will provide an overview of the analytical toolkit available to characterize particulate matter from the quantification of particles in the micron range to isolating and identifying visible foreign particles found during visual inspection.
Finally we will discuss case studies highlighting common issues and lessons learned from dealing with particulates from development until commercial manufacturing and beyond.
Join our expert as we talk through the key considerations for the analysis and characterization of particulate matter. A good understanding of the strategies and tools available to effectively characterize particulates in any product is the basis for the development of suitable control strategies and thus safe and efficient products.
Key Learning Objectives
- Why particulate matter is an issue that needs to be addressed
- Guidance and regulation to consider with regards to particulate matter control
- Learn about the analytical toolkit available to scientists to address these issues
- See case studies and lessons learned from particulate matter characterization and identification
