The presence of visible particulate in a parenteral product has the potential to cause patient harm. It is for that reason that parenteral products must be essentially free of visible particles, however achieving that goal can be challenging for drug product manufacturers. Particles can be introduced to the product at various points throughout the manufacturing process and can originate from extrinsic, intrinsic or inherent sources. The FDA is in the process of publishing a guidance titled “Inspection of Injectable Products for Visible Particulates” which focuses on a holistic risk-based approach for controlling the presence of visible particles beyond establishing a visual inspection program.
In this webinar, we review the details of the draft guidance as well as the importance of component selection as it relates to establishing a risk-based approach. We also examine the role that the NovaPure® product line can play in component selection including the importance of applying an appropriate test method for particle analysis of components.
Additionally, we discuss the newly published TR-85 "Enhanced Test Methods for Visible Particle Detection and Enumeration on Elastomeric Closures and Glass Containers" and the role that it plays in testing components for visible particles.