A storage container can have a significant impact on the shelf life and quality of your pharmaceutical drug product, which makes it important to understand the potential risks presented by glass delamination. The phenomenon occurs when the surface of a glass container breaks down and sheds thin flakes of glass (termed “lamellae”) into solution. If the problem is detected in a marketed product, then you could be faced with expensive recalls, regulatory investigations, and damage to your brand’s reputation.

Gateway Analytical offers both proactive and reactive glass delamination testing capabilities. Stability studies can be conducted during drug development to assess the suitability of glass containers for specific drug products (USP<1660>). Similarly, the presence or absence of active glass delamination can be detected within products, such as vials rejected during visual inspection.

We rely on high resolution SEM images acquired from the interior surfaces of glass containers, using a secondary electron detector, to show signs of breakdown in the surface. Microscopy and SEM-EDS can then be used to analyze lamellae present. Inductively coupled plasma (ICP) and pH / conductivity testing can be requested for full USP<1660> testing, which is conducted at an approved subcontract lab.

Contact our experts (and army of SEM machines) today to discover how Gateway Analytical can ensure your product quality remains up to your standards.