Glass Delamination Studies
Glass Delamination, while considered rare, remains a significant concern in the pharmaceutical industry. It occurs when the inner surface of a glass container, serving as the primary container for a drug product, deteriorates. This degradation can lead to the formation of thin, reflective flakes, known as glass lamellae, within the drug product. Often, the root cause of glass delamination is an inherent incompatibility between the drug product’s formulation and the glass container’s chemical composition. In response to this issue, regulatory agencies now require pharmaceutical companies to include glass delamination data in their regulatory filings.
Stay ahead of regulatory requirements. Our testing aligns with FDA and global standards, ensuring your products meet and exceed compliance. With over ten years of expertise in glass delamination testing, we bring a wealth of experience to every analysis, ensuring your drug products are secure on your journey to market.
Glass Delamination Testing: Your Gateway to Analytical Precision
Gateway Analytical has been a leader in glass delamination testing for over a decade. Our extensive experience and expertise have been crucial in determining whether commercial drug products should be recalled from the market or whether such actions are unnecessary.
Having analyzed thousands of samples, we have the capability to precisely assess the risk of glass delamination events and the potential need for product recalls.
For any inquiries or concerns regarding glass delamination testing, Gateway Analytical is ready to assist. Contact us to benefit from our in-depth expertise and experience in glass delamination testing, and ensure the safety and integrity of your pharmaceutical products.
