White Paper - GLASS CONTAINERS FOR PHARMACEUTICALS - Delamination and Interaction Studies
Analytical approaches to mitigate the risks associated with glass delamination
The phenomenon of glass delamination is a serious quality issue. Delamination is characterised by the formation of small glass flakes, also known as lamellae, which are shed from the internal surface of the glass container, pH changes and extraction of ions from the glass material leaching into the product – all of which have significant potential to compromise product quality whilst also compromising the overall glass structure.
It is possible to evaluate potential glass containers through the application of suitable analytical approaches as part of early product development. This white paper summarises testing approaches (such as USP<1660>), predictive screening studies, interaction studies, leaching experiments and microscopy investigations which can help to mitigate the risks which glass delamination pose to product quality and patient safety.
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