Focus on Delamination Could Narrow Options for Pharmaceutical Glass Packaging

  Research and development

Independent researcher sees trend to label problems with pharmaceutical glass packaging as delamination when many resulted from other causes.

Glassdelam
The left image shows glass flakes, while the right shows an interior glass surface exhibiting delamination sites
The current focus on delamination could be clouding the bigger pharmaceutical glass packaging picture and narrowing the options for potentially more cost-effective solutions, according to a leading glass analyst.
Daniel Capon of independent experts Glass Technology Services Ltd (GTS) said that there was a clear trend to badge any perceived problem with glass used in pharmaceutical packaging as delamination, when in fact many resulted from other causes, some of which were potentially much simpler and cheaper to remedy.
“It is vital not to make generalisations, based on recent product recalls,” said Daniel. “Glass containers remain the preferred choice for most medicinal products and risk can be mitigated and controlled to ensure both product quality and patient safety.
“Where I think the industry could be missing a trick is in not assuming delamination in the first instance, but instead analysing each appearance of flakes or particles to address the root cause.”
Based on extensive experience of samples sent to GTS for delamination analysis, Daniel said that often what looked like tiny glass fragments, flakes (lamellae) or deposits, were actually naturally occurring compounds that had precipitated out of solution and dissolved back into the solution by the time the sample reached the GTS laboratory or were foreign bodies introduced during subsequent production and filling processes or by the end user.

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