Proactive vs. Reactive Testing for Glass Delamination in Pharmaceuticals

Authors & Contributors

Emily Landsperger

February 16, 2016

Glass delamination is a phenomenon which can occur when top layers of a glass surface separate and flake off or detach from the inner surface, typically in the microscopic range. Glass delamination is the result of several factors including the product formulation, the glass resistance and the glass manufacturing process itself.  The formation of glass lamellae has a significant impact on product and patient safety.  USP <1660> details the testing requirements for the assessing the durability of glass container surfaces.

The purpose of this webinar is to recommend “approaches to predict the potential of a drug product to cause formation of glass particles and delamination and to detect their occurrence.” These methods are not only applicable to the common vials encountered, but also to syringes, ampules, and other glass containers that house drug products. Examples of Glass Delamination will also be presented.

Topics Covered Will Include

  • An overview of glass delamination and glass lamellae morphology
  • USP <1660> details and testing requirements
  • An overview of proactive and reactive testing for glass delamination
  • Case study examples of proactive and reactive testing for glass delamination

Who Should Attend?

You should attend this webinar if you are involved in guaranteeing the quality and safety of parenteral drug products and are involved in glass delamination investigations.

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