Avoiding glass delamination

Published: 12-Aug-2011
Packaging

Contamination with glass flakes caused by delamination of the internal finish of container closure systems or prefilled syringes has caused numerous drug recalls. Surface imperfections and aggressive drug components can lead to interaction between product and container, resulting in leaching, dissolution, ion exchange and formation of precipitants or particles; use of cyclic olefin polymers as an alternative to glass can avoid these issues

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In the light of recent drug recalls attributed to glass delamination, Diane Paskiet, West Pharmaceutical Services, reviews possible causes and aspects of glass container compatibility that can affect product quality.

Glass has long been considered the traditional material for use in drug product container closure and delivery systems and dominates the pharmaceutical market. Desired properties for container closure suitability include strength, transparency, stability, impermeability and resistance to chemical attack.

These characteristics are critical to preserving the quality of pharmaceutical products, and glass is an affordable choice. However, the potential for hidden costs related to breakage, glass delamination and contamination may not be readily apparent. An alternative choice of material may provide a lower total cost option as well as overall long-term benefits.

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When considering the lyophilisation of moisture-sensitive biopharmaceuticals, companies must not only consider the moisture transfer via the container but also the stopper, as Dr Heike Kofler, West Pharmaceutical Services, explains

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    Selecting stoppers for use in the lyophilisation of moisture-sensitive drugs When considering the lyophilisation of moisture-sensitive biopharmaceuticals, companies must not only consider the moisture transfer via the container but also the stopper, as Dr Heike Kofler, West Pharmaceutical Services, explains

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