Tracking the Cracking: How to Optimise Pharma Fill-and-Finish Processes by Use of Strength Testing and Fractography

Fractography (fracture analysis) is an underestimated technique which makes it possible to objectively determine the true root cause of glass breakage. It is particularly well-suited for examining breakage as it occurs during the fill-and-finish process and enables corrective actions to be taken to prevent recurrence, ultimately leading to safer and more efficient operations. To gain this valuable data, optical and microscopical methods are applied to examine shape, size and arrangement of macroscopical fragments, as well as the microscopical topographical features of fracture surfaces, as they contain a variety of details about the fracture incidence itself. Extracting and interpreting this information in a systematic, forensic approach allows conclusions to be drawn about the failure-inducing flaw and the failure-inducing mechanical load, which are the two fundamental contributors to brittle failure. SCHOTT is well aware of the potential of this analytical tool and intensively applies it to solve breakage incidents of ampoules, cartridges, syringes and vials during development and operation and in response to returns from the field.