Degradation and Stabilization of Elastomers and the Impact on the Extractables Profile of Container Closure Systems

The characterization and control of extractables and leachables in elastomers used in medical packaging and container closure systems is a formidable task for the pharmaceutical industry. Obtaining information from vendors regarding the composition of container closure system components can be a challenge, and even when this data is supplied, peaks corresponding to unknown components are often detected in chromatograms associated with extractable and leachable studies. The source of these unexpected migrants can often be traced back to the fabrication of the container closure system and are usually polymer additives that have unintentionally been added to the manufacturing process or degradation and transformation products that result from the active chemistry that occurs during the polymer processing. The goal of this presentation is to describe the chemistry associated with the degradation and subsequent stabilization of elastomers, including a discussion on typical additives used in these substrates and their impact on the extractables profile of these rubber components. Best practices for proactively analyzing the additive composition in the laboratory as a means of confirming vendor information and predicting the performance of the components will be discussed.