Rubber oligomers, originating from rubber closures (vials) or plungers (e.g., syringes or cartridges), represent a class of compounds that requires increased attention, particularly when they are chlorinated or brominated. These halogenated oligomer compounds have demonstrated reactivity with drug products under certain conditions, and their potential toxicity is a significant concern.
In this presentation at the 2022 Nelson Labs Virtual Symposium, we will explore the structure of rubber oligomers and how it relates to their reactivity and toxicity. Attendees will gain a comprehensive understanding of the chemical properties of these compounds and the conditions under which they pose a risk to drug products.
The presentation will also delve into the formation of rubber oligomers, explaining the processes that lead to their presence in pharmaceutical packaging. Participants will learn about the techniques used to detect and identify these compounds in extractable or leachable studies. Understanding these detection methods is crucial for developing effective strategies to manage the risks associated with rubber oligomers.
By examining the reactivity and toxicity of rubber oligomers, this session will provide valuable insights into the potential impacts on drug product safety and efficacy. Attendees will gain knowledge on how to interpret the results of extractable and leachable studies, helping to ensure that their products meet the highest standards of quality and regulatory compliance.
This presentation is essential for professionals involved in pharmaceutical development, packaging, and regulatory compliance. By attending, participants will acquire the knowledge and tools needed to address the challenges posed by rubber oligomers, enhancing the safety and effectiveness of their pharmaceutical products.