Extractables and leachables (E&L) is a very popular and very important topic for the pharmaceutical industry. If E&L are not assessed thoroughly and mitigated, they can cause serious adverse events such as product recalls, or worse, compromising on safety and even causing deaths. There are many information available on the topic such as in the USP chapters <1663> and <1664>. Although these documents provide detailed guidance and recommended best practices regarding assessment of E&L, they provide no specifications. This is because E&L needs to be assessed according to the specific drug application (Drug product, dosing, target population, etc.). Therefore, E&L remain as the hot topic for the industry especially for high risk applications such as injectables.
This session will first review the regulatory requirements and guidance relevant to E&L. Following that, it will focus on the elastomeric closures used for pharmaceutical applications and their evolution. Particularly of interest is the barrier film lamination, which is applied over the drug contact surface of closures, to help mitigate the risk of leachables from the closure over the drug product shelf life.
This will lead us to discuss an ideal systematic approach to E&L evaluation. This approach emphasizes the importance to mitigate risk by planning and starting E&L assessment early to avoid mistakes at later phase which are typically more costly. Join us to learn more and engage in conversations with West team regarding your project needs.
Key Learning Objectives:
- Learn the evolution of packaging closure technologies and benefits of quality barrier film laminated closures.
- Learn the ideal systematic approach to E&L evaluation and the importance to mitigate risk by planning and starting E&L assessment early.
