In this presentation at the 2022 Nelson Labs Virtual Symposium, we will cover the general principles of extractables and leachables (E&L) for small volume parenteral (SVP) applications. These principles are crucial for ensuring the safety and efficacy of SVP drug products, which are commonly housed in vials, cartridges, and pre-filled syringes— the primary container closure systems used in these applications.
Attendees will gain a comprehensive understanding of the methodologies used to identify and quantify extractables and leachables in SVP applications. The session will explain how different materials used in container closure systems can interact with the drug product, potentially leading to the presence of unwanted impurities.
The presentation will delve into the specifics of E&L testing, including the design and implementation of studies tailored to SVP applications. Participants will learn about the regulatory expectations and best practices for conducting these studies, ensuring that all potential extractables and leachables are identified and managed effectively.
By exploring the principles of E&L for SVPs, attendees will understand how to mitigate the risks associated with these impurities, safeguarding the quality and safety of their drug products. The session will provide practical insights into the testing processes, data interpretation, and regulatory compliance, helping professionals navigate the complexities of E&L studies.
This presentation is essential for professionals involved in the development, testing, and regulatory compliance of small volume parenteral drug products. By attending, participants will gain valuable knowledge on the best practices for managing extractables and leachables in SVP applications, ensuring their products meet the highest standards of safety and quality.