Over the years, Extractable and Leachable studies (E/L) have become a requirement and the expectations for an acceptable study have also changed-and keep changing. Whether you are conducting E/L studies for a container closure system (CC), a plastic component of a single-use/multiuse manufacturing system (SUS/MUS), or a medical device used as a drug delivery system (combination product), the seemingly constant evolution of E/L studies can make it difficult to complete the study without costly delays and additional testing.
In this webinar, participants will learn the basic terminology of extractable leachable testing and review the current/emerging regulations and guidance as a starting point. This foundational information, in combination with emerging expectations, will be used as the building blocks for designing an E/L study tailored to the study type, whether it involves container closure, SUS/MUS, or combination products. Understanding the common pitfalls and leveraging available tools and resources will help you avoid costly oversights and deliver a robust study report with the safety assessment/risk assessment in mind.
Designing Extractable/Leachables studies for your program can be stressful and frustrating. However, leveraging the right resources can mitigate many of the challenges, saving you valuable time and money.
Learning Objectives:
- Gain insights into the current and emerging regulatory landscape, along with regulatory expectations.
- Understand the significance of the relationship between safety assessment/risk assessment and extractable/leachable studies.
- Avoid common pitfalls encountered in extractable/leachable studies.
- Acquire knowledge of the essential components for designing a successful extractable or leachable study from the outset.
