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ON-DEMAND WEBINAR

ON-DEMAND WEBINAR

A Structured Approach to Selection of Container Closure Materials for Small Volume Parenterals – Pipe Dream or Necessity?

Published Date: July 6, 2022

This presentation will provide reasons why material selection for small volume parenteral container closures should be built upon well-defined attributes rather than a random selection or just previous use. It will explore some of the factors and attributes to consider such as compatibility, material extractables, dimensional stability, and regulatory expectations. It will also delve into questions like what is meant by compatibility and how might extractable testing design choices influence selection.

Explore how performance, quality, safety, and functionality are all interconnected and affected by the choices made. Additionally, find out more about an ideal timeline for selection.

Learn more about the presenter below.

Jason Creasy

Managing Director and Principal Consultant – Maven E&L

Jason Creasey is a graduate analytical chemist. In 2019, he established Maven E&L Ltd, as is its Managing Director and Principal Consultant. Maven E&L was set up to provide advice to clients working in the pharmaceutical industry on all aspects relating to the topic of extractables and leachables (E&L) and the risks that leachables pose to the quality and safety of drug products. Prior to this, he worked for GSK where he was the Director of their R&D E&L Team. He has worked in the area of E&L since the mid 1990’s on a wide range of modalities and dose forms watching this area expand and grow in significance for the pharmaceutical and medical device industries. In addition to running his consultancy, he is a scientific advisor to the ELSIE consortium. Since setting up Maven E&L he continues to present, discuss, and write about E&L. He now publishes a regular E&L blog through LinkedIn and his Website (www.MavenEandL.com), for the exchange of ideas and discussion. As well as supporting client projects, among recent E&L activity, he is presenting and commenting on risk- based approaches to E&L requirements within the pharmaceutical industry that he hopes will form part of an ICH guidance in the not-too-distant future and has helped ELSIE publish and discuss their whitepapers linked to Concepts in Leachable Risk Management and to further develop their database.

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