In the upcoming 2022 Nelson Labs Virtual Symposium, this presentation will emphasize the importance of selecting materials for small volume parenteral container closures based on well-defined attributes rather than relying on random choices or previous use. This session will delve into the critical factors and attributes that should guide material selection, ensuring that the chosen materials meet stringent performance and regulatory standards.
Key considerations such as compatibility, material extractables, dimensional stability, and regulatory expectations will be thoroughly examined. Participants will gain a clear understanding of what is meant by compatibility in the context of container closures and how different extractable testing design choices can significantly influence material selection. By addressing these questions, the presentation aims to provide a comprehensive framework for making informed decisions.
The presentation will explore how the interconnected aspects of performance, quality, safety, and functionality are influenced by material choices. It will highlight the necessity of selecting materials that not only meet regulatory requirements but also ensure the integrity and efficacy of the drug product throughout its lifecycle.
Moreover, attendees will be guided through an ideal timeline for material selection, illustrating the step-by-step process to ensure timely and effective decision-making. This timeline will help manufacturers plan and execute their material selection process efficiently, minimizing risks and optimizing product development timelines.
By attending this presentation, participants will gain valuable insights into the strategic considerations for material selection, helping them to make informed decisions that enhance the quality and safety of their small volume parenteral products. This knowledge is essential for professionals involved in the development, testing, and regulatory compliance of pharmaceutical packaging materials.