Survival Kit For Quality Regulations: A Closer Look At Lyo Packaging

Elastomeric container closures for parenteral pharmaceuticals have been around for a little more than a century. Can these older technologies meet the increased demands of both the growing complexities of pharmaceutical formulations and the increasing stringency of regulatory requirements? Which risks should be considered and challenges addressed to perform better? And what uncertainties lie ahead?

Component selection is not trivial, but a multivariate process in which considerations should be evaluated concurrently with drug development. This webinar explores primary packaging developed following well-established ICH principles for sustainable compliance. As illustrated by the revised EU GMP Annex 1 for the manufacture of sterile medicinal products, using the appropriate primary packaging components contributes to a robust container closure system and contamination control strategy.

View the webinar below to learn more and hear a conversation with the West Pharmaceutical Services team regarding vial container closure systems for your product development and commercial manufacturing needs.

Key Learning Objectives:

• Explore how the Quality by Design approach helps manage uncertainty and minimize quality risks of extractables & leachables and particulate matter.
• Examine proactive considerations for sustainable compliance when selecting a container closure.
• Deep dive into how elastomeric closures can keep pace with advancements in technology and the increasing demands of new innovative pharmaceuticals.
• Investigate the science-based approach of a glass blowback agnostic component design and verification.
• Understand component features that influence the lyophilization process performance, manufacturability and total cost of ownership.