Recent years have seen a rise for pre-filled syringes from a niche product to the primary container of choice for most parenteral drug delivery systems. This is the result of a number of factors, although the improved safety and increased convenience of a pre-fillable device is the leading reason. The global market for pre-fillable syringes today comprises of more than 2.2 billion syringes, with over half of these supplied sterile. This Master Class aims to address the development of pre-fillable syringe systems as well as examine the documentation and regulatory issues faced by these systems.

Participants will learn the design approach for a pre-fillable syringe system in regards to functionality, container closure integrity, extractables and leachables, both from a vendor's and customer's perspective.

This half day masterclass will provide an overview of the relevant practical aspects of developing and designing pre-filled syringe systems focusing on functionality testing and regulatory issues. Within the course ready-to-fill syringe system concepts will be presented and discussed.