Determination of Oxygen Ingress Through Syringe Packages by Using Laser Headspace Analysis

Abstract

  Syringes and cartridges need to be a barrier to microbial ingress and in some cases (e.g. oxygen sensitive formulations) oxygen ingress. Container Closure Integrity (CCI) is the main measure of a packages ability to maintain stability and sterility over the intended shelf life.
  We develop laser headspace analysis for assessing oxygen ingress rates into two types of syringe packages. We measure oxygen ingress to a Luer Tip and Staked Needle syringe package. The syringe packages were prepared in a way that allowed isolated study of different parts of each syringe so that oxygen ingress rates could be determined for each part of the syringe.