CCI Test Method Validation For Pre-Filled Syringes

Background

• Regulators are paying closer attention to the proper design of robust Container Closure Integrity (CCI) studies and the validation of CCI test methods.
• A method was developed for CCI testing of pre-filled syringes and then validated.
• The purpose of Method Validation is to demonstrate sufficient accuracy and reproducibility of a method, in this case to detect CCI defects at the plunger seal of a pre-filled syringe.
• The developed CCI test method uses Headspace Gas Ingress analysis to identify changes in the headspace content of the syringe that result from gas ingress through a leak.

The Method
The method applied uses an FMS Headspace Gas Analyzer and a CCI Test Vessel, offering a robust solution for CCI Testing. This method utilizes Headspace Gas Ingress analysis to measure changes in the headspace gas composition of the syringe that result from gas ingress through a leak. The CCI Test Vessel creates an environment that accelerates gas ingress through an open defect. Samples are placed inside the vessel and exposed to a tracer gas (in this case carbon dioxide). In the case of a closure defect, CO₂ will leak into the syringe headspace and will be detected by performing headspace analysis.