Case Study: Compatibility Testing of Pre-Filled Syringe Stopper Technology with Vaporized Hydrogen Peroxide Terminal...

Area of Science:

• Pharmaceutical packaging
• Sterilization technologies
• Ophthalmic drug delivery

Background:

• Growing industry trend towards Vaporized Hydrogen Peroxide (VHP) sterilization as an alternative to Ethylene Oxide (EO).
• VHP sterilization requires deep vacuum pulsing, posing challenges to prefilled syringe container integrity.
• Conventional siliconized syringes can cause issues like subvisible particles and inflammation in ophthalmic applications.

Purpose of the Study:

• To test and report compatibility of the 0.5 mL GORE IMPROJECT plunger with VHP terminal sterilization.
• To evaluate a silicone-free syringe solution for ophthalmic applications.
• To address challenges associated with conventional prefilled syringe systems.

Main Methods:

• Case study collaboration between STERIS and W.L. GORE.
• Testing compatibility of the GORE IMPROJECT plunger with deep vacuum VHP terminal sterilization.
• Evaluation of primary container integrity, stopper off-gassing/ingress, and visual inspection.

Main Results:

• Successful compatibility of the GORE IMPROJECT plunger design and material with deep vacuum VHP terminal sterilization.
• Demonstrated integrity of the primary container closure system.
• No adverse effects observed regarding stopper off-gassing or ingress.

Conclusions:

• The GORE IMPROJECT plunger is a viable silicone-free solution for ophthalmic prefilled syringes.
• The plunger meets strict container closure and terminal sterilization requirements for ophthalmic applications.
• Successful VHP sterilization compatibility supports its use in sensitive pharmaceutical applications.