Syringe for a High Viscosity Drug Delivered in an Auto-injector
The customer developed a high viscosity drug (>1,500 cP) that will be packaged in a pre-filled syringe and used in an auto-injector. The drug may be terminally sterilized with gamma irradiation. Due to the high injection forces, it is not possible to use a glass syringe due to the risk of breakage. Moreover, borosilicate glass discolors when subjected to gamma irradiation.
- SiO2 developed a custom 2.25 mL staked needle syringe composed for use in an auto-injector that can withstand the injection forces of the high viscosity drugs.
- SiO2 worked with the customer’s autoinjector provider to conduct a stress analysis to determine the high stress areas of the design based on the autoinjector interface to the syringe. The design was optimized based on the analysis. SiO2 conducted a mold flow analysis of the proposed design and developed a mold to produce the syringe.
- SiO2 developed the product and scaled up an automated manufacturing line. The syringe incorporated SiO2’s barrier and lubricity coating technology. SiO2 developed the internal diameter of the syringe based on a standard plunger to withstand the high injection forces expected and not leak past the plunger.
- Verification testing showed that the syringe can withstand a force of 320N (an internal pressure of 800 psi, 5,535 kPa) – this exceeds the force requirements for the high viscosity drug.
Custom Designed 2.25mL staked needle syringe with a thicker barrel