ZebraSci performed Device verification, Transit Simulation Testing, and Shelf-life testing to support a client transitioning their vaccine from a vial to a prefilled syringe configuration (COVID-19 Emergency Use)

DRUG COMBINATION PRODUCT DESIGN VERIFICATION TESTING

Timeline

Development activities were completed 2.5 months after contract was signed.

Benefit

Company successfully transitioned their vaccine from a vial to a prefilled syringe configuration.

We developed all test methods used to support their program and authored custom Test method protocols to meet their requirements.

ZebraSci led the following development activities:

  • CCI: Dye Ingress
  • Deep Cold CCI and Stopper Movement Studies
  • Closure System Liquid Leakage
  • Liquid Leakage at Syringe Plunger Stopper
  • Flange to Plunger Rod Distance Dimensional Analysis
  • Deliverable Volume Testing
  • Luer Cone Breakage Resistance
  • Tip Cap Removal Torque
  • Needle Attachment Torque
  • Break Loose and Glide Force
  • Flange Breakage Resistance
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ZebraSci performs a wide array of functional and CCI methods to support lot release activities on syringes, pens, auto-injectors and vials