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.

Illustration of two vaccine vials labeled "COVID-19 VACCINE," with a dropper about to release a drop into one of the vials.

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

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