ZebraSci performs a wide array of functional and CCI methods to support lot release activities on syringes, pens, auto-injectors and vials

COMBINATION PRODUCT INCOMING TO LOT RELEASE TESTING

Benefit

We’ve developed and validated custom deterministic CCI methods for client to use to test the integrity of samples for the purposes of lot release.

A man in a blue shirt demonstrating the use of a pen-like device with a highlighted hand gesture in the background.

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

CCI:

  • High voltage leak detection
  • Helium leak detection
  • Dye ingress
  • Vacuum decay testing
  • Performed feasibility with these methods and chose compatible method

A full suite of syringe functional tests including:

  • RNS removal
  • Breakloose glide force
  • Deliverable volume
  • Silicone scanning
  • Safety device activation force
  • Safety device override force
  • And several others

A full suite of AI functional tests including:

  • Cap removal force
  • Activation force
  • Force required to override lockout or other needle safety mechanisms
  • Deliverable volume
  • Injection time
  • Injection depth
  • And several others
Schedule a consultation and learn more about our capabilities  

Related case studies

Illustration of three people with blood donation equipment, a large blood drop with a cross, and a syringe, on a yellow background with plants and clouds.

New development: E&L studies with AET calculation and toxicological report assessment – 2 temperature conditions

A hand holds a syringe over a bar graph and a rising line graph, symbolizing vaccination impact on statistical trends or data growth.

Design change: E&L studies with AET calculation and toxicological report assessment

A syringe with a droplet is near two labeled COVID-19 vaccine vials, one blue-capped and one orange-capped, against a dark background.

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)

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