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



From strategy definition to delivery of toxicological report assessments ~10 months


  • Speed of execution
  • Leverage our knowledge on materials to successfully develop the new wearable device
  • Flexibility of our offer

Customer was developing a new wearable device containing a drug. We performed E&L studies and toxicological assessments at two different temperature conditions to support customer design verification activities and regulatory submission.

We led the following development activities:

  • E&L strategy support
  • Extractables study on solvent (as agreed with customer)
  • AET calculation
  • TRA on extractables
  • Analytical method validation for all components above AET
  • Leachables study over the combination product shelf-life
  • TRA on leachables at body temperature
  •  TRA on leachables at 40°C
Schedule a consultation and learn more about our capabilities  

Related case studies

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

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

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)