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



Extractables study execution: 2.5 months AET and TRA delivery: 2 months


Leverage our knowledge on materials to successfully and quickly support the transition to the new syringe

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

We led the following development activities:

  • E&L strategy support
  • Extractables study on solvent (as agreed with customer)
  • AET calculation
  • TRA on extractables (as per customer’s request to show 1st results to authorities)
  • Analytical method validation for all components above AET
  • Leachables study on 3 batches over the combination product shelf-life
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