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

E&L ANALYTICAL TESTING

Timeline

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

Benefit

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

An illustration of a hand holding a syringe with a background of rising bar graphs and a line graph indicating growth in a data visual.

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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