PDA Parenteral Packaging 2018

Expert Analytical Services for Your Medtech Products

Leverage AMRI’s scientific expertise and state-of-the-art technology for both routine and custom testing for your parenteral products.

Detailed suite of medical device and product-based testing:

  • Container closure integrity testing
    • Leak test method development/validation
      • Vacuum decay leak detection
      • High voltage leak detection
      • Laser-based headspace analysis
      • Helium mass spectrometry
    • Inherent integrity characterization
    • Routine stability support
  • Extractables and leachables
    • Extractable profiling & compound ID
      • Container/closures, SUS & devices
    • E/L risk assessment for manufacturing processes
    • Trace organic compound analyses
      • Genotoxic impurities & leachables
    • Drug substance & drug product impurity ID
    • PGI hazard assessment & control strategy
  • Device efficacy and functional testing
    • Dose accuracy
    • Deliverable volume
    • Functional testing of pre-filled syringes

Extractables & Leachables Workshop

This workshop explores multiple factors regarding Extractables & Leachables and its role in the safety and quality of drug products. Click here for more information about the workshop (external link).

  • Day 1
    Thursday (March 1) | 09:00-18:00
  • Day 2
    Friday (March 2) | 09:00-16:30

Dennis Jenke, PhD
Chief Executive Scientist, Triad Scientific Solutions
Piet Christiaens, PhD
Scientific Director, Toxikon Europe
John Iannone
Director of Extractables/Leachables and Impurities, AMRI