- Medical Device Testing Guide
- Preclinical Medical Device Test Request Forms
- Preclinical Safety Testing for Pharma and Biotech
- Business Development and Client Services
- White Papers
- Sponsor Package
- Ensuring Patient Safety of Medical Devices
Extractables and Leachables
Toxikon has developed extensive methodologies for designing studies to identify extractables and leachables in medical devices and pharmaceutical products. The demand for these types of studies by U.S. and other governing bodies is increasing, as data from these assessments identifies potential contaminants that migrate from containers, closure systems, tubing, and other materials, potentially rendering drug products unsafe. These materials include, but are not limited to polymers and other plastics, elastomers, coatings, accelerants, and antioxidants. Degradation products from gamma to e-beam sterilization processes to residual solvents from manufacturing may also be present.
Toxikon's Extractables and Leacheables testing capabilities include evaluations for:
• Drug Delivery Systems
• Container Closure Systems
• Raw Material/Polymers
• Material Comparison
• Residual Analysis
Click the image for more information on Toxikon's Extractables and Leachables testing.