Extractables and Leachables
Collaborate with our experts to ensure the materials your product comes into contact with do not affect its safety or efficacy, and that your product satisfies all FDA extractables and leachables (E&L) testing requirements.
Strategic vision and novel solutions are key to how we can guide you through the process of ensuring the purity of your product.
With a multidisciplinary team of material scientists, analytical chemists, biomedical engineers, toxicologists and biocompatibility specialists, we deliver E&L evaluations critical to your successful product development and regulatory submissions.
We base our E&L studies on the recommendations of the:
- Product Quality Research Institute’s Extractables and Leachables Working Group
- USP <1663> and USP <1664>
- Bio-Process Systems Alliance Extractables and Leachables Subcommittee
- FDA Container Closure Systems for Packaging Human Drugs and Biologics Guidance for Industry
- ISO 10993 Part 18, Biological Evaluation of Medical Devices (chemical characterization of materials)