About Extractables & Leachables Testing

Our scientists help clients navigate the regulatory requirements and convert the regulations into relevant analytical protocols.  We have performed extractables and leachables testing on many products for numerous clients to advance their projects.

  • Approaches

    We have performed extractable tests for many clients.  Similarly, leachable tests are a continual portion of our workload.  Often, we use the extractables protocol to establish a worst-case scenario in terms of chemical and quantities that may be released.  This helps set parameters and establish detection limits for the subsequent leachables tests.

  • Sample Considerations

    The sample requirements need to be discussed on a project specific basis because the specific parameters of the extractables and leachables tests will dictate the amount of sample. 

    Our staff will guide the process to ensure the proper amount of a sample is submitted in order to achieve excellent extractable and leachables tests.  Contact us with specific questions about your extractables and leachables testing needs.

  • Experience

    Products we've tested:

    • Pre-filled syringes
    • Vials
    • Packaging for surgical supplies
    • Components of metered dose inhalers
    • Medical tubing