Extractables & Leachables Testing

    The Need for Extractables & Leachables Testing

    In the pharmaceutical industry, manufacturers need to demonstrate a product’s physical and chemical properties. It’s also critical that suitable packaging is selected and shown to preserve the integrity of the drug product. This is why regulatory organizations, such as the FDA, are concerned with the interaction of drug delivery devices (such as inhalers and nasal sprays), medical devices and pharmaceutical equipment with drug products and patients.

    Extractables & leachables testing ensures that primary drug containers and other packaging components do not interact adversely with the drug product. Extractables and leachables can contaminate a product and migrate into the patient in three ways:

    • Directly – Direct to the patient through medical devices such as contact lenses or implant devices.
    • Indirectly – From packaging to the patient via plastic primary packaging or containers.
    • From process equipment – Migration from filters, disposable plastic process equipment or tubing that from part of the drug product manufacturing process stream and therefore can end up in the drug product.

    For these reasons, the FDA and other regulatory organizations have recommended drug manufacturers adhere to extractables & leachables testing regulations. Smithers Rapra specializes in performing for extractables & leachables testing in OINDP that meet FDA and other regulatory guidelines.

    Request a quote for our extractables & leachables testing services.