INTERTEK

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E&L(용기적합성)

  • What we deliver to our E/L customers:

    Tailor-made extractables and leachables studies for all types of container closure systems and packaging materials, process equipment or medical devices including printings and adhesives according to MFDS, EMA and FDA requirements

    Consultancy for E/L studies in all phases of drug or device development of, e.g. evaluation and assessment of already available E /L data, gap analyses

    Toxicological assessment of the results of extractables and leachables studies

    Validation of analytical methods for leachables studies (according to GMP)

    Interaction studies for APIs with the packaging materials (according to GMP)

    Additive analysis in all types of polymer

    Assessment & analyses of process materials

    Structural elucidation of unknowns

    Seminars and training on extractables & leachables

    Our Experts

    Our centre of excellence for cGMP-compliant extractable and leachable services is located in Reinach close to Basel (Switzerland).
    Our experts have specialized in analytical support for the pharmaceutical and medical device extractables / leachables and have over 30 years experience in this field coupled with an extensive knowledge of the polymer and packaging industries.

    Consultancy for E/L studies in all phases of drug or device development of, e.g. evaluation and assessment of already available E /L data, gap analyses

    E/L study of Container Closure System

    Prefilled syringe

    Glass vial and rubber stopper

    Infusion bag

    Transdermal patch

    Process contact materials (e.g. silicon tubing, bag, filter)

    Plastic bottle for eye drop

    Disposable bag or plastic bottle for drug substance storage

    Medical devices

    Secondary/tertiary package (e.g. label, paper box, pouch)

  • Extractables / Leachables Toolbox

    Intertek uses advanced analytical equipment to characterize both organic and inorganic elements and compounds:

    GC/MS: thermodesorption, headspace, liquid injection

    HPLC: LC-DAD, LC/MS, LC/MS/MS (ESI and APCI)

    MS: EI, CI, high resolution, commercial and in-house mass spectral libraries

    Elemental using and quantiative determination X-ray fluorescence, ICP-AES or ICP-MS

    TOC determination in aqueous extract

    Modern tools for structural elucidation and absolute quantification (1H-, 13C-NMR, FTIR, UV, LC-HRMS, GC-HRMS, prep-LC/MS)

    Reference standards (commercial + in-house synthesized)

    Other service

    Particles Matter Investigation

    GMP and CMC Laboratory Services

    Our Partner

    QBD (Quality by Design Inc.) is working together with us.