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Toxikon - Preclinical Safety and Efficacy Testing for Medical Devices

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Material Qualifications and Class Testing

Using “qualified” materials is one of the central tenets of building safe medical devices. Toxikon provides testing services to qualify the materials used to manufacture life science products and their packaging to help demonstrate safety.

We offer a combination of analytical, in-vivo, & in-vitro services to comprehensively evaluate your materials to a variety of standards including, USP, EP, or Class I-VI standards.

With experience characterizing raw materials, conducting material comparisons, assessing cytotoxicity, and determining biological reactivity, Toxikon can assess your material from start to finish.

Testing Standards

  • – United States Pharmacopoeia (USP) Testing
    • – USP 87 In-Vitro Biological Reactivity – Cytotoxicity Testing
    • – USP 88 In-Vivo Biological Reactivity – Class I–VI Testing
    • – USP 381 Elastomers Closures for Injections
    • – USP 661 Plastic Packaging Systems and Their Materials of Construction
    • – USP 1663 Assessment of Extractables Associated with Pharmaceutical Packaging / Delivery Systems
    • – USP Class I – USP Class VI
  • – US FDA – CFR Testing
    • – CFR 176.2600 Rubber Articles Intended for Repeated Use.
    • – CFR 177.2400 Perfluorocarbon Cured Elastomers
    • – CFR 177.1520 Olefin Polymers
  • – European Pharmacopeia (EP) Testing
    • 1 Series; Materials Used for the Manufacture of Containers
      • – 1.9 Silicone Elastomer for Closures and Tubing
    • 2 Series; Containers
  • – Japanese Pharmacopoeia (JP) Testing
  • – International Organization for Standardization (ISO)
    • – ISO 3826-1
    • – ISO 3826-4
    • – ISO 9626
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Toxikon - Preclinical Safety and Efficacy Testing for Medical Devices