Polymers are some of the most commonly used materials in medical device manufacturing. Characterization of the relevant properties is key to ensure their quality and performance standards.

Medical grade polymer testing is integral to device development, improvement, and failure analysis investigations. With an experienced eye on current regulatory specifications, °Ä²Ê¿ª½±½á¹û’s highly qualified polymer experts have the expertise to help you improve and qualify your materials and products.

In addition to standard polymer characterization, we have developed techniques and capabilities specific to pharmaceuticals and medical devices, including:

  • Gel permeation chromatography (GPC) of water-soluble polymers/excipients
  • Gelatin bloom strength
  • Pre-filled syringe extrusion force
  • Syringe break and glide force
  • Particulate counting and identification
    Development of custom testing programs
  • 510(k) programs to compare medical devices to predicate devices
  • Medical patch adhesion strength
  • Actuation force
  • Chemical exposure testing (e.g. cleaners and antimicrobials)
  • Evaluation of tissue adhesives

Fourier Transform Infrared (FTIR) Spectroscopy for material identificationÌý

Differential Scanning Calorimetry (DSC) for material thermal properties (Tg, Tm, thermal transitions in protein-based devices, residual cure)Ìý

Thermogravimetric Analysis (TGA) for filler content and deformulationÌý

Mechanical testing – Tensile, Compressive, Flexural, Density, Hardness, Melt FlowÌý

Scanning Electron Microscopy/Energy Dispersive Spectroscopy (SEM/EDS) for morphology and elemental analysisÌý

X-Ray Diffraction (XRD) for the crystal structure of drugs in combination polymer/drug devicesÌý

Gel Permeation Chromatography (GPC) for Molecular Weight (MW) and Molar Mass Distribution (MWD) of polymers

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