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, Element’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 identification
Differential Scanning Calorimetry (DSC) for material thermal properties (Tg, Tm, thermal transitions in protein-based devices, residual cure)
Thermogravimetric Analysis (TGA) for filler content and deformulation
Mechanical testing – Tensile, Compressive, Flexural, Density, Hardness, Melt Flow
Scanning Electron Microscopy/Energy Dispersive Spectroscopy (SEM/EDS) for morphology and elemental analysis
X-Ray Diffraction (XRD) for the crystal structure of drugs in combination polymer/drug devices
Gel Permeation Chromatography (GPC) for Molecular Weight (MW) and Molar Mass Distribution (MWD) of polymers
The Element advantage
Element is accredited to ISO/IEC 17025 through A2LA and the Standards Council of Canada and is regularly inspected by the Food and Drug Administration (FDA) and Health Canada. Our polymer scientists are experienced across a range of medical devices, including Class I, II, and III devices.
As a comprehensive medical device testing partner, you’ll enjoy the benefit of a single source supplier for all of your testing needs, from feasibility and R&D to product development and production quality control. We offer a full suite of medical device testing, including mechanical testing, product qualification, material characterization and failure analysis.
For more information about our medical grade polymer testing, contact us today.
Medical Product Testing
With a clear understanding of your markets, regulations, and challenges, we provide our expertise and experience with medical product testing to help your product reach the market sooner and with safety and quality built in.
Mechanical and Physical Testing of Polymers
We provide comprehensive physical and mechanical testing services of polymers and plastic products, including tensile testing, impact resistance, and chemical exposure.
Medical Device Product Development and Prototyping
Element’s medical device product development services enable safe and quality products to reach the market faster.
Successful FDA 510(k) submissions are critical to your market success. Incomplete or inaccurate submissions can lead to failure and may delay your product launch.