Material Compatibility

Material Compatibility is the understanding of whether or not the different component materials in a combination product can negatively interact with each other and impact the performance or safety of the overall product. It is important to determine the material compatibility of combination product as device leachables may accelerate degradation of a drug product. Another part of medical device compatibility analysis is the effect of disinfectants, sterilization, and/or cleaning. Material compatibility studies will likely need to be performed as part of Premarket Application (PMA) and 510(k) testing.

The experts of STEMart have years of experience understanding the diverse reasons why device materials can fail and why some materials are incompatible with others. STEMart works with manufacturers to understand how prospective materials may interact, and we provide data to help them choose the best materials for production of their combination product.

Test Capabilities

• Physical-Chemical Compatibility
• Interaction Studies

Material Expertise

• Polymers: plastic, rubber, elastomer, coatings, adhesives, etc.
• Metals: alloys, electroplated material, titanium, stainless steel, etc.
• Ceramics: alumina, aluminum oxide, zirconia compounds, etc.
• Specialty and Composite Materials

We accomplish material compatibility testing through various analytical techniques which stress materials under controlled or accelerated conditions.

Analytical Techniques

• Chromatography – HPLC, LC/MS, GC/MS, GC/FID, GC/TCD, GPC/SEC
• Spectroscopy – ICP-MS, NMR, MS, PXRD, TF-XRD, UV-Vis, FTIR, Raman
• Microscopy – SEM, TEM, AFM, STM, LSCM
• Other- TGA, DSC, TOC, BET Surface Area/Pore Size Analyzer

STEMart provides material compatibility testing services of combination product to flag potential material incompatibility or to find material combination options that pose the least amount of risk of causing a medical device failure. If you want to learn more detail about our stability testing services, or would like to consult with the experts at STEMart, please feel free to contact us.