Coating & Particulate Testing

Element tests intravascular devices including drug-eluting stents, examining coated surfaces for defects, anomalies, or artifacts. Our testing covers both metallic and polymeric materials used in cardiovascular devices. We evaluate drug-eluting stents for coating integrity and durability, focusing on potential impacts to therapeutic benefit and clinical performance. 

We provide acute and chronic particulate testing, coating integrity inspections for baseline and simulated use conditions, and particulate evaluation through light obscuration or filtration/microscopy methods. Our testing includes counting total defects per unit area, measuring representative and worst-case defect areas, and conducting spectral analysis and element mapping. 

We employ filtration/microscopy methods for detailed particle identification and quantification. Our simulated use testing includes tortuous path fixtures that mimic challenging in vivo conditions. We conduct testing on finished products that have undergone all manufacturing processes, including sterilization, and can evaluate overlapped or bent stent configurations following device instructions for use. 

• Coating Integrity Inspections:  
  Coating integrity inspections assess the device's coated surfaces for defects, anomalies, or damage that could impact clinical performance. Issues like delamination, flaking, or degradation must be identified and characterized. FDA guidelines recommend inspections of the finished product after all manufacturing processes, including sterilization. 
   
  Simulated Use Testing 
  We perform coating integrity assessments under both baseline and simulated use conditions. Devices are subjected to a tortuous path fixture that simulates challenging in vivo conditions and then expanded in air or an aqueous solution. 
   
  Defect Documentation and Reporting 
  Defects are carefully documented, including their size and quantity, as part of the coating integrity evaluation. Test reports include details on how defects were quantified, such as counting defects per unit area and measuring representative and worst-case defect sizes. 
   

• Acute Particulate Testing: 
  FDA guidance and industry standards outline acute particulate testing, using either light obscuration or filtration/microscopy methods. The light obscuration method offers high throughput but only categorizes particulates by size. On the other hand, the filtration/microscopy method can quantify and identify particulates by size, color, shape, or composition. We use the filtration/microscopy method for its flexibility in meeting device manufacturers' specific needs. 
   

• Chronic Particulate Testing: 
  Our chronic particulate testing integrates particle counting modules with stent graft test systems and uses customized flow loops, flow meters, and filters for mock vessels. This setup minimizes flow compliance effects, ensuring accurate testing under physiological conditions. 
   
  Filters are sampled at specific intervals during long-term fatigue tests to analyze particulates. With our in-house filtration/microscopy capabilities, we can quickly analyze particulates while the durability test is ongoing. 

We utilize SEM with automated particle size analysis, providing magnification up to 100,000x. Our sample chamber accommodates samples up to 100mm long x 80mm wide x 25mm high. The system includes Automatic Feature Analysis (AFA) capabilities for spectral analysis, line scans, and element mapping of solid inorganic materials. 

Our team operates from strategically located Life Sciences labs, providing convenient access to our expert capabilities. Find your nearest Life Sciences hub on our Locations Page.   

We combine particle counting modules with stent graft test systems and individualized flow loops. Our design minimizes flow compliance effects while maintaining physiological radial strains for fatigue testing. Filters for mock vessels are sampled at pre-determined intervals throughout long-term fatigue tests.