Coating Integrity and Acute Particulate Characterization

As active members of the ASTM, AAMI and ISO standards committee, the BDC Laboratories’ team participates first-hand in outlining the guidance and expectations for both coating integrity testing and acute particulate testing. Our understanding of these methods goes beyond simply testing practices to allow us the ability validate the use of any simulated use tracking pathway, including: peripheral, neurological, coronary and radial access pathways within our established test apparatus. The BDC Labs team has proven experience for regulatory submissions evaluating many technologies including: Stents, Heart Valves, Endovascular Delivery Systems, Occluders, Guidewires, Guide Catheters, PTCA Catheters, Drug Coated Balloons (DCBs) and Vena Cava Filters.

As the premier testing service provider for coating integrity and acute particulate studies, BDC Labs programs meet the published guidance documents listed below, as well as the AAMI TIR42 technical report for the Evaluation of Particulates Associated with Vascular Medical Devices. As experts in validating and executing these testing programs, entrust BDC to ensure these complex studies are executed correctly the first-time.

Testing Services

ASTM F2743

  • Pre-Test Coating Inspection
  • Post-Test Coating Inspection
  • Baseline Particulate Assessment
  • Simulated Use Particulate Assessment

ASTM F3320

  • Balloon Drug Coating Integrity
  • Simulated Use Acute Particulate Testing

FDA Guidance

  • Pre-Test Coating Inspection
  • Post-Test Coating Inspection
  • Simulated Use Particulate Evaluation