Testing Services

Comprehensive Testing Services for Medical Devices

Measure the performance of your device coating program by utilizing the full portfolio of testing services Harland offers. Our experience in measuring coating performance and our expertise in designing coating testing equipment makes Harland the ideal partner for your coating testing needs. A quick turnaround means you can rely on Harland testing to keep your coating program on schedule.

Particulate Measurement Services

Coating integrity is receiving increased scrutiny from medical device manufacturers, coating suppliers and regulatory agencies. Harland Testing Services can provide quick and accurate measurements of particle size and counts from test samples submitted by customers.

Particles as small as 2µm up to 125µm can be sized and counted using either light obscuration or microscopy, the methods recommended by USP 788 and other particle counting  standards. Counts can be reported in up to five size ranges depending on your internal specifications or those from external standards.

A Particle Measurement Test Unit Collection Kit and instructions for collection will be provided for you to collect and submit test samples. Particle suspensions can be generated by you using  your simulated use  technique or generated by Harland as described in Particulate Generation.

Friction Testing Services

Whether it’s for a one-time project or ongoing needs, Harland offers complete friction testing capabilities. Using the Harland FTS Friction Testing System, Harland Testing Services can provide timely results using your protocol or one recommended by our experienced test method engineers.

We also offer dry-out testing of hydrophilic coatings using time series friction tests.

When you want to bring this testing into your own facility, you can get set up with the Friction Test System that has set the industry standard for years. Whether you need to measure hydrophilic coating lubricity or durability; or if you simply want to know the friction properties of an uncoated device surface, Harland Testing Services is ready to help.

Coating Thickness Testing Services

Coating thickness is an important factor in evaluating the quality, uniformity, and integrity of a medical device coating. As new medical devices and clinical procedures require the delivery of increasingly complex devices into ever smaller vasculature, coating thickness and overall device diameter become critical design variables.

In addition, coating thickness is a valuable complement to performance tests such as lubricity, durability, and particle generation. An increase in coating thickness may indicate a problem with any of these performance factors.

Coating thickness is measured using the Harland CTS Thickness Testing System featuring a highly accurate LED micrometer to precisely measure the diameter of a coated part. By measuring the diameter both dry and after hydration, the CTS calculates coating thickness. Measurements can be taken at discrete points on the test unit or taken by a continuous scan of the test units up to 60 cm of length.

FTIR Analysis

Fourier-transform infrared spectroscopy (FTIR) is a surface analysis technique to identify the composition of a medical device surface and any contaminants that may be present. This test provides crucial information about the material’s composition that you can use to ensure your medical devices meet the required specifications.

Particle Generation 

Particle generation for medical device coatings is a critical evaluation process aimed at assessing the potential release of particulate matter from a coated medical device. This testing method is essential for ensuring the safety and quality of medical devices by examining the coatings’ propensity to shed particles that could pose risks to patients or impact device functionality.

Highly sensitive equipment and techniques are used to quantify any particles generated during simulated use or under controlled conditions. By conducting particle generation testing, manufacturers can use the information to help meet stringent regulatory standards and safeguard patient well-being in the healthcare industry.

Coating Coverage Test

The Coating Coverage Test for Medical Devices is a crucial quality control procedure designed to assess the uniformity of coatings applied to medical devices. This test ensures that the coatings on medical devices are consistent.  This information can assist in determining if the device meets the required specifications.

Coating Characterization Profile (CCP)

The Coating Characterization Profile for Medical Devices is a comprehensive set of tests and assessments which provide and economical profile of the performance and quality of a medical device coating. This profile includes:

  • Coating Coverage Test

    See independent test for more information.

  • Friction Testing Service

    See independent test for more information.

  • Coating Thickness Testing

    See independent test for more information.

  • Inclusions Analysis

    not available as an independent test

    The analysis of coating inclusions for medical devices identifies the presence of contaminants within the applied coating.  This test helps identify potential problems in the coating process that could compromise the coating integrity and even patient safety.

  • Coating Color and Clarity

    not available as an independent test

    Coated test units are assessed for visual appearance against a standard from the Gemological Institute of America.

  • Tactile Assessment

    not available as an independent test

    A manual assessment of coating texture using the sense of touch. Skilled technicians scrutinize the coatings roughness, that may compromise device performance.

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All of Your Coating Needs in One Place

Every medical device is unique and bringing it to market is a major challenge. That’s why Harland’s Coatings 360 approach tailors a complete answer to your distinct product coating needs and goals. We’re the industry’s only comprehensive source for high-performance coatings, equipment and production coating services—everything you need to coat your medical device on time and within budget. We provide it all in-house, so when you partner with us, you have one resource for everything coatings.

White Paper: 10 Essentials for a Hydrophilic Coating Program

10 essential elements to consider when selecting a coating program for medical devices such as catheters, guidewires, introducers and other devices.