Automated medical device coating equipment improves throughput and boosts operational flexibility. These automated systems play a critical role in high-volume medical device manufacturing. As such, nearly all manufacturers use semi or fully automated coating lines for their quality, precision, and efficiency.
The demand for safe, high-quality, and effective medical devices continues to grow. OEMs and startups must meet these requirements while also controlling costs. To address these pressures, they have started automating the entire medical device coating application process. The transition to automated lines has helped manufacturers reduce labor costs, increase efficiency, and maintain consistency in large-scale production. A big benefit of these lines is their integrated testing capabilities for lubricity and durability, which make quality control more efficient and reliable.
Recently, Hydromer®, Inc. launched a portfolio of automated production lines with integrated lubricity and durability testing capabilities. These modules enable quick and efficient assessment of the hydrophilic coatings applied to the devices. And because this testing is integrated it can significantly reduce costs and time. This allows manufacturing operations to validate performance directly on the coating line.
In this article we use Hydromer’s 40+ years of coating and equipment expertise to cover integrated lubricity and durability testing in detail. If you are an engineer or operations professional involved in the medical device manufacturing industry you will find this article valuable.
Limitations of Traditional Medical Coating Lines
Conventional coating lines were designed to apply coatings to medical devices. They included a variety of modules for loading and unloading parts, applying coatings, storing liquid formulations, and curing coatings at the end of the line. Testing of the devices was done separately once the parts or pieces left the coating line. The testing was part of quality control procedures, not the coating process. Older generations of coating lines lacked integrated performance verification capabilities.
Here are a few problems associated with testing coating performance manually or away from a coating application line:
- Longer production cycle
- If a part failed the coating test, the entire batch often required rework due to timing of the information
- Limited real-time feedback
Ensuring quality and performance is a critical step in the industrial coating application process. The time the information is obtained is critical. Integrating these testing capabilities into the automated coating system allows for faster production cycles and faster quality feedback.
Below are the most popular tests used to evaluate the performance of popular coatings, such as hydrophilic medical device coatings:
- Pinch test for lubricity and durability
- Contact angle measurements for wettability
- Particle counts for stability
- Fibrinogen assay for thrombogenicity
Integrating these tests into the automated coating lines provides many benefits for manufacturers.
Overview of Integrated Testing Modules
Hydromer® manufactures a wide range of custom, hydrophilic coatings. Leveraging technological advancements and extensive industry experience, the company has developed automated coating application lines with integrated performance-testing modules. These integrated testing capabilities are especially beneficial for lubricious coatings.
With integrated coating-testing modules, automated lines can easily identify coating problems and determine how well they will perform in the dynamic biological environment. The main advantage of having such equipment built inline in the coating systems is that operators can use data from the friction test step to adjust coating machine parameters in real time.
Below we cover the basics of both integrated lubricity and durability testing for hydrophilic coatings.
Integrated Lubricity Testing (Pinch Test Module)
Hydromer® automated coating systems feature pinch test modules for inline lubricity (coefficient of friction (CoF) testing. Lubricity is a key property for invasive medical devices. It determines how easily these devices can be inserted, navigated, and how well they function within the body.
The integrated lubricity testing module measures friction performance immediately after coating and curing processes. This approach streamlines high-volume hydrophilic coating applications. It is especially useful for devices that rely on lubricity, such as catheters, guidewires, and introducer sheaths.
How the Pinch Test Module Works
An automated coating line uses controlled handling systems to transfer devices to the pinch test module after coating. The main goal of the pinch test module is to measure the coefficient of friction (COF).
The module is equipped with two soft pads, rollers, or plates based on the type of device to be coated. The device is pulled through them, and the resulting friction is measured using the load cells. Throughout the process, a fluid-wetting system is used to ensure a hydrated environment or to replicate clinical conditions.
Integrated Durability Testing Module
Some advanced automated coating lines also include integrated durability testing equipment. These modules measure the mechanical robustness, coating integrity, abrasive resistance, substrate adhesion, etc. of coatings under repeated motion.
Devices such as catheters and guidewires often travel through complex anatomical pathways. In this case, it is essential to ensure the coating can maintain its integrity and prevent wear, delamination, or particulate generation that could pose serious health risks.
How the Durability Testing Module Works
This module uses a tortuous-pathway fixture with multiple channels and bends to simulate complex vascular pathways and apply mechanical stress to the applied coating. It is designed for tortuous path simulation and clinical simulation to determine how well the coating performs in a simulated in-vivo environment.
The automated system repeatedly advances and retracts the device. Each cycle includes measurements of friction forces, coating wear, and device condition.
Benefits of Integrated Testing Modules in Automated Hydrophilic Coating Lines
Integrating coating testing modules at the end of an automated coating line offers several key benefits. The benefits of inline inspection / inline quality control (QC) are outlined below:
- Real-Time Performance Verification: Critical parameters such as the coefficient of friction (COF) and coating adhesion are measured immediately after coating and curing. Operators no longer need to wait for part transfers or offline quality control procedures for feedback. With inline quality control (QC) issues can be spotted sooner, reducing waste and eliminating reworks.
- Reduced Risk of Batch Failures: Early defect detection significantly lowers the risk of batch failures. Closed-loop manufacturing allows data to be sent back into equipment so that parameters can be adjusted immediately. These automated adjustments of coating parameters can save substantial costs and valuable project time.
- Improved Coating Line Efficiency: Inline testing removes the need for separate laboratory tests and repeated quality checks. Hydromer®, Inc’s advanced automated coating lines with built-in testing modules streamline application procedures and can greatly increase production throughput.
- Enhanced Regulatory Compliance: Coating friction and durability data are recorded and maintained within a single system. This improves traceability and supports efficient regulatory compliance and audits.
Common Applications of Automated Coating Systems with Integrated Testing Modules
Hydrophilic coatings for medical devices are currently the most popular lubricious coatings due to their performance and versatility. They can also be made as custom formulations, such as formulations offered by Hydromer. This allows the coatings to provide other benefits such as antimicrobial properties, thromboresistance, and drug-eluting capabilities.
Here are the devices that benefit most from advanced automated coating lines offered by companies like Hydromer:
- Interventional Catheters: catheters require lubricious coatings for smooth, safe navigation through complex vascular pathways. Lubricity and durability testing are used to ensure consistent performance, even after repeated use. Learn more about hydrophilic catheter coatings.
- Guidewires: these devices navigate complex anatomical pathways. Friction and durability testing modules are equally beneficial to ensure they can perform as needed.
- Neurovascular Devices: devices used for neurovascular applications must navigate the delicate and complex brain vasculature. Smooth navigation and prevention of particulate generation are critical for their coatings.
- Minimally Invasive Devices: Many medical devices are coated with hydrophilic coatings to enhance navigation and safety during minimally invasive procedures.
Hydromer®: Hydrophilic Medical Coating Manufacturer and Coating Equipment Supplier
Hydromer®, Inc. is a leading manufacturer and supplier of advanced hydrophilic coatings with over 40 years of industry experience. We support every stage of product development, from contract R&D and formulation to coating and testing equipment and contract coating services.
We supply high-performance, fully automated coating systems to medical device clients and are trusted by leading OEMs and CMOs. All of our coating lines come with optional integrations or upgrades based on your production requirements. We also offer custom equipment builds where necessary.
Hydromer® Automated Coating Lines (with Optional Integrations)
Our three most popular coating equipment offerings are:
- Hydrophilic Coating System: This automated system features integrated UV curing as well as the Lubricity and Durability testing modules. It requires one or two operators and offers an annual production capacity of 200,000 to 300,000 units.
- Fully Automated Coating System: This end-to-end automated line is suitable for industrial applications and can apply various medical-grade coatings. It requires a single operator and is ideal for large-scale production of devices with complex geometries, such as catheters and guidewires.
- Friction Testing Equipment: Drawing on years of manufacturing experience, we have developed high-performance vertical and desktop friction testers. These are compliant with industry standard YY/T 1898-2024 and accurately measure the lubricity and durability of hydrophilic coatings.
To learn more about our range of coating systems and equipment, click here.
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