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How to Reduce Foreign Material Rejects in Coated Catheter Manufacturing Processes

by | Jan 6, 2023

As the demand for medical devices with lubricous coatings increases, it is important to understand the potential impacts that foreign materials and particulates can have on their purity and yield. These contaminants can potentially cause several issues, including decreased performance and increased risk of failure.

One of the main ways that foreign materials and particulates can negatively impact the purity and yield of micro catheters with lubricous coatings is through the contamination of the coating process. These contaminants can get trapped in the coating during the application process, which can result in a less smooth and less effective coating. This can lead to reduced performance and increased wear on the catheter, leading to a higher risk of failure.

Lubricious coated catheter rejected for foreign material contamination.

Lubricious coated catheter zoomed in to show fiber and particle contamination.

Contamination found on catheter dip casting machine.

In addition to the impact on performance, foreign materials and particulates can also affect the yield of micro catheters with lubricous coatings. If these contaminants are present in the coating process, it can result in a higher number of defective or non-conforming products, leading to a decrease in overall yield. This can be especially costly for medical device manufacturers, as it can result in increased production costs and reduced profits.

To mitigate the negative impacts of foreign materials and particulates on the purity and yield of micro catheters with lubricous coatings, it is important to implement strict quality control measures and use proper handling techniques during the coating process. This includes ensuring that the coating equipment is clean and properly maintained, as well as using appropriate filtration systems to remove any contaminants that may be present.

Overall, it is essential for medical device manufacturers to be aware of the potential impacts that foreign materials and particulates can have on the purity and yield of micro catheters with lubricous coatings. By implementing proper quality control measures and handling techniques, manufacturers can ensure that their products are of the highest quality and meet the needs of their customers.

Polycellulose Wipe Side Profile After Wiping Stainless Steel Surface

Polyester Wipe Side Profile After Wiping Stainless Steel Surface

UltraSORB® Wipe Side Profile After Wiping Stainless Steel Surface

For cleanroom wiping applications that demand great absorbency, UltraSORB® is made of hydrophilic, open-cell foam. UltraSORB® is the best choice for medical device applications because, unlike fabric wipers, its polyurethane foam composition prevents FM (particles > 25 mm) from leaking into the cleanroom. For difficult manual assembly tasks, UltraSORB’s® low shedding properties work well to catch and eliminate contamination. For cleaning catheter bodies and balloons composed of Pebax®, PTFE, ePTFE, platinum-cured silicones, urethanes, and nylon, UltraSORB® is ideal due to its low tribocharging of plastic surfaces and static dissipative properties.

Pebax® is a registered trademark of Arkema

To learn more about UltraSORB Wipes:

https://www.foamtecintlwcc.com/products/cleanroom-wipes/foam/ultrasorb-wiper

For questions or inquiries:

Website: www.foamtecintlwcc.com

Email: contact@foamtecintlwcc.com