In the world of medical device manufacturing, precision and cleanliness are paramount. One critical step in producing catheters, particularly in radiofrequency (RF) catheter tipping operations, involves using cleanroom wipers to clean and apply mold release to the pre-tipped extrusion. Foreign material (FM) is a significant source of rejects in the manufacturing process. Fortunately, Foamtec’s UltraSORB foam wipers offer a groundbreaking solution to this problem. This blog will explore how Foamtec’s innovative foam wipers can significantly reduce FM contamination in RF catheter tipping operations.
The Challenge of FM Contamination
In medical device manufacturing, foreign material contamination (FM) can lead to costly defects, rejections, and compromised product quality. In the context of catheter manufacturing, FM can result from various sources. Still, one major contributor is using traditional “lint-free” wipers during the cleaning and mold release application process.
Cellulose and Polyester fibers from cleanroom “lint-free” polycellulose wipes found on the tip forming station at a catheter manufacturing facility.
Typical Process Flow
Before RF tip formation, the catheter manufacturing process involves cleaning and applying mold release to the pre-tipped extrusion. This is a critical step to ensure smooth and precise tipping. However, using lint-free wipers in this process can introduce FM contamination. Although these wipers are intended to be clean and free from lint, they may still shed microscopic particles that can adhere to the catheter’s surface, leading to defects and rejections.
The Solution: Foamtec’s UltraSORB Foam Wipers
Recognizing the need for a cleaner and more efficient solution, Foamtec developed the UltraSORB foam wipers. These innovative foam wipers are manufactured from a 12-sided interconnected open-cell pore structure, which sets them apart from traditional lint-free wipers. This unique design offers several advantages:
- Reduced FM Contamination: The open-cell sponge wiper’s structure minimizes the shedding of particles, significantly reducing FM contamination during cleaning and mold-release application.
- Even Mold Release Application: Foamtec’s UltraSORB foam wipers evenly apply mold release, ensuring a consistent and controlled layer on the catheter’s surface. This precision contributes to the catheter’s quality and performance.
- Efficient Cleaning: The absorbent properties of the foam wipers allow for efficient cleaning of the catheter’s surface while applying mold release. This dual functionality saves time and resources in the manufacturing process.
When used to clean surfaces, polycellulose and polyester are highly susceptible to shedding.
Leading producers of catheters have already experienced the benefits of using Foamtec’s UltraSORB foam wipers. By replacing traditional lint-free wipers with these advanced foam wipers, they have reported:
- Reduced Reject Rates: The decrease in FM contamination has significantly reduced catheter rejects, resulting in cost savings and improved product quality.
- Increased Productivity: The foam wipers’ efficient cleaning and mold release application capabilities have streamlined the manufacturing process, increasing productivity and throughput.
- Enhanced Reputation: Consistently delivering high-quality catheters with reduced rejects has enhanced the reputation of these leading producers, leading to increased customer trust and loyalty.
In the world of medical device manufacturing, precision and cleanliness are non-negotiable. Foamtec’s UltraSORB foam wipers offer a game-changing solution to the problem of FM contamination in RF catheter tipping operations. Their unique open-cell pore structure reduces contamination, ensures even mold release application, and enhances the overall efficiency of the manufacturing process. By switching to Foamtec’s innovative foam wipers, manufacturers can significantly reduce rejects, increase productivity, and maintain a sterling reputation for producing high-quality catheters.
Learn more about UltraSORB Wipes