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How to Reduce Particle Rejects in the Manufacturing of Silicone-Based Medical Devices

by | May 1, 2023

The medical device industry goes to great lengths to ensure its products are safe and reliable for patient use. However, despite following strict guidelines for production and assembly, particle contamination remains a significant issue.

Particle defects commonly cause rejected devices, even when the airborne particle count is within specifications. This has led to the need for more precise methods of identifying and eliminating root causes of contamination in medical device facilities.

Below are images showing fiber contamination coming from the medical device facility’s cleanroom “lint-free” wipers.

Silicone elastomers, extrusions, molded parts, epoxies, and oils manufacture medical devices such as catheters, cosmetic implants, neurological shunts, syringes, and leads. These materials are highly susceptible to particle contamination, leading to device failure and rejection. The rejection of these devices not only causes financial loss to the manufacturer but can also harm patient health.

Several prominent medical device firms have turned to Foamtec’s innovative PolyCHECK particle identification system to combat this issue. This system allows for quick and economical sampling of surfaces to identify root sources of particle contamination. Particles greater than 25 microns have the mass to resist becoming airborne. Since silicone is highly mobile and attracts particles, all equipment and cleanroom surfaces become reservoirs for particles not registered by in-line airborne particle counters.

The PolyCHECK system can quickly and accurately identify these particles and enable quality engineers to understand and eliminate the root cause sources of particle contamination. This innovative system has proven to be a game-changer in the medical device industry, allowing for better quality control and improved patient safety.

In conclusion, the need to sample equipment surfaces in medical device facilities that employ silicones is essential to eliminate particle defects in devices. The PolyCHECK particle identification system provides a reliable and efficient method for identifying root sources of particle contamination, allowing for better quality control and improved patient safety. The use of this system in the medical device industry clearly indicates the importance of innovation in addressing critical issues that impact patient health and safety.

Learn more about the PolyCHECK Particle Identification System

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