Solving Foreign Material Contamination in Neurostimulator Manufacturing with PolyCHECK Surface Sampling
by Foamtec WCC | Jun 19, 2025 | cleanroom wipes, foreign particle contamination, Medical Device
Liquid silicone rubber (LSR) over-molding is critical for producing biocompatible and reliable neurostimulator components, such as leads and connectors. However, foreign material (FM) contamination—particulates, fibers, residue, or molding flash—remains a persistent...
Solving FM Contamination Issues in Medical Device Facilities: The Challenges and How Foamtec’s PolyCHECK® Process Can Help
by Foamtec WCC | Oct 9, 2024 | cleanroom wipes, Medical Device, particle identification
Controlling foreign material (FM) contamination in medical device manufacturing is critical. FM is often the leading cause of rejects and rework in many facilities. However, identifying the root cause of particle contamination is often a complex and frustrating task....
Tackling FM-related CAPAs in the Medical Devices Industry: A Foamtec International Perspective
by Foamtec | Jun 8, 2023 | cleanroom cleaning, foreign particle contamination, particle identification, Swabs
Today, we are going to talk about an essential aspect in the medical devices industry: FM-related Corrective and Preventive Actions, commonly known as CAPAs. As a renowned global leader, Foamtec International is at the forefront of addressing this significant concern,...
How to Close FM Related CAPAs with a Root Cause Solution
by Foamtec | Feb 24, 2023 | cleanroom cleaning, foreign particle contamination, Medical Device, particle control
In the world of medical device manufacturing, the term CAPA (Corrective and Preventive Action) is a crucial one. It refers to the process by which companies investigate and address quality issues, aiming to not only fix them but also prevent them from happening again...