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Foamtec’s CleanWIPE ISO 7 Foam Wipes: Revolutionizing FM Contamination Control in Medical Device Manufacturing Facilities

by | Feb 20, 2024

Introduction:
Foreign material (FM) contamination persists in medical device manufacturing facilities, leading to rejected devices and costly rework processes. Extensive research has shown that fabric-based “lint-free” wipers, often used in cleanrooms, contribute significantly to FM contamination. However, Foamtec’s CleanWIPE ISO7 foam wipers provide an innovative polyurethane foam construction solution that eliminates particle shedding during wiping. This blog will explore how CleanWIPE foam wipers can drastically reduce FM contamination, simplify the qualification process, and enhance cost-effectiveness in medical device manufacturing facilities.


The Challenge of FM Contamination:
FM contamination poses a significant challenge in medical device manufacturing, with fabric-based “lint-free” wipers identified as a significant source of contamination. These wipers, made from non-woven polycellulose or polypropylene materials, shed particles during wiping, contributing to FM contamination in critical areas such as the gowning room. This contamination leads to device rejection and necessitates time-consuming and costly rework processes.

The Costly Nature of Rework:
Reworking devices to address FM contamination is labor-intensive and time-consuming. Manual processes involving foam swabs or tweezers are often employed to remove fibers and particles from the devices. However, due to the manual nature of rework, eliminating the source of fibers is much more cost-effective. This is where CleanWIPE foam wipers offer a significant advantage over fabric-based alternatives.

The Solution: CleanWIPE ISO7 Foam Wipers:
Foamtec’s CleanWIPE ISO7 foam wipers provide an innovative solution to FM contamination, specifically designed to address particle shedding during wiping. Unlike fabric-based “lint-free” wipers, CleanWIPE foam wipers are constructed with polyurethane foam, ensuring they do not shed particles during use. This unique feature sets CleanWIPE foam wipers apart and makes them an ideal choice for reducing FM contamination in medical device manufacturing facilities.

Advantages of CleanWIPE Foam Wipers:
1. Particle-Free Wiping: CleanWIPE foam wipers, constructed with polyurethane foam, do not shed particles during wiping. This ensures that the wiping process does not contribute to FM contamination, significantly reducing the risk of rejected devices.

2. Simplified Qualification Process: CleanWIPE foam wipers, utilizing the same 100 PPI polyurethane foam as foam swabs, streamline the qualification process. Their consistent material composition simplifies compatibility assessments, making it easier and more cost-effective for facilities to adopt these wipers.

3. ISO10993 Certification and ISO7 Cleanroom Processing: CleanWIPE foam wipers are entirely ISO10993 certified, ensuring their compliance with biocompatibility standards. Additionally, they are processed in an ISO7 cleanroom environment, maintaining strict quality control measures to minimize contamination risks during manufacturing.

Conclusion:
Foreign material contamination remains a significant challenge in medical device manufacturing facilities. However, Foamtec’s CleanWIPE ISO7 foam wipers offer a groundbreaking solution by eliminating particle shedding during wiping. Unlike fabric-based “lint-free” wipers, CleanWIPE foam wipers, constructed with polyurethane foam, drastically reduce FM contamination risks. These wipers simplify the qualification process, as their material consistency is akin to foam swabs. With ISO10993 certification and ISO7 cleanroom processing, CleanWIPE foam wipers ensure the highest quality and performance standards. By adopting CleanWIPE foam wipers, medical device manufacturing facilities can significantly reduce rejected devices, streamline processes, and increase cost-effectiveness. Embracing this change is crucial to revolutionizing FM contamination control in the industry.

Learn more about CleanWIPE Cleanroom Foam Wipes: