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Unveiling the Hidden Culprits: The Impact of Work Surface Particles on Medical Device Quality

by | Aug 17, 2023

Introduction:
When it comes to ensuring the utmost quality and safety of medical devices, meticulous attention to detail is essential. While operators have long been considered the primary source of particles in medical device facilities, recent research suggests that work surface particles play a significant role in the overall contamination levels. In this blog, we will explore the importance of addressing work surface particles and how Foamtec’s innovative PolyCHECK® sampling and verification wiper has revolutionized the identification and management of particle sources in over 100 medical device facilities.

Understanding the Particle Size Threshold:
Particles in the air within medical device facilities can have varying size distributions, ranging from larger particles to those that are microscopic. However, not all particles pose the same level of risk to device quality. Research indicates that particles measuring 25 microns and larger are of utmost concern. These larger particles are more likely to compromise the integrity of medical devices and increase the risk of contamination-related issues.

The Role of Work Surface Particles:
While operators may generate a significant number of particles, it is crucial to recognize that most of these particles are smaller than 5 microns. Although these smaller particles can impact bio burdens, they are well below the size threshold required to negatively affect device quality. Therefore, it becomes evident that work surface particles play a more substantial role in contributing to particles of concern (25 microns and larger) in medical device facilities.

Foamtec’s PolyCHECK® Sampling and Verification Wiper:
To combat the challenges posed by work surface particles, Foamtec has developed an innovative solution: the PolyCHECK® sampling and verification wiper. This groundbreaking technology has been successfully implemented in over 100 medical device facilities, empowering quality engineers to accurately characterize the sources of FM contamination.

By utilizing the PolyCHECK® sampling and verification wiper, medical device facilities gain invaluable insights into the specific areas and processes that contribute to particle contamination. This enables them to pinpoint the sources and take targeted corrective actions, improving device quality and reducing contamination risks.

Benefits of PolyCHECK® Sampling and Verification Wiper:
1. Precise Source Identification: The PolyCHECK® wiper allows quality engineers to identify the exact work surfaces and processes contributing to concerning particles, enabling focused remediation efforts.

2. Enhanced Contamination Control: By understanding the sources of FM contamination, medical device facilities can implement effective preventive measures, reducing the risk of device quality compromise and associated regulatory issues.

3. Optimized Cleaning Protocols: Armed with accurate data from the PolyCHECK® wiper, facilities can fine-tune their cleaning protocols to address specific areas prone to particle buildup, minimizing the potential for future contamination events.

Conclusion:
Recognizing the significance of work surface particles in medical device facilities is crucial for maintaining optimal device quality and patient safety. Foamtec’s PolyCHECK® sampling and verification wiper has emerged as a game-changer, allowing quality engineers to identify and address the sources of FM contamination with precision. By leveraging this innovative technology, medical device facilities can enhance their contamination control strategies, minimize risks, and ultimately deliver superior-quality devices to the market.

Remember, when it comes to particle contamination, every effort counts in ensuring the well-being of patients and the success of medical device manufacturers.

Learn more about Foamtec’s PolyCHECK® Sampling and Verification Wipe:

https://www.foamtecintlwcc.com/products/cleanroom-wipes/cleaning-validation/polycheck-wiper