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Selecting a Cleanroom Wiper that Meets Both Particle and ISO 10993 Biocompatibility Requirements for Use in Medical Device Manufacturing

by | Feb 14, 2023

When producing long-term medical implants, selecting the right cleanroom wiper is critical to ensure the product is free of particulate contamination, pyrogens, and cytotoxic agents. Medical implants are inspected for particles and are subject to rejection or rework for particle contamination above 20 microns in size. With so much at stake, choosing the right wiper is essential to maintain the highest cleanliness levels and compliance with ISO 10993 standards.

In medical device manufacturing, it is common to use polyester fabric or non-woven “lint-free” cleanroom wipers. However, fabric wipers are exposed to water during the wash cycle, which can lead to endotoxin contamination. Endotoxins are a type of pyrogen that can cause fever and other adverse reactions in patients. Stringent process controls and pyrogen-free water are a must to produce pyrogen-free wipers.

Non-woven wipers, constructed of Polycellulose, are another popular choice for cleanroom wiping. However, they tend to shed large volumes of fibers and particles during use, many of which are greater than 100 microns in size. This can pose a severe risk to patients, as these particles can enter the body and cause harm.

20x Photo Micrograph of Polyester Wipe before and after use

20x Photo Micrograph of Polycellulose Wipe before and after use

Many medical device manufacturers have adopted cleanroom foam and microfiber wipers to address the need to control particles and meet ISO10993 standards. These wipers are designed from the ground up to be ISO10993 compatible and to shed significantly fewer particles during wiping. This makes them a much safer choice for medical device production.

Polyurethane Foam’s 12 sided flexible cell spread out the load imparted to the wiper during use to prevent abrasion generated fibers. The open pores also entrap and remove particle contamination.

Constructed from an open cell polyurethane foam with 12 interconnecting struts, cleanroom foam wipers are specifically designed to provide abrasion resistance during wiping. Moreover, the open pores are a magnet for particle contamination. The foam is produced in a controlled environment to ensure it meets strict cleanliness and particulate standards. Microfiber wipers, on the other hand, are made from synthetic fibers designed to trap and hold particles rather than shedding them. This makes them an ideal choice for critical cleaning tasks in the medical device industry.

20x Photo Micrograph of UltraSORB Wipes before and after use

20x Photo Micrograph of MiraWIPE – Microfiber Wipes before and after use

When selecting a cleanroom wiper for medical device production, it’s essential to consider a range of factors, including particle shedding, material compatibility, and overall cleanliness. Cleanroom foam and microfiber wipers offer superior performance in these areas, making them the best choice for producing safe and reliable medical implants. By choosing the right wiper, manufacturers can ensure their products meet the highest cleanliness and safety standards while avoiding costly rework and rejection due to particle contamination.

For more information:

UltraSORB Wipes

MiraWIPE Microfiber Wipes

For questions or inquiries