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Selecting the Right Cleanroom Wiper for Medical Device Production Facilities

by | Feb 1, 2023

Medical device production facilities require strict control of bioburdens and environmental contamination to ensure the safety and quality of implantable medical devices. The selection of the right cleanroom wiper is crucial in maintaining a clean and controlled environment in these facilities.

When choosing a cleanroom wiper for use in medical device production facilities, it is important to consider the following key characteristics:

  1. Particle Shedding: Medical device production requires a wiper that does not shed particles during use. Many cleanroom wipers are marketed as “lint-free”, however, they often shed fibers that are larger than 30 microns, which can lead to rejects during visual inspection and compromise the integrity of the medical device.
  2. Lint-free Quality: To ensure that the wiper does not contribute to particle contamination, it must be truly lint-free. The wiper should be free of loose fibers, nubs, and other contaminants that can transfer to the device or tooling during use.
  3. Absorption: A cleanroom wiper should have good absorbency to effectively clean and remove contaminants from work surfaces and tooling.
  4. Softness: The wiper should be soft enough to avoid damaging the surface of the medical device or tooling, yet durable enough to withstand repeated use.
  5. Compatibility: The wiper should be compatible with the cleaning solutions used in the cleanroom to avoid any adverse reactions or additional contamination.
  6. Packaging: The wiper should be packaged in a manner that prevents contamination, such as being vacuum-sealed or individually wrapped.
  7. Bioburdens: The wiper should be low in bioburdens and should be able to provide a 3-log reduction of micro-organisms on surfaces when wetted with 70% isopropyl alcohol.

Polycellulose Wipe before and after use

Polyester Wipe before and after use

While polyester and polycellulose cleanroom wipers are considered “lint-free”, FM studies carried at numerous medical device manufacturing sites have shown that most fiber-based particulates on rejected devices originates these wipers. Below are examples of FM studies showing that device rejects originate with current generation “lint-free” wipers.

Foamtec has pioneered the development and manufacturing of foam and microfiber wipers that are designed from the ground up to resist generating particles when subjected to abrasion loads typical of wiping.

UltraSORB® is constructed from hydrophilic, open-cell foam sponge for cleanroom wiping applications that require high absorbency. Unlike fabric wipers, UltraSORB’s polyurethane foam construction eliminates the shedding of fibers and FM (particles > 25μm) to the cleanroom, making it ideal for medical device applications.

MiraWIPE® is a woven cleanroom microfiber wiper that enhances absorbency and foreign particle contamination removal versus traditional polyester wipers. The high-density, super smooth woven polyester/nylon fabric minimizes the shedding of submicron particulates and practically eliminates shedding of > .50 micron FM from the face of the wiper when used in heavy-duty equipment cleaning tasks. The non-stretch fabric and ultrasonic sealed edge will not split during use eliminating a major source of particle generation. MiraWIPE’s non-symmetrical microfiber structure enables stubbornly adhered contamination to be dislodged, entrapped and removed product contact surfaces and components.

UltraSORB Wipe before and after use

MiraWIPE Wipe before and after use

By considering these key characteristics when selecting a cleanroom wiper, medical device production facilities can ensure that their work surfaces and tooling remain clean and free of contaminants, reducing the risk of rejects and maintaining regulatory compliance.

In conclusion, the selection of a cleanroom wiper for use in medical device production facilities requires careful consideration of several critical characteristics. It is important to choose a wiper that does not shed particles, is truly lint-free, has good absorbency, is soft yet durable, is compatible with cleaning solutions, and is packaged appropriately to prevent contamination.

Polycellulose Vs. UltraSORB® Abrasion Comparison Video

Polyester Vs. MiraWIPE® Abrasion Comparison Video

UltraSORB® Product Page

MiraWIPE® Product Page

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