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Choosing the Right Cleanroom Wiper: Crucial Considerations for Medical Balloon Formation and Catheter Assembly

by | Mar 6, 2024

In the world of medical devices, precision and cleanliness are paramount. This holds especially true for delicate procedures like balloon formation and catheter assembly, where even particle contamination ( FM) can compromise the integrity and safety of the final product. Selecting the right cleanroom wiper is vital in ensuring a contamination-free environment, crucial for successful device production, meeting stringent regulations like ISO 10993, and minimizing costly rejections.

The Challenge of Foreign Material Detection:

Balloon formation and catheter assembly operations involve extensive inspection for foreign material (FM), which can be incredibly challenging due to:

  • Opaque plastics: The prevalent use of opaque plastics in these devices makes distinguishing FM, especially fibers shed, from traditional cleanroom wipers challenging.
  • “Lint-free” misnomer: Extensive research using Foamtec’s PolyCHECK process has revealed that even so-called “lint-free” cleanroom polyester and non-woven wipers are most often the primary source of fiber contamination in medical device manufacturing cleanrooms. These seemingly harmless fibers can escape detection during inspection, leading to:
    1. Slowed down production: Meticulous inspection for hidden fibers significantly extends production times.
    2. Increased device rejections: Undetected fibers can lodge in welds and bonds, compromising the device’s integrity and leading to product recalls and costly rejections.

Critical Considerations for Wiper Selection:

Particle Control, Conformability, and Visibility:

    1. Absolute non-shedding: The wiper should release minimal to zero particles during use to prevent contamination of critical components. Look for wipers with materials proven to be non-shedding through rigorous testing methods like Foamtec’s PolyCHECK process.
    2. High absorbency and 360-degree conformability: Choose wipers with superior liquid absorption capabilities and a flexible design that can easily conform to the entire 360-degree circumference of the catheter and balloon components. This ensures effective cleaning, as complete contact with the device is essential to remove contamination.

Surface Compatibility and Tribocharging Prevention:

    1. Material selection: Opt for wipers designed for compatibility with various plastics used in balloon catheters, such as Nylon, PEBAX, and PU. Incompatible materials can cause tribocharging, where friction between surfaces generates static electricity, attracting and adhering particles. Look for wipers with anti-static properties to further minimize this risk.
    2. Minimal abrasion: The wiper material should be soft, non-abrasive, and gentle on plastic surfaces to avoid scratching or damaging the delicate balloon, which could compromise its functionality and integrity.

Cleanroom Compatibility and User Comfort:

      1. Certificate of lot analysis: Look for wipers with published specifications, not just typical values for contamination, and are backed up with lot certifications.
      2. Ergonomic design: The wiper should be comfortable to hold and use for extended periods, minimizing fatigue and potential operator error.
      3. Efficient cleaning: Opt for wipers with appropriate size and shape to facilitate efficient cleaning of various catheter components and tight spaces while delivering uniform volumes of cleaning solution (usually 70% IPA) during use.

Biocompatibility and Regulatory Compliance:

        1. Cytotoxin-free and pyrogen-free: Select wipers free of cytotoxins and pyrogens, which can harm or trigger adverse reactions in human cells.
        2. Static dissipative: Choose static dissipative wipers to prevent tribocharging of the plastic surfaces being cleaned.
        3. ISO 10993 compliance: Ensure the wipers comply with ISO 10993 standards, guarantee biocompatibility and minimize the risk of adverse biological reactions upon contact with the human body.


Conclusion:

Choosing the right cleanroom wiper for medical balloon formation and catheter assembly requires careful consideration of several factors. By prioritizing the above criteria, you can ensure a clean and safe environment for producing high-quality medical devices. Over and over, device engineers find that a small investment in the right wiper can significantly impact the overall quality and success of your medical device production process.

Ready to find the perfect wiper for your critical cleaning needs? Foamtec offers two industry-leading solutions ideal for medical device manufacturing:

  • MiraWIPE: These cleanroom-grade microfiber wipers are renowned for their exceptional non-shedding characteristics, 360-degree conformability, and compatibility with various plastics.
  • UltraSORB: Constructed from a highly absorbent, non-linting polyurethane foam, UltraSORB wipers deliver superior particle entrapment and minimal fiber shedding, ideal for cleaning delicate components and preventing tribocharging.

Visit our website to learn more about MiraWIPE and UltraSORB, and discover how Foamtec can help you achieve optimal cleanliness in your medical device manufacturing facility:

UltraSORB®

MiraWIPE®