Many are Armoloy-coated. Although single-use devices will only be utilized once, doctors, dentists, and the patients who rely on them need the item’s performance to be maximized. For many types of medical instruments, that means applying a biocompatible chromium coating.
ISO 10993-11
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Understanding Pyrogens and Their Impact
Pyrogens are substances—often microbial contaminants—that can cause fever when introduced into the bloodstream or tissues. In industries like medical device manufacturing, pharmaceuticals, and biotechnology, ensuring that materials do not introduce pyrogens is critical for patient safety.
At Armoloy, we provide biocompatible thin dense chrome coatings that undergo USP Pyrogen Testing to confirm their safety and suitability for medical and surgical applications.
What is a Pyrogen Test?
A pyrogen test evaluates whether a material induces a fever response when introduced into a biological system. ME-92 Operations recently conducted a USP Pyrogen Study on our ME-92-coated 304 stainless steel coupons to verify their nonpyrogenic properties.
The study followed United States Pharmacopeia (USP) guidelines and ISO 10993-11: Biological Evaluation of Medical Devices, which ensure compliance with international safety standards.
ME-92 Coating: Proven Nonpyrogenic
In a controlled laboratory setting, the pyrogen test involved:
- Extracting the ME-92-coated stainless steel in a sterile 0.9% sodium chloride solution
- Injecting the extract intravenously into test rabbits
- Monitoring temperature changes over three hours
Results: No Pyrogenic Response
The test concluded that ME-92-coated stainless steel showed no significant temperature increase, meeting USP guidelines for non-pyrogenicity. This confirms that ME-92 coatings do not introduce harmful pyrogens and are safe for use in medical environments.
Why Pyrogen-Free Coatings Matter
Medical devices, implants, and surgical instruments must be free from pyrogen contamination to prevent adverse patient reactions. ME-92’s biocompatible thin dense chrome ensures:
- Pyrogen-free surfaces, reducing infection risks
- Enhanced corrosion resistance for long-term durability
- Biocompatibility, making it ideal for medical and pharmaceutical applications
Other Biocompatibility Standards
Explore more compatibility standards we certify to.
Frequently Asked Questions
Yes, as long as the weld is machined and blended. This is a positive application to consider since a welded area is very susceptible to corrosion during autoclave.
Biocompatible coatings enhance the durability, safety, and performance of surgical instruments by preventing corrosion and wear while ensuring they remain safe for use in the body. To learn more about the key benefits and differences between coating types like BIO-TDC and ME-92, read our full blog here.
A disposable medical instrument must perform as well as a reusable device and even disposable instruments require autoclave prior to use. Disposable instruments experience galling and dulling of edges during their short usage, but still must perform to a high level. The ME-92® biocompatible coating reduces these undesirable occurrences.
Partner With Us
At Armoloy, we specialize in biocompatible coatings that meet the highest industry standards. Our USP-tested, non-pyrogenic coatings help manufacturers ensure safety, compliance, and reliability in critical applications.