Color anodized aluminum is widely used in the medical device industry. Whether it is used for a tool handle or a tray, repeat-use devices must undergo regular cleaning and sterilization treatments and it’s important that the original finish be preserved.
Several types of sterilization methods are in use today, but those which incorporate hydrogen peroxide injection are particularly challenging for a color anodized finish to endure. Fading or significant discoloration typically occurs after only a few sterilization cycles. STERRAD systems use low-temperature, hydrogen peroxide gas plasma technology to sterilize instruments and medical devices safely and effectively.
However recent studies have demonstrated that, using the correct sealing technology, inorganic dyed coatings can be produced to withstand 100 such cycles with no noticeable effect.
With the proper selection of dyes and sealants, anodizers now have the capability to meet the demands of the expanding medical device industry.
This post was submitted by Mark Jozefowicz, VP – Technical Services for Reliant Aluminum Products.
Promoting the use of anodized aluminum to the general public, to academia, and to end-users worldwide.
Great! To guarantee that great quality affirmation practices are utilized for the design of medical devices and that they are steady with quality framework necessities around the world, the Food and Drug Administration amended the Current Good Manufacturing Practice (CGMP) prerequisites by fusing them into the Quality System Regulation, 21 CFR Part 820. A paramount segment of the correction is the expansion of design controls. thanks!
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