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Traditionally, stainless steels were thought to be the only material that would meet FDA approval for manufacturing biocompatible medical devices. However, innovations in die casting surface treatments allow medical manufacturers to choose among a variety of specialized coatings and surface finishes to meet the Rigourous testing and validation required by the FDA/EMEA. Today, you don’t have to limit your material choice to one or two options. With Dynacast surface treatments, you can take advantage of the speed and cost savings of zinc multi-slide or our thin wall Aluminium casting while still remaining compliant with the FDA.
Anodized Aluminium for medical castings
Aluminium is often chosen in many applications for its weight to strength ratio, relatively low manufacturing cost, and ability to be Coloured, all while maintaining a high degree of thermal conductivity. Medical and healthcare manufacturers can take advantage of the benefits of Aluminium for external medical applications by utilizing surface finishes for optimal biocompatibility.
In the medical industry, the process of anodizing Aluminium is often an important first step that allows for other necessary surface treatments and enhances the material’s durability and corrosion resistance. Anodizing is an environmentally safe electrochemical process that changes the surface of Aluminium into a porous Aluminium oxide, creating an end product whose finish is more receptive to Colouring or protective coating, like parylene. In healthcare, this means that anodized Aluminium medical equipment will last longer and be made to pass biocompatibility regulations.
Parylene Surface Finish
Parylene has been used as a stable surface treatment for medical equipment for decades. The reliable protective coating is biocompatible and conforms to the USP Class VI and ISO 10993 standards. It is transparent, pin-hole free, and conforms exactly to any surface’s features. Parylene coats extremely consistently and thinly (as thin as 0.0005”), providing coverage in even the most complex geometries, and adds very little weight or volume.
These features make parylene an ideal coating for zinc and Aluminium die cast medical components. The die casting process offers many advantages over machined components, such as unmatched strength and precision, as well as cost savings. The addition of parylene allows medical manufacturers to take advantage of the benefits of die casting without sacrificing compliance or complexity.
E-Coating and conversion coating (Chem film)
Conversion coating, or chem film, is an FDA/NSA approved treatment process for Aluminium medical components. Conversion coating produces a conductive protective coating without any dimensional change, and enhances corrosion resistance while also improving adhesion for paint finishes. E-coating provides medical devices with a cosmetic finish and extra layer of protection. Much like anodizing, e-coating and conversion coating surface treatment extends the durability of medical equipment while also meeting FDA regulations. And like parylene, conversion coating is extremely thin (with thickness of less than .000001”), so you don’t have to sacrifice complex geometry.
Want to see e-coating and conversion coating at work? Check out this portable oxygen concentrator.
Improving your surface finish with Dynacast
It’s the healthcare provider’s job to improve the patient’s condition, and it’s the job of the medical manufacturer to improve the tools used to best serve the patient. Depending on your project requirements, there are several biocompatible surface treatments and finishes to choose from that allow you to take advantage of the die casting process and alloys.
While anodized Aluminium, parylene, and conversion coating are great options for metal medical components that need to be more highly biocompatible, there are several other options available for parts with less stringent regulations. At Dynacast, we have experience solving problems and engineering solutions for the medical industry, including streamlining FDA validation.
Could your medical product benefit from converting to die casting? Contact our engineering team to learn more about the process and solutions we’ve offered in the past.
If you’re interested in learning about the array of surface treatment options offered at Dynacast and expert tips for process control, download our on-demand webinar Surface Finish 101 here!