Sandvik Additive Manufacturing, a division of Sandvik AB, headquartered in Stockholm, Sweden, reports that its new titanium powder plant in Sandviken, Sweden, has received ISO 13485:2016 medical certification for its Osprey titanium powders. This now means its titanium powder is approved for use in the Additive Manufacturing of medical applications.
The company’s titanium powder plant was inaugurated at the end of 2019, and since then, Sandvik states that extensive work has been ongoing to ramp-up the highly automated plant. This has included fine tuning the process and optimising the powder to ensure the best possible consistency, morphology and quality required for AM. Earlier in the year, the powder plant also achieved the AS9100D aerospace certification.
“Achieving the ISO 13485:2016 medical certification will allow our medical customers to complete the necessary regulatory supplier approvals when bringing a medical application to market, utilising Osprey titanium powders from Sandvik,” stated Keith Murray, VP and Head of Global Sales at Sandvik Additive Manufacturing.
According to the company, the properties of the metal powders used directly impact the reliability of the performance of the AM-process, as well as the quality and performance of the finished product. The medical certification ensures that best practices and continuous improvement techniques – including the company’s development, manufacturing, and testing capabilities – are leveraged during all stages of the powder lifecycle, resulting in a safer medical device.
Murray added, “In Additive Manufacturing it is essential to use high-quality metal powders with consistent quality, adapted to the different additive manufacturing processes. Sandvik’s highly automated manufacturing process ensures excellent consistency.”
Product traceability is especially important in the medical industry and Sandvik explains that it offers complete traceability for its titanium powder, made possible by having the full supply chain in-house – from titanium sponge to finished powder.
The new titanium powder process uses advanced electrode induction melting inert gas atomisation technology to produce highly consistent and repeatable titanium powder with low oxygen and nitrogen levels. The production facility also includes dedicated downstream sieving, blending and packing facilities – integrated through the use of industrial robotics.
The powder plant is located next to Sandvik’s Additive Manufacturing facility in Sandviken, Sweden, which includes all relevant metal AM processes. This means that Sandvik can tailor the powder to different Additive Manufacturing processes on the same site, states the company.
The first two powders produced at the plant will be Osprey Ti-6Al-4V Grade 5 and Osprey Ti-6Al-4V Grade 23.
“Now we are one of few metal powder and Additive Manufacturing companies that holds both the AS9100D quality certification for aerospace and the ISO 13485:2016 certification for medical. This will facilitate many customer collaborations going forward. Imagine what 158 years of leading materials expertise can do for your additive process,” Murray concluded.