Sandvik’s new powder plant in Sweden recently received the ‘ISO 13485:2016’ medical certification for Osprey titanium powders, now approved for use in the additive manufacturing of medical applications.
Sandvik’s titanium powder plant, located in Sandviken Sweden, was inaugurated in 2019. Since then extensive work has been ongoing to ramp-up the automated plant, finetuning the process and optimizing the powder to ensure consistency, morphology and quality required for additive manufacturing. As a result, the ’ISO 13485:2016’ certification for medical was recently received in August. Earlier this year, the same powder plant also achieved the prestigious ‘AS9100D’ aerospace certification.
This 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.
Sandvik 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 atomization 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.
Titanium has exceptional material properties, being strong yet light and offering high levels of corrosion resistance. At the same time, it is biocompatible. However, the cost and complexity of machining from titanium billet have historically restricted its use. Additive manufacturing opens up new opportunities.
The first two powders produced at the plant will be Osprey Ti-6Al-4V Grade 5 and Osprey Ti-6Al-4V Grade 23. Other alloys are available on request. In addition to the ISO 13485:2016 and AS9100D certifications, the new titanium powder plant is also certified according to ISO 9001, ISO 14001 and ISO 45001.