Author: Mia

Expanite® receives Master File for Devices (MAF) acknowledgment letter from FDA on their patented process for surface hardening of stainless steel in medical devices applications. and solving some of their challenges with wear on the titanium parts in their racing car.

Expanite announces it has submitted a Master File for Devices (MAF) to the United States Food & Drug Administration (FDA) and has now been issued the submission number MAF3078.

Expanite has successfully submitted a Master File for Devices (MAF) to the Center for Devices and Radiological Health (CDRH) at the FDA for SuperExpanite®, their patented process for surface hardening of stainless steel and received an Acknowledgment letter from FDA confirming submission filing. The MAF covers necessary information such as technology, production processes and facility information, as well as test data and more. The SuperExpanite Master File has been issued submission document control number MAF3078.

“We are very pleased to have achieved this significant milestone. The FDA registration makes it easier for our U.S. customers to obtain approval for new medical products that use Expanite surface hardening. Expanite is now able to provide a signed and named Authorization letter to our customers on their request, for the purpose of their product registrations at FDA. This is the first of many MAFs to come” says Expanite CEO, Thomas Abel Sandholdt.

Benefits of MAF implementation

The advantages of the MAF being submitted at FDA for the manufacturers who utilize Expanite surface hardening technology and register their products at FDA are many e.g.:

• Expanite, individually, invested time to search and understand the FDA requirements for MAF submission
• Documentation compiled, as required, and submission confirmed by FDA.
• Surface hardening technology documentation available for FDA’s review as of now.
• Eliminates communication time and effort between manufacturer and Expanite on MAF build and requirements.
• Expanite responsible to maintain MAF up to date, as appropriate.

Master File for Devices now available

For the manufacturer ‘s medical devices registrations purposes, the SuperExpanite Master File for Devices is now available for reference and review at FDA. Expanite shall provide MAF Authorization letter on customer requests to make Expanite technical documentation available for FDA’s review in context of their product registration.

Please contact Thomas Abel Sandholdt to hear more about the FDA Master File for Devices, SuperExpanite MAF content and request a signed and named Authorization letter for your product registrations.

About Expanite

Expanite offers state-of-the-art solutions for surface hardening treatment of stainless steels and titanium.
With Expanite’s processes, it is possible to increase the material’s surface hardness tenfold while at the
same time maintaining and even increasing its corrosion resistance. Expanite is a global organization with
a combined development and production facility near Copenhagen, Denmark, and hardening capacity in
both US, Germany, Korea and China. Expanite’s solutions are flexible and can be introduced directly into a
customer’s own production line as part of a licensing arrangement. Learn more on www.expanite.com

Expanite, the Danish pioneer within surface hardening of stainless steel and titanium has successfully been ISO9001:2015 certified. In parallel with this certification, Expanite’s quality management system is now also complying with the CQI-9 standard for heat treatment within automotive.

ISO9001:2015 cover the production in all locations

Expanite originally achieved the ISO 9001:2008 certificate in 2013 for its Danish headquarter but with the recertification to the ISO 9001:2015 the scope is extended to cover the production, laboratory, shipping and office facilities in all locations; Germany, US and Denmark.

“We are very proud of being among the first companies to reach the ISO certification according to the 9001:2015 edition. The recertification to the new standard for all our locations marks an important milestone for Expanite; with the certification, our customers can be confident that Expanite is dedicated and committed to maintaining the same high quality in processes, services and procedures no matter where customers are being serviced. Our motivation to obtain the certifications is driven by a desire to meet customer needs and continue to improve customer satisfaction”, says CEO, Thomas Abel Sandholdt.

ISO9001:2008 vs 9001:2015

The most noticeable change to the standard is its new structure is:

• The emphasis on leadership
• The focus on risk management
• Emphasis on objectives measurement and change
• Communication and awareness
• Fewer prescriptive requirements

About Expanite

Expanite offers state-of-the-art solutions for surface hardening treatment of stainless steels and titanium. With Expanite’s processes, it is possible to increase the material’s surface hardness tenfold while at the same time maintaining and even increasing its corrosion resistance. Expanite is a global organization with a combined development and production facility near Copenhagen, Denmark, and hardening capacity in both US, Germany, Korea and China. Expanite’s solutions are flexible and can be introduced directly into a customer’s own production line as part of a licensing arrangement. Learn more on www.expanite.com

Expanite, the Danish specialist in heat treatment and surface hardening of stainless steel and titanium, is thrilled to announce the addition of Thorsten Schild as Business Development Manager. With 25+ years expertise within the field, the appointment of Thorsten Schild will further strengthen Expanite’s commercial and technical service, and thereby support the company’s ambitious growth strategy.

Prior to joining Expanite, Thorsten Schild worked for Bodycote’s S3P division as group sales director, and he was one of co-founders of BorTec-SMT. All-in-all, Thorsten Schild can in many ways be regarded as one the most experienced people within sales and marketing of stainless steel surface hardening. Over more than 25 years, he has assisted countless customers across many industries globally on finding solutions for wear and galling on stainless steel.

As Business Development Manager within Expanite, Thorsten will play a key role in expanding Expanite’s
reach and solidifying the position as a leader in surface hardening solutions. With his extensive industry knowledge and network, he will contribute to the company’s strategic initiatives and drive business growth.

“We are delighted to welcome Thorsten to the Expanite team,” says Thomas Abel Sandholdt, CEO at Expanite. “Combining his proven sales expertise with Expanite’s unique process-related benefits in surface hardening of stainless steel makes it a perfect match. The appointment will reinforce our commitment to deliver cutting-edge solutions and services for all sectors requiring increase protection against wear, galling and corrosion.”

Thorsten Schild already started his role as Business Development Manager at Expanite. and will collaborate closely with the existing team to drive innovation, strengthen customer relationships, and identify new business opportunities.

About Expanite

Expanite offers state-of-the-art solutions for surface hardening treatment of stainless steels and titanium.
With Expanite’s processes, it is possible to increase the material’s surface hardness tenfold while at the
same time maintaining and even increasing its corrosion resistance. Expanite is a global organization with
a combined development and production facility near Copenhagen, Denmark, and hardening capacity in
both US, Germany, Korea and China. Expanite’s solutions are flexible and can be introduced directly into a
customer’s own production line as part of a licensing arrangement. Learn more on www.expanite.com

We’re proud to announce that Expanite – the Danish specialist within surface hardening and heat treatment of stainless steel and titanium – has achieved the ISO 14001 certification.

ISO 14001 has become the international standard for designing and implementing an environmental management system. Companies that achieve the certification have proper procedures in place to measure, reduce and manage their environmental impact.

Audited by TÜV Nord, one the world’s largest inspection, certification and testing organization, Expanite demonstrated that our environmental management system meets the requirements of ISO 14001.

An important milestone for Expanite

The certification requires Expanite to consider all environmental issues relevant to the business, to have a strategy for managing issues, and to continually improve. Since the foundation of Expanite, sustainability and environmental aspects hereof has been a part of our company DNA. Expanite is the leader in sustainable surface hardening solutions – and in this light, the ISO14001 is a very important milestone.

“Sustainability and reducing the environmental impact are important guiding principles of Expanite, principles that we work hard to live up to. We are committed to sustainability and have a responsibility to the communities in which we operate. The completion of the global ISO 14001 certification process is a strong testament to that commitment”, says CEO Thomas Abel Sandholdt.

What is ISO 14004

Any organisation that achieves ISO 14001 certification must consider a wide variety of potential environmental impacts, including air pollution, water and sewage issues, waste management, soil contamination, climate change mitigation and adaptation, resource use and efficiency.

ISO 14001 certification is a guarantee for quality in the environmental management system, and the company’s compliance can be audited. This means anyone doing business with Expanite can be reassured we have procedures in place to measure, reduce and manage our environmental impact.

Setting targets for Expanite’s environmental impact

At Expanite, certification and the active management of our environment management system will ensure that we among other topics will focus on:

• A reduction in the use of resources and materials
• Less waste production (and therefore reduced costs for waste management)
• An increase in the share of renewable resources
• Improve our internal structures to guarantee efficient performance resulting in sustainability
• Pushing the standards for our industry

Finally, the ISO14001 certification is an opportunity to demonstrate to our team, our customers, and the community that we´re committed to the environment. Expanite also holds ISO 9001 certification, and we believe that both ISO certificates reflect our commitment and dedication to working to the highest possible standards in every aspect of our business.

About Expanite

Expanite offers state-of-the-art solutions for surface hardening treatment of stainless steels and titanium.
With Expanite’s processes, it is possible to increase the material’s surface hardness tenfold while at the
same time maintaining and even increasing its corrosion resistance. Expanite is a global organization with
a combined development and production facility near Copenhagen, Denmark, and hardening capacity in
both US, Germany, Korea and China. Expanite’s solutions are flexible and can be introduced directly into a
customer’s own production line as part of a licensing arrangement. Learn more on www.expanite.com

Hydrogen – whether applied in shipping, steel production, refineries or power-to-x application – it has become the energy source of the future, yet already used in many sectors. Due to its special properties, the hydrogen gas poses several technical challenges for the respective components with which it comes into contact, so that the use of corrosion-resistant stainless steel is essential. This in turn is susceptible to wear and galling and this is exactly where the technology of the Danish pioneer for surface hardening of stainless steel and titanium comes into play.

Hydrogen – the element that comes first in the periodic table and is therefore the smallest and lightest atom among all elements – has been traded for some time as the greatest hope for future energy supply. With a mass fraction of about 70%, hydrogen is the most common chemical element in the universe. On Earth, however, its mass fraction is only 0.87% and is largely bound in water.

Starting with production, over to transport ending with the actual usage, wherever hydrogen is involved, stainless steel components are also used, some of which are subject to extreme wear depending on the application and naturally subject to galling. In the past, this problem was countered with traditional wear protection methods and the respective components were protected with a coating (e.g. hard chrome plating, DLC or chrome carbide) or classic plasma nitriding or salt bath diffusion layers. However, these processes are generally known to affect the corrosion resistance of the stainless steel parts negatively.

The solution to this dilemma – a surface hardening that protects against wear and galling while at the same time maintains or even improves the corrosion resistance of the materials was developed by the founders of the Danish company Expanite and is increasingly being used in the hydrogen sector. For example, components of high pressure and control valves or clutch systems used in the hydrogen infrastructure up to components for fuel cells are hardened.

Sustainably prevent hydrogen embrittlement

“Our customers often ask whether the Expanite technology increases the risk of hydrogen embrittlement, which is not the case,” explains Dr. Holger Selg, application expert and Expanite Sales Director DACH, who going further into detail: “The cause of the hydrogen embrittlement can be traced back to the diffusion of the hydrogen into the material, and in theory the Expanite layer acts as a diffusion brake to a certain extent. Charged with nitrogen and carbon, the Expanite surface is harder for the hydrogen to penetrate than an untreated surface”

The gas-based diffusion process from Expanite is significantly more energy-efficient and environmentally friendly than comparable wear protection processes, and thanks to the treatment in a vacuum, no time-consuming cleaning of the parts, e.g. with aggressive chemicals, is necessary after hardening.

The Expanite technology, specially developed for corrosion-resistant materials, offers a solution for austenitic, martensitic, ferritic and duplex stainless steels as well as for expensive nickel-based alloys such as Inconel and Hastelloy. The new special process ExpaniteHard-Ti, which the Expanite team of experts in Denmark has developed to market maturity in recent years, is used for titanium materials.

About Expanite

Expanite offers state-of-the-art solutions for surface hardening treatment of stainless steels and titanium.
With Expanite’s processes, it is possible to increase the material’s surface hardness tenfold while at the
same time maintaining and even increasing its corrosion resistance. Expanite is a global organization with
a combined development and production facility near Copenhagen, Denmark, and hardening capacity in
both US, Germany, Korea and China. Expanite’s solutions are flexible and can be introduced directly into a
customer’s own production line as part of a licensing arrangement.

Engineer Zsolt Pataki wanted to create the ultimate fountain pen using innovative production methods with advanced materials. The result is a fountain pen made from a solid titanium bar for the ultimate weight, look and feel, hardened by ExpaniteHard-Ti to make it long-lasting and virtually unscratchable.

Hunting for the superior scratch resistance

Aerospace engineer Zsolt Pataki got a crazy idea; he wanted to create a unique fountain pen using his experience from aerospace in design, materials, and manufacturing. He chooses titanium grade 23 from the very beginning of the development process, but also knew that he wanted to go further. Mr. Pataki states: “In my search for increased wear resistance of the titanium, I was eager to avoid the hurdles of a coating; adding layers affecting the dimensions combined with the risk of layers chipping off – as I preferred a monolithic design with the original titanium surface instead of a coating”.

In the search for alternatives to coating, Mr. Pataki attended a webinar with Expanite presenting their unique hardening solution for titanium. “I soon realized that the ExpaniteHard-Ti process was the only matured and commercially available interstitial hardening technology for titanium. The webinar combined with the details of the technology on their web site helped me to develop realistic expectations and I reached out to them”, Mr. Pataki continues.

The solution

The ExpaniteHard-Ti process provides highly effective protection against wear and scratches. The method is not a coating process, hence all the drawbacks of coatings, including the risks of chipping/spalling off and inconsistencies in layers are completely avoided. In fact, it is the surface of the material itself, which is hardened. The ExpaniteHard-Ti process has a significantly greater level of protection against scratches than that afforded by the hardness of the base material and the hardened parts retains the design colour or as Mr. Pataki describe it: “I tried hard to scratch the pen after the process, but it is practically impossible – I made before and after comparison and the results are spectacular; the pen is now virtually unscratchable”

Professional knowledge sharing

Through the dialogue with the Expanite team, the optimal solution to increase scratch resistance of the fountain pen was found – Mr. Pataki states: “Throughout the whole process, the Expanite team has been very supportive and open to discuss questions and possible issues ensuring that I got exactly the solution that suited my requirements for the pens and the fact that the results were much better than advertised in terms of case depth of the hardened zone!” The ExpaniteHard-Ti process provides highly effective protection against wear and scratches.

About Capillaris

Capillaris was founded by aerospace engineer Zsolt Pataki. Working from his workshop in Budapest,
Hungary he created each sole piece of the fountain pen carved out of solid titanium himself. The
concept features a lightweight monolithic construction pen with continuous outer contour and
hexagonal sides reminiscent of a supersonic airfoil which enables the pen to lay stable on a desk. Visit
www.capillaris.eu for more.

About Expanite

Expanite offers state-of-the-art solutions for surface hardening treatment of stainless steels and titanium.
With Expanite’s processes, it is possible to increase the material’s surface hardness tenfold while at the
same time maintaining and even increasing its corrosion resistance. Expanite is a global organization with
a combined development and production facility near Copenhagen, Denmark, and hardening capacity in
both US, Germany, Korea and China. Expanite’s solutions are flexible and can be introduced directly into a
customer’s own production line as part of a licensing arrangement.