BioDur® 108, A Nickel-Free, Cobalt-Free Alternative to 316/316L

What is BioDur® 108?

BioDur® 108 is an  innovative material designed to meet the demanding requirements of biomedical applications, particularly in the medical and industrial industries.

Traditional implant materials such as stainless steel and titanium alloys can sometimes pose challenges in terms of wear resistance, fatigue strength, and biocompatibility. BioDur® 108 addresses these challenges by offering a unique combination of properties tailored specifically for biomedical applications. One of its key features is its exceptional corrosion resistance, which helps prevent degradation over time when exposed to bodily fluids and other corrosive environments. Corrosion resistance is essential for implants intended for long-term use, as it helps ensure the longevity and reliability of the implant.

BioDur® 108 exhibits high strength and toughness, making it suitable for load-bearing applications such as hip and knee implants. Its mechanical properties are carefully engineered to mimic those of natural bone, reducing the risk of stress shielding and other complications that arise from mismatched stiffness between the implant and surrounding tissue.

It is designed to be highly biocompatible, meaning it is well-tolerated by the body and does not elicit an adverse immune response. This is important for ensuring the long-term success of orthopedic implants, as it minimizes the risk of rejection or other complications.

Medical Applications

BioDur® 108's unique combination of properties makes it well-suited for a range of medical applications, where durability, biocompatibility, and corrosion resistance are significant factors. Below are some of the medical applications of BioDur® 108:

Orthopedic Implants: One of the primary applications of BioDur® 108 is in the manufacturing of orthopedic implants, such as hip and knee replacements. These implants require materials that can withstand the demanding mechanical loads and corrosive environments within the human body. BioDur® 108's high strength, toughness, and corrosion resistance make it an excellent choice for these load-bearing applications.

Dental Implants: Dental implants are used to replace missing teeth and restore oral function and aesthetics. BioDur® 108's biocompatibility and corrosion resistance make it suitable for use in dental implants, where it can withstand the harsh conditions of the oral environment while providing long-lasting support.

Bone Plates and Screws: BioDur® 108 is also used in the manufacturing of bone plates, screws, and other fixation devices used in orthopedic surgery. These devices are used to stabilize fractures and facilitate the healing process. The corrosion resistance of BioDur® 108 ensures that these implants remain stable and intact during the healing process, reducing the risk of complications.

Spinal Implants: Spinal implants, such as rods, screws, and cages, are used in spinal fusion surgeries to stabilize the spine and relieve pain. BioDur® 108's high strength and fatigue resistance make it suitable for use in these implants, where it can withstand the mechanical stresses and strains experienced by the spine.

Surgical Instruments: BioDur® 108 is also used in the manufacturing of surgical instruments, such as forceps, scissors, and retractors. Its corrosion resistance ensures that these instruments remain sterile and functional throughout their lifespan, reducing the risk of contamination and infection during surgery.

Cardiovascular Devices: In some cases, BioDur® 108 may also find applications in cardiovascular devices such as stents and pacemaker components. Its corrosion resistance and biocompatibility make it suitable for use in these devices, where it can withstand the corrosive and dynamic conditions of the cardiovascular system.

Industrial Applications 

BioDur® 108 showcases a plethora of industrial applications owing to its properties, such as corrosion resistance, strength, and durability. Here are some of the key industrial applications of BioDur 108:

Aerospace Components: BioDur® 108 is used in aerospace applications where materials must withstand harsh environmental conditions, including high temperatures, corrosive atmospheres, and mechanical stress. Components such as engine parts, turbine blades, and structural elements benefit from BioDur® 108's combination of strength and corrosion resistance, contributing to the reliability and longevity of aerospace systems.

Oil and Gas Equipment: In the oil and gas industry, equipment operates in demanding conditions, including exposure to corrosive fluids and high-pressure environments. BioDur 108's corrosion resistance makes it suitable for components such as valves, fittings, and downhole tools, which helps prolong equipment life and reduce maintenance costs.

Chemical Processing: Chemical processing facilities often handle corrosive substances and operate at high temperatures and pressures. BioDur® 108's resistance to corrosion makes it an ideal choice for equipment such as reactors, heat exchangers, and piping systems in chemical plants, where it ensures reliable performance and long-term durability.

Marine Equipment: BioDur® 108's resistance to corrosion makes it well-suited for marine applications where equipment is exposed to seawater and other corrosive elements. Components such as marine valves, fittings, and propeller shafts benefit from BioDur 108's durability and longevity, reducing maintenance requirements and extending service life.

Power Generation: In power generation facilities, components such as turbines, generators, and heat exchangers are subject to high temperatures, pressures, and corrosive environments. BioDur® 108's strength and corrosion resistance make it suitable for use in these applications, where it contributes to the efficiency and reliability of power generation systems.

Automotive and Transportation: BioDur® 108 may find niche applications in automotive and transportation industries, particularly in components exposed to corrosive environments or requiring high strength and durability. Examples include exhaust systems, engine components, and transmission parts, where BioDur® 108 enhances performance and longevity.

 

The Electro-Slag Remelting (ESR) Process

The Electro-Slag Remelting (ESR) process is a specialized method used in metallurgy to refine and produce high-quality ingots of various alloys, particularly stainless steels, tool steels, and high-temperature alloys. It's a crucial step in the manufacturing process of materials destined for applications in industries such as aerospace, automotive, energy, and more.

Process Overview

Preparation of Electrodes: The process begins with the preparation of consumable electrodes made from the desired alloy. These electrodes are typically cylindrical in shape and are placed vertically within a water-cooled mold.

Initiation of the Process: The mold is filled with a layer of powdered flux, which serves multiple purposes. It helps to protect the mold from the high temperatures generated during the remelting process, facilitates the initiation of the electric arc, and helps to improve the quality of the final ingot by promoting refining reactions and reducing the occurrence of inclusions.

Application of Electric Current: Once the electrodes and flux are in place, an electric current is applied across the electrodes. The current passes through the electrodes, generating intense heat due to electrical resistance. The resistance heating melts a portion of the consumable electrode, creating a molten pool of metal.

Formation of Slag Pool: As the molten metal descends into the mold, it passes through a layer of slag, which is maintained in a molten state by the heat generated by the electric arc. The slag layer serves several important functions, including protecting the molten metal from atmospheric contamination, promoting refining reactions, and aiding in the removal of impurities and inclusions.

Solidification of Ingot: As the molten metal descends further into the mold, it gradually solidifies, forming a solid ingot of the desired alloy. The ingot is allowed to cool slowly within the mold, resulting in a homogeneous microstructure with improved mechanical properties and reduced levels of segregation and inclusions.

Advantages of the ESR Process

Improved Quality: The ESR process allows for the production of ingots with superior quality compared to traditional casting methods. The controlled solidification and refining reactions facilitated by the process result in ingots with reduced levels of segregation, inclusions, and other defects.

Enhanced Mechanical Properties: The refined microstructure achieved through the ESR process leads to ingots with improved mechanical properties, including higher strength, toughness, and fatigue resistance. These qualities make it ideal for applications where reliability and performance are critical.

Better Control Over Composition: The ESR process offers better control over the composition of the final ingot, allowing manufacturers to produce alloys with precise chemical compositions tailored to specific applications.

Waste Reduction: By promoting refining reactions and reducing the occurrence of inclusions and defects, the ESR process helps minimize material waste and improves overall production efficiency.

Applications of ESR Process

The ESR process is widely used in industries where high-quality alloys with superior mechanical properties are required. Some common applications include the production of aerospace components, turbine blades, tool and die steels, high-performance bearings, and components for power generation and automotive industries.

 

BioDur® 108 vs Nickel-Containing Alloys 316/316L

BioDur® 108 and nickel-containing alloys such as 316/316L stainless steel are materials commonly used in various industrial and biomedical applications. Let's compare these two materials across several key factors:

Corrosion Resistance

BioDur® 108: BioDur® 108 is specifically engineered to provide corrosion resistance, particularly in biomedical applications where it is exposed to bodily fluids. Its corrosion resistance exceeds that of many conventional stainless steels, making it highly suitable for implants and surgical instruments.

316/316L Stainless Steel: Stainless steel grades like 316/316L also offer good corrosion resistance, especially in environments containing chlorides. However, compared to BioDur® 108, they may be more susceptible to corrosion in certain aggressive environments, such as those encountered in the human body.

Biocompatibility

BioDur® 108: BioDur® 108 is designed with biocompatibility in mind and is nickel-free and cobalt-free. It is widely used in biomedical applications, including orthopedic implants and dental devices. BioDur® 108's biocompatibility profile has been extensively evaluated and tested in accordance with ISO 10993, making it a preferred choice for medical devices. The full report is available upon request.

316/316L Stainless Steel: While stainless steel grades like 316/316L are generally biocompatible, they may not be as optimized for biomedical applications as BioDur® 108. Some individuals may exhibit allergic reactions to nickel-containing alloys, which can limit their use in certain medical devices.

EU MDR Compliant

BioDur® 108: The European Union implemented regulatory changes (EU MDR) to limit the cobalt content in medical devices. Because BioDur® 108 is nickel-free and cobalt-free, medical device manufacturers may use it to create products without needing a warning label (applicable to items with more than 0.10 wt% cobalt).

316/316L Stainless Steel: Due to impurities during the melting process, 316/316L stainless steel typically contains 0.5 to 0.40 wt% cobalt, rendering it non-compliant with new EU MDR regulations. The Center for Devices and Radiological Health (CDRH) estimates that about 15% of the general population is sensitive to cobalt and/or nickel, leading to adverse side effects in medical devices.

Mechanical Properties

BioDur 108®: BioDur® 108 offers high strength, toughness, and fatigue resistance, making it suitable for load-bearing applications such as orthopedic implants. Its mechanical properties are tailored to mimic those of natural bone, reducing the risk of stress shielding and implant failure.

316/316L Stainless Steel: Stainless steel alloys like 316/316L also exhibit good mechanical properties, including strength and ductility. However, they may not match the mechanical performance of BioDur® 108, particularly in demanding biomedical applications.

 

BioDur® 108, A Nickel-Free & Cobalt-Free Alternative

When considering materials for applications, particularly in biomedical and industrial sectors, the choice between BioDur® 108 and nickel-containing alloys such as 316/316L stainless steel hinges on a variety of factors.

BioDur® 108 emerges as a standout option for biomedical applications due to its corrosion resistance, biocompatibility, and tailored mechanical properties. Nickel-free and cobalt-free, BioDur® 108 was engineered specifically for implants and surgical instruments. BioDur® 108 offers superior performance and reliability in demanding environments, such as those encountered within the human body.

On the other hand, nickel-containing alloys like 316/316L stainless steel remain viable options for a wide range of industrial applications where corrosion resistance and mechanical properties are crucial. These alloys offer good performance at a more affordable price point, making them suitable for applications such as chemical processing, marine equipment, and automotive components.

The selection between BioDur® 108 and nickel-containing alloys depends on the specific requirements of the application, including performance, cost considerations, regulatory compliance, and environmental factors. By carefully evaluating these factors, engineers and designers can make informed decisions to ensure the success and reliability of their projects. Whether it's enhancing patient outcomes in the medical field or improving efficiency in industrial processes, choosing the right material is essential for achieving optimal results.

 

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