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(888) 868-2900 | Medical device manufacturers have no room for error when it comes to ensuring defect-free, hygienic and compliant metal parts for their components and devices.
With its critical role in the healthcare system, medical device manufacturing is highly regulated and requires the utmost attention to sanitation, safety and biocompatibility. Used both internally and externally, devices must be ultraclean, defect-free, biocompatible and compliant with stringent regulatory and testing requirements.
Among other concerns, medical device manufacturers must guard against a wide variety of flaws and defects left behind in the machining process to prevent potential harm to patients. Unmitigated, metal surface defects like burrs and microcracks can lead to an array of unacceptable risks:
Many medical device and surgical instrument engineers and manufacturers specify electropolishing for their metal parts for its ability to eliminate defects by removing a microscopically precise layer of surface material as well as for an array of other benefits unmatched by other metal finishing processes.
Able specializes in providing electropolishing services for a variety of common and specialty metal alloys. These include refractory metals like titanium and Nitinol, prized for their elasticity, durability and “shape memory.” Nitinol in particular, is a material of choice for implantable devices like stents, orthopedic staples and fine grade medical wire. The enhanced pathogen resistance and cleanability that electropolishing gives to metal parts made of Nitinol make it well-suited for the makers of such medical implants. Electropolishing gives Nitinol parts the ultra-smooth, ultraclean surface needed.
At Able we helped create the process for electropolishing this highly specialized alloy – one of a long list of of alloys we can electropolish.
From implantable devices to surgical instruments, electropolishing offers medical device manufacturers a reliable, high-quality, ultraclean surface finish that improves fit, finish and function – and yields better patient outcomes.
Electropolishing works by eliminating surface defects left behind by metalworking and fabrication processes including burrs, contamination, scale and tool marks. In addition, mechanical polishing can leave behind an “amorphous layer” creating space that can trap bacteria, water or other liquids.
Electropolishing can remove such defects with microscopic precision and leaves behind an ultraclean surface that impedes the attachment and growth of bacteria and other pathogens and is highly resistant to biofilm production.
Heightened concerns over the spread of antibiotic resistant bacteria and electropolishing’s unique ability to create a pathogen-resistant and highly-cleanable surface area for critical metal parts continue to drive its use among medical device manufacturers.
Electropolishing, often referred to as a “reverse plating” process, uses a combination of rectified current and a blended chemical electrolyte bath to eliminate surface defects from metal parts by removing a microscopically precise layer of surface material.
As the largest electropolishing specialist in the world, Able Electropolishing has honed its proprietary processes over decades of innovation and collaboration with engineers in industries that include medical device manufacturing, aerospace, food and beverage, pharmaceutical and semiconductor, among others.
Able’s processes include customized racking and suggested prototyping for each part, with an array of electrolyte formulations tailored to the specific alloy. These newer electrolytes, combined with advanced parts handling techniques and the introduction of robotic automation, have improved production yields on a wide range of metal products.
While electropolishing is well-known for the bright and shiny surface polish it imparts, there are numerous other benefits of this highly-precise finishing method. These include deburring, microfinish improvement, ultraclean finishing, and significantly improved corrosion resistance, among others.
Electropolishing uses a power source to convert AC current to DC at low voltages. A rubber-lined tank, usually fabricated from steel, is used to hold the chemical bath.
A series of copper or stainless steel cathode plates are lowered into the bath and installed to the negative (-) side of the power source. A part or group of parts is fixed to a rack made of titanium, copper or bronze. That rack in turn is fixed to the positive (+) side of the power source. As the adjoining illustration depicts, the metal part is charged positive (anodic) and immersed into the chemical bath.
When current is applied, the electrolyte acts as a conductor to allow metal ions to be removed from the part. While the ions are drawn toward the cathode, the electrolyte maintains the dissolved metals in solution. Gassing in the form of oxygen occurs at the metal surface, furthering the cleansing process.
Once the process is completed, the part is run through a series of cleaning and drying steps to remove clinging electrolyte. The resulting surface is ultraclean, ultrasmooth and defect-free.
Orthopedic and cardiovascular implants are some of the most common medical devices manufactured today that demand high levels of biocompatibility. To ensure better patient outcomes and reduce the risk of inflammatory and allergic reactions, special focus has been placed on the surface treatment of these components. Cardiovascular implants including defibrillators, pacemakers as well as artificial heart valves, all have metal components that require proper finishing. In these cases, these parts have to stand up to blood and other body fluids.
With implants such as those for knees, hips, shoulders, and elbows constantly evolving, medical device manufacturers need high-quality finishing processes to ensure biocompatibility of implantable devices.
By removing the outer skin of metal along with the surface contaminants embedded during the various manufacturing steps, electropolishing effectively creates a contaminant-free surface.
The uniform removal of surface imperfections and contaminants creates an ultrasmooth and oxygen-rich surface that is excellent for inhibiting bacterial growth.
By removing the imbedded free iron and other contaminants, electropolishing creates a passive, oxygen-rich surface that helps retard corrosion.
Electropolishing results in a clean, contaminant-free surface with enhanced corrosion resistance and improved resistance to bacterial growth creating biocompatible devices and components that are safer for internal use.
Electropolishing is a common process for improving surface finish and reducing the microdefects that can lead to premature failure.
The customer was experiencing premature failure due to imperfections and irregularities in the Nitinol wire. Cracks, notches and microdefects left on the surface can become initiation sites for crack propagation or corrosion.
The customer came to Able Electropolishing to explore electropolishing as a method for improving the surface finish of the Nitinol wire. Electropolishing is a common process for improving surface finish and reducing the microdefects that can lead to premature failure.
Cutting instruments, drills and blades are critical devices used in surgical procedures. It is critical that blades used in surgical procedures are free from burrs and laser slag and remain sharp for accurate cutting. Remaining burrs created during manufacturing can break off, causing harm to the patient during procedures.
In addition to requiring a burr-free, smooth finish, these items also require an ultra-sanitary finish that not only inhibits the harboring of bacteria, but also retards corrosion. Therefore, a contaminant-free surface is of critical importance for these tools.
By removing material more aggressively from the high points on the surface, electropolishing effectively removes burrs from blades and other surgical tools resulting in safer instruments.
Electropolishing removes surface contaminants and leaves surfaces with improved resistance to pathogen growth.
Electropolished components and devices have a passive, oxygen-rich surface that retards the onset of corrosion.
Unlike parts that undergo other finishing processes, electropolishing can remove a far more precise and consistent layer of surface material from the part surface.
The grinding operation used to manufacture this stainless steel part left the teeth of the blade with large, hanging burrs. The client needed a deburring solution that would maintain the sharp, uniform condition of the edges. Hand deburring was neither an economical nor a consistent solution — The client needed a process that would be efficient, cost-effective and consistent on every edge of every part.
As a controlled metal removal process, electropolishing proved to be a highly efficient and consistent method of deburring these parts. Electropolishing is highly precise, allowing us to remove the burrs while retaining the sharp blade that the client needs. In addition to deburring the part, electropolishing creates an ultraclean, exceptionally corrosion resistant surface across the entire part. This is particularly useful in medical applications such as this, in which unexpected corrosion can have serious consequences.
Drivers, trocars, forceps, stylets, retractors, stapler components, bone screws, clamps, and blades are just a few examples from among a wide array of metal surgical instruments. These components require a surface finish free of defects that can lead to malfunction or create opportunities for pathogen growth. Among other imperfections, electropolishing removes burrs and rough edges and leaves instruments with improved fit, finish and function.
The pathogen-resistance and cleanability of such surgical instruments and medical devices is a high stakes process, especially in an era of new urgency around the growth of antibiotic-resistant bacteria like methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Staphylococcus (VRSA).
Designing “cleanability” into the design of medical devices is a critical area of focus and electropolishing is increasingly built into the specifications as device designers and infection control researchers try to find the solutions that lie between device design, pathogen-resistance and cleanability.
Metal parts that contain burrs, fissures or surface defects left behind in the machining process can trap liquids, bacteria and debris, initiating the growth of dangerous pathogens and making devices more difficult to clean. In addition, burrs pose the added risk of any displaced metal, with the potential to break free of the part. In this case, the 303 stainless steel medical component was originally specified for passivation only. However, when the manufacturer encountered burr problems associated with machining the slot, electropolishing was added to both remove the burrs and passivate the part all in one operation.
Able Electropolishing processed samples with various parameters and was able to pinpoint the correct range of material removal to eliminate the burrs consistently. The manufacturer adjusted machining and grinding to allow for the material removed in the electropolishing process.
Machining and thread rolling can be dirty processes, embedding cutting fluid and iron into a part. In the parts below, friction and heat from the thread rolling operation caused a black discoloration to form on the threads.
The client had tried multiple solvents and solutions in ultrasonic cleaning tanks to remove the discoloration, but none of these metal finishing attempts worked. Besides a grimy appearance, the contamination left the part subject to corrosion and bacterial growth–unacceptable for its medical application. Before undertaking final machining operations, the client needed a consistent and cost-effective way to remove the discoloration and contamination.
Electropolishing is a preferred solution for titanium parts for medical and surgical use as it provides a corrosion resistant, clean, smooth and defect-free finish by removing a microscopically precise layer of surface material.
We electropolished samples with the minimum amount of material removal to clean and passivate the part: approximately .0005” total material from the part’s diameter (.00025” per surface), leaving a consistent finish acceptable for medical use. In addition to cleaning the threads, electropolishing reduces the coefficient of friction by creating a better finish on the thread. This can reduce galling and provide a better functioning part.
Challenged with the need to produce highly precise instruments at a low cost, medical device manufacturers often turn to disposable medical parts and instruments. However, the use of manufacturing methods such as stamping or 3D printing often results in surfaces that are unsuitable for medical applications.
The resulting low-quality surface finish of mass produced components and instruments leads to higher rejection rates during quality assurance testing, resulting in financial losses for device manufacturers.
Faced with low cost pressures, manufacturers in the medical industry are left with few reliable options when it comes to surface finishing after the manufacturing process. Electropolishing produces a superior finish that yields a consistently high quality surface for disposable medical devices. This is critical for reduced rejection rates and efficient production.
An advanced surface finishing process, electropolishing improves the microfinish resulting in a superior surface condition for protection during sterilization processes.
Electropolished devices have increased corrosion resistance for protection during sterilization processes.
By effectively removing embedded contaminants from the surface of components, electropolishing creates a passive, clean surface critical in the medical industry.
Able’s electropolishing process utilizes static parameters and as a result, the repeatability from part to part and lot to lot is excellent.
Able Electropolishing Co., Inc. has had years of success electropolishing 420 SS surgical stapler components. To ensure that the staples fire freely and do not jam, the parts require a burr-free, smooth surface.
In addition, electropolishing is used to remove the heat tint from heat treating, leaving the parts with a decorative, clean and passive finish.
Medical imaging is an important component of the diagnostic process for many conditions, and it plays a critical role in improving public health. Accurate diagnostic imaging can prevent unnecessary surgeries, leading to better treatments and patient outcomes. The components used for medical imaging and diagnostics need to meet highly specific requirements.
Cathodes, focus cups, anodes, collimators, and shields are examples of components used in imaging equipment and can be made from nickel, copper, molybdenum, tungsten, niobium, or aluminum. Due to the critical role that they play in equipment performance it is paramount that they are properly cleaned prior to installation.
Because the functionality of the x-ray tube electrical circuit is key to it producing x-ray waves, the components need to eliminate unwanted arcing of the electrical current. Producing x-rays requires a high degree of precision. Electropolishing helps with the components of the x-ray tube by improving surface finish to ensure uniform current flow. Electropolishing removes the top layer of metal, treating imperfections and burrs, keeping the electrical circuit from producing unwanted arcs and potential damage to the equipment.
One of our customers manufactures sophisticated imaging equipment. They use various components manufactured from nickel, tantalum, Kovar and stainless.
They require a precise Ra value to ensure proper conductivity between parts. An inadequate surface finish can lead to unwanted arcing that can ultimately damage the particular piece or equipment. Where high voltage is present improper finish can cause interruptions in the current path, leading to costly equipment damage.
By processing and testing various samples, we determined the ideal amount of surface metal removal to improve surface finish and leave a clean, contaminant free surface.
Nitinol, an alloy prized for its elasticity, durability and “shape memory” is a material of choice for manufacturers of medical devices like stents, orthopedic staples, dental implants and fine-grade medical wire.
Discovered in 1959, Nitinol combines nickel and titanium in an alloy that is lightweight, heat resistant and remarkably elastic, with a unique ability to return to its original shape.
Nitinol’s use in a variety of implantable devices, including finely meshed stents, is one of the reasons behind the growing demand for electropolishing among medical manufacturers.
Electropolishing’s ability to remove a microscopically precise layer of surface material with consistent results makes it an ideal solution for parts made of Nitinol. Regardless of how intricate the design, electropolishing leaves such parts defect free, more durable, cleanable and with improved fit, function and appearance.
Electropolishing of Nitinol parts creates a uniform and ultrasmooth finish even within a small diameter, leaving interior cavities free of the burrs and surface residues that other machining processes leave behind.
Titanium is another alloy favored by manufacturers of implants and surgical instruments for its natural corrosion resistance, high tensile strength and biocompatibility, as well as its resistance to high temperatures. Electropolishing is often the finishing process of choice for titanium medical parts because it improves the alloy’s performance while maintaining the properties that make it unique.
A good example is electropolishing’s ability to improve titanium’s natural corrosion resistance and biocompatibility by removing a tightly controlled layer of surface material to eliminate microscopic surface imperfections that can become initiation sites for corrosion.
By removing the outer skin of metal under a highly controlled process, electropolishing eliminates surface defects like microcracks, microburrs and other imperfections that can become initiation sites for corrosion. Electropolishing leaves metal parts with 30x more corrosion resistance than passivation, while also leaving parts in a passive state.
With its ability to remove a microscopically precise amount of material from the thickness or diameter of a part, Ra value can be improved by as much as 50%. Electropolishing is consistent and precise, even for the most fragile parts. It uses a rack process that can be customized for each part.
Titanium and Nitinol parts used in medical applications must be burr-free. Unlike passivation, electropolishing is an effective deburring operation that leaves the surface of medical device parts free of micro imperfections and embedded contaminants that can impede performance and durability.
Electropolishing titanium and Nitinol medical parts and devices removes residual debris and other embedded contaminants as well as imperfections that can create initiation sites for pathogen growth. This comprehensive cleaning operation is used for critical implantable medical devices like dental and surgical implants, which must be bacteria-free before use.
Electropolishing reduces the coefficient of friction by creating a better finish and reducing galling, a critical improvement for threaded titanium parts.
Electropolishing is also prized for the high shine surface left behind – a surface that also has been shown to inhibit the growth of pathogens and the formation of biofilms resistant to some forms of cleaning.
Parts for medical and surgical devices, tools and implants must meet exacting specifications for sizing and fit. Electropolishing can remove as little as .0002” of surface material in a consistent, highly controlled and customizable process.
A key benefit of electropolishing for critical metal parts is the enhanced corrosion resistance that results as the process removes imperfections along with a microscopically-precise layer of surface material.
Electropolished parts have a passive, oxygen-rich surface that impedes the onset of corrosion.
Corrosion of metal parts and instruments poses a serious problem in the healthcare setting and is a key reason many medical manufacturers specify electropolishing for their metal parts.
Corrosion not only impacts the durability and lifespan of medical parts, but it also creates conditions that impede cleanability and can promote the growth of pathogens.
In addition to the corrosion-resisting effects that result from the elimination of microcracks and other surface defects, electropolishing also enhances the corrosion resistance of stainless steel parts by enriching the chromium layer.
Results of salt spray testing have shown electropolished metals to be 30 times more corrosion resistant than parts that are only passivated.
The biocompatibility of medical devices, implants and instruments to ensure that every part that comes into contact with the human body poses no risk of irritation or harm is a fundamental requirement for medical manufacturers.
Biocompatibility requirements also apply all the way through the manufacturing chain. As a partner to our medical manufacturing clients, our metal finishing processes for surgical instruments, implants and other medical parts must meet stringent requirements for biocompatibility.
ISO 10993 Part 1 standards are a key regulatory standard designed to ensure the biocompatibility of parts that will come into contact with living human tissue, including skin, tissue, bone and blood. Our electropolishing processes are compliant with these important standards to ensure that medical device parts are finished using processes and materials that pose no threat to the biocompatibility of the finished product.
A cardiovascular implant manufacturer, working on a tight deadline as part of the FDA approval process, needed to determine the precise amount of stock removal that would produce the best results for a tiny arterial clip made of Nitinol. We made our engineering staff available on a tight deadline for a series of tests to evaluate the microfinish improvement at various levels of stock removal. The Able team worked closely with the client to learn much more about the part application, critical features, and specific measurements required to determine the thickness before and after electropolishing. Our efforts and collaboration in this case resulted in a safe and effective part and left our client on track for FDA approval on a challenging timeline.
During Illinois’ Shelter in Place order in 2020, we helped ensure the continued production of critical parts for medical industry clients. For one client working to alleviate the shortage of ventilators, we expedited the electropolishing of parts used in the manufacture of this critically needed equipment. This project called for the expedited electropolishing of more than 1,000 ventilator components needed by the next morning. As we do for each part we electropolish, we used our on-site tooling capability to create custom racking for the parts. This particular part required the additional step of masking to ensure that only a certain area of each part was exposed for electropolishing. Robotic automation helped ensure the speed and consistency of the process.
Able Electropolishing is America’s largest electropolishing specialist, employing 150 people 24/5 in our 50,000-square-foot, state-of-the-art facility in Chicago. With more than 2,500 customers worldwide in industries that include medical device manufacturers, aerospace, pharmaceutical, food and beverage, semiconductor, and automotive, among others, we finished more than 41 million parts last year.
Our clients depend on us for the highest-quality results for their critical metal parts, including enhanced durability, corrosion resistance and pathogen resistance.
We are an ISO 9001: 2015, ISO 13485: 2016, and AS9100:2016 registered company. These standards allow us to provide finishing services for critical parts in industries like medical device, manufacturing, aerospace, pharmaceutical, automotive and more.
By meeting or exceeding the various standards and quality management system requirements set by these organizations, we can provide electropolishing, passivation and vacuum vapor degreasing while giving our clients a sense of true security and consistency in our quality. You can enjoy the peace of mind that we are meeting high standards, whether you’re sending us one part or thousands. We continue to add state-of-the-art equipment to keep at the forefront of our industry.
With seven decades of innovation and collaboration with engineers across industries, the Able team includes deep expertise in metal finishing solutions. Our process ensures the highest quality results for every part and we offer assistance as early as the prototyping stage to help ensure the best results for your part.
With unmatched customer service, rapid turn around times and three fully-staffed shifts, the Able Difference is one that manufacturers worldwide have trusted for 70 years.
As an ISO certified company, we keep extensive processing records from the initial sampling/R&D process all the way through production. Once we work with a customer to customize our process for their part and application, detailed engineering records are maintained electronically. If the customer initiates any changes over the life of the job, those changes are documented and remain permanent on the electronic engineering record.
Able Electropolishing takes pride in our exceptional, expedited electropolishing and passivation processes. By providing our signature metal finishing service for prototype parts in a timely manner, we assist our customers in speeding new products to market.
Able is America’s largest electropolishing specialist, employing 150 people on three shifts at its state-of-the art facility in Chicago. Literally thousands of companies, in every industry worldwide, employ Able technology for their metal parts. Our process meets industry standards like ASTM B912 and is customized to meet the individual specifications of each customer. Over seven decades of innovation and collaboration, Able has earned the trust of engineers and manufacturers in the world’s most challenging industries. Our attention to detail includes unmatched customer service.
Our processes also include assistance in the design phase to ensure that parts are designed free of geometrics that can trap liquids or other materials and impede finishing results.
The best way to determine if electropolishing is the right solution for YOUR part is to send us a sample. We will electropolish it for FREE and send it back to you in a few days.
From implantable devices to surgical instruments, electropolishing is a single-process treatment that results in biocompatible, safe and ultra clean parts.
We offer aerospace vendors and original equipment manufacturers our signature metal finishing services to increase fatigue-resistance for their metal parts, rendering them capable of withstanding the stress and corrosion that comes with long-term use.
Our strict adherence to industry standards ensures that pharmaceutical components are electropolished in accordance with ASTM B912 and ASME BPE specifications. These products are clean and smooth, corrosion resistant and contaminant free.
Corrosion resistance and microfinish improvement are essential for critical automotive parts, making electropolishing an increasingly beneficial option for automakers.
Our metal finishing services help increase corrosion resistance for these parts, and by removing the outermost layer of metal withelectropolishing the durability and longevity of these appliance components is increased.
Electropolishing materials for this industry eliminates the buildup of bacterial biofilms, as well as keeping the equipment free of contaminants like Salmonella. Electropolishing delivers the level of sanitation required by a number of regulatory agencies.
From robotics to mobile equipment, the uses of electropolishing in the hydraulics and pneumatics industry are many. By helping prevent premature part failure, electropolishing reduces downtime and increases the life cycle of these components.
Improving conductivity and performance is just one benefit electropolishing offers for electronics parts. The surface finish is improved by as much as 50%, removing imperfections from the material without material removal.
They may be microscopic, but the tiny jagged microburrs left behind on metal parts that have undergone machining processes can be big problems for manufacturers.
The extreme heat resistance and resilience characteristic of refractory metals like niobium, molybdenum, tungsten, tantalum and TZM make them useful in applications like aerospace components, small modular reactor components and other parts that must withstand extreme environments.
A wide array of modern assemblies for everything from aerospace parts to medical devices depend on high-quality springs that must perform to incredibly precise specifications, often in very tiny spaces.
Small modular reactors are entering component fabrication under tight schedule pressure. Across every coolant technology, surface integrity is becoming a qualification gate — not an afterthought.