Advanced Plating Technologies provides ISO 13485 compliant services in applying medical device coatings for applications within the medical device and contract manufacturing market. A wide range of medical device coatings is currently offered including biocompatible duplex gold plating, electrolytic and electroless nickel plating, passivation of titanium & medical alloys and powder coating services.
Examples of current applications include:
- Gold plating of electrical contacts, forceps, arthroscopic & endoscopic components for biocompatibility and scanning components for high temperature join-ability;
- Passivation of catheter eyelets, arthroscopic & endoscopic tools, titanium & cobalt-chrome implants and medical device springs and wire forms for corrosion resistance;
- Tin, electroless nickel and high purity nickel coatings on anesthesia delivery components, laryngoscope handles, radiation focus plates, radiation lead and tungsten shielding, and scanning components for joinability;
- Powder coating of stethoscope chest pieces, radiological vessels, component tool kits and various structural and device housing components.
Advanced Plating Technologies provides medical device coatings to the demanding requirements of ISO 13485 for both OEMs and contract manufacturers. APT can provide Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ) validation of medical device coatings to ensure specification compliance and consistency in processing.
A brief summary of IQ, OQ and PQ validation for medical device coatings is provided below:
Installation Qualification (IQ): Provide objective evidence that the equipment used in the process adheres to the manufacturer’s specifications and that the recommendations of manufacturer are considered in the installation. In other words – is the equipment installed properly within the facility?
Operation Qualification (OQ): Provide objective evidence that the process control limits and action limits will result in a finished product that meets design requirements. In other words – will the finishing process be maintained within limits that will produce parts that meet specification?
Performance Qualification (PQ): Provide objective evidence that the process will consistently produce a product that meets design requirements under anticipated operational conditions. In other words – is production quality consistently achieved with multiple production runs and various production operators?
Advanced Plating Technologies offers a range of plated medical device coatings to improve biocompatibility as well as enhance the hardness, corrosion resistance, wear resistance or lubricity of a medical device. A brief summary of plated medical device coatings and benefits is provided below:
Gold Plating Services: High purity gold (99.9%) provides an excellent biocompatible coating when plated to sufficient thicknesses (commonly 0.00005 to 0.0002 inches depending on the application). Gold is a noble precious metal, providing outstanding corrosion resistance in virtually any environment. It is highly conductive and can be alloyed with cobalt to improve hardness for interconnect or contact conducting applications.
Silver Plating Services: Silver is has an inherent antimicrobial effect, making it an excellent choice where device-associated infection is a concern. Silver is an outstanding thermal and electrical conductor as well, surpassing even gold. Due to its precious nature, silver offers excellent corrosion resistance in most applications, including many strong mineral acids. Silver will form silver sulfide (tarnish) when exposed to sulfur-bearing compounds and this characteristic needs to be taken into design consideration.
Electroless Nickel Plating Services: Electroless nickel offers completely uniform deposition of complex geometries due to the electroless nature of its deposition – even within the ID of tubulars. Electroless nickel has outstanding as-plated hardness near 600 HV100 and can be heat-treated to achieve hardness near 1000 HV100. Electroless nickel has improved lubricity over standard nickel coatings due to the codeposition of phosphorus with the nickel. Electroless nickel deposits are either magnetic (less than 10% P) or nonmagnetic (greater than 10% P) based upon the amount of codeposited phosphorus. Electroless nickel deposits have superior corrosion resistance and resistance to most anesthetics including desflurane.
High Purity Sulfamate Nickel Plating: Sulfamate nickel plating is a high-purity (99.9% pure nickel) deposit best suited for joining applications in laser welding, brazing or soldering. Sulfamate nickel offers excellent ductility plating in a compressively stressed state. For this reason, sulfamate nickel is the preferred undercoat for gold or silver plated contacts that flex, such as those made from beryllium copper or phosphor bronze.
Tin Plating Services: Tin is a non-toxic and non-carcinogenic metal that offers good corrosion resistance and is extremely ductile. For this reason it is commonly used as top coating to lead and tungsten shielding and abatement components employed within radiological and magnetic resonance imaging machines as well as within nuclear medicine.
Advanced Plating Technologies offers a range of passivation of titanium and medical-grade alloys including cobalt chromium, tantalum, MP35N and 316LVM stainless steel. The passivation of these alloys for medical device coatings is specific and involve much more than standard commercial passivation practices. The cleaning, rinsing, drying and packaging methods are all designed around the micro designs and specific cleanliness requirements of the medical device market. Specific information regarding the techniques and methods involved in passivation medical coatings can be found on our passivation of titanium and medical-grade alloys solutions page.
Within the metal finishing industry, there are numerous powder coating companies due to low barrier to entry and minimal environmental compliance concerns with the powder coating process. However, most companies lack the ability to handle the selective powder painting, high cosmetics, high cleanliness, and specific packaging requirements that the medical device market demands.
Advanced Plating Technologies excels in medical device powder coating, welcoming applications requiring selective powder painting, small or delicate components, and high cosmetics common within the medical industry. In addition, anti-microbial powders can be provided for most applications where infection and cross contamination are a concern.
APT finishing engineers develop cosmetic standards for any cosmetic or selective application in medical-grade powder coating. An APT cosmetic standard classifies each surface of the component based upon customer input and the cosmetic requirements for those surfaces are clearly quantified and defined. Acceptance of those standards is part of the qualification process for any new medical device coating in powder paint. Production parts are 100% inspected against the approved cosmetic standard using trained operators, stereoscopes and scaled loops.
Advanced Plating Technologies has successfully taken over numerous medical device coatings in powder paint in which the incumbent powder coater had cosmetic rejects in excess of 50%. Our success in these programs has been based on our ability to properly define standards, develop a pretreatment protocol, apply and inspect medical-grade powder coating services.