In other words – will the finishing process be maintained within limits that will produce parts that meet specification? 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 – is the equipment installed properly within the facility? 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. 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.Ī brief summary of IQ, OQ and PQ validation for medical device coatings is provided below:
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Powder coating of stethoscope chest pieces, radiological vessels, component tool kits and various structural and device housing components.Īdvanced Plating Technologies provides medical device coatings to the demanding requirements of ISO 13485:2016 for both OEMs and contract manufacturers.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.Passivation of catheter eyelets, arthroscopic & endoscopic tools, titanium & cobalt-chrome implants and medical device springs and wire forms for corrosion resistance.Gold plating of electrical contacts, forceps, arthroscopic & endoscopic components for biocompatibility and scanning components for high temperature join-ability.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.Įxamples of current applications include:
Selective Plating Services (Electroplating and Electroless Plating)Īdvanced Plating Technologies provides ISO 13485:2016 compliant services in applying medical device coatings for applications within the medical device and contract manufacturing market.Plate to Gauge or Plate to Dimension Services.Copper Plating of Bullets and Projectiles.Black Nickel Plating (Electrolytic) Services.
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