An array of Color Anodized 3D Printed Porous Products from Danco Medical.

Color Titanium Anodize on 3D Printed Porous Product

Danco Medical is excited to announce that we have completed testing and validation related to the processing of 3D printed devices with porous features utilizing the Titanium Color Anodize, Laser Marking and Passivation processes.

This was a joint effort between our organization and one of our customers to develop a worst case challenge coupon based on the design of product from manufacturing designs that already have FDA 510K Clearance.

The following is a summary of the steps taken:

  • Product was processed by the manufacturer and submitted to all known manufacturing processes applicable to this type of device and product contact materials used within their manufacturing process. Subsequent testing was performed by Nelson labs to ensure the removal of all manufacturing agents as required in FDA 21 CFR 820.70(h).
  • Product was then submitted to Danco Medical for processing within the Titanium Color Anodize (DPP-5358) process. Once determination was made that this was a feasible process to perform (yielding aesthetically acceptable product and acceptable cleanliness levels), Danco Medical performed a comprehensive validation of the process to ensure that the most extensive manufacturing process flow would achieve acceptable product.
  • Product was processed under the guidelines of Danco Medical Internal QMS Procedure: DQP-2500 Validation and documented within required IQ / OQ / PQ Documentation. Danco Medical’s Validation system is based on the requirements and guidance detailed in FDA 21 CFR §820, ISO 13485:2016, ISO 9001:2015, AS9100D, GHTF/SG3/N99-10: 2004 and FDA Guidance for Industry Process Validation General Principles and Practices.
  • Testing was performed by Nelson labs to ensure the removal of all manufacturing agents as required in FDA 21 CFR 820.70(h). All test results were acceptable.

Danco Medical can now certify that we are effectively removing our contact materials within 3D printed devices with porous features.  We now have the confidence and objective evidence to move forward processing these types of manufactured components.

Please reach out to our sales department for quoting and questions. Kathy.s@dancomed.com or Adam.c@dancomed.com

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