What is a Validated Printing Workflow?

June 22, 2021 1 min read

A validated workflow is a complete process, start-to-finish, for consistently producing safe parts that are compliant with the stringent standards that are set for medical devices. Validated workflows are more than just printing parameters.


A common myth is that if aresin is biocompatible in a liquid state, then it is suitable for producing medical devices. However, this couldn’t be further from the truth.


Resins in a liquid state are highly hazardous to human health and the environment as shown in their respective MSDS. However, if cured correctly as shown in the instructions for use (IFU) by the manufacturer and with the correct printing parameters and post processing protocol, they are able

Ackuretta 3D printing post processing equipment
to produce biocompatible parts. At the end of the day, it is the printing and post curing processes that qualify a medical device.

 

Procedure for a validated workflow

Therefore, the following steps are required for a validated workflow:

  1. Curing time for the resin;
  2. Shrinkage calibration for the resin to produce geometrically accurate parts;
  3. Definition of the cleaning liquid and optimal cleaning time and process;
  4. Post curing time and requirements of nitrogen or not; and
  5. Post finishing instructions if any.

 

Typical FDA and CE regulatory bodies in the US and EU respectively have defined safety standards for 3D printing resins  and therefore the workflow requirements. A validated workflow is then an assurance to the user of the printer and the resin being safe and compliant with regulations.

Jose Galiano
Jose Galiano

Head of Marketing
jose.galiano@ackuretta.com



Also in Blog

Layer Thickness and Print Accuracy Report
Layer Thickness and Print Accuracy Report

July 29, 2021 3 min read

The common dental myth is that objects with thinner layer thickness, will result in more accurate prints. To put this theory to test, we made a comparison of the accuracy of five different prints that are produced from the same STL file but with different layer thicknesses.
Read More
Dental 3D Printer Pricing - What do you Get for your Money?
Dental 3D Printer Pricing - What do you Get for your Money?

July 21, 2021 7 min read

Searching 'dental 3D printer' online will leave you with an overwhelming amount of choices - printers come in all shapes, colors, sizes, and especially prices! Let's take a closer look at the quality differences between inexpensive 3D printers and premium printers and why you should invest in a quality printer.

Read More
What to Expect when Investing in a Dental 3D Printing Workflow
What to Expect when Investing in a Dental 3D Printing Workflow

July 15, 2021 3 min read

Transitioning to digital dentistry can seem like a daunting task. Many fear the costs and the need for tech training. While it is definitely a significant initial investment, it will pay off down the road by maximizing the efficiency of a dental clinic or lab and minimizing the need for outsourcing. To learn more about the entry costs of digital dentistry, read this article.
Read More
0