Fraunhofer Institute for Manufacturing Engineering and Automation IPA
Fraunhofer Institute for Manufacturing Engineering and Automation IPA

Medical cleanliness in additive manufacturing

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Additive manufacturing has developed into a global growth market and is not only being used in prototype construction and small series production, but also increasingly in series production in a wide range of sectors, such as medical technology, the automotive sector and many other industries.

Purity plays a decisive role in the quality and performance of printed products. Particles and other impurities can affect the mechanical properties, surface quality and even the safety of the parts. In medical technology in particular, 3D-printed implants, prostheses and instruments must be sterile and free of any contamination in order to be used safely in or on patients.

  • Identification of critical impurities
  • Definition of acceptance criteria
  • Development of a requirements-based cleaning and testing strategy, from cleaning validation to root cause analysis

 

Chemical impurities

  • Residue analysis with FTIR, IC, GC/MS, UPLC etc.
  • Determination of TOC according to DIN EN 1484
  • Cleanliness and outgassing testing of materials/components with thermal extraction chambers up to 300°C from 0.001 L to 200 L
  • Method for selective measurement of condensable substances

 

Particulate impurities

  • Purity (of medical devices in the manufacturing process), B3.3, particulate contamination, light microscopy (automated with image processing) in accordance with VDI 2083, Sheet 21 (accredited test procedure DAkkS and ZLG)

 

Biocompatibility tests

  • Biocompatibility tests as part of the DIN EN ISO 10993 series
  • Determination of in-vitro cytotoxicity according to DIN EN ISO 10993-5 of medical, research and industrial products (accredited test methods DAkkS and ZLG).
  • Determination of in-vitro irritation of medical devices according to DIN EN ISO 10993-23 (registered for accreditation).

Our range of services

Advice and expertise

We are at your service with our extensive knowledge in additive manufacturing processes and purity. We offer individual consulting services to understand your specific requirements and provide customized solutions.

Process optimization

We analyze your production processes in the field of additive manufacturing and identify optimization potential in terms of purity. We develop efficient workflows and make recommendations for improving product quality and consistency.

Quality control and testing

Our experts perform comprehensive quality checks to ensure the purity of your printed products.

This covers everything from the detection of chemical and particulate impurities to biocompatibility tests.

To achieve this, we employ state-of-the-art analytical methods and equipment to identify and evaluate contaminants, particles and other critical factors.

Training courses and workshops

We offer training and workshops to educate your team on the importance of purity in additive manufacturing. We share best practices, training materials and practical knowledge to ensure your staff has the know-how to produce high-quality products.

Cleaning strategies

We are continuously involved in research and development projects to develop innovative solutions to improve cleanliness in additive manufacturing. We provide support, starting with the identification of critical impurities and the definition of acceptance criteria through to the derivation and implementation of needs-based cleaning and testing strategies.

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