Surface Analysis and Cleanliness

The cleanliness of medical product surfaces is an essential quality feature throughout the processing chain. Apart from sterility, physical and chemical surface quality and cleanliness are also important, e.g. for implants. Impurities on the product surface can be particles, films/layers or a combination of both.

SGS offers tests for all types of contamination which then permit identification, material group screening or even detailed qualification.

We would be delighted to support you in the failure analysis of particle contamination or deposit-forming substances which can occur as a result of corrosion, condensation, sedimentation, absorption, abrasion or simply through cleaning residue. Apart from routine tests, we also carry out complex project-based and problem-oriented tests.

Information On:

  • Quality assurance of cleaning processes
    • Cleaning success and possible residue
    • Cleaning capability of products
    • Cleaning resistance of surfaces
  • Inspection of implant surfaces
    • Comparative analyses of organic impurities on implant surfaces in nanoscale depth resolution
    • Carbon and foreign atom occupancy (chemical composition) of the surface in the depth range up to 10 nm as surface concentration (at/cm²)
    • Quantitative analysis of ionogenic surface contamination (e.g. salt load, etc.)
    • Morphological appraisal of the surfaces (roughness, structure, etc.)
  • Identification of particles
    • Spectroscopic material group analysis of particle residue on the surface
    • Chemical identification of particles in medical products after separation or extraction as far as the lower µm range
    • Comparison of identified particles in or on medical products with reference materials of manufacturing relevance or with packaging materials of transport relevance
  • Testing production aids related to surface contamination
    • Material composition of oils, fats and aqueous solutions
    • Media purity
    • Analysis of chemical contamination

Our Methods

  • Light-microscopic identification and documentation of surface coatings or particles in liquids or on medical products
  • Identification of particles and coatings using Raman or FT-IR
  • Analysis of surface cleanliness/contamination using XPS and ToF-SIMS
  • Extraction of the sample surface and analysis of ionic contamination using IC or element analysis via ICP-MS
  • Analysis of organic contamination after extraction using GC-MS or FT-IR

Contact

SGS INSTITUT FRESENIUS GmbH
Königsbrücker Landstr. 161
01109 Dresden

t +49 351 8841-200
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