Particulate testing of medical devices and cleaning media

In addition to biological, chemical and microbiological-hygienic testing of medical devices, the focus is also on particulate contamination of medical devices or media. CleanControlling has a special and extensive competence for this, which has been intensively built up since 2006 with the company's origins in particulate analysis in the field of technical cleanliness.

CleanControlling has comprehensive know-how and equipment for sophisticated particle extraction and various methods for the highly accurate measurement and typification of particles. The methods are based on the relevant standards and guidelines (e.g. VDI 2083 sheet 21, VDA 19.1, USP 788, etc.) or can be developed and adapted by our experts for special problems. 

Particle contamination from the manufacturing process often originates in the machining process, for which the final cleaning of the products is a decisive factor for particle cleanliness. In this context, particle analyses of samples of the cleaning media from the cleaning process are of high importance for the validation and monitoring of the process. 

Process optimization to avoid particle contamination can often also be assisted by identifying the material of the particles to determine the particle origin from previous processes. CleanControlling has various analysis methods at its disposal for this purpose, such as SEM/EDX or IR spectroscopy.

Test methods

  • Paricle extraction with microscopic evaluation according to VDI 2083 sheet 21, VDA 19.1
  • Liquid samples by means of optical particle counter (OPZ) following/according USP 788
  • Material identification of inorganic particles by SEM/EDX
  • Material identification of organic particles by IR spectroscopy

Material identification of particles