Particle Counting Laboratory

The European and international regulations impose a counting of the particulate contaminations on the DM

Various regulations require manufacturers of implantable medical devices to review their cleaning processes with regard to particulate contamination. The Filab laboratory assists medical device manufacturers in the application of these regulations.

The ISO 19227:2018 standard refers to the text of the AAMI TIR42 published in 2010, which in turn refers to the methods recommended and described in the USP 788 on 29.19 of the European Pharmacopoeia.

In order to validate or not the cleanliness of a medical device, the objective of these evaluations is to characterize the quantity, size and nature of the particles potentially present on the surface as a result of the cleaning processes.

FILAB laboratory, expert in particle contamination counting on DM

The identification and particle counting procedure on DM is done by leaching according to physiological conditions close to those applied to HCT/COT measurements. FILAB is now COFRAC 17025 accredited according to ISO 19227 for particle counting. 

The interpretation of the results and the classification of the identified particles take into account the USP788 specifications but also the type of DM and the specific requirements of the manufacturers.

The Filab laboratory assists medical device manufacturers in the analysis of particle counts on their implantable devices thanks to its COFRAC ISO 17025 accreditation.

  • Extraction and particle counting on implants – USP 788 methodology
  • Particle counting on implantable DM by Optical Microscope
  • Particle contamination analysis according to USP 788
Eve BALEY Technical Sales Representative
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