Particulate contamination counting laboratory
European and international regulations require particulate contamination counting on medical devices
Different regulations require manufacturers of implantable medical devices to review their cleaning process regarding particulate contamination counting. The Filab laboratory supports medical device manufacturers in applying this regulation.
ISO 19227:2018 refers to the text of AAMI TIR42, published in 2010, which itself refers to the recommended methods described in USP 788 and section 29.19 of the European Pharmacopoeia.
To validate or invalidate the cleanliness of a medical device, the aim of these assessments is to characterize the quantity, size, and nature of particles potentially present on the surface following the cleaning processes.
The FILAB laboratory, expert in particulate contamination counting on medical devices
The procedure for identifying and counting particles on medical devices is carried out by leaching under physiological conditions similar to those applied in TOC/TN analysis. FILAB laboratory is now COFRAC 17025 accredited according to ISO 19227 standard for particle counting.
The interpretation of the results and the classification of the identified particles take into account USP788 specifications as well as the type of medical device and the specific requirements of manufacturers.
Filab laboratory supports medical device manufacturers in analyzing particle counting on their implantable medical devices thanks to its COFRAC ISO 17025 accreditation.
- Particle extraction and counting on implants – USP 788 methodology
- Particle counting on implantable medical devices by Optical Microscope and SEM
- Particulate contamination analysis according to USP 788
