Loose particles in your materials and in surgical sites have the potential to cause serious harm if they are implanted into the body. If you have particulates present in your vascular materials and applications we can characterize them, assess their level of potential harm and identify their source. We work to improve manufacturing and cleaning processes to prevent the potential of particle formation.
Using a combination of techniques we offer analysis of wear debris. In addition to following the ASTM standard, using SEM evaluation to provide qualitative information, we also use laser diffraction techniques to gather more detailed, quantitative information such as particle size distribution, and chemical analysis to understand the composition of the particles.
In the medical device industry, contamination of devices and materials can have fatal consequences. Problems such as staining can also be dangerous and, in any industry, can be aesthetically displeasing.
At Lucideon our failure analysis team uses a combination of analytical techniques to:
- Determine the chemical composition of a contaminant or stain
- Fingerprint suspect materials
- Validate the cleaning/manufacturing process to discover where the contamination was introduced.
Contaminants can be introduced at each phase of manufacture (such as milling, turning, blasting, polishing, lapping, deburring, laser treatment, printing and surface modification such as plasma deposition).
We help you to understand and monitor the effectiveness of each cleaning stage. Using surface analysis, residue analysis and particulate assessment, we monitor each step to determine where contamination is introduced. We have a proprietary validation service, VALIDATA, which determines the effectiveness of the cleaning process and environment on an ongoing basis.