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SERVICES

Particle Analysis

 

Analysis of particulate (implant) debris is done by characterizing either proteinaceous (serum) or saline media by isolation treatment (either protein or acid digestion), and includes written reports and documentation attesting to:

 

1. Low Angle Laser Light Scattering (LALLS), also known as Laser Diffraction Analysis (0.1-700 microns) for providing quantitative particle size.

 

2.Extensive Scanning Electron Microscopy (SEM) and Energy Dispersion Analysis by X-ray (EDAX) analysis of particles to determine qualitative particle shape.

 

 

 

Particle Production of implant materials is generally done by taking as-manufactured parts post-sterilization and then using either cryomilling, cryogrinding and/or cryopulverization to manufacture separate implant materials into particualte debris. 

 

Then a series of separation techniques is used to obtain the appropriate size range desired by our clients. Particulate powder is provided cleaned and well characterized using laser diffraction and SEM/EDAX analysis in glass containers capable of being gamma sterilized. 

Particles are endotoxin cleaned and tested with accompanying documentation (LAL Kinectic QCL test-detection limit 0.01Eu).

 

Particle Production

 

Corrosion Testing, Coating Characterization and Implant Analysis

 

We at  BioEngineering Solutions are expert strategists, helping our clients with their complex challenges faced in the biomedical field and building solutions to help them achieve sustained growth.

We begin helping our clients by providing Corrosion testing services, coating characterization along with Implant analysis consultation services for a wide variety of implantable medical devices.

 

Our in vitro corrosion testing services include fretting, crevice, galvanic and pitting tests. BioEngineering Solutions provides state-of-the art testing facilities for evaluation of corrosion of medical devices followed by in depth analysis using scanning electron microscopy (SEM). We perform all tests under ASTM standards and ISO standards.

 

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