Biomaterials and Particles Analysis Lab

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This presentation briefly describes the capabilities of the BPAL in the analysis and characterization of wear debris and metal ions

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  • And here is a typical SEM image of a metal-on-metal sample. Note how the particles are well separated. Topography is clearly visible. The excellent separation of the particles allows for a much more efficient and sensitive chemical composition identification via EDS……(NEXT)
  • Biomaterials and Particles Analysis Lab

    1. 1. Wear Debris Isolation and Characterization<br />The J. Vernon Luck, Sr., M.D., Orthopaedic Research Center<br />Orthopaedic Hospital, Los Angeles <br />
    2. 2. Most Advanced Purification Protocol<br /><ul><li>Optimized digestion
    3. 3. Optimized density gradient centrifugation
    4. 4. Complete separation of particles from organic contaminants
    5. 5. Negligible level of artifactual agglomerates
    6. 6. Applicable to most materials
    7. 7. Suitable for simultaneous separation of coexisting particles of different materials (for example PE and CoCr)
    8. 8. Applicable to saline solution, serum, synovial fluid and tissue</li></li></ul><li>Choice of Basic, Standard or Advanced Protocols<br />
    9. 9. Basic Protocol<br />Dynamic Laser Scattering<br />(ISO 13320-09)<br />ADVANTAGES<br /><ul><li>Short turnaround time
    10. 10. Excellent monetary value
    11. 11. Particles classified by ECD, number and volume
    12. 12. Well-suited for homogeneous samples:
    13. 13. low level of contaminants
    14. 14. less than 10X size range</li></li></ul><li>Standard Protocol<br />Same as Basic Protocol, plus:<br /><ul><li>qualitative SEM characterization of particle shape
    15. 15. qualitative EDS chemical characterization </li></ul>ADVANTAGES<br /><ul><li>Short turnaround time
    16. 16. Excellent monetary value
    17. 17. Particles classified by ECD, number and volume
    18. 18. Qualitative SEM/EDS analysis
    19. 19. Well-suited for homogeneous samples:
    20. 20. low level of contaminants
    21. 21. less than 10X size range</li></li></ul><li>3. Advanced Protocol<br />Silicon Wafer Display (SWD) protocol1 - particles purified by density gradient centrifugation and collected on a Si wafer<br />ADVANTAGES<br />Centrifugation @ 84,000 G<br /><ul><li>No filtration => no particle loss
    22. 22. > 90% particle recovery rate
    23. 23. Even dispersion of particles on Si wafer</li></ul>Enzyme-Digested Sample <br />Particles (density<2.0)<br />Protein Fragments (density<2.0)<br />Sample r = 1.1 g/cc (average density)<br />Denaturant Layer (density 1.25 g/cc)<br />Barrier Layer (density 2.0 g/cc) <br />Si Wafer or TEM Grid<br />Tube Plug (density= 2.2 g/cc)<br />1 Recognized with the 2011 John Charnley Award, The Hip Society<br />
    24. 24. 2. Advanced Protocol<br /><ul><li>Classification based on FE-SEM/STEM/EDS and detailed morphological analysis (exceeds ASTM F1877-05 and ISO 17853-10)
    25. 25. Excellent particle-background contrast
    26. 26. Accurate chemical identification via EDS
    27. 27. Semi-automated particle analysis (shape, size, chemical ID)
    28. 28. 3D reconstruction of particle shape and volume – available on request
    29. 29. Well-suited for non-homogeneous samples:
    30. 30. high level of contaminants
    31. 31. more than 10X size range</li></li></ul><li>MOM – HIP – Bovine Serum 25% + NaN3<br />
    32. 32. MOPE – HIP – Bovine Serum 95% + NaN3<br />1 µm<br />Arrows indicate nanometer-size particles<br />
    33. 33. Ion Concentration<br />Evaluated via ICP-DRC-MS<br /><ul><li>Free Ions
    34. 34. Total Load (free ions + particles)
    35. 35. Cr speciation [Cr (III) vs. Cr(VI)] - available on request
    36. 36. Accelerated Corrosion Tests - available on request </li></li></ul><li>Laboratory Policy<br /><ul><li> The laboratory meets the Code Federal Regulation Title 21 (21CFR58) for Good Laboratory Practices (GLP).
    37. 37. All electronic data encrypted with 256-bit key on two separate hard drives (one mirroring the other) and copied to DVD.
    38. 38. All data, documents, and samples preserved for five years unless otherwise specified.
    39. 39. Morphological characterization used in the Advanced Protocol exceeds ISO and ASTM standards.
    40. 40. Our reports have been used by several orthopaedic and spinal device manufacturers in obtaining FDAapproval or CE marking for new products.</li></li></ul><li>Laboratory Policy<br />You will receive:<br /><ul><li> Preliminary assessment indicating approximate starting and completion date.
    41. 41. Weekly updates on the status of the analysis.
    42. 42. Where applicable, intermediate report.
    43. 43. Final report delivered via e-mail and on DVD.
    44. 44. Request for further data analysis will be possible at an additional cost.</li></li></ul><li>COSTS<br />1 Up to five samples + one control.<br />2 For the SWD Protocol a minimum of five sample is requested. In special cases less samples can be run at an additional cost. If the SWD Protocol is requested after the Basic or Basic Plus Protocol, the additional fee will be the difference in cost plus a surcharge of $208 per sample.<br />3 The SWD protocol can be customized to specific requirements.<br />
    45. 45. Contact<br />Fabrizio Billi, Ph.D.<br />Director, Biomaterials and Particle Analysis Laboratory<br />The J. Vernon Luck Sr., M.D., Orthopaedic Research Center at Orthopaedic Hospital <br />Orthopaedic Hospital<br />2400 South Flower Street <br />Lowman Building - 5th FloorLos Angeles, CA 90007-2629<br />office: +1 213 742 1352<br />Cell: +1 424 442 0364<br />fax: + 1 213 742 1090<br />e-mail: fb@orthopaedicparticleanalysis.com<br />www.orthopaedicparticleanalysis.com<br />

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