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Home Your ApplicationsImplants/ Medical device
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Foreign Particle Studies and Routine Analysis: |
The Single Particle Explorer (SPE) technology is a result of many years of research and development in cooperation with leading coronary,coronary stent. dental implant,and implant manufacturers.
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Origin of particles from Medical Device
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Example: |
We test implants with functionalized surfaces, such as hydrophilized dental implants and modern drug-eluting stents for foreign particles.
The absence of particles is particularly important for critical cardiovascular applications.
Test solutions and storage liquids are filtered through the filtr.AID membrane or a standard cellulose nitrate membrane. Particle Explorer technology determines the number and size of foreign particles as well as coating particles located in the membrane. Optimum parameters for coating quality can be defined using this kind of analysis.
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This method also enables the user to perform routine analyses. If foreign particles are detected, they can be identified by their chemical composition. Particle sources can thus be eliminated in the production process.
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We are qualified and experienced in foreign particle analysis:
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Foreign particle status in hydrophilized dental implants |
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Particle release behaviour of "drug-eluting stents" |
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Cleanroom audits in medical device manufacturing plants with particle source determination |
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Results: |
Results can be obtained like this table, combining image analysis result (CSS) and particle identification by automated raman (CSS).
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>10 |
>25 |
>100 |
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254 |
214 |
34 |
6 |
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75 |
57 |
15 |
3 |
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506 |
409 |
76 |
21 |
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835 |
680 |
125 |
30 |
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Publications: |
VALET, O., LANKERS, M., (2008), Automated Imaging Analysis coupled with Raman Identification of 0.5-5000 µm Particles – Particle Explorer, PSA 2008
VALET, O., LANKERS, M., (2008), Higher Yield and Quality through Particle Identification, Journal of the IEST, October 2008
VALET, O., (2006), Automatische Partikelidentifikation - Aufklärung von Mikrometer Kontaminationen ab 500nm, rap-ID Particle Systems GmbH
RÖSCH, P., et. al., (2005) Chemotaxonomic Identification of Single Bacteria by Micro-Raman Spectroscopy: Application to Clean-Room-Relevant Biological Contaminations, Applied and Environmental Microbiology, March 2005
VALET, O., LANKERS, M., (2005) Automated Raman Spectroscopy of ambient Aerosols with Airborne Particle Explorer, AAAR 2005
VALET, O., (2002), Made to Measure, Cleanroom Technology, Polygon Media
LANKERS, M., (2002), Determining particle composition: Consider the path to the source, Cleanrooms, PennWell
LEWANS, M., (2001), Fingerprinting particles "automatically” , CleanRooms Magazine, 9
VALET, O., (2001), Woher stammen Partikel, Reinraumtechnik, GIT-Verlag
VALET, O., (2001), Schnelle Materialbestimmung von Mikropartikeln, Laborzeitschrift, GIT-Verlag
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