Problem: Unknown particle in a medical end product
In the present case, a particles of unknown origin discovered in a medical end product. The challenge was to determine the structure and composition of this particle to identify its source and potential impact on the product.
Strategy: Step-by-step characterization of the particle
The GWP has a step-by-step approach to particle analysis chosen to ensure precise characterization of its structure and composition.
Step 1: Light microscopic examination and isolation
First, the particle was examined using a light microscope. fibrous structure of the particle, the semitransparent These first observations gave clues to a possible plastic material.
Step 2: Initial characterization using SEM-EDX
In the next step, the particle was scanning electron microscopy (SEM) and Energy dispersive X-ray spectroscopy (EDX) further characterized. The analysis showed that it is Abrasion of a plastic component. The elemental composition showed predominantly carbon and small amounts of Oxygen, suggesting a polymer-based origin.
Step 3: Material determination using FTIR spectroscopy
To determine the exact material, the particle was FTIR spectroscopy (Fourier transform infrared spectroscopy). The comparison with literature spectrum revealed that it was High Density Polyethylene (HDPE) a material that is often used in technical components. There were also signs of a thermal aging of the particle.
Interim result: Interpretation with the customer
In collaboration with the customer, the results to date were interpreted. Based on this data, the hypothesis was put forward that the particle could have originated from a component of the final product.
Step 4: Comparative material analysis of a plastic plain bearing
In the next step, a Plastic plain bearingsthat was installed in the product was examined comparatively. The spectroscopic analysis showed that the material of the plain bearing with the particle identical which confirmed the suspicion.
Final report: Origin of the particle identified
The originally unknown particle could be clearly identified as Abrasion of a polyethylene plain bearing (HDPE) can be identified.
Follow-up investigation: Damage analysis of the plain bearing
The next step was to damage analysis of the plain bearing is recommended to investigate the cause of the abrasion and to develop preventive measures to avoid further contamination in the final medical product.