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Surface Analysis by XPS
Objective
The purpose of the surface analysis by X-ray Photoelectron Spectroscopy (XPS) is to assess the PALTOP implant surface in order to verify that any substances used in the process have been washed off the surface with no remaining undesirable occlusions.

Protocol
The XPS examination of the PALTOP implants was performed at the Solid State Physics Institute, Technion Research and Development Foundation of Israel. PALTOP implants were compared to international leading competitors as a reference.

The method of analysis is based on X-ray Photoelectron Spectroscopy (XPS). For surface analysis, the samples were irradiated with monochromatic X-rays. Survey spectra were recorded with a pass energy of 150eV, from which the surface chemical composition was determined.

The atomic concentrations were calculated using elemental sensitivity factors without applying any standardization procedure. The core level binding energies of the different peaks were normalized by setting the binding energy for the C1s at 285.0eV.

Results
Examination was performed in the two randomly chosen areas. The results of elemental quantitative analysis and Ti oxide layer thicknesses are summarized below.

The XPS analysis report shows the chemical composition of the implant surface. Except of the Ti-Al-V raw material, we can find high levels of Oxygen belonging to the Titanium oxide, which is the substrate for osseointegration. Nitrogen and Carbon are derived from the atmosphere. No other contaminations or residues from the production process remain on the implant surface, proving that PALTOP implant surface is ultra clean.

Conclusions
Surface treatment, dimensions and various other product attributes are regulated by PALTOP through a statistical process control. This system ensures continuous monitoring of parts, instead of inspecting finished products – thus ensuring that all parts meet spec limitations. This pro-active approach allows PALTOP to promptly identify manufacturing process changes that could affect products – thus ensuring that adjustments are made so that reject parts are not produced. This “on-line, real-time” monitoring ensures more consistent and reliable products, more efficient production processes, and more competitive pricing as customers do not have to absorb hidden costs of production line problems

Atomic composition calculated from XPS survey (%) and oxide thickness (nm)
calculated from HR-XPS spectrum.
It can be concluded that PALTOP’s surfaces with regards to undesirable contamination, occlusions and residues are pure and safe for use.

Surface Analysis by SEM/EDS
Objective
The purpose of the surface analysis by SEM/EDS test was to verify that the desired macro and micro structures were achieved (surface roughness and morphology) and to assess the PALTOP implant surface in order to verify that no particles from processing remained.

Protocol
The surface analysis was performed by using Scanning Electron Microscopy and Energy-Dispersive Spectroscopy (SEM/EDS) analysis utilizing FEI Inspect SEM with the attached INCA EDS micro-analyzer. BSE images were used to emphasize the contaminations

The test was performed at the Israel Institute Of Metals in the Technion research and development foundation (IIT, Technion Israel Institute of Technology).

Results
As can be seen in Figure 1.5, photomicrographs of blasted surfaces show no particles remaining behind on the surface, meaning that the particles used for sand blasting the implant surface were removed and that the substances used for PALTOP implant processing have been thoroughly washed.

< In addition, microscope SEM images show nano crater shaped structures with macro, micro and nano surface structure which very much resembles the bone morphology.

It can be concluded that the PALTOP implant shows rough-surface which favor both bone anchoring and biomechanical stability, as well as surface free of contaminations, occlusions and residues.

SEM Surface Analysis,
EDI Journal download
 
SEM/EDX Study Report, Keulen University download