The surface cleanliness of metal parts of medical products needs to be at a very high level to meet safety requirements in human medical applications. Testing the cleanliness of medical products such as implants and tubing that come into contact with the human body can significantly reduce medical risks. The SITA Surface Cleanliness Tester utilizes the principle of quantitative fluorescence to enable non-contact testing of the cleanliness of some parts to ensure consistent cleanliness of medical device products.
Cooling lubricants, corrosion protection materials and drawing oils are all used in the mechanical production of medical products. The chips and particles left on the surfaces of the parts produced by these materials are their main source of contamination. This contamination on the surface of the part must be cleaned before delivering the product and starting the next production step. This is because subsequent production steps require a high level of cleanliness on the part.
The Analytical Tower SITA Surface Cleanliness Meter allows easy and fast monitoring of the cleanliness of parts to evaluate the quality of the cleaning process, immediately eliminating the effects of parameter deviations and equipment failures, and resulting in a significant increase in process reliability.
The German Analytical Tower SITA Surface Cleanliness Gauge detects residual contaminants, such as oil or cooling lubricants, by means of fluorescence from an ultraviolet light excitation source. A photodiode in the head of the cleanliness meter's sensor measures the intensity of fluorescent radiation reflected at a wavelength defined in the blue light range.
Figure 1: Analytical Tower SITA Surface Cleanliness Meter
The higher the intensity of the fluorescence, the higher the level of residual contaminants on the surface of the part, and the lower the cleanliness value displayed as a percentage by the measuring instrument. A 100% cleanliness value corresponds to an absolutely clean and fluorescence-free surface. In the case of a highly contaminated part surface, the measuring device will display a cleanliness value of 0%.
The SITA Surface Cleanliness Meter can be calibrated on an absolutely clean surface defined as 100% clean. Measure the diameter of the point to 1mm and press the "START" start button to begin measurement directly.
Figure 2 shows the Part Percentage Cleanliness measurements of an articulating prosthesis after it has been taken off the production line after the final cleaning. As can be seen in Figure 2, Part 5 (part 5) is the part that does not meet the cleanliness requirements. The limit value for a sufficient cleanliness value depends on the practical application for which the definition must be realized and corresponds. In the example given above, the limit value is 95%.
On the basis of the received measurement results, the quality inspector is able to recognize the cleanliness quality of the product and can therefore take the necessary measures to avoid uncleanliness and to carry out further cleaning processes on the basis of the measurement results.
Figure 2: Percentage cleanliness of parts for samples 1-5
The SITA Surface Cleanliness Tester offers the best performance test in the field of biomedical engineering, and can be used in production and laboratories, both stationary and mobile, because of its simplicity and reliable operation, as well as its small size and portability.
German Analytical Tower SITA Surface Cleanliness Meter Working Principle
Analytical Tower SITA Surface Cleanliness Meter adopts the ****focusing method, which emits the optimal wavelength of UV light to the substrate by the light source, and the sensor detects the fluorescence intensity of the reflected light right away.The optimal wavelength of the UV light source detects the tarnish of the metal surface, the sensor on the other side detects the fluorescence intensity and the fluorescence intensity is reflected by the light source. The UV light source emits the optimal wavelength of light to detect the tarnish on the metal surface, while the sensor on the other side detects the fluorescence intensity, which depends on the tarnish at the test point. With the help of a complete UV light source and sensor, the Analytical Tower SITA Metal Surface Cleanliness Tester is able to achieve the highest sensitivity and comparisons with many laboratory systems. In addition, the surrounding light source, surface temperature and surface roughness have no influence on the test results. The test results are expressed as a percentage or RFU, with a test point diameter of 1 mm, where the higher the intensity, the higher the amount of organic residue in the test point, and the lower the measured value in the RFU, the cleaner the surface.
This approach allows us to quickly quantify the results of parts testing and directly determine cleaning conditions, thus providing a reliable basis for "parts cleaning quality control", effectively avoiding decreased adhesion due to surface oils, false soldering, desoldering and other phenomena, and ensuring that the final product quality is up to standard.
Wengkaier is the sole agent of SITA in China, welcome to contact Wengkaier to learn more about SITA's product information and technical applications.