In October 2019, the Association of German Engineers (VDI) published a new guideline on the purity of medical devices (VDI 2083 Blatt 21: 2019-10). In this article we inform customers and interested parties about essential aspects of the new directive.
It is often surprising for our customers if we find hard mineral particles on their components during residual dirt analysis. Customers ask: "How can that be? We were not able to determine anything in our own cleanliness tests. ”The question of contamination from hard minerals is so important because these particles have an abrasive effect and thus massively damage mechanical systems such as gears and motors.
The determination of technical cleanliness according to VDA-19.1 and ISO-16232 has become an integral part of quality control and error analysis - because the cleanliness of components is crucial for the quality and error-free functioning of the product. In addition to particles, film contamination is a problem, as the following example from quality assurance in the production of electrical drive systems shows.
Heilbronn University has had a MicroQuick particle scanner from RJL Micro & Analytic GmbH since the beginning of this year. Prof. Dr. Katja Mannschreck from the process engineering and environmental technology course and her students have already successfully used the particle scanner in several projects.
In December 2018, the revised quality standard ISO-16232 "Road vehicles-cleanliness of components of fluid circuits" was published. This international standard for the cleanliness analysis of automotive parts complies with the regulations of VDA 19.1, in whose development RJL Micro & Analytic GmbH was significantly involved. We are particularly pleased that our MicroQuick particle scanner meets this standard as the standard for cleanliness analysis [...]
A central requirement in the production of pharmaceutical products is the avoidance of visible foreign particles. Our testing laboratory has developed innovative and at the same time simple methods to reliably quantify foreign particles in pharmaceutical powders.
The identification of metallic particles is an important requirement in cleanliness analysis. In recent years, the light-optical detection of metallic particles has commonly been performed by the means of gloss. On the basis of our laboratory experience, we have found that the light microscopic analysis often leads to incorrect typifications, which can be easily avoided by a material analysis using SEM-EDX.
Which problems smallest remainder dirt particles can cause, has recently experienced a German car manufacturer: He had to recall numerous vehicles due to malfunction in the engine. Reason were production residues consisting of hard particles, which lead to a capital engine damage - in the worst case to burning cars. Hard residual dirt particles usually come from the fine machining of surfaces by glass blasting, vibratory grinding, honing [...]
Bearing shells have the function to unroll and support rolling elements. In four-stroke engines, for example, the connecting rod, which connects the piston to the crankshaft, rotates in a bearing. This is lubricated with oil, which reduces the friction and thus wear. In the lubricant, however, various residual dirt particles are contained, which can settle in the bearing shell. In the past, the [...]
Distilled water finds many uses in everyday life, for example, as cooling water in the car or steam iron. It is reputed to be purer than tap water, which is why it is also used in cleanliness analysis in the laboratory with distilled water. Residues in the water would contaminate the samples during the analysis and falsify the results. Before we distilled water for [...]