Manufacturers of medical products face special challenges. These include, for example, medical approvals, often at a national level. The tests required for this often apply to new or modified products, as well as to the development of new markets. The Analytik Service Obernburg provides advisory support in advance on request.

 

A typical question is the control of an active ingredient content or the testing for impurities.

Of course, the classic areas of raw material and product analysis or damage analysis are also of interest for medical technology products. This leads to the use of a wide range of analytical and physical methods:

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• Material identification using NMR

• Substance purity and content by HPLC

• Spectroscopy , for example on functionalized surfaces

• XRD to determine phase purity (crystalline structure)

• Elemental impurities in the trace range ( ICP-MS )

• Laser diffraction and SEM-EDX for the size and distribution of drug particles

 

The issues investigated include, for example, the design, composition and structure of membranes for filtration or dialysis. But medical textiles, reaction vessels, cannulas, contact lenses, bone substitutes and general medical technology materials are also the subject of analysis in the field of medical technology.

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