Cleaning validation and efficiency evaluation of the high-gradient magnetic separator in pharmaceutical design

K. Wolz*, M. Franzreb, M. Ebeler, G. Grim, ANDRITZ KMPT GmbH, Germany

Various studies have been conducted in high-gradient magnetic separation (HGMS) technology over the past few years. The major advantages of this technology are obvious when processing highly complex feed stocks, such as blood. The current state-of-the-art technology for protein fractionation is liquid chromatography, which needs several time-consuming and costly purification steps upstream to be able to process the feed stock. In contrast, HGMS allows the extraction of one protein fraction directly from the non-purified complex feed stock. With HGMS technology, the efforts of downstream processing can be decreased massively while the yield is increased.

The principle of the technology is to bind a specific protein fraction to magnetic beads with a highly selective functionalized surface. By using a magnetic field, it is possible to extract the magnetic beads and also the specific fraction from a non-purified feed stock together with these beads in a single unit operation. Application fields for this technology are slurries involving high downstream effort, extremely low titer, and highly valuable components like hormones, antibodies, enzymes, or simply the functionalized particles themselves.

In industrial pharmaceutical applications two major concerns need to be overcome to allow establishing a new technology, first the product quality must be proven and second the economic advantage in comparison to state of the art technologies must be verified.

The product quality is a consequence of efficient cleaning in place routines as well as high selectivity of the separation process. The selectivity of the process needs to be evaluated for each product individually, whereas the cleaning efficiency is mainly confirming a well design apparatus. The cleaning validation of the ANDRITZ rotor stator magnetic separator was done at the Karlsruhe Institute of Technology (KIT) by the Institute for Functional Interfaces (Prof. Dr. Ing. Matthias Franzreb) under the 10ppm criteria which gave extraordinary results in terms of cleanability. The 10ppm criterion was easily passed and it was shown that...

Session: L12 - Novel Processes and New Separation Concepts
Day: 15 March 2018
Time: 09:00 - 10:15 h

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