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In non-homogenous magnetic separators, monitoring the entire separation process is difficult to impossible. As a result, errors in the magnetic separation process, such as using the wrong magnetic beads or using buffers with the wrong properties are not detected until the final QC testing stage.

Download our FREE guide about Biomagnetic Separation for Production HERE

But homogenous Magnetic Bead systems can be monitored from start to finish of the separation process. Technicians can watch for changes in the projected separation time and, if a deviation is detected, can immediately take corrective actions.

This post is about Magnetic Bead Separation in the production of magnetic beads for IVD kits. If you want to know its most important elements, download our free eBook The basic guide to use Magnetic Bead Separation in production processes:

The production of magnetic bead-based products is comprised of many steps including incubations, washings, conjugations, etc. If a mistake is made in any one of these steps, the entire lot can be jeopardized. Functional QC tests are expensive, so they are typically performed only at the end of the production process, if the SOP is followed with no mistakes. If errors happened during the process, therefore, they are only detected at the very end of production.

Mantaining the magnetic force with homogenous Magnetic Bead Separation processes

In homogenous Magnetic Bead Separation processes, the magnetic force is constant and the force is defined by the magnetic field gradient, therefore, the percentage of magnetic beads initially in suboptimal conditions is small and the separation time is short. If these production parameters are fixed, the separation time would then depend solely on the suspension characteristics, including:

  • Magnetic bead characteristics of size, magnetic charge and surface charge

  • Concentration of magnetic beads

  • Suspension viscosity, pH and/or ionicity

Using a continuous optical monitor like the SEPMAG QCR to check the opacity of the liquid, the separation time can be objectively measured and compared to a standard curve. Deviation from the expected curve would indicate that something is wrong, allowing technicians to take immediate corrective actions if possible. If not, the batch can be discarded, saving the cost of performing additional steps and allowing technicians to start a new batch earlier. This avoids or minimizes delays in product delivery.

It is important to note that not all QC issues can be detected. But some of the most critical QC issues (e.g. the use of wrong beads or the wrong bead concentrations not matching specifications) that the SEPMAG QCR detects can dramatically affect the IVD kits performance.

If you found this post about using Magnetic Bead Separation for production useful, don’t forget to check these related posts:

Check www.sepmag.eu/ebooks to access to FREE eBooks on the subject, or contact us. We will be glad to help you to achieve an efficient magnetic bead separation process!

basic guide biomagnetic separation

Lluis M. Martínez | SEPMAG Chief Scientific Officer

Founder of SEPMAG, Lluis holds a PhD in Magnetic Materials by the UAB. He has conducted research at German and Spanish academic institutions. Having worked in companies in Ireland, USA and Spain, he has more than 20 years of experience applying magnetic materials and sensors to industrial products and processes. He has filed several international patents on the field and co-authored more than 20 scientific papers, most of them on the subject of magnetic particle movement.

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