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Biomagnetic separation used to take place in academic labs, but recently it has become a very industrial application. As processes are scaled up and volumes increase, the investment required for each batch is larger, but the expected economic return is also larger.

Free PDF guide:  "Validation of Magnetic Bead Separation Processes" 

When production mistakes happen in magnetic bead separation processes, investments returns and the viability of the product on the market are both endangered. In order to minimize production mistakes, industries must establish Standard Operating Procedures (SOP), Quality Control Protocols (QCP) and Validation Audits (VA).

This post is about magnetic bead separation and how to validate this process. If you are interested in this topic, and are willing to learn more about it, download our Free Guide The Starting Guide to Validate Biomagnetic Separation Processes:

Why must we monitor Magnetic Bead Separation?

When a company uses Magnetic Bead Separation, they usually only require that a technician signs off on the conformity of the process. No other records are typically produced for that process, so if something is wrong with the product, the production manager cannot backtrack using the production records and deduce the problem with the magnetic separation. This is not the optimal way to ensure consistency between lots.

When using homogenous Magnetic Bead Separation technology, as Sepmag uses, all of the beads move at the same speed and so one can make optical measurements of each single batch over time and compare results between lots of the same product. Changes in the characteristics of the suspension will change the data gathered from the optical sensor (i.e. will detect changes in the behavior of the bead movement during production).

In the beginning, a standard curve can be validated and compared against the behavior of each lot. Objective parameters can be measured (such as the t50). If anything causes a deviation from the standard curve, it can be an early warning of quality problems in the batch. Some causes of deviation from the standard curve include:

  • Magnetic bead property variations (i.e. size and magnetic content) which can change the speed of separation.
  • Magnetic bead concentration variations which also can change the speed of separation.
  • Suspension viscosity variations which will alter magnetic force.

Optical recorders, such as Sepmag’s QCR system, will allow companies to not only be warned that there is a problem sooner, but will also be able to identify and rectify the specific problem with production.

Sepmag's QCR allows companies to detect problems with magnetic bead separation earlierIf you found this article interesting and want to get a deeper insight in the topic of magnetic bead separation, make sure to check these articles from our blog:

 

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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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