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.
But homogenous biomagnetic 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 biomagnetic 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 biomagnetic 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 biomagnetic separation processes
In homogenous biomagnetic 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 biomagnetic separation for production useful, don't forget to check these related posts:
- Perfecting the magnetic separation process in magnetic bead IVD kit production
- Detect Resuspension Problems with Biomagnetic Separation Processes
- 3 Key Parameters for Defining a Production Process in Biomagnetic Separation