If one wants to scale up production from small lab lots to full-scale large lots, a non-homogenous magnetic separation process will result in lot-to-lot inconsistencies. Homogenous biomagnetic separation conditions, however, guarantee consistent results regardless of production scale.
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:
In order to have consistency from a small lab scale to a large production scale, it is vitally important to have well-defined conditions. Unfortunately, if the biomagnetic conditions are not homogenous (i.e. by using simple magnets or classical magnetic separators), it is difficult to determine production conditions and to therefore have large-scale production results that are consistent with the results determined during development (i.e. during small scale production). You are using different devices with different conditions and the separation processes will not be the same. Scaling up almost always results in greater material losses and irreversible greater aggregation processes.
How to guarantee lot-to-lot consistency
Homogenous biomagnetic separation devices like the SEPMAG systems achieve consistency by imposing two important conditions:
- The devices magnetically saturate the beads by applying a field higher than 0.1 Tesla. That would be enough to saturate magnetite. For other magnetic pigments the field value may differ.
- The devices generate a well-characterized and constant magnetic field gradient.
By fulfilling these two conditions, the force is guaranteed to be the same across all of the beads, regardless of their position in the separation vessel. When the field is small, the magnetic susceptibility is constant (i.e. the magnetic moment depends linearly with the field) and it is difficult to get a homogenous force. When you magnetically saturate the beads, the magnetic moment is near constant, the gradient is constant, and then the force on each bead will be independent of volume. This allows for significantly less to no material loss and significantly fewer to no irreversible aggregation problems.
Because of these conditions and the lack of material loss, consistency in production batches is therefore, guaranteed. No additional process development is necessary in order to achieve consistency. No additional resources and effort is required to find production conditions. Homogenous biomagnetic separation necessarily leads to a final product that is consistent with the laboratory specifications.
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
- The Use of Biomagnetic Separation in Production Processes
- Centrifugation and Filtering with Biomagnetic Separation