When magnetic bead reagents are produced in quantity, often you cannot know if you have the correct properties of the beads until the final quality control step. But if these properties are wrong, finding out the properties at the end of the magnetic separation process for production does not allow you to salvage the lot. Knowing magnetic bead properties, such as size, magnetic charge and surface charge, is critical in order to have excellent reproducibility in the final product (e.g. IVD kits).
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:
Not only is the final product at issue, but if you have beads with inappropriate properties, the biomagnetic protocols you have are useless. The force exerted on beads in a biomagnetic separation device depends both on the separator and on the bead properties. If the beads have variable properties, they will move at different speed and therefore a protocol would not work because you have no set parameters on which to base the protocol.
Monitorizing the production process
If the production process is not monitored all the way through, you have no way of detecting that there is a problem until the very end. In this scenario, Quality Control is tested hours or days after the separation steps are complete.
But, if you have a well-parameterized process such as a homogeneous biomagnetic separation, and you monitor the process as it proceeds, monitoring of the process will alert you to problems early in the protocol. This type of monitoring can allow the technician or scientist to modify the protocol by stopping the process and taking corrective measures. In this way you can save hours or even days as well as money by saving lots that may be lost completely with no monitoring.
Sometimes it is cheaper to start a new production cycle over instead of rectifying a lot that went wrong because the major cost is in running the process and not in the raw materials. Regardless, you will always save time when you use a monitoring system.
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
- How to save space in the clean room
- Problems that stem from linking your production process to a specific type of equipment