Genetically engineered cells are cultivated in a bioreactor where they produce the insulin. When fermentation is terminated, the cultivation is harvested and the bacteria filtered off. The cell mass is then broken up to release the insulin. Finally, the insulin goes through purification steps to extract the pure product. As insulin is broken down in the digestive tract, it needs to be injected into the blood stream. This means, that the demand on purity is very high. Additionally, the concentration of insulin within each vial must be very precise in order to prevent under- or overdosage.
Due to these requirements, preparation of the product before dosing it into vials is a major task and requires a series of mixing steps.
In order to assure homogeneous concentration during dosage preparation the insulin mixture must be well agitated. However, it is a known fact that shear forces can easily denature the protein, resulting in its deactivation.
The physical changes accompanying the denaturation process involves early agitation-induced aggregation of the proteins with final fibrillation.
The FUNDAMIX® is proven to be the best equipment on the market to prevent such denaturization while assuring effective mixing at the same time. It has the ability to move large volumes of liquid without affecting the sensitive proteins. The vibrating action induces a high degree of random distribution without baffles and at very low shear effects on the proteins.
With the absence of any rotating part, the FUNDAMIX® allows complete isolation of the sterile medium from the environment and hence is ideally suited for this task. With a simple membrane sealing which is mechanically fixed to the shaft you are assured of an absolutely sterile environment. There are no requirements for a mechanical seal or a magnetic drive.
The FUNDAMIX® represents itself as an easy to install mixing device for dissolving and dispersing processes of soluble powders and crystals into liquids at high concentrations. With resulting mixtures showing low agglomeration tendencies it is an ideal equipment for the preparation of batches upstream of filling lines.
Due to its vertical mixing direction no baffles are required, which allows this agitating device to be applied for a wide range of applications and tank designs. Its sealed membrane guarantees aseptic conditions, adaptable amplitudes assure homogeneous product mixtures even during the emptying phase and the parts in contact with the process can easily be cleaned and sterilized. It is a low-maintenance device which can be handled with ease in mobile vessels.