Softgels are crucial to modern healthcare and medicine, but how are these products made? What goes into the softgel manufacturing process that many of us benefit from? This process has a lengthier history than many realize, and involves an ingenious system of heating, rolling, drying, and filling.
We will be looking at softgel tech equipment and manufacturing processes in more detail to examine how these handy pharma solutions are produced.
A Brief Overview of Softgel Tech
We often think of softgels as a modern form of medication delivery. They are certainly a common sight on pharmacy shelves and medicine cabinets in the twenty-first century. However, the technology and processes used to manufacture softgels have been around for almost a century.
Robert Pauli Scherer — a Detroit-born inventor and manufacturer — originated the process at the beginning of the 1930s. He theorized a method to insert medicine powders and liquids into a “soft gel” capsule, which human patients could easily ingest. Then, the capsule would digest within the patient’s stomach, and the medicine would release. Scherer patented his invention in 1931, and his method of producing pharma products became universal.
In brief, Scherer’s encapsulation method involves the production of two flat ribbons of encapsulation material. First, these flat ribbons are pressed together to form a flat profile and then cut into small individual pieces — these pieces will eventually form the capsules themselves. Next, medicine in powder or liquid form is pumped between the two flat sheets, inflating the pill into a three-dimensional shape that is ready to be sealed.
While softgel tech has undoubtedly advanced significantly over the last nine or more decades, the fundamental principles have remained the same. However, as technology and methods become more sophisticated — and as automated processes take much of the time, labor, and cost out of the production line — pharma manufacturers can produce large batches of softgel products quickly and efficiently. This is certainly a boost to the pharmaceutical industry and patients alike.
The Process of Manufacturing Softgels
We’ve already seen a highly-simplified account of how softgel encapsulation works and the history of this process, but let’s take a look at these in a bit more detail.
The first phase of the softgel manufacturing process involves the creation of the ribbons used to make the finalized softgel products. These ribbons will form the external casing encapsulating the medicine powders or liquids.
The ribbon is made of a gelatin mixture heated and pressed into a thin, flat shape. This mixture will be strong enough to hold the medicine within the capsule once it is dried and sealed and be easily digestible within the human stomach. While the mixture is still warm and in liquid form, it is spread across rotating cylinders and stretched into shape. Next, cool air is applied to solidify the gelatine ribbon into a thin, stable layer.
Each softgel capsule requires two layers of this gelatin mixture. This means two ribbons are necessary for each softgel batch. The ribbons are then fed into the softgel machine side by side and pressed flat together to create a two-dimensional shape with a flat profile. As the ribbons press together, they are sealed along the edges to create a flat pocket. Although there is no space between the two layers, they are still distinctly separate. It is between these individual layers that the medicine is added.
The two ribbons will then be cut into shape, forming individual softgel pockets. Automating this phase of production with a softgel encapsulation machine means that there is little to no wasted material, and the pockets are uniform. The pockets are then transferred to the next phase of the softgel tech line to be filled.
Fill Material Pumping
During the filling process, the softgel capsules take on their more familiar shape and dimensions. Before this stage, the capsules are still flat and do not look like a softgel. However, when they arrive at the fill material pumping phase, they are injected with the medicine liquid or powder, and a pressurized pump forces the medicine into the capsule.
This liquid or powder sits between the two flat layers discussed above. The pressure of the fill material causes the capsule to inflate into a small, three-dimensional pocket. Softgel encapsulation machinery can fill these capsules en masse, processing thousands of units at high speed and completing each batch in a matter of minutes.
The encapsulation process requires a high level of climate control. The temperature inside the unit stays between 70 and 75 degrees Fahrenheit, with a relative humidity of 30% to 35%. The softgel manufacturing tech may rely on liquid or dry desiccants to remove moisture from the air, supported by refrigeration units that control the temperatures.
After the capsules are filled, they must be sealed. The sealing process is the final step of manufacturing, creating three-dimensional, capsule-shaped pockets that we recognize as softgels. Again, automated systems ensure that none of the materials within the pocket go to waste and that the capsules are uniform in size.
Capsules may also need to be dried, which means they should be subjected to drier climate conditions than those we have seen in the encapsulation chamber. Again, liquid or dry desiccants help remove excess moisture, bringing the relative humidity down to only 20%.
Softgel Manufacturing Processes Remain Key to the Pharmaceutical Industry
Today’s processes are far more efficient and effective than they were back in the 1930s. However, the softgels of the modern age still owe a significant debt to the innovation of Detroit’s Robert Pauli Scherer all those years ago. Advances in speed, efficiency, automation, and standardization continue to gather pace, but those original principles, first laid down in the first half of the twentieth century, can still be seen.