The use of softgel capsules continues to be popular because of their effectiveness and convenient delivery of liquid or semi-liquid drugs. If you are in the pharmaceutical, dietary, or nutraceutical industry, your knowledge of the softgel manufacturing process is critical.
In this post, we share details about all the key stages you should be aware of in the softgel manufacturing process.
Softgel Capsule & Its Important
A Softgel is a special oral dosage that is also referred to as a soft capsule. It has an outer shell that mainly consists of gelatin which can either be vegetable-based or made from vegan starch. The other enrichment ingredients forming the outer gelatin shell are color additives, glycerin, and preservatives.
The gelatin shell encapsulates liquid or semi-liquid medical or dietary fill material for easy swallowing. Softgel also ensures the convenient and effective delivery of drugs, or essential minerals or nutrients to the bloodstream after swallowing.
The 10 Stages In Softgel Manufacturing Process
Before undertaking a complete softgel manufacturing process, you must choose and invest in the softgel manufacturing machine that suits your production needs.
Here are the 10 key softgel manufacturing process stages you must know to ensure high-quality production.
#1. Softgel Formulation /Ingredients Preparation
This initial stage of the soft gel manufacturing process involves the correct selection, formulation, and preparation of active pharmaceutical ingredients (APIs) or dietary ingredients.
You must ensure that the ingredients are in their correct composition. It is also important that you properly mix your ingredients with other suitable excipients or additives to achieve your desired product
#2. Preparation of Softgel Filling Material
After preparing your softgel ingredients in their right formulation, the next step is to transform them into the right softgel fill materials depending on your needs.
So, you may require the mixture to be in liquid or semi-liquid. Some materials for softgel fill material can also be in the form of oil form or suspensions.
Therefore, to get the right quantity of your softgel fill material, your mixture needs to be processed in a special milling and mixing tank.
During the milling and mixing process, air bubbles form which can affect the quality and consistency of the fill material. This is resolved by passing the final mixture through a vacuum.
You need to store the soft gel fill mixture in a special tank to await the filling and sealing process or encapsulation.
#3. Gelatin Material Preparation
With your gel mixture ready and stored in a service tank, the next step of the softgel manufacturing process is to prepare the outer shell of your softgel which is gelatin. This requires the preparation of a gel mass.
You require a gelatin melting tank for this particular process. Gelatin is mixed with other ingredients such as glycerin, water, and desired color or flavor additives for melting and blending within the tank.
The type of gelatin you use will determine the level of melting temperature you should set.
#4. Softgel Filling and Sealing (Encapsulation Process)
SaintyCo-How Softgels Are Made
This stage is a critical step in the manufacturing process of softgel and involves the precise filling of softgel fill material into a gelatin shell and sealing the shell.
As complex and long as the process may be, it is interesting to note that the softgel encapsulation process
To effectively and efficiently begin and complete your softgel capsules manufacturing process, you require a reliable encapsulation machine with the most suitable softgel support equipment
The filling and sealing of your softgels are achieved by the softgel machine’s rotary die.
Here are the key stages in your softgel encapsulation process that you must pay keen attention to:
Filling Step 1: Gelatin Spreading and Cooling
Softgel gelatin liquid material is delivered in two special boxes at a temperature of 60℃. The boxes evenly spread the flowing gel into special drums with inbuilt cooling systems and outer die pockets.
As the two casting drums turn, they cool and solidify the gelatin material to form two similar ribbons.
Filling Step 2: Gelatin Feeding
The two solid or soft gelatin ribbons move with the help of well-lubricated rollers on either side. This ensures they do not stick but move smoothly.
The rollers position the two ribbons side by side to the injection wedge. At this point, they are pressed by a special die roll to form a flat profile while being sealed along their edges forming a flat gelatin pocket.
Filling Step 3: Softgel Fill Material Pumping
Softgel fill material from the service tank flows into a special hopper. The fill material from the hopper is forced into the injection wedge using a pump.
Filling Step 4: Softgel Shell Formation & Material Filling
The pump injects the fill material between the two flat gelatin ribbon layers through dosing channels. The fill material under the pump pressure, causes the gelatin ribbon shells to bulge to form the three-dimensional shape of a softgel capsule. The die-roll pockets determine the shape and size of the softgels you intend to produce.
Filling Step 5: The Sealing Process
Further rotation of the softgel die rolls ensures the ribbon pockets are sealed and the injected fill material remains between two shell pockets.
Note: For effective sealing of the two halves of softgel shells, you must set the right sealing pressure with a temperature range of about 40 degrees Celsius.
Filling Step 6: Softgel Capsules Removal
The continued rotation of the die roll releases a gelatin ribbon with sealed softgel capsules still attached to the die roll pockets.
Die-roll brushes remove softgels from the die rolls. However, the die-roll brushes may not remove all the softgels. So, the gelatin ribbon has to pass through two stripper rollers to remove any stubborn softgels!
All the softgels are now ready for the pre-drying and drying process.
Filling Step 7: Gelatin Ribbon Collection
After successfully removing all the softgels, the gelatin ribbon net goes to the collection section for recycling. With modern automated softgel encapsulation machines, there is very little gelatin material waste.
Rotary Die Process, Softgel capsule machine capsules, #youtubeshorts
#5. Softgel Manufacturing Process: The Drying Phase
Pre-drying
Following the encapsulation process(filling and sealing), your softgels capsules then move to a special moving drum for a uniform pre-drying process. This stage aims to remove excess water from the shells and enhance the structural integrity of the softgels.
Complete Drying
The pre-dried softgels are then fed on trays where they are evenly distributed in readiness for the full drying process.
The drying process is the flow of air that moves in the opposite direction of the softgel trays. To maintain the quality of the softgel, proper control of the drying temperature is critical.
#6. Softgel Inspection and sorting
To maintain the quality standard of your softgel capsules, you must inspect and sort them accordingly. This allows you to identify and remove softgels with defects or deformation from the processing line while the good quality ones continue to the next stage.
#7. Softgel Manufacturing Process: Cleaning and Polishing
This cleaning and polishing stage removes any form of dirt, oil, lubricants, or leaked material from the softgel capsules
Where cleaning alone is not adequate, you may need to take your softgels through a polishing machine to remove stubborn residues
Though some manufacturers use ethanol as a cleaning detergent, its volatility makes it less safe.
So, the best option is the use of Medium-chain triglycerides (MCT) oils. This is because they are safe for humans. They are also non-volatile with no negative environmental impacts.
The cleaning and polishing process should leave your softgels both clean and dry.
If your softgels do not require special coating, they are ready for customized printing, or identity markings. You can achieve this using a laser machine or any other specialized printer.
However, if you need to produce softgels with enteric coating, consider all your requirements for this process.
#8. Softgel Coating Process
Softgel coating is optional. Therefore, it only applies where necessary and for a good reason. For instance, enteric coating is applicable when manufacturing special softgels that need protection from the stomach’s gastric acids.
Taste enhancement can also be another reason for softgel coating.
The coating process involves applying a sub-coat to your softgel shells using the recommended coating material and other additives.
So, you must invest in a suitable softgel coating machine if necessary. Some of the Available coating options you may consider include:
- Organic coating
- Vegan Coating
- Enteric Coating
- Colored or Clear Coating.
#9. Quality Control Tests
In this stage of the softgel manufacturing process, you need to assess the quality of your products to ensure they conform to the set standards and specifications.
The quality control tests you must conduct include a dissolution test, and a disintegration test using a suitable disintegration tester.
Other parameters you must asses include the weight, shape, and color of your produced softgels.
To ascertain the quality, you also need to analyze the strength of your softgel shell using a texture analyzer.
For some softgel, you must assess if the light that passes through them conforms to the required standard. Therefore, you need a Transparency Tester for this process.
#10. Softgel Packaging/Bottling
This processing stage requires softgel packaging equipment configured to your packaging or bottling needs.
At this stage, softgel counting should also be an important part of your packaging process.
So, integrating your packaging solution with an Automatic Softgel Counting Line will enhance the efficiency of your softgel packaging and manufacturing process as a whole.
Conclusion
Softgel capsules are popular, especially in the pharmaceutical and food supplement manufacturing industries. This is mainly because of their versatility and ease of use.
The softgel manufacturing process requires that you investment in the right machines and support equipment. The production process also demands close attention at each stage
Ensuring that your softgels conform to the necessary test standards is critical in determining your capability and ability to produce products that conform to the desired international standards.
