Softgel Manufacturing Process – How are softgels made?

Soft capsules are a dosage form used to produce nutritional supplements such as: Vitamin E, Collagen, Omega 3... Possessing a soft, flexible, tough capsule shell, forming a unified block - the most prominent feature of this dosage form. So do you know how they are made? What are the steps in the soft capsule production process?

→ Don't forget to refer to the article below by NanoFrance for more answers!

I. What is a soft capsule? Characteristics of soft capsules

1. What is a softgel?

Soft capsules are soft masses containing active ingredients and excipients enclosed in a sealed shell with many different shapes and sizes. They are often used to contain active ingredients in suspensions and solutions.

2. Characteristics of soft capsule dosage form

Some characteristics of soft capsule dosage form:

• The capsule shell is a unified, soft, flexible mass.
• The ingredients inside are active ingredients prepared in the form of suspensions and solutions.
• Soft capsule shell is made of a mixture of gelatin, plasticizers, colorants, and preservatives.

While hard capsules are created by pressing powdered ingredients into a uniform mass.

Although they are both capsule formulations, the manufacturing process of soft capsules and hard capsules is not the same!

II. Learn now: Softgel capsule manufacturing process

The specific steps of the soft capsule production process are currently being applied by many businesses:

1. Prepare raw materials for soft capsule production

Before production, raw materials will go through processing, sterilization, weighing, etc. According to regulations on soft capsule production, the processing area must meet high standards of hygiene, temperature, humidity, specifically:

• Production room: production temperature: about 20-22ºC; relative humidity: <40%
• Capsule drying room: temperature 21-24ºC; relative humidity 20-30ºC

2. Making capsules – Step 2 in the softgel capsule manufacturing process

The specific steps in the process of making capsule shell solution are as follows: Soak gelatin in demineralized water → Stir, heat, dissolve gelatin (stir uniformly) → Obtain shell solution → Vacuum to remove air bubbles.

The capsule shell fluid will be maintained at a temperature of approximately 57-60ºC throughout the softgel capsule manufacturing process.

3. Prepare the fluid inside the cyst

As mentioned above, the ingredients inside the softgel capsule shell are often in the form of solutions, suspensions, and emulsions. Therefore, the step of preparing the solution to produce softgel capsules is similar to preparing syrup. The solution is prepared by stirring the mixture of ingredients, homogenized by passing it through a blender.

4. Create a wet gel strip

At this stage of the softgel capsule manufacturing process, the shell fluid is spread into a suitable thin layer on the surface of two metal drums. At this time, the temperature is maintained at about 13-14ºC. The shell fluid will gel at low temperature and form a gelatin gel strip of suitable strength for making the capsule shell.

5. Molding, capsule filling

The gelatin gel strip from step 4 will be transferred to two capsule forming rollers that rotate continuously in two opposite directions. Each roller has the task of creating half of the capsule shell. At the moment the two shell halves are pressed together by the rollers, they will be sealed by high temperature.

The capsule base is sealed first, while the core is also filled into the formed capsule shell. The mold continues to be shaped, sealing the two halves of the shell to form the complete capsule, while the capsule is cut away from the gelatin strip.

6. Clean the cyst

After the capsules are formed, they are transferred to a rotating cage, rotated with cotton or poly urethane towels to clean and remove oil on the capsules.

7. Dry the cyst

After cleaning, softgels are transferred to the drying equipment. These machines usually have drums with continuously reversible walls. Capsule drying conditions: Relative humidity 20-30%, temperature 21-24ºC. They will be dried until the shell content is about 6-10%.

8. Final step of softgel manufacturing process: Packaging

Softgel capsules can be packed in bottles, jars or blister packs. At this step, the staff will test the quality and check the solubility of the capsules before releasing the product to the market.

Some important machines that are indispensable in the soft capsule processing process: spray dryer and fluidized bed granulator, capsule filling machine, blister packing machine, bottle labeling machine.

Hopefully, the above information will help you understand more about the soft capsule manufacturing process. Currently, NanoFrance does not accept processing of soft capsule products. In case you want to produce other dosage forms of dietary supplements such as: tablets, hard capsules, granules - powder, solutions..., do not forget to contact us!