Softgel capsules are a popular and convenient way to take various types of supplements and medications. The softgel manufacturing process involves several steps that ensure the production of high-quality capsules. In this article, we will discuss the softgel manufacturing process, including the steps and techniques involved.
- Formulation Development
The first step in the softgel manufacturing process is formulation development. In this step, the formulation of the capsule contents is developed, which includes the active ingredient and other excipients that make up the capsule fill material. This step also involves selecting the appropriate capsule shell material, which can be made of gelatin or other materials like HPMC (hydroxypropyl methylcellulose).
- Gelatin Preparation
If gelatin is used as the capsule shell material, the next step is the preparation of the gelatin. Gelatin is melted and sterilized, and other ingredients such as plasticizers and water are added to achieve the desired properties of the shell material.
- Capsule Shell Formation
The capsule shell formation step involves the actual production of the capsule shell. The gelatin solution is fed into the softgel machine, which forms the capsule shell by dipping pins into the solution. The shell is then cooled to solidify.
After the capsule shell is formed, the filling step begins. The capsule shells are filled with the previously formulated capsule fill material, which includes the active ingredient and other excipients. This step may be done manually or using an automatic filling machine.
Once the capsules are filled, the next step is sealing. The two halves of the capsule shell are joined together using heat, pressure, or a combination of both. This step ensures that the capsule contents are sealed inside the capsule and protected from environmental factors.
After the capsules are sealed, they are dried to remove any moisture that may have been introduced during the manufacturing process. Drying is critical to prevent the capsules from sticking together or becoming discolored.
- Inspection and Quality Control
The final step in the softgel manufacturing process is inspection and quality control. The capsules are inspected for defects, including cracks, leaks, and discoloration. They are also tested to ensure that they meet the required specifications for size, weight, and disintegration time.
There are several techniques used during the softgel manufacturing process to ensure the production of high-quality capsules. These include:
- Automated Filling: Automated filling machines ensure that the capsules are filled accurately and consistently, reducing the risk of errors and increasing production efficiency.
- Quality Control Testing: Quality control testing is performed at every stage of the manufacturing process to ensure that the capsules meet the required specifications and quality standards.
- Color Matching: Color matching is performed during the capsule shell formation step to ensure that the capsule shells are consistent in color and appearance.
- Tamper-Evident Seals: Tamper-evident seals are used to ensure that the capsules have not been tampered with and are safe for consumption.