How does a Factory Make Empty Hard Gelatin Capsule Shells from Bovine Bones?

The pharmaceutical industry relies on a variety of packaging solutions to ensure the safe and effective delivery of medications. Among these solutions, hard gelatin capsules stand out for their versatility and ease of use. But have you ever wondered how these capsules are made? In this blog post, Wecaps will share the process of converting bovine bones into empty hard gelatin capsule shells, a journey that involves several stages of transformation and purification.

The Raw Material: Bovine Bones

The starting point for hard gelatin capsules is the gelatin itself, which is derived from collagen. Collagen is a naturally occurring protein found in the bones, skin, and connective tissues of animals. Bovine bones are a rich source of collagen, making them an ideal raw material for the production of gelatin.

Extraction of Gelatin from Bovine Bones

1. Cleaning and Crushing: The process begins with the thorough cleaning of bovine bones to remove any impurities. The cleaned bones are then crushed into smaller pieces to increase their surface area, facilitating the extraction process.

2. Decalcification: The crushed bones are treated with a dilute acid solution to remove calcium phosphate, a mineral that makes up the hard structure of bones. This step is crucial for obtaining a high-quality gelatin.

3. Gelatin Extraction: After decalcification, the bones are boiled in water to extract the collagen. As the bones break down, the collagen molecules unravel and dissolve into the water, forming a gelatin solution.

4. Purification and Concentration: The gelatin solution is filtered to remove any remaining impurities and then concentrated by evaporation. The concentrated gelatin is cooled to form a solid mass, which is then ground into a fine powder.

Manufacturing the Capsule Shells

1. Dissolving Gelatin: The gelatin powder is mixed with water and heated to form a liquid solution. Additional ingredients such as plasticizers, coloring agents, and preservatives may be added at this stage to enhance the properties of the capsules.

2. Dipping Process: The liquid gelatin is poured into a capsule mold, which has two halves. The mold has a series of small cylindrical holes representing the shape of the capsules. A stainless-steel pin, called a "dipping pin," is dipped into the gelatin solution, allowing it to coat the pin.

3. Solidification: The gelatin-coated pin is then cooled in a controlled environment to allow the gelatin to solidify. This forms a thin layer of gelatin on the pin, which corresponds to the body of the capsule.

4. Separation and Reapplication: Once the gelatin has solidified, the pin is removed from the mold, leaving behind the lower half of the capsule shell. The process is repeated with the other half of the mold to create the cap of the capsule. The two halves are then recombined to form a complete capsule shell.

5. Drying and Trimming: The assembled capsule shells are dried in a controlled environment to remove any residual moisture. After drying, the capsules are trimmed to ensure uniformity in size and shape.

Quality Control and Packaging

1. Inspection: Each capsule shell undergoes a thorough visual inspection to check for any defects or inconsistencies in appearance.

2. Leakage Testing: Capsules are tested for their ability to withstand moisture, ensuring that they maintain their integrity when filled with medication.

3. Packaging: The qualified capsules are then packaged in bulk or in blister packs, depending on the requirements of the pharmaceutical company.

Wecaps strictly controls the source of raw materials. The gelatin capsules produced are made of high-quality bovine bone glue and do not contain impurities. The production process is strictly monitored to avoid the production of harmful substances and fully meet the strict requirements of pharmaceutical products.

Frequently Asked Questions

1. What are the primary materials used to make hard gelatin capsule shells from bovine bones?

The primary material is gelatin, which is derived from the collagen found in bovine bones. Additional ingredients may include purified water, plasticizers, and pigments for coloring.

2. What is the role of plasticizers in the capsule-making process?

Plasticizers are added to the gelatin to increase its flexibility and make it easier to mold into the desired shape of the capsules. Common plasticizers include glycerin and sorbitol.

3. How are the gelatin solutions prepared for capsule making?

Gelatin is dissolved in water to create a solution of specific concentration. This solution is then filtered and deaerated to remove any impurities and air bubbles.

4. How do factories ensure the capsules are free from contaminants?

Factories use a combination of good manufacturing practices (GMP), rigorous cleaning and sanitation protocols, and regular testing to ensure the capsules are free from harmful contaminants.

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