1.Gelatin Sourcing: Gelatin, the main component of empty gelatin capsules, is derived from collagen, a protein found in the skin, bones, and connective tissues of animals. Common sources of gelatin include bovine (cow) and porcine (pig) sources. The quality and purity of the gelatin used in capsule production are paramount to ensure the safety and effectiveness of the final product. Manufacturers often carefully select suppliers that adhere to strict standards for animal husbandry and processing to guarantee the quality and safety of the gelatin. Additionally, the gelatin may undergo further processing to remove impurities and ensure consistency in properties such as viscosity and clarity. This involves steps such as heating, filtering, and refining the gelatin to achieve the desired characteristics required for capsule production.

2.Preparation of Gelatin: Once sourced, the gelatin undergoes a series of preparation steps to prepare it for capsule formation. This includes dissolving the gelatin in water or another suitable solvent to form a solution with the desired concentration. The solution may then be heated to a specific temperature to facilitate mixing and achieve uniformity. During this process, any remaining impurities or particulate matter may be removed through filtration. Additionally, additives such as plasticizers or colorants may be incorporated into the gelatin solution to modify its properties or enhance its appearance. The prepared gelatin solution is then ready for the capsule formation process.

3.Capsule Formation: Capsule formation is a critical step in the manufacturing process, where the gelatin solution is molded into two distinct halves: the capsule body and the capsule cap. This is typically achieved using specialized equipment such as encapsulation machines or dipping machines. In a typical encapsulation process, stainless steel pins or molds are dipped into the gelatin solution, coating them with a thin layer of gelatin. The coated pins are then cooled to solidify the gelatin, forming the capsule halves. The size and shape of the capsules can be adjusted by controlling factors such as the viscosity of the gelatin solution, the dipping time, and the temperature of the molds. This allows for the production of capsules in various sizes to accommodate different dosages and applications.

4.Trimming and Drying: After the capsule halves are formed, they undergo trimming and drying processes to prepare them for assembly. Trimming involves removing any excess gelatin and shaping the edges of the capsule halves to ensure a proper fit and seal when joined together. This is typically done using automated trimming machines that precisely trim the capsules to the required dimensions. Once trimmed, the capsules are dried to remove excess moisture, which helps prevent sticking and ensures stability during storage. Drying may be accomplished through methods such as air drying or vacuum drying, depending on the specific requirements of the manufacturing process. Proper drying is essential to maintain the integrity and quality of the capsules and to prevent issues such as microbial growth or capsule deformation.

5.Joining: The dried capsule halves are then joined together to form complete capsules ready for filling with active ingredients or supplements. This is typically done using a process known as "banding," where the edges of the capsule halves are slightly moistened to facilitate adhesion and then pressed together using specialized equipment. The joining process must be carefully controlled to ensure a tight seal and prevent leakage or contamination of the contents. Manufacturers may employ automated capsule filling and sealing machines to achieve high throughput and consistency in the joining process. Additionally, visual inspection systems may be used to detect any defects or imperfections in the joined capsules, allowing for corrective action to be taken as needed.

6.Quality Control: Quality control is a crucial aspect of capsule manufacturing to ensure that the finished product meets rigorous standards for safety, purity, and quality. Throughout the manufacturing process, various quality control measures are implemented to monitor and evaluate the quality of the capsules at each stage. This includes testing the gelatin for purity and consistency, conducting visual inspections of the capsule shells for defects or irregularities, and performing physical and chemical tests to assess factors such as weight variation, disintegration, and microbial contamination. Additionally, samples of the finished capsules may be subjected to stability testing to assess their shelf-life and ensure that they remain safe and effective over time. Any deviations from established quality standards are promptly identified and addressed to prevent the release of substandard products into the market.

7.Packaging: Once the capsules have passed quality control checks, they are packaged into containers suitable for storage, distribution, and consumption. The packaging process may vary depending on factors such as the intended use of the capsules, market requirements, and regulatory guidelines. Common packaging options for gelatin capsules include bottles, blister packs, sachets, or bulk packaging for industrial use. The packaging materials must be selected carefully to ensure compatibility with the capsules and to provide adequate protection against environmental factors such as moisture, light, and oxygen, which could degrade the quality of the capsules or affect the stability of the contents. Labels containing important information such as dosage instructions, expiration dates, and safety warnings are applied to the packaging to provide consumers with the necessary information to use the product safely and effectively. Additionally, tamper-evident seals or other security features may be incorporated into the packaging to provide assurance of product integrity and prevent tampering or contamination during storage and transport.

Enteric-coated Hollow Capsules
Product introduction: Enteric gelatin hollow capsules are made of gelatin and enteric coating materials.
Product Category: Pharmaceutical Excipients
Product application: It is often used in special packaging for drugs or health care products that are irritating to the stomach or are unstable in the presence of acid, and that need to be dissolved in the intestine and exert their curative effect.