Formulation, filling, and sealing are some capsule production procedures. Gelatin or other suitable materials are first used to create the capsule shell and filled with the formulation. The capsule is then packaged for delivery, sealed, and quality-checked.
Capsules are one of the essential components of the pharmaceutical sector. They are mainly used to hold dry powder or little pellets of medication and are made using specific machinery and techniques. The capsule's production method entails pharmaceutically active ingredients, additives, and a cover. Every pharmaceutical business understands capsule manufacturing takes time, and the reason is the critical measures.
Did you know?
India produces a wide variety of capsules to meet the different requirements of the pharmaceutical and nutraceutical industries. These include soft gelatin capsules, hard gelatin capsules, and vegetable capsules.
What Is a Capsule?
Capsules are solid forms of medication in which contents are encased in either a soft or hard, dissolving container or shells made from appropriate gelatins. Capsules have the benefit of being palatable, readily ingested, and widely available in large numbers.
Capsules are classified into two categories based on the amount of gelatin present.
- Hard Gelatin Capsule
- Soft Gelatin Capsule
The fundamental difference between the two is that hard gelatin capsules are less plasticised than soft gelatin capsules. In addition, hard gelatin capsules have two parts, the "cap" and "body". Hard gelatin is widely used and filled with powder drugs or medicine pellets.
The Dipping Method used to manufacture hard gelatin capsules involves steps like Dipping, Rotation, Drying, Striping, Trimming, and Joining.
This article will discuss the manufacturing process for hard gelatin capsules.
However, the procedure for processing capsules is now automated. As a result, it is a two-step process whereby the initial hollow capsule casings are created separately and then filled using various types of equipment.
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The Capsule Manufacturing Process
Capsule production is critical for medicine and pharmaceutical firms. Typically, the process entails actions that must be taken to get the desired results. It includes the entire process, from dissolving raw materials through printing to transporting finished capsules.
Knowing the procedure will assist your employees and company in producing capsules smoothly. Therefore, let's start and study the overall stages in the following part!
Raw Materials and the Manufacturing Environment
One of the critical elements in capsule manufacturing is the hard gelatin casing, mostly made of gelatin. Synthetic dyes, plasticisers, stabilisers, and opacifying chemicals are also used to aid capsule creation and performance measures.
12 to 16% water is also included in hard gelatin capsules, and the quantity of water depends on processing conditions. Dip-coating is a technique used to make hard gelatin capsules.
Raw Material: To produce the highest quality capsules, it is essential to use high-quality raw materials in the capsule production process, such as USP-NF, JP, and EP.
Colourant: One can choose to keep their products transparent or colourful. High-quality colourants are typically employed during the melting process to give vibrant colours to the medicine casing.
Environment: Cleanliness and hygiene become essential factors when producing high-quality capsules. The most critical thing to do is to keep the production area sanitary. Pharmaceutical and medical enterprises must adhere to ISO 14644-1 class 8 standards.
Employees or personnel involved in capsule manufacture must adhere closely to hygiene standards and ensure cleanliness from the beginning. This is before accessing the facility.
Step By Step Capsule Manufacturing Process
The capsule manufacturing process involves several steps, so let’s take a closer look at each step of the capsule manufacturing process.
Step 1. Raw Material Melting & Coloration
The first step in the process involves an acceptability test for raw materials. The materials that pass this test are then melted and coloured for easy identification.
1. Raw materials, having passed the acceptance test in the testing phase, are sent to the production line.
2. The feeder (hopper) raw material is weighed precisely, accurately, and placed in containers.
3. The weighed material is transferred from the container to the melting unit.
4. Purified water is added to the melting unit before the melting process begins.
5. The melted raw material is then stirred to make a homogenous jelly-like substance called gelatin.
6. If required, a colourant is added to capsules.
Step 2: Blending
This concentrated gelatin solution is blended and dissolved in demineralised water heated to seventy degrees Celsius. The solution at this stage is very viscous and contains 30 to 40% gelatin.
A vacuum process is also used to reduce air bubbles in the solution, which would otherwise cause issues during the filling and preservation stages. Colourants and pigments can also be added at this stage to give the capsule's final look.
An additional consideration is the thickness of the gelatin solution. The solution's thickness can directly influence the subsequent production process, thus making it a crucial factor.
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Step 3: Molding and Trimming
1. The capsule manufacturing machines receive coloured gelatin in the capsule processing chamber. The caps and bodies of the capsules are made. The gelatin solution must attain the desired viscosity before the dipping process.
2. The capsule moulding pegs or pins are dipped into the gelatin mixture. This is accomplished by either gravity or a pumping device, and the pins must be completely immersed in the solution. The moulded pins are then transferred to the drying chamber.
3. These pins are dried at a constant temperature and consistent humidity level in the drying chamber. After the curing process, the pins are sent to the following processing step.
4. The dried caps and bodies of the capsules are now removed from the moulding pins and trimmed to the proper length before being pre-locked. The pin plate enters the stripping machine.
Here, the capsules are separated into two equal or nearly equal sizes. Shell trimming occurs after the stripping procedure is completed. The machine then automatically joins the two capsule halves. These capsule bodies are then transferred to the conveyor belt and, eventually, to the next step.
5. In the following steps, we perform an immediate visual inspection of every capsule to eliminate abnormal products as soon as possible. The image processing technology is used to identify irregular features. The inspection is done by lighting the capsules on a revolving bench and taking digital images for a quality check.
6. The finished capsules are placed into containers in the last phase.
Step 4: Printing & Packaging
1. Printing company labels are significant for product identification.
2. The required graphic is imprinted on the capsules using the company's ink and stamping equipment.
3. An alternative printing method is a laser printing machine, which labels the product to the specific pharmaceutical.
4. The printing stage includes all vital information, such as prescription recommendations, advertisements, and capsule branding.
Step 5: Testing, Packaging & Shipping
1. After the printing phase is completed, the quality testing phase begins. The end products must undergo stringent quality inspections to ensure that the capsules are of the best quality and possess a long shelf life.
2. An automatic capsule inspection system detects faults in capsules. Advanced visual analysis and automated technologies make inspecting the product and achieving desired standards possible.
The inspection system has various characteristics that make it appropriate for industrial use. The machine's functioning is simple and easy for personnel to learn and use. The machine can identify faults like inadequate filling, perforations, internal chips, splits, grooves, short bodies, multiple caps, curved caps, brittle produce, short and long caps, bubbles, black spots/heterochromatic spots, and many others.
3. Many firms perform various other tests before packaging and shipping products. Factors like dimensions, appearance, moisture content, separation, and other factors are typically examined for capsules. Following are some tests that can be employed:
- Visual Appearance Evaluation
- Dimensional Evaluation
- Microbiological Examination
- Separation Examination
4. Packaging is the final stage in capsule processing. Capsules are now packaged conventionally. Standard packaging is preferred because it makes the capsules more manageable. After confirming the quantity, capsules are moved to the next process.
5. Packed capsules are kept in a temperature and humidity-controlled facility until shipping.
Method for Filling the Capsules
Let's have a look at the gelatin capsule filling procedure now. For successful capsule filling, many capsule-filling devices are available. Here's a basic rundown of how capsules can be filled:
1. Automatic Filling of Powder Formula
- Locate the empty gelatin capsules on the detachable plate. You must be certain about the downward-facing positioning.
- Carefully disengage the cap and body.
- Fill the composition into the capsule body using a plastic ladle. The excessive powder in the capsule must be discarded.
- Finally, seal the filled capsule casings. Dislodge the capsule now.
2. Manual Filling of Powder Formula
Manual powder filling of hard gelatin capsules is critical for various reasons. Let’s see how we can fill gelatin capsules by hand:
- Put the filling powder on a ceramic plate or clean parchment.
- Proceed by pushing the open end of the capsule downward.
- Continue pressing until the capsule is full.
- Finally, seal the capsule with the cap.
Capsule manufacturing production facilities equipped with small-scale hand-operated equipment produce around 200 to 2000 capsules each hour. At the same time, automatic capsule-filling machines are the best option for filling capsules in bulk.
It has a production capacity of up to 42,000 capsules per hour and is ideal for large batch production with frequent product changes.
Conclusion
Capsule manufacturing involves several procedures to ensure a high quality product suitable for human consumption. Manufacturers use extreme caution at all stages to guarantee that the completed product fulfils all relevant safety and quality requirements.
Capsules are a common type of medication because of their simplicity of consumption and low cost. They come in a variety of sizes and forms and can be filled with a variety of substances.
Capsule processing is highly controlled and includes several quality control steps to guarantee that the completed product is effective and safe.
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