Capsule Manufacturing Process: Step By Step Guide




Capsule Manufacturing Process: Step By Step Guide

Capsule Manufacturing Process: Step By Step Guide
Capsule Manufacturing Process: Step By Step Guide - Capsules are the most important elements of the pharmaceutical industry. They are made using particular equipment and procedures. All pharmaceutical companies are aware of how long it takes to produce a single capsule. The important procedures that must be followed are the cause. This blog includes everything to help you with the effective Capsule Manufacturing Process: Step By Step Guide.

Some steps involved in producing capsules are formulation, filling, and sealing. Gelatin or another suitable material is used to create the capsule shell, which is then filled with the formulation. After that, the capsule is quality inspected, sealed, and prepared for delivery. India manufactures a broad range of capsules to satisfy the various demands of the nutraceutical and pharmaceutical sectors. These come in three varieties: vegetable, hard, and soft gelatin capsules.

What Is a Capsule?

Medication in the form of solid capsules is enclosed in a shell made of suitable gelatins or a soft or hard, dissolving container. The advantages of capsules are their taste, ease of ingestion, and accessibility in large quantities. 
The capsules are classified into two categories depending on the amount of gelatin present.
  • Hard Gelatin Capsule
  • Soft Gelatin Capsule 
Hard gelatin capsules are less plasticized than soft gelatin capsules, which is the main distinction between the two. Furthermore, hard gelatin capsules' "cap" and "body" are two separate components. Hard gelatin is frequently used and filled with pills or powdered medication. Hard gelatin capsules are made using the Dipping Method, which includes stages including dipping, rotating, drying, stripping, trimming, and joining. 

What Is A Capsule Manufacturing Process?

Capsule manufacturing is a critical step for organizations that deal with medications and supplements. The steps that must be taken to get the desired results are typically included in the process. Everything is involved, from printing to delivering the packaged capsules to melting the raw material. 
Comprehending the procedure will enable your employees and business to produce the capsules effectively. 

Capsule Manufacturing Process: Step By Step Guide

Melting the raw material is the first step in the manufacturing process of capsules. Additionally, the coloring is done to make distinctions simple. Let's review the pertinent information and procedures for creating capsules:
 
Step Process Description Key Considerations
Formulation Development Design the active pharmaceutical ingredients (API) and excipients to create a stable formulation. Ensure compatibility between API and excipients. Consider bioavailability and dosage form.
Raw Material Sourcing Procure high-quality raw materials (API, excipients, gelatin, etc.) from verified suppliers. Supplier qualification, raw material testing for purity, potency, and quality.
Blending Mix API and excipients uniformly to ensure consistency in dosage. Homogeneity is critical; over-mixing can affect the quality.
Granulation Convert the blended powder into granules to improve flowability and compressibility. Two methods: wet granulation and dry granulation; consider moisture content.
Capsule Shell Preparation Prepare gelatin or alternative materials (e.g., HPMC) for the capsule shells. Ensure proper viscosity and temperature during gelatin processing.
Capsule Filling Fill the prepared capsules with the blended formulation using a capsule filling machine. Adjust the machine for accurate dosage and minimize product loss.
Capsule Sealing Seal the capsules, especially for liquid or semi-solid formulations, to prevent leakage. Use banding or other sealing techniques as required.
Quality Control Testing Test the filled capsules for weight variation, disintegration, dissolution, and content uniformity. Follow pharmacopeial guidelines and ensure all batches meet quality standards.
Polishing and Inspection Polish the capsules to remove any dust and inspect for defects like cracks, dents, or color variation. Automated or manual inspection to ensure visual and structural integrity.
Packaging Pack the capsules in blister packs, bottles, or bulk containers under controlled conditions. Protect from moisture, light, and oxygen; ensure proper labeling and documentation.
Storage and Distribution Store the packaged capsules in controlled conditions and distribute to the market. Maintain proper temperature and humidity; ensure compliance with regulatory standards.

PART 1: Raw Material Melting & Coloration

  • After passing the acceptance test, the raw material is brought into the production area. 
  • The hopper's raw material is automatically weighed in the container.
  • The weighted material will now be moved from the container to the melting tank.
  • Before starting the melting process, purified water is poured into the melting tank.
  • After it begins to melt, the mixture is stirred to form a uniform jelly.
  • At this stage, coloring matter may be added to the colored capsules.

Part 2: Capsules Molding & Cutting

  • The colored jelly is fed into the capsule manufacturing machines in the capsule production room.
  • After that, the pins are submerged in the jelly mixture. After that, the molding pins are moved to the drying unit.
  • There will be no changes in the temperature or humidity during the drying process. These move on to the next section once they have dried.
  • The bodies and dried caps are now taken off of the molding pins.
  • After being appropriately lengthened, the bodies and caps will be pre-locked.
  • Following this, all capsules will be immediately visually inspected. Lights are shined on the rotating capsule, and digital images are captured by cameras. Furthermore, image processing techniques are used to detect abnormal shapes.
  • In this final stage, the conformal capsules will be packed into containers.

Part 3: Printing, Inspection & Packaging

1. Capsule Printing
At this point, the capsules were printed to identify the product.
Using the company's ink and printing machine, the designated design is printed inside the capsules.
For inkless printing, there is an additional choice. This section allows you to utilize the laser printer.
2. Automatic Capsule Inspection Machine 
Using automation and sophisticated visual processing, the automatic capsule inspection machine is made to detect flaws in capsules. It is perfect for use in industrial settings because of several features. 
The staff can easily learn how to operate and operate the machine because of its simple operation. In addition to detecting flaws like less filling, holes, cracks, notches, thin spots, short bodies, double hats, concave tops, internal chips, short and long hats, bubbles, black spots/heterochromatic spots, and others, the machine can test specifications for 00#, 0#, 1#, 2#, 3#, and 4# capsules.
  • The capsule inspection machine will now be used to examine the capsules.
  • We're going to count the capsules.
  • The capsules that have conformed will be moved to the following container.
  • In the product warehouse, capsules are kept in sealed containers with regulated humidity and temperature.

PART 4: Shipping Tests & Shipment

Before the correct capsule products are shipped, the companies can conduct certain tests. The dimensions, appearance, moisture content, separation, and other aspects of capsules are typically tested. You can run the following tests on your manufactured capsules:
  • Visual Appearance Test
  • Dimensional Test
  • Microbial Test
  • Separation Test

Part 5: Capsules Filling Process

Let's now examine the filling procedure for gelatin capsules. For efficient capsule filling, a variety of capsule-filling machines are available. An overview of how capsules can be filled is provided below:
First, find the empty gelatin capsules by taking the detachable plate. You must be certain that you are facing downward.
  • Properly separate the bodies from the cap.
  • Fill the capsule body with the formulation using a plastic spatula. It is necessary to take out the extra powder from the capsule.
  • Seal the filled capsule shells as the final step. Expel the capsule now.
Conclusion
Hope you receive the complete information related to the Best Capsule Manufacturing Process: Step By Step Guide. Several steps are involved in the production of capsules to guarantee a high-quality product fit for human ingestion. To ensure that the finished product satisfies all pertinent safety and quality regulations, manufacturers take great care during the entire process. Because they are inexpensive and easy to take, capsules are a popular kind of medication. They can be filled with several materials and are available in a range of shapes and sizes.
Frequently Asked Questions (FAQs)
Question 1. Which company is the Leading Capsules Manufacturing Company in India?
Answer.
Lifevision Healthcare is the Leading Capsules Manufacturing Company in India.

Question 2. How are medicine capsules made/filled?
Answer.
Usually, the capsules are filled by admitting the powdered form into the capsule body from the hopper. It is done using the filling rings.