The pharmaceutical and nutraceutical industries rely heavily on softgels, or soft gelatin capsules. These capsules are uniquely suited for liquid or semi-solid fillings which include oils, vitamins, herbal extracts and even prescription medicines. Soft gelatin capsule manufacturing facilities of India are famous in the pharmaceutical industry. So what happens in a softgel manufacturing plant?
In this blog, we will take you through the entire process of soft gelatin capsule manufacturing in India starting from selection of raw materials till the final product comes out of the packing machine and delve into the quality control procedures and technologies used.
Understanding Soft Gelatin Capsules
These capsules are made of gelatin and of a combination of a plasticizer like glycerin or sorbitol and water. They are favored over hard capsules due to their smooth and pleasant mouth feel as well as for being easy to swallow.
Softgels are however more convenient for containing sensitive formulations that are oil based or fat soluble because they are hermetically sealed.
Softgel producers in India service the following industries:
- Pharma (Omega-3, multivitamins, analgesics)
- Nutraceuticals (e.g., Dietary oils, herbal supplements)
- Veterinary products and cosmeceuticals
The Manufacturing Process, SImply Explained
1. Gelatin Mass Preparation: The gelatin mass preparation step is the first in the sequence of steps to follow. Pharmaceuticals are placed in large stainless-steel tanks where they are stirred and heated. Gelatin, together with a plasticizer and purified water, is mixed and heated. This heated mixture goes through de-aeration which prevents air bubbles that cause inconsistencies on the shell of the capsule.
- Ingredients: Gelatin, glycerin or sorbitol and water
- Duration: Between 8 and 12 hours to completion
- Quality Checking: pH, viscosity and moisture.
2. Filling Material Preparation: During readying the gelatin mass, it is also necessary to prepare the liquid or semi-solid material for encapsulation. Herbal extracts, oils, vitamins and even pharmaceutical ingredients can be included. This design is formulated, emulsified to attract as many particles as possible to one spot and get them mixed and homogenized to create an even blend.
- Focus on: Control of temperature, the speed of mixing and mixing’s solubility of the ingredients.
- Evaluation encompasses: Measurements of viscosity, potency and microbial limits.
3. The Procedure for Encapsulation: Encapsulation is done with a rotary die encapsulation machine. It forms two ribbons of gelatin mass which are rotated over a set of dies. At the same moment, the fill material is injected into the space between the ribbons. The capsule is filled, formed and sealed as the dies turn.
- Primary rotary die encapsulators.
- Watch: Weight of the fill, seal crack and ribbon thickness.
4. Curing and Drying: Recently encapsulated softgels must be dried because they are still new and soft. The capsules are then moved to the class B drying tunnels or tumble dryers which use air circulation and temperature control. The capsules take the final shape and hardness during this step.
- Time needed: 24 to 48 hours.
- Conditions: 20-25 C with 20-30 percent humidity.
Critical point is to avert moisture retention at all costs to maintain guaranteed shelf life of the product.
5. Inspection and Sorting: Capsules are inspected manually or use an automated system that performs inspection troubled capsules containing leaks or deformed or improper fill will block that trick.
- Inspection criteria: Uniformity in size, shape, color and surface imperfections
- Automated Systems: Sorters and high-speed cameras
6. Packaging and Labeling: The approved softgel capsules are counted and sealed under sterile conditions before being blister packed into bottles or jars. The labels containing batch numbers, expiry dates and appropriate labeling according to guidelines are done afterward.
- FSSAI, GMP, WHO-GMP or USFDA depending on the market for Compliance.
- Final Check: evidence of tampering, shelf life and stability.
What Makes Indian Manufacturers Gain Trust Worldwide
India’s soft gelatin capsule manufacturers excel in:
- Producing at a lower cost while maintaining high production levels.
- Meeting quality control standards such as ISO and WHO-GMP.
- Having R&D advanced infrastructure.
- Custom exporting capabilities.
Having access to an extensive pharmaceutical network allows the country to provide quality softgel services for international markets at lower prices.
Conclusion
If you are looking for a Soft Gelatin Capsules Manufacturer in India, Healthwise Pharma is an emerging first choice for manufacturing soft gelatine products, for pharmaceutical companies in India. This primarily because we have set us apart from our competitors by ensuring exceptional manufacturing practices, sterility and timely delivery services. Our manufacturing unit is renowned for its highly skilled staff, outstanding products and exceptional documentation for our clients to place themselves firmly in the market.