How Softgel Capsules Are Made: Complete Manufacturing Process Guide

Softgel capsules (sometimes called soft capsules or soft gelatin capsules) are one-piece gelatin shells filled with liquid or semi-solid medicine or nutrients. Unlike hard (two-piece) kapsüller, softgels are formed and filled in one continuous process. They are widely used for dietary supplements, vitamin, and pharmaceuticals because they are easy to swallow and can seal oils or sensitive ingredients tightly. Bu kılavuzda, we’ll walk through exactly how softgel capsules are made, from raw ingredients to the finished pill, in a friendly, easy-to-read way.

What Are Softgel Capsules and Why Use Them?

A softgel (softgelatin capsule) is essentially a flexible gelatin shell (sometimes called a gelatin softgel capsule) that encases a liquid or semi-solid fill. You may also hear them called yumuşak kapsüller, especially when referring to the gelatin cover. Softgels were invented in the 1930s and have become very common in pharmaceuticals and supplements. Örneğin, many fish oil or vitamin D supplements are delivered as softgel capsules.

Softgels differ from hard capsules in that two softgel ribbons are sealed together around the fill in one go, creating a watertight seal. Tersine, a hard capsule has a separate cap and body that are filled with dry powder and then closed. This continuous encapsulation process lets softgels hold oils and liquids without leaking. According to industry sources, softgel manufacturing “involves meticulous attention to detail and a deep understanding of the materials and processes.” It’s a precise, multi-step procedure that requires specialized equipment.

Key Ingredients and Materials

Softgel production starts with selecting the right materials for both the shell and the fill.

• Jelatin: The main material for the shell is gelatin (from animal collagen) or a similar polymer. The gelatin provides a smooth, digestible shell. High-purity (USP-grade) gelatin with consistent particle size is required. Son yıllarda, plant-based alternatives (like carrageenan or modified starches) have emerged to meet vegan or halal demand, but traditional gelatin is still the standard.
• Plasticizer (Glycerin): Glycerin (also called glycerol) is added to the gelatin mixture to make the shell soft and flexible. It prevents the shell from becoming brittle and cracking.
• Water: Purified water (distilled or deionized) is needed to dissolve the gelatin and control the viscosity of the shell mixture.
• Colorants/Opaquers: To give capsules their color or opacity, manufacturers add water-soluble dyes or pigments (like titanium dioxide). These can be mixed in during or after the gelatin melt. Örneğin, a dye solution is usually filtered into the gelatin tank to avoid lumps.
• Active Fill Ingredients: The interior (doldurmak) can be oils (fish oil, vitamin E oil, evening primrose oil, vesaire.), çözümler, süspansiyon, or emulsions containing the active pharmaceutical ingredients (API'ler), vitamin, bitkisel özler, or nutrients. Powders (örneğin. vitamin) are milled to a fine size (around 80 ağ) to stay suspended. The fill may also include stabilizers or emulsifiers depending on the formulation.

Özetle, a softgel (soft gelatin) capsule is made from gelatin, glycerin, water, and optional colors in the shell, with a carefully prepared liquid or semi-solid fill inside. All raw materials must meet strict quality standards.

Üretim süreci (Adım adım)

The softgel manufacturing process has several key steps. Below is a simplified, friendly overview of each major step, from shell to finished capsule.

1. Prepare the Gelatin Shell Mixture:

A large stainless-steel melter (mixing tank) heats and mixes the shell ingredients. Birinci, water and glycerin are heated to about 70–80 °C. Then gelatin powder is slowly added while stirring. This can be done by a hot melt or cold melt process, but in both cases a vacuum is applied to pull out air bubbles. After mixing, the molten gelatin syrup is very viscous and should be clear of any clumps. Operators often check viscosity in a simple way (Örneğin, dipping a finger and seeing if the gel “strings” about 4–5 inches). Once mixed, the gelatin mass is transferred to a heated receiver tank to “season” for several hours (often 3 ile 24+ saat). This holding period at around 65–70 °C lets trapped air escape and ensures a uniform, stable temperature. Bu noktada, a color solution (if used) may be added through a fine filter to evenly tint the mass. After seasoning, the gelatin shell mixture is ready to form the capsule walls.

Key equipment: stainless-steel melter with agitator and vacuum pump, heaters, and insulated holding tanks.

2. Prepare the Fill Material:

While the shell is being prepared, the fill material is also made in parallel. In dedicated mixing tanks (often stainless steel), all active ingredients, yağlar, and solvents are blended. Powders (like vitamins or APIs) are milled and sieved to avoid large particles. Liquids and liquids/solids are mixed using high-shear mixers, homogenizers, or magnetic agitators to achieve a uniform suspension or solution. During mixing, care is taken to avoid trapping air (using slow, smooth stirring or even vacuum). Some sensitive oils (like fish oils) may be blanketed with nitrogen gas to prevent oxidation during processing. The goal is a smooth, lump-free fill. Once complete, the final fill mixture is pumped into the encapsulation machine’s hopper.

Key equipment: stainless steel fill tanks (with lids/valves), high-shear mixers, mills/colloid mills, transfer pumps, and filtering screens.

3. Ribbon Formation and Filling (Encapsulation):

Now comes the heart of the process. A rotary die softgel machine simultaneously forms, doldurma, and seals capsules in one continuous motion. Here’s what happens inside the machine:

• Gelatin Ribbon Casting: The seasoned liquid gelatin is pumped into two chilled casting drums. Each drum rotates and spreads the hot gelatin into a thin, uniform ribbon (çarşaf) of gel. Cooling fans or drum jackets solidify the ribbon to the exact thickness (often around 0.8 mm). You end up with two parallel sheets of soft gelatin film, one from each drum.
• Doldurma: These ribbons are brought together in the machine. A precisely timed injection wedge (a heater/nozzle assembly) injects a metered amount of the liquid fill between the two gelatin ribbons. An injection pump controls the exact fill volume for each capsule. As the ribbons move past the wedge, the fill is sandwiched between them.
• Sealing and Cutting: Immediately after injection, rotary die rolls press and heat the gelatin ribbons. The dies cut the ribbons into capsule shapes and simultaneously seal the edges, trapping the fill inside. Each die cavity gives the capsule its final shape (round, oval, oblong, vesaire.). The pressure and mild heat cause the gelatin layers to fuse around the fill. Lubrication rollers in the machine apply a thin layer of food-grade oil (like MCT oil) to the ribbon to prevent sticking.
• Exit: Fully formed softgels drop out of the die area onto a conveyor or discharge chute. At this point each capsule is a complete, sealed soft gelatin capsule (i.e. a softgel).

In simpler terms, the machine works like this: Two gelatin ribbons come together, liquid is pumped in between, and rotating dies seal and cut out individual softgel capsules all in one step. Because it’s all one continuous operation, softgel production is very efficient and produces uniform capsules.

Key equipment: rotary die encapsulator with casting drums, spreader boxes, injection wedge, rotary dies, lubrication system, cooling fans, and control panel. (Major manufacturers include Technophar, Orada, Jinlupacking, vesaire., and they all use this basic rotary die method.)

4. Drying and Polishing:

The freshly made softgel capsules are still warm and soft, with high moisture (often 30–40% water in the shell). They must be dried and hardened. This is typically done in two stages:

• Tumble Drying: The capsules go into a tumble dryer (a rotating stainless steel drum or vibratory dryer). Warm, humid air passes over them to remove most of the moisture quickly. This step cuts the moisture down significantly.
• Tray (Tunnel) Kurutma: After tumble drying, capsules are spread on trays (like a convection tunnel or cabinet) and dried further in a climate-controlled room. Air temperature and humidity are carefully regulated (Örneğin, around 25–30 °C and 20–30% RH) so the capsules dry slowly without cracking. Over several hours to a day, moisture drops to the final target (often <5–10%).

After drying, the capsules are solid, glossy, and no longer tacky. They often receive a light polishing or coating (with edible oils or beeswax) to give a shiny finish and prevent sticking. Any slug or scrap capsules are removed (Örneğin, via a sieve or destoner).

Key equipment: tumble dryer, drying tunnel or cabinet, cooling trays, and finishing machines. (Dryers often have humidistat control – industry sources suggest drying chambers may be kept at ~20–25% RH during capsule drying.)

5. Final Quality Control:

• Throughout and after production, thorough quality checks ensure the softgels meet all standards. Technicians inspect:
• Ribbon Quality: Before filling, the cast ribbons are checked for correct thickness, clarity, and absence of air bubbles.
• Fill Uniformity: The capsule fill weight is measured regularly to confirm dose accuracy.
• Seal Integrity: Random softgels are tested (burst tests or leak tests) to make sure seals are complete and capsules won’t leak.
• Dış görünüş: Finished capsules are examined for color consistency, şekil, and surface defects.
• Stability and Dissolution: Finished batches undergo tests for chemical stability, and a subset is tested in dissolution machines to confirm the medicine will release properly in the body.

Common production issues (like air trapped in fill or uneven capsules) are addressed by adjusting mixing or machine settings. Genel olarak, strict controls during mixing and encapsulation (Örneğin, milling powders fine and degassing liquids) help avoid problems like leaks or non-uniform fills.

Note: Softgel lines require a clean, climate-controlled environment. Manufacturing rooms are usually kept around 20–22 °C and 25–30% humidity to keep the gelatin flexible. Drying rooms are drier (often ~20% RH) to cure the capsules.

Putting It All Together

Özetle, making soft gelatin capsules is a careful, multi-step process. You mix a gelatin/plasticizer solution, prepare a uniform fill, then feed both into a specialized encapsulation machine. That machine casts gelatin ribbons, injects the liquid fill, seals and cuts each capsule, and produces softgels at high speed. The new capsules are then dried to the correct moisture level and inspected.

By following each step precisely and using the right equipment, manufacturers produce high-quality softgels that meet pharma standards. With this knowledge, you (or your production team) can better understand softgel lines, troubleshoot any issues, and ensure your softgel capsules come out consistent and effective every time.

If you’re interested in exploring softgel capsule manufacturing — whether you want to discuss production capacity, machine customization, or get a detailed equipment quote — we’re here to help. Contact us today to request a free quote or learn more about our softgel encapsulation machines.

FAQs on Softgel Capsules

Referanslar：
1.Softgel — Wikipedia
2.The manufacturing process of softgel capsules — Softcaps.science
3. IJCRT (International Journal / Creative Research Thoughts) — “Manufacturing of soft gelatin capsules” (IJCRT2306100)
4.PharmaTutor — “Yumuşak Jelatin Kapsüller (Softgels)”