Soft capsule
Soft capsules are a technologically advanced form of delivering active ingredients, valued for their high effectiveness, precise dosing, and bioavailability. They feature a soft, flexible shell, most often made of gelatin or plant-based materials, enabling the encapsulation of active ingredients in a liquid or semi-solid form. The special design of soft capsules ensures faster and more effective release of active ingredients in the gastrointestinal tract while protecting them from oxidation, moisture, and exposure to light. These advantages have led to their widespread use in the dietary supplement, pharmaceutical, and cosmetics industries worldwide.
Manufacturer of Soft Capsules
Jako International Organic Company (IOC), we specialize in soft capsule productionAt our modern production facility in Poland, we offer comprehensive services that include developing innovative formulas, production of soft capsules in various sizes and a guarantee of the highest quality at every stage.
We offer custom softgel production across all business models. We provide solutions ranging from rapid market entry ( White Label ) to building a strong brand ( Private Label ) and implementing unique, proprietary projects ( Contract Manufacturing of Dietary Supplements /OEM ).
Contract manufacturing of capsules softgel
As part of contract manufacturing capsules softgel we use the most efficient rotary die method, which enables: continuous forming and filling capsules, precise dosing of the charge (oil, emulsion, suspension), tight connection of the halves of the gelatin casing.
IOC – Global Contract Manufacturer of Softgel Capsules Softgel
International Organic Company (IOC) since 2009 it has been specializing in the production of soft capsules (softgel). As renowned manufacturer of soft capsules softgel operating in a modern production plant in Poland, we offer the highest quality products, confirmed by international certificates ISO and GMPThe key advantages of our capsules are their unparalleled quality, precision manufacturing, and efficient delivery of active ingredients.
Process Definition: Capsule Production Softgel
The softgel production process involves preparing a gelatin shell in the form of two heated ribbons and a liquid, oily, or semi-solid filler. The filler is precisely injected between the ribbons , which are then sealed and cut to form the capsules.
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Strategic Partnership: Industrial Potential and Operational Security
In a global supply chain, predictability is key. IOC it's more than just a production plant - it's Contract Manufacturing Organization (CMO) Premium. We offer process stability, industrial scalability, and full regulatory transparency for over 350 entities in international markets.
1. Pure-Play Business Model Contract Manufacturer"
We eliminate the risk of conflict of interest at the strategic level. As one of the few entities in Europe, IOC does not have or develop its own brands (Private Label).
- No Competition Guarantee: Our R&D resources are focused solely on your brand's ROI. We will never compete with our partners.
- Strict NDA: All process innovations and formulations are the exclusive intellectual property of the Client.
2. Supply Chain Resilience
We manage commodity risk through vertical integration. We eliminate the dependence on intermediaries thanks to our own structures in Asia.
- Direct Sourcing (India): Through a subsidiary EKLAVYA BIOTECH, we control the quality and availability of key APIs and extracts at the source.
- Business Continuity Plan (BCP): We have strategic warehouse buffers that guarantee production continuity even in crisis situations on global markets.
3. Industrial Scalability and Operational Redundancy
Our machinery has been configured to handle high-volume volumes in continuous mode (24/7).
Critical Infrastructure: 3 x High-Speed Rotary Die
We operate on three independent, fully automated lines Industrial-grade encapsulators. This ensures 300% technical redundancy.
Total Plant Capacity: Our production potential exceeds 100,000,000 (100 million) capsules per monthWe are prepared to handle the largest network contracts in Europe while maintaining short lead times.
| Strategic Parameter | Standard IOC | Value for the Partner |
|---|---|---|
| Monthly Capacity | > 100,000,000 pcs. | Security of stocking of large retail chains. |
| Single Batch | 5 million – 20 million+ pcs. | Batch uniformity for large export orders. |
| Redundancy | 3 Independent Lines (24/7) | Minimizing the risk of downtime (Risk Mitigation). |
| Quality Rate | Zero Defects (16 years old) | Elimination of disposal costs and reputational risk. |
4. Information Security Policy: "Closed Facility"
Our priority in B2B relationships is the protection of intellectual property (IP). Our facility operates under a closed system to outsiders.
Trade Secret Protection Protocol
To ensure confidentiality of information, we do not conduct reference visits to the production floor . This strict policy ensures that the technological processes and production volumes of our partners remain strictly confidential.
Quality Assurance is based on:
- Full access to System Documentation and Quality Reports.
- The results of audits carried out by State Sanitary Inspection (Sanepid) and ISO/GMP certification bodies.
Soft Capsule Production Technology (Softgel) – Pharmaceutical Standard
Production of soft capsules (Softgel) is one of the most complex processes in contract manufacturing (CDMO). Unlike hard capsules, shell formation and fill encapsulation occur in a fraction of a second, in a single machine cycle. This process requires precise control of critical parameters: temperature, relative humidity, and gelatin viscosity.
Key Stages of the Rotary Die Process
In our modern production facility, this process goes beyond standard mixing of ingredients. To ensure the stability of the final product (no leaks, resistance to oxidation), we implement the following steps:
- Preparation of gelatin mass (Melting and Degassing): The process begins in vacuum reactors. The gelatin mass (or a vegan starch/carrageenan-based substitute) is heated and – crucially – subjected to a deaeration process (removal of air bubbles)This prevents oxidation of the fill and guarantees perfect tightness of the capsule seam.
- Homogenization of the Batch (Formulation): In parallel, the feedstock is prepared – most often oils (e.g. Omega-3), suspensions or pastes. At this stage, using AI algorithms (in the case of IOC), we verify the so-called input-envelope interactionsto avoid migration of plasticizers, which is a common cause of capsules "hardening" over time.
- Encapsulation (Rotation Method): This is the heart of the process. Two gelatin ribbons pass through heated drums. A precisely measured dose (accurate to the milligram) is injected between two dies, which instantly seal the capsule. Important: In the case of raw materials sensitive to oxygen, this process takes place in an inert gas (nitrogen) shield.
- Two-Step Drying (Key to Durability):
- Stage 1 (Tumble Dryers): The capsules are placed in rotating drums, where approximately 30% of the water is removed from the capsule.
- Stage 2 (Drying Tunnel): The capsules are transferred onto trays to rooms with strictly controlled humidity (below 20% RH). This process takes 24 to 72 hours and determines the final hardness and microbiological stability of the product.
Why Softgel? Technological Advantage of Form
The choice of a soft capsule in contract manufacturing is a strategic decision, dictated not only by aesthetics, but above all by pharmacokinetics:
- Increased Bioavailability: An ideal formulation for lipophilic (fat-soluble) and water-insoluble substances. The liquid formulation accelerates absorption.
- Hermetic Barrier: The uniform coating provides an excellent barrier against oxygen and light, protecting sensitive active ingredients from degradation (rancidity).
- Dosing Precision: Technology Rotary Die provides higher Content Uniformity than standard tableting.
Tip for the Client: W IOC The softgel production process is subject to the same quality standards (GMP, HACCP) as pharmaceutical production. Thanks to the "Zero Private Label" model, each production line is individually configured for your unique formulation, eliminating the risk of cross-contamination.
Critical Control Points (CCPs) in Soft Capsule Production
Capsule production Softgel is a process sensitive to hundreds of variables. IOC We don't rely on "luck," but on hard data. Our manufacturing process is designed to eliminate the most common market defects in softgel capsules before the product even reaches blister packaging.
How do we eliminate risk? Technology Analysis
For B2B customers, shelf stability is paramount. Below, we present how our SOPs address common issues with this type of delivery:
| Typical Market Failure | Technical Cause | Solution Implemented in IOC |
|---|---|---|
| "Sweating" and sticking capsules together (Leaking & Sticking) |
Too high residual moisture in the envelope or water migration from the hygroscopic load. | Precision tunnel drying: We do not release the batch until the shell moisture content has reached Equilibrium Moisture Content at the level of 8-10%. |
| Cross-linking of the shell (Cross-linking) |
The reaction of gelatin with aldehydes in the fill, causing the capsule to harden and not dissolve in the stomach. | Addition of acids organic(e.g. amber) to the gelatin mass, which inhibit the cross-linking process. Regular aging tests (Stress Tests). |
| Charge Oxidation (Rancidity) (Oxidation) |
Enclosing air bubbles inside the capsule during the injection process. | Nitrogen (N2) encapsulation: The injection process takes place in an anaerobic environment. Additionally, we vacuum degas the gelatin mass before molding. |
Maturation and Polishing Phase
Once formed, the capsule Softgel is "alive" – it continues to release moisture. Therefore, the final stages are crucial:
- Tumble Drying: Removes the top layer of technical oil and gives shape.
- Static Drying (Tray Drying): It lasts from 24 to 72 hours. The air in the tunnel has a humidity of <20%. This is where the capsule gains mechanical hardness that makes it resistant to transport.
- Polishing (Finishing): Instead of using chemical solvents, we use absorbent cotton fabrics, which ensures a high gloss without the risk of dulling the coating.
Innovations in Production Softgel: Industry 4.0 and AI
Modern contract manufacturing of softgels is undergoing a transformation from a craft-based model to a data-driven process. IOC We don't follow trends - we implement them, integrating classic pharmacy with digital solutions.
Key Technologies That Increase Competitive Advantage
- PAT systems (Process Analytical Technology): Instead of traditional post-processing inspection, we use real-time monitoring. Laser micrometers measure the thickness of the gelatin ribbon with micron precision, ensuring that each capsule has identical mechanical strength.
- AI and Stability Prediction (Author's Model) IOC): We use machine learning algorithms (recognized by Forbes) to simulate capsule behavior before production. Our AI can predict the risk of so-called cross-linking of gelatin – a process in which the capsule hardens and becomes insoluble over time. This allows us to modify the shell composition during the R&D phase, eliminating future complaints.
- 360° Visual Inspection: High-resolution cameras analyze each capsule for micro-air bubbles in the seam, which is crucial for the tightness of oil products (e.g. CBD, Omega-3).
Eco-Transformation and Clean Label: More than a Trend
Sustainability in contract manufacturing isn't just marketing, but also a regulatory requirement (ESRS) and an expectation of informed consumers. How do we address this technologically?
- TiO2 (Titanium Dioxide Free) Challenge: Following the EU ban on titanium dioxide (E171), we introduced stable opacifier substitutes based on calcium carbonate and rice starch. We offer fully opaque capsules that meet the standard. Clean label.
- New generation plant capsules: We've moved away from the unstable first generations of vegan starches. We use advanced modified starches (pea/tapioca) and carrageenan, which are as strong as animal gelatin but allow for certification. Vegan & Halal.
- Heat Recovery in Drying Tunnels: The capsule drying process is energy-intensive. Our plants utilize heat recovery systems, which reduce the carbon footprint of each batch by approximately 15% compared to standard lines.
Market Trends and Your Brand Strategy
As a CDMO partner (Contract Development and Manufacturing Organization), we are observing changes that will impact the profitability of your products in the coming quarters:
- Personalization and "Combo" Formulas: The market is moving away from single-dose supplements (e.g., vitamin D3 alone). The trend is toward complex matrices (e.g., plant extracts suspended in omega oils), which require advanced knowledge of ingredient compatibility to avoid chemical interactions within the capsule.
- Regulatory Compliance: EFSA and GIS have increased their rigor. Our legal department verifies not only ingredients but also health claims on labels (Claims), protecting your brand from regulatory risk.
- Miniaturization (Easy-to-swallow): Consumers are seeking smaller, easier-to-swallow forms. Thanks to precise dosing, we can encapsulate the same active doses in smaller capsule formats (e.g., Oval 2 or 3), increasing patient compliance.
Contract Manufacturing of Soft Capsules – CDMO Model
Choosing a production partner soft capsules (Softgel) is a strategic decision. IOC Ltd. We offer more than just production line rental. We operate in a model CDMO (Contract Development and Manufacturing Organization), which means full technological support: from the development of a stable recipe, through testing in accredited laboratories, to the finished product.
Why over 350 brands have chosen IOC as your producer?
- 16 Years of Experience (since 2009): The longest track record in specialized contract manufacturing on the Polish market, without proprietary brands. Your formula doesn't compete with our products because we don't have them.
- Production Safety (GMP & ISO): Our plant in Gdynia operates in accordance with strict standards ISO 22000: 2018 and GMP (Good Manufacturing Practice). We guarantee full traceability of raw materials.
- Scalability and Flexibility: We carry out both pilot implementations for innovative start-ups and multi-million dollar series for global pharmaceutical companies.
As a certified manufacturer of softgel capsules , we combine precision production engineering with scientific rigor, delivering products of consistent quality that build trust with your customers.
The most important stages of production at a glance:
The Origins of Technology Softgel: From Scherer's Patent to Industry 4.0
The foundation of modern soft capsule production is the groundbreaking invention of Robert Paul Scherer . In 1931, he developed and patented the rotary die encapsulation process . This was a turning point in industrial pharmacy – for the first time, it became possible to hermetically encapsulate liquids, oils, and suspensions in a single-piece, flexible shell on a mass scale.
Process Evolution: What Has Changed in 100 Years?
While the fundamental physical principle—forming two gelatin ribbons and simultaneously injecting the charge—remains unchanged, the standard of execution has undergone a technological revolution. In a modern CDMO facility such as IOC, Scherer's mechanical concept has been improved with digital solutions:
- Dosing Precision: Historical machines had a significant margin of error. The modern injection systems we use guarantee dose repeatability down to microliter tolerances, which is crucial for highly potent substances.
- Protective Atmosphere: Unlike the original methods, today's encapsulation process for sensitive oils (e.g. fish oils) takes place in a nitrogen blanket, eliminating oxidation at the production stage.
- From Powder to Suspension: We have perfected our homogenization technology, which allows us to encapsulate not only pure oils, but also complex suspensions (powders dispersed in an oil carrier) in soft capsules, while maintaining their stability and bioavailability.
Soft capsule shell formation
Two thin, flexible ribbons are formed from heated gelatin mass (of animal or plant origin). They are cooled to obtain a stable but still plastic form.
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Filling and forming soft capsules
Both gelatin ribbons are fed into the machine, where they are joined together. A precise dose of medication is injected between them under pressure. This filling pressure gives the soft capsule its characteristic three-dimensional shape.
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Closing and drying of soft capsules
The filled soft capsules are immediately hermetically sealed (heat-sealed). They are then transferred to a drying room where, under strictly controlled conditions (low humidity, approximately 20%), they achieve their final hardness and stability.
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Key Aspects of Soft Capsule Production IOC:
- Cover to choose from: Gelatinous or vegetarian – something for everyone.
- Fill Protected: Perfect for liquids and sensitive substances. Masks taste, protects contents.
- Versatile Application: Medicines, dietary supplements, cosmetics. Convenience and precise dosage.
- Quality is the basis: Rigorous standards (e.g. GMP – Good Manufacturing Practice) are a guarantee of safety.
- Modern Technology: Advanced production lines ensure repeatability and the highest class of the product.
Capsule production softgel is a process where expert knowledge, technology and attention to every detail create a product worthy of your trust.
Bioavailability Enhancement Technologies IOC
As a CDMO partner focused on clinical product efficacy, IOC Ltd. We depart from standard solutions where science allows us to achieve an advantage. In softgel production, the key isn't simply "encapsulating oil in gelatin," but designing a carrier system that maximizes the potential of the active ingredient.
Delivery System Comparison: Standard vs. High-Tech
The choice of technology determines the product's price and market positioning (Mass Market vs. Premium). The following analysis helps you choose the optimal implementation path:
| Technology | Mechanism of Action | Business Advantage (USP) |
|---|---|---|
| Standard Softgel | Mechanical protection of the oil charge. Disintegration in the stomach (15-30 min). | Low cost of production (COGS). Ideal for bulk vitamin products (A+E, D3). |
| Enteric Softgel (Enteric) |
Coating resistant to gastric pH. Release in the intestine (pH > 6.8). | Elimination of fish "bouncing". Crucial for Omega-3 and premium probiotics. |
| SEDDS & Liposomal (Nano-Systems) |
Self-emulsifying micelle-forming systems bypass digestion and enter the bloodstream. | Max Bioavailability. It allows you to reduce the dose of an expensive raw material (e.g. CBD, Q10) while maintaining the effect. |
| Twist-Off | Capsule with a tail for precise dosing of the liquid (without swallowing the capsule). | Dominance in the Pediatric (babies) and Cosmetic (serum) segments. |
Raw Materials Engineering: What happens before encapsulation?
The capsule itself is just packaging. We build the quality of the final product at the pre-formulation stage, using processes that eliminate chemicals and thermal degradation:
- Supercritical CO₂ Extraction (Green Chemistry):
Instead of cheap hexane-based extracts, we use raw materials obtained with pure carbon dioxide.
Effect: Absolute chemical purity of the feed (no solvent residues) and a full spectrum of phytonutrients. - Low Temperature Homogenization:
The process of combining ingredients takes place at a controlled temperature (Cold Processing).
Effect: Preservation of the biological activity of thermolabile ingredients, such as enzymes and natural vitamins. - Microencapsulation in Suspension:
For minerals in the oil matrix we use particle micronization.
Effect: This prevents sedimentation (falling) of ingredients to the bottom of the capsule, guaranteeing perfect dose uniformity (Content Uniformity) throughout the entire batch.
Technology & Business FAQ (2025 Edition)
Answers to key questions for Product Managers and Brand Owners, based on current EFSA and GIS regulations.
How do you solve the problem of the ban on Titanium Dioxide (E171) in opaque capsules?
This is the most important technological challenge in recent years. After the ban on the use of TiO2 in dietary supplements came into force, IOC we have implemented stable hybrid technology Based on calcium carbonate and micronized rice starch, it allows for full opacity and an elegant, matte appearance of the capsule, which is 100% compliant with "Clean Label" requirements and safe for Sanitary Inspection (Sanepid) inspections, without the risk of the capsule "graying."
Are your vegan capsules stable? (Concerns about cracking/hardening)
The market is rightly concerned about first-generation vegan capsules (based solely on carrageenan), which have been known to be fragile. IOC however, we use 3rd generation technology based on pea starch (Pea Starch)Our aging tests (Real-Time Stability) confirm that these coatings remain flexible for 24-36 months, do not react with the oil fill, and are fully resistant to micro-cracks during transport.
Why Logistic Minimum (MOQ) For Softgel is 300 thousand pieces?
This is due to the specific nature of rotary machines and the so-called "start-up waste" (technical waste). Calibration of the web thickness and seal requires the use of a certain amount of gelatin and feedstock. For small batches (e.g., 50), the cost of this waste would have to be added to the price of each capsule, making the product uncompetitive. The level of 300.000 (approximately 5000 packages) is the cost optimization point (Break-Even) , which guarantees you a market-leading unit price.
Can you combine oils with plant extracts (powders) in one capsule?
Yes, we specialize in Complex Suspensions . The key to our success is our process of micronizing solid particles to a size below 180 microns. This prevents the powder from settling (falling) to the bottom of the capsule and clogging injection nozzles. This allows us to combine, for example, Omega-3 fatty acids with Lutein or Ashwagandha, guaranteeing perfect dose uniformity (Content Uniformity) in every capsule.
Do you provide carbon footprint data (for ESG/CSRD reports)?
Yes. We understand that, from 2025, the CSRD directive will require large companies to report on their supply chain (Scope 3). Our Gdynia plant utilizes heat recovery systems in the drying process, which allows us to provide B2B partners with data on the reduced environmental footprint (LCA - Life Cycle Assessment) for outsourced production batches.
How long does it actually take to implement a new product (Time-to-Market)?
For ready-made recipes (Private Label), this time is approximately 8-10 weeks. For new implementations (R&D), the process takes on average 14-16 weeksThis time includes: purchasing raw materials (4-6 weeks), production and drying (2-3 weeks), and mandatory microbiological testing and batch release by Quality Control (2 weeks). IOC We do not artificially shorten the drying time, because this guarantees no complaints about "glued" capsules.