Explore our export-grade capsule shells and finished dietary supplement solutions manufactured under strict NSF/ANSI 455-2 GMP standards.
Providing global pharmaceutical and dietary supplement buyers with unmatched material stability, precise weight tolerances, and cross-linking resistant capsule shells.
We source premium bovine hide and bone gelatin with gel strength calibrated between 180 to 260 Bloom. This guarantees optimal mechanical rigidity, reduced brittleness during high-speed filling, and rapid in-vivo dissolution.
Our manufacturing lines operate under strict NSF/ANSI 455-2 GMP, US FDA DMF Registration, ISO 22000, and Halal/Kosher accreditations. Full batch traceability and Certificate of Analysis (CoA) accompany every export container.
Gelatin capsule dipping, drying, and joining take place within ISO Class 8 cleanrooms with strictly stabilized ambient humidity (RH 35%–45%) and temperature (19°C–23°C) to eliminate moisture variance.
Incorporating specialized gelatin modification techniques to prevent cross-linking reactions when encapsulating complex formulations containing aldehydes, organic acids, or hygroscopic powders like pure Beta-NMN.
Offering axial, radial, and two-color customized capsule printing utilizing non-toxic, food-grade inks compliant with EU and US FDA regulations. Complete opacity control from transparent to 100% titanium-dioxide-free opaque.
From raw empty hard gelatin capsule export to fully filled, bottled, labeled, and blister-packed finished nutraceuticals, our integrated supply chain reduces international buyer procurement cycle times by up to 40%.
Hard Gelatin Capsules (HGC) remain the gold standard solid oral dosage delivery format across global pharmaceutical and nutraceutical sectors. Characterized by their rapid disintegration profile, high filling machine compatibility, and cost-effectiveness, gelatin capsules accommodate dry powders, granules, pellets, and non-aqueous liquids. As a premier China gelatin capsule factory and global exporter, our facilities leverage advanced continuous automated dipping technology, stringent rheological monitoring of gelatin solutions, and rigorous quality control protocols to supply worldwide B2B partners.
The global demand for high-speed capsule filling performance—often exceeding 150,000 capsules per hour on machines such as Bosch, Harro Höfliger, and IMA—requires empty hard gelatin capsules to possess impeccable dimensional uniformity, moisture stability, and mechanical strength. This technical whitepaper delves into the physicochemical properties, manufacturing parameters, quality assurance criteria, and emerging procurement trends shaping the gelatin capsule export industry.
The performance of a hard gelatin capsule shell is fundamentally governed by the molecular characteristics of its underlying raw material. Gelatin is a natural protein derived through partial hydrolysis of collagen extracted from animal connective tissue, bone, and skin. Key raw material specifications include:
| Physicochemical Parameter | Pharmacopeial Standard (USP / EP / ChP) | Our Factory Export Standard | Impact on Capsule Quality |
|---|---|---|---|
| Gel Strength (Bloom) | 180 – 260 Bloom | 220 – 250 Bloom ± 5 | Prevents deformation & brittleness under pressure |
| Viscosity (60°C, 6.67%) | 3.0 – 5.5 mPa.s | 4.0 – 4.8 mPa.s | Ensures uniform wall thickness across body & cap |
| Moisture Content | 12.5% – 16.0% | 13.5% – 15.0% | Maintains structural elasticity & prevents cracking |
| Loss on Drying | ≤ 16.0% | ≤ 14.5% | Critical for storage stability in humid environments |
| Ash Content | ≤ 2.0% | ≤ 1.0% | Indicates raw material purity & low mineral residue |
| Heavy Metals (Pb, As, Hg) | ≤ 10 ppm Total | ≤ 1 ppm Individual | Guarantees safety compliance for global markets |
| Disintegration Time | ≤ 15 Minutes (USP <701>) | ≤ 8 Minutes in Deionized Water | Rapid bio-accessibility of active ingredients |
Selecting the appropriate capsule size is critical for achieving target fill weights based on the bulk density (g/mL) of the powder formulation. Our factory produces a full range of standard pharmaceutical sizes from Size #000 down to Size #5, including extended length formats (#00el, #0el) designed for high-capacity applications.
| Capsule Size | Volumetric Capacity (mL) | Typical Powder Fill (0.6 g/mL) | Typical Powder Fill (1.0 g/mL) | Locked Length (mm) |
|---|---|---|---|---|
| Size #000 | 1.37 mL | 822 mg | 1370 mg | 26.14 ± 0.40 mm |
| Size #00el | 1.02 mL | 612 mg | 1020 mg | 25.30 ± 0.40 mm |
| Size #00 | 0.91 mL | 546 mg | 910 mg | 23.30 ± 0.40 mm |
| Size #0el | 0.78 mL | 468 mg | 780 mg | 24.20 ± 0.40 mm |
| Size #0 | 0.68 mL | 408 mg | 680 mg | 21.70 ± 0.40 mm |
| Size #1 | 0.50 mL | 300 mg | 500 mg | 19.40 ± 0.40 mm |
| Size #2 | 0.37 mL | 222 mg | 370 mg | 17.80 ± 0.40 mm |
| Size #3 | 0.30 mL | 180 mg | 300 mg | 15.90 ± 0.40 mm |
| Size #4 | 0.21 mL | 126 mg | 210 mg | 14.30 ± 0.40 mm |
The manufacturing process of empty hard gelatin capsules is a highly precise thermodynamic operation. Our Chinese production facility utilizes fully automatic dipping lines housed in ISO Class 8 cleanrooms. The six core phases of manufacturing include:
Deionized water, high-Bloom gelatin, and optional pigments melted under vacuum at 60°C–65°C.
Temperature-controlled stainless steel mold pins submerged into gelatin solution of exact viscosity.
Pins pass through multi-zone humidity-regulated tunnels to evaporate moisture down to 13.5%–15%.
Dried capsule halves stripped from pins and trimmed to micrometric length tolerances by rotary blades.
Cap and body halves joined into pre-locked state; automatic optoelectronic sorting detects visual defects.
A recognized technical challenge with gelatin capsules is cross-linking—a covalent reaction between peptide chains triggered by exposure to trace aldehydes, elevated heat, or high humidity. Cross-linking forms a thin, water-insoluble pellicle during dissolution testing, delaying active pharmaceutical ingredient (API) release. To eliminate cross-linking risk for export clients, our manufacturing protocols include:
Global procurement metrics indicate a significant evolution in buyer requirements. Importers in the US, Europe, and Asia-Pacific are increasingly aligning with specific regulatory shifts and consumer demands:
Following the European Food Safety Authority's (EFSA) reclassification of Titanium Dioxide (E171) as a food additive, international demand has shifted rapidly toward TiO2-free white and opaque capsules. Our factory leads this market transition, offering alternatives such as Calcium Carbonate (CaCO3), zinc oxide-free mineral blends, and modified starch opacifiers that achieve high opacity while complying 100% with EU regulations.
Advanced longevity supplements like 99% Pure Beta-Nicotinamide Mononucleotide (NMN) are extremely moisture-sensitive. Filling NMN into standard capsules with high free-water content can induce powder clumping, degradation, or capsule softening. China exporters are deploying Low-Moisture Tailored Gelatin Capsules (moisture content tuned to 10.0%–12.0%) and modified moisture barrier shells specifically formulated for premium active powders.
Global pharmaceutical buyers require absolute biosecurity. All bovine-derived gelatin exported from our facility carries certified TSE/BSE-Free documentation issued by national quarantine authorities, backed by complete raw material lot tracking from slaughterhouse to final empty capsule package.
Clear, direct technical and commercial answers for international procurement managers, brand owners, and contract manufacturers.
For standard clear or natural white gelatin capsules in stock sizes (#00, #0, #1), our standard export MOQ is 1 carton (typically 100,000 to 140,000 capsules depending on size). For custom color matching or specialized logo printing, the MOQ is 2 million to 3 million pieces per run.
Gelatin capsules offer superior mechanical strength, faster disintegration rates (<8 mins vs. 10-15 mins), and a significantly lower cost structure (30%–50% more economical than HPMC). HPMC capsules are preferred for strictly vegan formulations or highly moisture-sensitive hygroscopic drugs due to their lower equilibrium moisture content (4%–7%).
Our manufacturing complex operates in full compliance with NSF/ANSI 455-2 GMP, US FDA DMF (Drug Master File) Registration, ISO 9001, ISO 22000, HACCP, Halal (JAKIM/MUI), and Kosher certifications. Full regulatory dossiers (including CoA, MSDS, TSE/BSE Free Certificate, and Allergen Statements) are provided with every order.
Yes. In addition to exporting empty hard gelatin capsule shells, our facility provides full OEM/ODM contract manufacturing services. We can blend, encapsulate, bottle, label, and blister-pack custom formulations—such as Beta-NMN, Creatine, Bovine Colostrum, and herbal extracts—under one roof.
Clients can supply Pantone color codes or physical sample caps. Our color laboratory matches the target hue using spectrophotometric analysis, preparing trial dipping samples for customer sign-off prior to commercial production runs.
Empty gelatin capsules should be stored in their original sealed barrier packaging at temperatures between 15°C and 25°C (59°F to 77°F) and relative humidity between 35% and 65%. Avoid direct exposure to sunlight, localized heat sources, or sudden thermal fluctuations that could induce condensation inside the liner bags.
Elevate your product line with high-speed compatible capsule shells, low moisture options, and complete contract manufacturing support.
