Gelatin capsules manufacturers

When sourcing gelatin capsules, buyers must focus on disintegration time, which should typically be less than 15 minutes for rapid release. Ensure the moisture content is maintained between 13% and 16% to prevent brittleness or softening. Additionally, verify the microbial limits (Total Aerobic Microbial Count <1000 cfu/g) and ensure the capsules are manufactured from 100% bovine bone gelatin or pharmaceutical-grade raw materials for structural integrity.

Suppliers must adhere to GMP (Good Manufacturing Practice) standards and hold ISO 9001 or ISO 22000 certifications. For pharmaceutical and nutraceutical applications, compliance with USP (United States Pharmacopeia) or EP (European Pharmacopoeia) is essential. If targeting specific markets, ensure the products are Halal or Kosher certified to meet dietary and religious requirements.

Request a Certificate of Analysis (COA) for every batch to verify chemical and physical properties. Conduct a brittleness test (dropping a weight on the capsule) and a tightness test to ensure the cap and body lock securely without leakage. It is highly recommended to source from suppliers on Made-in-China.com who offer third-party inspection services and provide samples for machine-filling compatibility tests.

Gelatin is highly sensitive to environmental changes. They must be stored in a controlled environment with a temperature between 15°C and 25°C and relative humidity between 35% and 65%. Improper storage leads to capsule deformation, sticking, or cracking, which can cause significant losses during the automated filling process.

The biggest risks include moisture damage during sea transit and customs rejection due to missing health certificates. To mitigate this, ensure the supplier uses heavy-duty corrugated boxes with anti-static plastic liners and provides all necessary BSE/TSE-free declarations to satisfy import regulations.

Standard MOQs for custom colors or sizes (like #000 or #4) are usually higher, around 1 million pieces (one full carton). For bulk orders exceeding 5 million pieces, negotiate for a 10-15% volume discount. Always clarify if the price includes customized printing or if there are additional plate-making fees.

Use Secured Trading Services on Made-in-China.com to ensure payment is only released after the goods pass quality inspection. For shipping, choose temperature-controlled containers (Reefer containers) if shipping through tropical climates to prevent the gelatin from melting or clumping together during the voyage.

Since gelatin is an animal-derived product, many countries require a Veterinary Health Certificate. Verify that your supplier is registered with the FDA (for US imports) or has an EORI number (for EU imports). Failure to provide these documents can lead to the immediate destruction of the cargo at the port of entry.