Empty gelatin capsule shell manufacturers

Buyers must prioritize Size Accuracy (000, 00, 0, 1, 2, 3, 4) to ensure compatibility with filling machines. The Moisture Content should strictly be maintained between 13% and 16%; levels outside this range lead to brittleness or softening. Additionally, verify the Disintegration Time, which should typically be less than 15 minutes in gastric juice to ensure effective drug release.

Since these are pharmaceutical/health product components, suppliers must possess GMP (Good Manufacturing Practice) certification. For specific markets, ensure compliance with USP (United States Pharmacopeia) or EP (European Pharmacopoeia) standards. Furthermore, Halal and Kosher certifications are essential if you are targeting religious markets, and the gelatin source (Bovine or Porcine) must be clearly documented with BSE/TSE-free certificates.

The quality of the Pharmaceutical Grade Gelatin determines the capsule's transparency, mechanical strength, and shelf life. High-bloom gelatin provides better structural integrity. Ensure the supplier uses FDA-approved colorants and opacifiers (like Titanium Dioxide) to prevent toxicity issues and ensure uniform appearance across batches.

Gelatin capsules are highly sensitive to environmental changes. They must be stored in a controlled temperature range of 15°C to 25°C and a relative humidity of 35% to 65%. Failure to maintain these conditions during transit or warehousing will result in capsule deformation or sticking, rendering them useless for automated filling lines.

The biggest risk is Thermal Damage during sea freight. It is highly recommended to use Reefer Containers (Refrigerated Containers) for long-haul shipping to prevent melting or warping. Always include Humidity and Temperature Data Loggers inside the packaging to monitor conditions throughout the journey for insurance and quality claims.

Request a Pre-Shipment Inspection (PSI) focusing on 'Locked Length' and 'Double-Cap' defects. Negotiate a Defect Rate Clause where the supplier compensates if the rejection rate exceeds 0.01% during automated filling. Use Secured Payment terms to ensure the funds are only released after the quality certificates and bill of lading are verified.

Empty capsules are often classified under HS Code 9602.00. You must check if your country requires a Health Certificate or an Import License for Animal-Derived Products. Ensure the supplier provides a detailed Certificate of Analysis (COA) for every batch to avoid customs seizures or lengthy laboratory testing delays at the border.