Enteric coated capsules manufacturers

Buyers must prioritize disintegration time and pH stability. Enteric capsules are designed to remain intact in the gastric acid (pH 1.2) for at least 2 hours and dissolve rapidly in the intestinal fluid (pH 6.8) within 30 minutes. Ensure the shell material is either HPMC (Vegetarian) or Gelatin with a specialized acid-resistant coating like CAP (Cellulose Acetate Phthalate) or methacrylic acid copolymers.

For pharmaceutical and nutraceutical grade capsules, suppliers must provide GMP (Good Manufacturing Practice) certification. Depending on the target market, look for FDA registration (US), CEP/EDQM (Europe), and ISO 22000. If targeting specific consumer groups, Halal and Kosher certifications are essential to ensure the raw materials meet religious dietary requirements.

Focus on the brittleness and moisture content. Ideal moisture levels for HPMC enteric capsules should be between 2% to 7%, while Gelatin should be 13% to 16%. Request a Certificate of Analysis (COA) for every batch to verify heavy metal limits (<10ppm) and microbial limits (Total Plate Count <1000 cfu/g). Conduct a filling machine compatibility test to ensure a low breakage rate (<0.01%) during high-speed production.

Enteric coated capsules are sensitive to environmental factors. They should be stored in a controlled temperature (15°C to 25°C) and humidity (35% to 65%) environment. Most high-quality capsules offer a shelf life of 2 to 5 years if kept in original airtight packaging. Avoid exposure to direct sunlight or extreme temperature fluctuations which can cause the enteric coating to degrade or become sticky.

Always request temperature-controlled shipping (Reefer Containers) or use thermal insulation blankets for sea freight, especially when crossing the equator. Ensure the supplier uses double-layered moisture-proof packaging with desiccant silica gel packets inside the cartons to prevent the capsules from softening or clumping due to humidity.

Leverage volume-based pricing; prices typically drop by 15-25% when ordering in full container loads (FCL). Negotiate for customized printing (axial or radial) and specific color matching at no extra cost for long-term contracts. Ask for free samples (usually 1,000-3,000 pieces) to test on your specific filling equipment before committing to a bulk purchase.

Utilize Secured Trading Services on Made-in-China.com to protect your payment until the goods are shipped. It is highly recommended to hire a third-party inspection agency (like SGS or Intertek) to perform a Pre-Shipment Inspection (PSI) to verify the enteric performance and quantity, ensuring the batch matches the approved sample.

Verify the HS Code (typically 9602.00 or 3503.00) with your local customs broker to determine the exact tariff rate. Ensure all shipping documents (Commercial Invoice, Packing List, COA, and Bill of Lading) clearly state the material composition to avoid delays. Some countries require a Medical Device or Food Supplement Import License prior to the arrival of the goods.