Hard Capsules

This gelatin grade delivers consistent viscosity, precise gel strength, and optimal film-forming properties for uniform hard capsule shells with reliable dissolution performance, meeting strict pharmacopoeia standards.

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Hard Capsules

Premium gelatin for two-piece capsule shell manufacturing

Consistent Quality for Reliable Capsule Production

Hard gelatin capsules remain the most popular oral dosage form due to their ease of swallowing, excellent stability and cost-effectiveness. Our pharmaceutical gelatin for hard capsules is engineered for consistent viscosity, precise gel strength and optimal film-forming properties, ensuring uniform capsule shells with reliable dissolution performance.

Consistent Quality

Tight viscosity and bloom specifications batch-to-batch

Low Microbial

Meets strict pharmacopoeia microbial purity requirements

Rapid Dissolution

Predictable disintegration and dissolution profiles

Customizable

Adjustable bloom strengths for specific capsule sizes

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Hard Capsule Applications
TECHNICAL SPECIFICATIONS

Hard Capsule Gelatin Specifications

Parameter Bovine (Bloom 220-260) Porcine (Bloom 240-280) Type A Acid-Processed
Bloom Strength 220–260 g 240–280 g 200–250 g
Viscosity 3.0–5.0 mPa·s 3.5–5.5 mPa·s 2.5–4.5 mPa·s
Moisture ≤12% ≤12% ≤13%
pH (1% Solution) 4.5–5.5 4.0–5.0 3.8–5.2
Ash Content ≤0.5% ≤0.5% ≤0.5%
Heavy Metals ≤20 ppm ≤20 ppm ≤20 ppm
Microbial Limits TAMC ≤1,000 CFU/g
TYMC ≤100 CFU/g
TAMC ≤1,000 CFU/g
TYMC ≤100 CFU/g
TAMC ≤1,000 CFU/g
TYMC ≤100 CFU/g
REGULATORY COMPLIANCE

Pharmacopoeia & Regulatory Standards

USP / EP / BP / JP

Full compliance with United States, European, British and Japanese pharmacopoeia monographs for gelatin

DMF / CEP Support

Drug Master File registered with FDA; CEP dossier support for European submissions

TSE / BSE Certificates

Valid TSE/BSE compliance certificates ensuring raw material traceability and transmissibility safety

ISO 13485

Quality management system certified to ISO 13485 for medical device and pharmaceutical-grade production

APPLICATION PROCESS

Hard Capsule Manufacturing Process

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Dipping

Capsule shell pins are dipped into temperature-controlled gelatin solution (30–40°C) to form a uniform film layer on the pin surface

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Drying

Controlled drying at 20–25°C with 40–50% RH removes moisture gradually to achieve the target 13–16% residual moisture content

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Stripping

Dried capsule halves are mechanically stripped from the pins, trimmed to precise length, and inspected for defects and dimensional accuracy

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Joining

Body and cap halves are precisely joined using interlocking design; pre-locked capsules are ready for high-speed filling operations

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