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Gelatin Capsule Manufacturing Process
1. Raw Material Preparation
Gelatin Sourcing: Derived from cattle bones/skin, pig skin, or fish scales (varies by region/religion).
Purification: Boiled in acid/alkali solutions to remove fats and minerals, then filtered to remove impurities.
Blending: Mixed with water, glycerin (plasticizer), and sometimes colorants to form a thick gel.
2. Gel Preparation
Melting: The gelatin mixture is heated to 60-70°C until fully liquid.
Viscosity Control: Adjusted to ensure uniform capsule wall thickness.
Defoaming: Vacuum-treated to remove air bubbles that could weaken capsules.
3. Dip Molding (Traditional Method)
Stainless Steel Pins: Dipped into the gelatin solution to form capsule halves.
Cooling & Setting: Pins are slowly withdrawn and cooled to 10-15°C for solidification.
Drying: Capsule halves are dried in controlled humidity chambers to prevent warping.
4. Trimming & Joining
Precision Cutting: Capsule halves are trimmed to exact lengths.
Assembly: Body and cap sections are mechanically joined.
Polishing: Rolled in cloth to smooth edges and remove excess gelatin.
5. Quality Checks
Visual Inspection: Rejects deformed, discolored, or uneven capsules.
Moisture Testing: Ensures 12-15% moisture content (too dry = brittle; too wet = sticky).
Weight & Size Verification: Capsules must meet strict pharmaceutical standards.
6. Packaging
Bulk Storage: Kept in low-humidity conditions to prevent softening.
Counting & Bottling: Automated machines fill bottles or blister packs.
| Stage | Key Process Details | Critical Notes |
| 1. Raw Material Prep | • Gelatin extraction: Boiling cattle/pig/fish parts in acid/alkali baths | – Halal/Kosher: Requires certified animal slaughter |
| • Additives: Glycerin (plasticizer), purified water, optional dyes | – No alcohol-based solvents permitted | |
| 2. Gel Melting | • Heated to 60–70°C until liquid | – Viscosity control ensures uniform capsule walls |
| • Vacuum defoaming removes air bubbles | – Stainless steel tanks only (no reactive metals) | |
| 3. Dip Molding | • Stainless steel pins dipped into gel, cooled to 10–15°C for solidification | – Dedicated molds: No cross-contamination with non-halal lines |
| • Dried in humidity-controlled chambers (~30% RH) | – Slow drying prevents brittleness | |
| 4. Trimming/Joining | • Capsule halves cut to precise length, joined mechanically | – No animal-fat lubricants in machinery |
| • Polished with food-grade cloths | – Metal detectors check for equipment debris | |
| 5. Quality Control | • Visual inspection: Rejects deformed/discolored capsules | – Moisture testing: 12–15% target (critical for shelf life) |
| • Weight/size checks: Automated sorting | – Dissolution testing verifies drug release rates | |
| 6. Packaging | • Bottled or blister-packed in low-humidity environments | – Barrier packaging prevents moisture absorption |
