Manufacturing Defects

  • Manufacturing Defects in Capsules: Include cracks, deformation, or uneven thickness.
  • Manufacturing Defect in Tablets: May involve chipping, capping, or hardness issues.
  • Causes: Poor materials, machinery faults, or improper handling.
  • Hard gelatin capsules can exhibit defects during production or filling, such as:

Common Issues with Gelatin Capsules

  1. Cracks: Caused by improper drying or excessive brittleness of gelatin.
  2. Deformation: Due to improper storage conditions (e.g., high humidity).
  3. Leaks: From improperly sealed liquid-filled capsules.
  4. Uneven Thickness: From inconsistent gelatin coating during dipping.
  5. Capsule Separation: Caused by poor fitting of cap and body.

Preventions of Manufacturing Defects:

  • Optimizing manufacturing parameters (temperature, humidity, viscosity).
  • Regular inspection of equipment and raw materials.
  • Ensuring proper storage conditions.
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