Common Tablet Manufacturing Defects in Pharma | Part-3
Black Spots
Black-colored specks or dots on the tablet surface.
Causes of Black Spots:
- Impurities are in the raw materials.
- The compression tooling poorly cleaned.
- Inadequate lubricant mixing cause agglomeration.
- Powder is not properly granulated.
- Oxidation of mixture cause discoloration.
Remedies for Black Spots:
- Use high-quality raw materials.
- Clean the compression tooling.
- Optimize the mixing process.
- Monitor granulation process.
- Store raw materials & tablets under appropriate conditions.
Inconsistent Thickness
Variations in the tablet thickness within a batch or across different tablets.
Causes of Inconsistent Thickness:
- Powder is not adequately granulated.
- Feeding system fails to uniform die fill.
- Inadequate or excessive compression force .
- Machine malfunction.
Remedies for Inconsistent Thickness:
- Monitor granulation process.
- Use reliable feeding systems.
- Use proper compression force.
- Replace worn punches or die.
Hardness Variation
Inconsistency in tablet hardness across a batch or within individual tablets.
Causes of Hardness Variation:
- Components are not blended sufficiently.
- Granule size & density are not consistent.
- Compression force varies.
- Uneven drying of the granules.
Remedies for Hardness Variation:
- Uniform mixing of components.
- Optimize granulation techniques.
- Adjust compression force.
- Implement controlled drying.
Weight Variation
Inconsistency in tablet weight across a batch or within individual tablets.
Causes of Weight Variation:
- Components are not blended sufficiently.
- Granule size & density are not consistent.
- Inadequate or excessive compression force.
- The dosing of powder varies during die filling stage.
Remedies for Weight Variation:
- Uniform mixing of components.
- Optimize granulation techniques.
- Use automated filling systems.
- Adjust compression force.
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