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Tablet hardness testing can present challenges, but understanding and addressing these issues ensures consistent product quality.
Frequent Issues and Fixes
1. Inconsistent Results
- Cause: Non-uniform tablets or uncalibrated equipment.
- Fix: Recalibrate the tester and adjust tablet press settings.
2. Out-of-Specification Hardness
- Cause: Incorrect compression or formulation.
- Fix: Modify press settings or reformulate with better binders.
3. Tablet Slippage
- Cause: Worn anvils or misalignment.
- Fix: Replace tester parts and properly align the tablet.
4. Environmental Impact
- Cause: High humidity or temperature fluctuations.
- Fix: Test in a controlled environment.
5. Hardness and Dissolution Mismatch
- Cause: Variability in manufacturing.
- Fix: Cross-check hardness with dissolution and disintegration results.
Tablet Press Maintenance
Regular maintenance prevents issues like inconsistent compression, which directly affects tablet hardness. Check punch quality and ensure proper lubrication.
Effective troubleshooting in tablet hardness testing minimizes production downtime and ensures quality consistency. By integrating robust testing protocols with tablet press optimization, manufacturers can maintain high standards while avoiding costly errors.