Proper calibration of tablet friability testers ensures accurate assessment of tablet mechanical strength according to pharmacopeial requirements.
Key Calibration Parameters
Rotation Speed
The drum must rotate at a fixed speed of 25 ± 1 rpm:
- Use a calibrated tachometer to measure speed
- If speed deviates, adjust motor controller
- Verify at beginning and during rotation cycle
Fall Height
The tablets must fall from a consistent height:
- Measured using a scale or gauge
- Must align with 6.3 ± 0.2 mm standard
- Check drum interior for wear or damage
Rotation Count
Standard test requires exactly 100 rotations:
- Verify counter accuracy
- Test timer correlation (4 minutes at 25 rpm)
- Check for consistent counting
Drum Condition
Inspect drum for:
- Cracks or chips
- Internal surface smoothness
- Proper mounting and balance
Calibration Procedure
- Visual Inspection: Check drum and drive system
- Speed Verification: Measure rotation speed with tachometer
- Count Verification: Confirm accurate rotation counting
- Height Check: Verify fall height specification
- Timer Verification: Compare to calibrated stopwatch
- Documentation: Record all measurements
Acceptance Criteria
Per USP <1216>:
- Rotation speed: 25 ± 1 rpm
- Test duration: 100 rotations
- Weight loss limit: Typically <1%
Maintenance
- Keep drum clean and free of tablet residue
- Check drive belt tension regularly
- Verify interlock safety systems
- Clean and inspect regularly
