Calibration of Friability Test Apparatus

1. Introduction

The friability test determines the ability of uncoated tablets to resist mechanical stress during handling, packaging, and transportation. The friability test apparatus (e.g., Roche Fryolator) rotates tablets in a drum, causing impact and abrasion.
Calibration ensures that the apparatus operates according to pharmacopeial specifications, giving reliable results.

2. Objective

• To verify that the apparatus meets the required speed, time, and drum dimensions.

• To ensure compliance with USP <1216>, IP, BP, and GMP.

3. Parameters to Calibrate

4. Calibration Procedure

1. Rotation Speed

   • Set apparatus for 100 rotations.

   • Measure the time taken with a calibrated stopwatch.

   • Calculate RPM:

     RPM=No. of rotations Time in minutes\text{RPM} = \frac{\text{No. of rotations}}{\text{Time in minutes}}RPM=Time in minutes No. of rotations​

   • Ensure result is 25 ± 1 rpm.

2. Timer Accuracy

   • Set apparatus for 4 minutes.

   • Compare elapsed time with a calibrated stopwatch.

   • Allowable deviation: ±1%.

3. Drum Dimensions & Drop Height

   • Use calibrated Vernier calipers or measuring tape to check diameter and tablet drop height.

   • Compare to pharmacopoeial requirements.

4. Counter Function

   • Set for a specific number of rotations and verify it matches the tachometer reading.

5. Frequency of Calibration

• Before first use of apparatus.

• Every 6 months or as per SOP.

• After major maintenance or relocation.

6. Documentation

• Equipment ID & Location

• Calibration date & next due date

• Measured values & acceptance criteria

• Analyst & reviewer signatures

• Calibration status label

7. References

• USP <1216> Friability of Uncoated Tablets

• IP & BP General Chapters

• ICH Q7, WHO GMP