While hardness testing measures the force required to break a tablet, friability testing measures how much a tablet crumbles or wears away under mechanical stress. It simulates the friction and impact tablets experience during coating, packaging, and transport.
The Friability Test Procedure (USP <1216>)
A standard friability test involves:
- Weight Initial: Weighing a sample of 10 or 20 tablets
- Rotation: Placing them in a rotating drum (Roche Friabilator) for 100 rotations at 25 RPM
- Weight Final: Removing dust and weighing the tablets again
- Calculation: Determining percentage of weight loss
Acceptance Criteria: For most tablets, weight loss of not more than 1% is acceptable.
Calibration Parameters
- The drum must rotate at a fixed speed of 25 ± 1 rpm, verified using a tachometer
- Fall height measured using a scale must align with 6.3 ± 0.2 mm standard
- Standard test duration involves 100 rotations (4 minutes at 25 rpm)
The Importance of 21 CFR Part 11 Compliance
The FDA's 21 CFR Part 11 regulation sets standards for electronic records and signatures:
- Audit Trails: Every test and parameter change logged with timestamp and user ID
- User Access Control: Multi-level password protection (Admin, Supervisor, Operator)
- Secure Data Export: Results exportable to secure formats like PDF
Equipment Types
There are three types of tablet friability testing machines:
- Single drum devices: Test one batch at a time
- Double drum devices: Test two batches simultaneously
- Triple drum devices: Maximum throughput for high-volume testing
The RFT-1V and RFT-2V Friability Testers meet rigorous pharmacopeial standards including USP <1216>, EP <2.9.7>, and JP <14>.