Dissolution testers must undergo regular calibration and validation to verify equipment functions correctly and meets regulatory requirements.
Performance Verification Testing (PVT)
PVT is conducted to confirm that the dissolution tester provides consistent and reproducible results using USP Prednisone and Salicylic Acid Tablets as reference standards. Prednisone tablets are commonly used due to their sensitivity to hydrodynamic variations.
USP Methods Covered
Calibration procedures apply to various USP apparatus methods:
- USP Method 1: Basket apparatus
- USP Method 2: Paddle apparatus
- USP Method 5: Paddle over disk
- USP Method 6: Cylinder apparatus
Key Calibration Parameters
Temperature Control
The dissolution medium must be maintained at 37°C ± 0.5°C, verified using calibrated thermometers or temperature probes.
Rotation Speed
Paddle or basket rotation must be verified at specified speeds (typically 50-100 RPM) using a calibrated tachometer.
Vessel Centering
The distance from the vessel center to the shaft must be within specified tolerances to ensure proper hydrodynamics.
Wobble Testing
Shaft wobble must not exceed specified limits to prevent inconsistent dissolution results.
Regulatory Compliance
Regulatory agencies such as the FDA, USP, and ICH provide guidelines ensuring test results are acceptable for regulatory submissions. Regular calibration is essential for GMP compliance.
Documentation Requirements
All calibration activities must be documented with:
- Calibration date and next due date
- Equipment identification
- Standards used
- Results and pass/fail criteria
- Technician signature