Calibration of Disintegration Apparatus

1.0 PURPOSE

The purpose of the standard operating procedure is to provide guidelines for calibration of Disintegration Apparatus.

2. SCOPE

The scope of this standard operating procedure includes calibration of Disintegration Apparatus.

3.0 PROCEDURE

3.1 Ensure that the equipment is clean.

3.2 Ensure that the equipment is free from any operational defects.

3.3 Switch on the equipment.

3.4 Switch on the temperature counter knob and set the temperature at 37 deg. C

3.5 Count the paddle movement raising and lowering cycles of the assembly (RPM) manually using a stopwatch.

3.6 Verify the count with a set point and the specified distance (50-60 mm) of 30 RPM.

3.7 Verify the temperature with calibrated thermometer in the range of 37 ± 2 deg.C

3.8 Take at least three to four readings at each set point for better accuracy and reproducibility.

3.9 Correlate the actual readings observed with the set point RPM, distance and temperature and apply corrections, if necessary.

3.10 IP/BP/USP allows a tolerance of ± 2 RPM < 50-60 mm and 37 ± 2 deg. C

CALIBRATION FREQUENCY- At every 3 Months

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