Calibration of Disintegration Apparatus.

 C

alibration of Disintegration Apparatus

PURPOSE

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

SCOPE

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

CBS CONFIDENT PHARMACY SERIES PHARMACEUTICAL CHEMISTRY I, 3/E FOR FIRST YEAR DIPLOMA IN PHARMACY


 PROCEDURE

  • Ensure that the equipment is clean.
  • Ensure that the equipment is free from any operational defects. 
  • Switch on the equipment.
  • Switch on the temperature counter knob and set the temperature at 37 deg. C
  • Count the paddle movement raising and lowering cycles of the assembly (RPM)
    manually 
    using a stopwatch.
  • Verify the count with a set point and the specified distance (50-60 mm) of 30 RPM.
  • Verify the temperature with calibrated thermometer in the range of 37 ± 2 deg.
    C
  • Take at least three to four readings at each set point for better accuracy and
    reproducibility.
  • Correlate the actual readings observed with the set point RPM, distance and
    temperature 
    and apply corrections, if necessary.
  • 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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