INSTRUMENT CALIBRATION DISINTEGRATION TEST APPARATUS

1.0 PURPOSE :
To provide a procedure for calibrating Disintegration tester.
2.0 SCOPE :
This covers the procedure for calibrating Disintegration tester ( QCI – 21 ).
MAKE & MODEL : Electrolab, ED-2L (USP).
3.0 RESPONSIBILITY :
QC officer.
4.0 PROCEDURE :
4.1 TEMPERATURE CHECK :
4.1.1 Keep about 800 ml of water in 1 liter beaker in the water bath.
4.1.2 Set the temperature to 37°C.
4.1.3 Wait until the set temperature reaches.
4.1.4 Observe and record the temperature,
Acceptance limit : 37°C ± 0.5°C.
4.2 STROKE HEIGHT:
4.2.1 Measure the distance between lowest and highest stroke,
Acceptance limit : 53mm to 57 mm.
4.3 CYCLES
4.3.1 Count the number of cycles per minute,
Acceptance limit : 28 – 32 cycles/minute.
5.0 FREQUENCY OF CALIBRATION :
Once in a month.