CALIBRATION OF DISINTEGRATION TEST APPARATUS

     A)     Number of cycles (With a constant frequency of 29 to 32) per minute:

1.       Record the frequency of moving up and down of the basket rack assembly, in a given time as shown below.

Start Time (Mins.)	End Time (Mins.)	Side A (Left hand side of the operator).		Side B (Right hand side of the operator).
		No. Of cycles (A)	No. Of cycles per min. (A/5)	No. Of cycles (B)	No. Of cycles per min. (B/5)
0	5
15	20
30	35
45	50
60	65

2.       Record the frequency (of moving up and down) manually with respect to time.

3.       Do not stop the instrument in between the operation.

4.       Measure the frequency initially and after each fifteen minutes interval from the start, for 5 minutes each.

5.       Record five readings.

6.       Divide the observed reading by five & note as frequency of moving up & down per minute.

7.       Perform the test for both the basket rack assembly positions (side A & side B) individually.

Acceptance criteria – The No. of cycles per minute should be within 29 to 32 throughout the period of operation.

     B)      Calibration for temperature Maintenance:

1.       Set the temperature to 37°C.

2.       Fill the beaker with water.

3.       Attach the basket rack assembly & start the constant frequency of moving up & down.

4.       Insert the calibrated thermometer in one of the tubes of the basket rack assembly.

5.       Wait till temperature reaches between 36°C to 38°C.

6.       Start recording the readings.

7.       Record the temperature readings initially & after each 15 minutes interval up to 120 minutes from the start.

8.       Perform the test for both the basket rack assembly positions (side A & side B) individually.

9.       While performing the test, do not keep thermometer inside the basket rack assembly constantly, but insert 2 to 3 minutes prior to the measurement to give stable reading.

Acceptance criteria – The temperature should remain within 37 ± 1°C, throughout the operation.

Time (In Mins.)	Temperature (In °C)
	Side A (Left hand side of the operator).	Side B (Right Hand side of the operator).
Initial
After 15
After 30
After 45
After 60
After 75
After 90
After 105
After 120

     C)      Calibration of the Distance Traveled:

1.       Attach the basket rack assembly firmly.

2.       Attach white paper firmly with out kinks on the instrument, parallel to the path of the arm of basket rack assembly.

3.       Select one point on the horizontal arm of the assembly & mark the same on the paper (pointed marker or pen can be used) when assembly is not moving & at its highest position.

4.       Start the instrument by pressing START / STOP key & followed by pressing the respective timer key.

5.       As soon as assembly reaches the lowest position, mark the same point again on the paper (Pointer marker or pen can be used) when assembly Is not moving & at its highest position.

6.       Measure the distance between two marks using calibrated ruler.

7.       Remove the paper.

8.       Perform the test initially, after 60 minutes from the start & after 120 minutes from the start.

9.       Perform the test for both the basket rack assembly positions (side A & side B) individually.

Acceptance criteria – Distance traveled is between 53 to 57 mm.

Time in mins.	Distance traveled by the basket
	Side A (Left Hand Side Of The Operator)	Side B (Right Hand Side Of The Operator)
Intial
After 60
After 120

Frequency: Once in Month.

Maintenance / Repair:

When the instrument does not comply with the requirement specified above; the instrument should be labeled as “Out of calibration” and should be repaired / serviced. After repairing / servicing, calibrate the instrument before use.

Reference:

United State Pharmacopeia

British Pharmacopoeia