Calibration of Disintegration Test Apparatus

 

Calibration of Disintegration Test Apparatus

Calibration of Disintegration Test Apparatus

¨  To Calibrate Disintegration Test Apparatus following parameters should be considered

¨  Number of Cycles per Minute

¨  Calibration of Temperature

¨  Calibration of the Distance Travelled

¨  Timer Calibration

¨  Sieve Integrity Test

Number of Cycles Per Minute

¨  Switch on the instrument and check if the instrument is ready for operation proceed further for calibration of number of cycles per minute.

¨  Take a pre-calibrated stopwatch.

¨  Operate the instrument as per the approved SOP.

¨  Start the instrument and stopwatch simultaneously.

¨  Record the number of cycles manually with respect to time and record the data.

¨  Instrument shouldn’t be stop in between the operation.

¨  Carry out the operation for a total of 6 times.

Start time	End time	Observed Cycles per minute		Acceptance Criteria
		Basket A	Basket B
0	5			29—32 Cycles per minute
15	20			29—32 Cycles per minute
30	35			29—32 Cycles per minute
45	50			29—32 Cycles per minute
60	65			29—32 Cycles per minute
75	80			29—32 Cycles per minute

 

Calibration for Temperature

¨  Switch on the instrument and press the heater button on to keep the heater on.

¨  Set the temperature at 37◦c.

¨  Fill the beakers with water and operate the instrument as per SOP so that the basket rack assembly starts oscillation.

¨  Place a pre-calibrated thermometer in one of the tube of basket rack assembly and wait till the temperature reach up to 36-38◦c.

¨  Now start recording the temperature of both the baskets initially and for every 15 minutes up to 2 hours.

¨  After placing the thermometer in the basket wait for 2 to 3 minutes so that the reading become stable and then record the data.

¨  During recording the temperature don’t place the thermometer constantly in the basket, after recording data remove thermometer from the basket.

Time (Minutes)	Temperature  of Basket A	Temperature  of Basket B	Acceptance Criteria
Initial			37± 1◦c
15			37± 1◦c
30			37± 1◦c
45			37± 1◦c
60			37± 1◦c
75			37± 1◦c
90			37± 1◦c
105			37± 1◦c
120			37± 1◦c

 

Calibration of Distance Travelled

¨  Switch on the instrument and keep the instrument in a condition where the basket rack assembly is positioning on its highest point.

¨  Now place a white paper parallel to the arm of the basket rack assembly and draw a mark on its highest position with the help of a pointer pen.

¨  Start the instrument by pressing the start button so that the basket rack assembly reach to its lowest position.

¨  Keenly observe that is the basket rack assembly is at lowest position if it is so then mark the point with a pointer pen.

¨  Now measure the distance between the two points with a calibrated ruler.

¨  Perform the test 3 times i.e initially then at 60 and 120 minutes.

¨  Procedure should be performed separately for both the baskets A and B.

Time	Distance travelled by Basket A	Distance travelled by Basket B	Acceptance Criteria
Initial			53– 57mm
60 minutes			53– 57mm
120 minutes			53– 57mm

 

Timer Calibration

¨  Switch on the instrument and check that is the instrument ready to be operate.

¨  Set the timer of the instrument “30” minutes.

¨  Now start the instrument and pre-calibrated stop watch simultaneously.

¨  Keenly observe the time on stop when the instrument stop.

¨  Record the data.

¨  Repeat the procedure for 3 times.

Acceptance Criteria

¨  Timer should not deviate ±1 minut

Sieve Integrity Test

¨  Check the integrity of the sieve attached to the base of the plate with the help of pre-calibrated vernier caliper.

¨  Aperture of the squares of the sieve should be within the limit of 1.8 to 2.2mm.

¨  Diameter of the wire should be within the limit of 0.57 to 0.66mm.

If the instrument was found to have all the parameters within the acceptance criteria it should be tagged as “Calibrated”.

In case of failure of any parameter the concerned person should be informed.