SOP for Operation and Calibration of Tablet Disintegration Apparatus

1.0 OBJECTIVE

To lay down the procedure for Operation and Calibration of Tablet disintegration tester.

2.0 SCOPE

This SOP shall be applicable to Quality Control Dept.

3.0 RESPONSIBILITY

Quality Control Supervisor

4.0 ACCOUNTABILITY

Sr. Manager Quality Assurance

5.0 PROCEDURE

5.1 Precautions

5.1.1 Do not switch on the mains if the water in the tank is not up to the mark.
5.1.2 While placing and removing the basket assembly do not apply excessive force.
5.1.3 Do not use abrasive materials to clean the instrument.
5.1.4 Do not bend the heater while cleaning the water bath.

5.2 Operating instructions

5.2.1 Ensure the cleanliness of the area and the instrument.
5.2.2 Ensure that clean purified water is filled in the beakers till the desired level.
5.2.3 Switch ‘ON’ the Main supply & the instrument ‘On/Off’ switch on the rear side.
5.2.4 Switch ‘ON’ the heater by pressing ‘Temp’ key.
5.2.5 Press ‘Set’ & ’Temp.’ key to set the temperature to 37°C.
5.2.6 Press ‘Set’ & ‘Timer’ key to set the desired test time.
5.2.7 Place one tablet/ capsules to be tested in each of the six cylinders of basket rack assembly.
5.2.8 Place the disks if mentioned in the monograph.
5.2.9 Press ‘Start/Stop’ key once to start the test.
5.2.10 Watch the complete disintegration of the tablet/ capsule and note down the time.
5.2.11 Press ‘Start/Stop’ key to stop the test.

5.3 Calibration

5.3.1 For Thermostat

5.3.1.1 Switch ‘ON’ the mains and switch on the instrument ‘On/Off’ switch on the rear side of the instrument.
5.3.1.2 Ensure that the beakers are filled with the DM water.
5.3.1.3 Press ‘Set’ & ‘Temp’ key and set the temperature to 37°C. Press enter key.
5.3.1.4 Allow the temperature to reach 37°C.
5.3.1.5 When the display shows the temperature 37°C, insert one calibrated thermometer into the beaker.
5.3.1.6 Note down the reading. Repeat the process two more times to confirm the results.
5.3.1.7 Result are found satisfactory if the temperature lies between 37°C + 2°C.

5.3.2 For cycles per minute

5.3.2.1 Switch ‘ON’ the mains and the instrument.
5.3.2.2 Press start key once to start the test.
5.3.2.3 Note the number of cycles in one minute. Repeat the test two more times to confirm the results.
5.3.2.4 Results are found satisfactory if the number of cycles per minute are in between 28 to 32.

5.3.3 For the distance of traveling

5.3.4 Switch ‘ON’ the mains and instrument.
5.3.5 Press ‘Start’ key once to start the test.
5.3.6 Note the traveling distance of the basket rack assembly on the device from a calibrated scale. Repeat the test two more times to confirm the results.
5.3.7 Results are found satisfactory if the distance traveled is between 53 mm to 57 mm.
5.3.8 Put duly signed ‘Calibration tag’ on the instrument. Note down the results into the calibration record.
5.3.9 If the results are found unsatisfactory, put ‘Out of order’ tag on the instrument. Inform the same to engineering department / manufacturer for the repair.

6.0 ABBREVIATIONS

6.1 SOP: Standard Operating Procedure
6.2 QA: Quality Assurance
6.3 QC: Quality Control
6.4 Dept.: Department

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