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
5.1 Precautions:5.1.1 Do not switch on the mains if 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 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:
220.127.116.11 Switch ‘ON’ the mains and switch on the instrument ‘On/Off’ switch on the rear side of the instrument.
18.104.22.168 Ensure that the beakers are filled with the DM water.
22.214.171.124 Press ‘Set’ & ‘Temp’ key and set the temperature at 37°C. Press enter key.
126.96.36.199 Allow the temperature to reach to 37°C.
188.8.131.52 When the display shows the temperature 37°C, insert one calibrated thermometer into the beaker.
184.108.40.206 Note down the reading. Repeat the process two more times to confirm the results.
220.127.116.11 Result are found satisfactory if the temperature lies between 37°C + 2°C.
5.3.2 For cycles per minute:
18.104.22.168 Switch ‘ON’ the mains and the instrument.
22.214.171.124 Press start key once to start the test.
126.96.36.199 Note the number of cycles in one minute. Repeat the test two more times to confirm the results.
188.8.131.52 Results are found satisfactory if the number of cycles per minute are in between 28 to 32.
5.3.3 For 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.
4.3.9 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
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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