1. OBJECTIVE
To lay down the procedure for operation of Disintegration Apparatus
2. SCOPE
This procedure is applicable to Quality Control Department
3. RESPONSIBILITY
• Officer QC
• Manager QC
4. SAFETY INSTRUCTIONS
• Proper handling the instrument
• Temperature should be carefully adjusted and maintained
• Don’t switch on the main board with wet hands
5. PROCEDURE
5.1 OPERATION
5.1.1 Weigh the specified number of tablets for the test.
5.1.2 Ensure that instrument is free from dust.
5.1.3 Ensure the cleanliness of area and the instrument.
5.1.4 Ensure that purified water in filled in beaker till the desired level.
5.1.5 Switch on the main supply and instrument “ONN/OFF” key.
5.1.6 Switch on the heater by pressing temperature key.
5.1.7 Press “Set” and “Temp.” key to set the temperature.
5.1.8 Press “Set” and “Time” key to set the time.
5.1.9 Place on the Tablet/ Capsule to be tested in each of the six cylinders of basket rack assembly.
5.1.10 Place the disk if mention in the monograph.
5.1.11 Press “Start” key once to start the test.
5.1.12 Watch the complete disintegration of tablet/ capsule and note down the time.
5.1.13 Press “Stop” key to stop the test.
5.2 CLEANING
5.2.1 Switch “off” the instrument
5.2.2 Switch “off” the main
Frequency: After every test
5.2.3 On completion of every disintegration test, remove the beakers and assembly along discs.
5.2.4 Wash them properly and keep aside
Frequency: Once in a week
5.2.5 Switch “off” the instrument
5.2.6 Switch “off” the main
5.2.7 Remove the external probe from the water bath
5.2.8 Remove beakers along with assembly from water bath of disintegration of test apparatus.
5.2.9 Remove the lid and heater electrical connector from the water bath
5.2.10 Wash the water bath with raw water, detergent solution and then with raw water until no foam of detergent remains in the bath, after that wash it with purified water.
5.2.11 Clean the external surface wet cotton cloth and finally clean with lint free cloth
5.2.12 Place the water bath to its original position
5.2.13 Fill the water bath with purified water up to the level indicated on the external surface of the water bath.
5.3 CALIBRATION
5.3.1 Number of Cycles
5.3.1.1 Record the frequency of moving up and down of basket rack assembly.
5.3.1.2 Record the frequency (of moving up and down) manually with respect to time.
5.3.1.3 Do not stop the instrument in between the operation.
5.3.1.4 Measure the frequency initially and after each fifteen minutes intervals from the start, for 5 minutes each.
5.3.1.5 Record five readings
5.3.1.6 Divide the observed reading by five and note as the frequency of moving up and down per minute.
5.3.1.7 Perform the test for both the basket rack assembly positions (Side A and Side B) individually.
5.3.1.8 Acceptance Criteria: The No. of cycles per minute should be within 29 to 32 throughout period of operation.
5.3.2 Calibration of Temperature Maintenance
5.3.2.1 Set the temperature to 37 ̊C.
5.3.2.2 Fill the beaker with water.
5.3.2.3 Attach the basket rack assembly and start the constant frequency of moving up and down.
5.3.2.4 Insert the calibrated thermometer in one of the tubes of basket rack assembly.
5.3.2.5 Wait till temperature reaches the 36 ̊C to 38 ̊C.
5.3.2.6 Start recording the reading.
5.3.2.7 Record the temperature reading initially and after each 15 minutes interval up to 120minutes from the start.
5.3.2.8 Perform the test for both the basket rack assembly positions (Side A and Side B) individually.
5.3.2.9 While performing the test, do not keep the thermometer inside the beaker rack assembly constantly. But insert to 2 to 3 minutes prior to the measurement to give stable reading.
5.3.2.10 Acceptance Criteria: The temperature should remain within 37 ± 1 ̊C throughout the operation.
5.3.3 Maintenance/ Repair
5.3.3.1 When the instrument does not comply with the requirements, the instrument should be labeled “OUT OF CALIBRATION” and should be repaired/ serviced.
5.3.3.2 After repairs/ serviced calibrate the instrument before use.
6. RELATED DOCUMENTS
Operational Log Book Format – Annex. I
Cleaning Log Book Format – Annex. II
Calibration Report Format – Annex. III
7. DISTRIBUTION INDEX
Original Copy will be retained by Quality Assurance Department.
DISTRIBUTION INDEX
Distributed To Copy No. Received By/Date
Quality Control Department 01
8. ABBREVIATIONS
Q.C Quality Control Department
9. REVISION HISTORY
Revision No Issue Date Supersedes
Reason of Change/ Description
Revision No. Dated
00 25-12-2015 NA NA First Version