Calibration of Disintegration Test Apparatus in pharma

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Calibration of Disintegration Test Apparatus:

The disintegration test is one of the test parameters to measure the time of tablet to disintegrate in a defined medium.

There are 5 parameters for calibration of disintegration test apparatus.

Disintegration test calibration parameters are:

  1. Bath Sensor
  2. External Probe
  3. Timer
  4. Number of Stroke per minute
  5. Sieve Integrity Check

1.Bath Sensor:

  1. The temperature should be set to 37.5°c with the Temp key and save it.
  2. Go back to the main menu.
  3. Use purified water as a medium.
  4. Once the temperature reached 37.5°c, immerse the calibrated thermometer into the tank and wait for 5 minutes to stabilize the temperature.
  5. Record the temperature shown by the instrument and measured by a calibrated thermometer in the record book.

Acceptance Criteria:

Acceptance criteria for bath sensor is, the difference between temperature shown by the instrument and measured by a calibrated thermometer should not be deviated by ± 2.0°c from the set temperature.

Note: Additional temperature points can be performed according to requirements.

2. External Probe:

  1. Set the bath temperature at 37.0°c by using the Temp key and save it.
  2. Go to the main menu.
  3. Use purified water as a medium.
  4. Once the temperature reached 37.5°c, immerse the calibrated thermometer into the tank and wait for 5 minutes to stabilize the temperature.
  5. Record the temperature shown by the instrument and measured by a calibrated thermometer in the record book.

Acceptance Criteria:

Acceptance criteria for bath sensor is, the difference between temperature shown by the instrument and measured by a calibrated thermometer should not be deviated by ± 2.0°c from the set temperature.

Note: Additional temperature points can be performed according to requirements.

3. Timer:

  1. Prepare and save the method or protocol with 1 minute, 30 minutes, and 60 minutes. (As per requirement)
  2. Use purified water as a medium.
  3. Select a method or protocol with 1 minute in the individual mode for Basket A.
  4. Press the ‘RUN/HALT’ key of Basket A.
  5. Start the instrument as well as a calibrated stopwatch at the same time.
  6. At end of set time, stop the stopwatch immediately.
  7. Continue the procedure for a second 30 minute and a second 60 minute temperature point.
  8. Repeat the procedure for Basket B and Basket C.

Acceptance Criteria:

The difference between set time and time shown by calibrated stopwatch as follows:

Set Time Acceptance Criteria
1 min ± 5 sec
30 min ± 60 sec
60 min ± 60 sec

4. Number of Strokes per Minutes:

  1. Prepare and save the method or protocol with a set time of 1 minute.
  2. Select a method or protocol for Basket A.
  3. Once the temperature is reached press the ‘RUN/HALT’ key of Basket A.
  4. Start instrument as well as the manual count of strokes at the same time.
  5. At end of set time, stop the manual count immediately.
  6. Record the number of strokes on the record book.
  7. Repeat the procedure for Basket B and Basket C.

Acceptance Criteria:

Acceptance criteria for the number of strokes is, the number of strokes of basket rack assembly should be 29 to 32 cycles per minute.

5. Sieve Integrity Check:

  1. Physical verification of each sieve for intactness, free of cracks, abrasions, etc.

Acceptance Criteria:

The sieve must be Intact, Free from cracks and abrasions.

 

These are the 5 parameters are used for the calibration of disintegration test apparatus in the pharmaceutical industry.

calibration-of-disintegration-test-apparatus
Calibration of Disintegration Test Apparatus

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