Learn the calibration process of the disintegration test apparatus.
The disintegration testing is an official quality control test for dosage forms such as tablets, capsules, and suppositories used to determine whether a tablet has disintegrated within a specified time when placed in a liquid medium (Water/buffer) under experimental conditions. This testing has sets standards for tablet disintegration testing according to the United States Pharmacopeia (USP).
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The apparatus consists of a basket rack holding six plastic tubes that are open at the top and bottom. A wire gauge (10 mesh screen) made of stainless steel is attached to the bottom of the lower plate. The upper and lower plates are placed in vertical metal rods at the periphery and the metal rod in the center of the upper plate is attached to the mechanical device. The rack is immersed in the appropriate liquid at 37°C. It moves up and down at a fixed rate. Each tube contains a sample, and the time it takes for it to disintegrate and fall through the screen is recorded.
How do you calibrate the disintegration apparatus?
- Operate the instrument as per standard operating procedure (SOP).
- The frequency of calibration of dissolution test equipment is once a month.
Calibration of the number of cycles:
- This test requires a pre-calibrated stopwatch. Run the instrument and stopwatch at the same time, and count how many oscillations there are per minute.
- Repeat the same five times and record the number of oscillations per minute each time in Annexure A.
- Perform the test individually for both basket rack assembly positions (side A and B).
- The acceptance limit for oscillations per minute is within the range of 29 to 32 cycles per minute through a distance of 53 to 57 mm.
Calibration of temperature:
- This test requires a calibrated thermometer.
- Fill about 800 ml of water in a 1-liter beaker in a water bath and set the bath temperature to 37°C.
- Connect the basket rack assembly and begin moving up and down at constant frequency.
- Place the calibrated thermometer into one of the basket rack assembly tubes and wait until the temperature reaches the desired level.
- Take temperature readings initially and then every 15 minutes for the next 120 minutes.
- Perform the test individually for both basket rack assembly positions (side A and B).
- The acceptance limit for temperature is 37± 1°C.
Calibration of distance traveled:
- This test requires a vernier caliper.
- Start the instrument and mark the up and down points as soon as the assembly reaches the highest and lowest positions.
- Start the apparatus and record the value in millimeters (mm) from the up and down positions.
- Record the value by subtracting the value down-position from the up-position.
- Perform the test individually for both basket rack assembly positions (side A and B).
- The acceptance limit for distance traveled by basket (A/B) is between 53-57 mm.
Calibration of timer:
- This test requires a stopwatch.
- Set a timer for 15 minutes, and turn on the instrument and stopwatch simultaneously.
- Immediately note down the stopwatch reading when the apparatus is stopped and note down the observations in annexure A.
- The acceptance limit for time should not deviate from ±1 min.
Acceptance criteria
Repair/ Maintenance:
If the equipment fails to meet the above requirements should be repaired or serviced by an authorized service engineer. To obtain accurate performance, regular maintenance of the equipment is also required.
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