Standard Operating Procedure (SOP) for Disintegration Test Apparatus
1.0 OBJECTIVE: To establish a procedure for the cleaning, operation, and calibration of the disintegration test apparatus.
2.0 SCOPE: This procedure is applicable to cleaning, operation, and calibration of the disintegration test apparatus used in the production department.
3.0 RESPONSIBILITY: Officer, Executive – Production Department
Manager – Production Department
QA Officer – In-process
4.0 DEFINITIONS:
NA (Not Applicable)
5.0 PROCEDURE:
5.1 Cleaning:
5.1.1. Clean the basket and disc.
5.1.2. Use 5-10 liters of purified water to clean the basket of the disintegration apparatus.
5.1.3. Dry the apparatus with a wet lint-free duster.
5.1.4. Clean the basket and discs after every disintegration test.
5.1.5. Cleaning of water bath:
5.1.5.1. Clean the water bath with 5-10 liters of purified water.
5.1.5.2. Dry the water bath with a wet lint-free duster.
5.1.5.3. Clean the water bath weekly.
5.2 Operation:
5.2.1. Ensure the cleanliness of the instrument.
5.2.2. Turn ‘ON’ the mains switch.
5.2.3. Turn on the power switch at the rear panel.
5.2.4. Set the conditions (Ensure that water is filled up to the mark in the water tank).
5.2.5. Setting the temperature:
5.2.5.1. Press the “SET” key; the yellow LED starts glowing.
5.2.5.2. Press ‘TEMP’ key; the right digit of the previously set temperature on the temperature screen starts blinking.
5.2.5.3. Set the required temperature using the Up/Down keys. After setting, press “DISP SEL” key to change the position of the blinking digit. After complete setting, press “ENTER” to store the temperature in the instrument’s memory.
5.2.6. Setting the timer:
5.2.6.1. Press the “SET” key; the yellow LED on the right side starts glowing.
5.2.6.2. Press “TIMER” key; the right digit of the previously set time starts blinking.
5.2.6.3. Enter the required time in minutes using the Up/Down keys. After setting, press “DISP SEL” key to change the position of the blinking digit. After complete settings, press “ENTER” to store the time in the instrument’s memory.
5.2.6.4. Press the “TEMP” key to start heating the water in the water tank; the red LED starts glowing.
5.2.6.5. Place two 1000 ml beakers filled with purified water or specified media up to the ¾th level in the instrument.
5.2.6.6. Measure the temperature of the selected area using the external probe by pressing “PROBE SEL” key. After achieving the set temperature, place the tablets in the basket (use discs if required), fix them on the clamps, and start the test by pressing “START/STOP” key. The instrument will automatically stop after the set time.
5.2.6.7. To pause the test, press “TIMER” key. The green LED of the “TIMER” key starts flashing, and the time stops increasing. To continue the test, press “TIMER” key once more.
5.2.6.8. To stop the test whenever required, press “START/STOP” key.
5.2.6.9. Clean the baskets, discs, and beakers for the next use.
5.2.6.10. Turn off the instrument from the rear panel and switch off the mains.
5.3 Calibration:
5.3.1. Operate the instrument as per step 5.2.
5.3.2. Start the machine and count the number of cycles per minute, recording it in Annexure-I.
5.3.3. Check the distance traveled by the mechanical device holding the cells and the discs using vernier calipers, recording the measurement in Annexure-I. Ensure that the mechanical device moves smoothly through a distance of 50 to 60 mm at a constant frequency.
5.3.4. Note the number of cycles per minute using a calibrated stopwatch, and record it in Annexure-I.
5.3.5. Set the required temperature, start the heater of the machine, and ensure the instrument maintains a stable temperature.
5.3.6. Check the water bath temperature with a calibrated thermometer and record it in Annexure-I.
5.3.7. Set the timer for 30 minutes, start the machine, and the calibrated stopwatch simultaneously. Note down the stopwatch reading when the machine stops.
5.3.8. Visually inspect the integrity of the sieve attached to the baskets and record the observation in Annexure-I.
5.3.9. Affix a calibration status label, duly filled and signed, on the equipment after completing the calibration.
5.3.10. In case of any discrepancies observed, inform the Head of the department and the engineering department for corrective action. Attach an ‘UNDER MAINTENANCE’ tag to the machine.
5.3.11. Recalibrate the machine after rectification and record it in Annexure-I.
5.3.12. The frequency of calibration is once a month.
5.4 Precautions:
5.4.1. Do not start the temperature controller until the water in the bath is filled up to the marked level without beakers.
5.4.2. Do not remove the baskets until they are disengaged from the hook.
5.4.3. Do not clean the bath with any strong solvent. Use purified water for cleaning.
5.4.4. Handle the external probe carefully.
Related SOP: SOP on Operation of Rapid Mixer Granulator
6.0 ABBREVIATIONS:
QA: Quality Assurance
SOP: Standard Operating Procedure
mm: Millimeters
7.0 REFERENCES:
NA
8.0 ANNEXURE:
ANNEXURE – I: Calibration Record of Disintegration Test Apparatus
