Standard Operating Procedure (SOP)

Here is a Standard Operating Procedure (SOP) for the Operation and Calibration of Tablet Disintegration Apparatus. This SOP ensures that the apparatus used for testing tablet disintegration is operating accurately and consistently, and that proper calibration is conducted for reliable results.

1. Purpose

To outline the procedures for the operation, calibration, and maintenance of the tablet disintegration apparatus, ensuring that tablet disintegration tests are performed accurately and consistently in accordance with standard pharmacopeial requirements.

2. Scope

This SOP applies to the operation, calibration, and maintenance of the tablet disintegration apparatus used in the quality control laboratory at [Company/Facility Name]. It covers the steps to operate the apparatus, calibrate it, and troubleshoot any potential issues.

3. Responsibilities

• Laboratory Technicians: Responsible for operating the tablet disintegration apparatus, conducting tests, and performing basic maintenance.

• Quality Control (QC) Supervisor: Ensures the correct operation and calibration of the apparatus. Reviews and approves calibration records and test results.

• Maintenance Personnel: Responsible for performing more extensive repairs and ensuring the equipment is in working order.

4. Materials and Equipment

• Tablet Disintegration Apparatus (e.g., USP Apparatus 1 or 2)

• Disintegration vessels (e.g., glass tubes, baskets)

• Water bath with temperature control

• Calibration standards (e.g., calibration tablets, standards for displacement)

• Stopwatch or timer

• Thermometer

• pH meter (if applicable)

• Record forms (e.g., calibration log, operational log)

• Distilled water (or other prescribed medium)

• Tablet samples for disintegration testing

5. Procedure

5.1 Operation of Tablet Disintegration Apparatus

1. Preparation for Testing:

   • Verify that the tablet disintegration apparatus is clean and free of any residues.

   • Check that the temperature of the disintegration medium (usually distilled water) is within the specified range, typically 37°C ± 2°C, using a calibrated thermometer.

   • Place the disintegration vessels into position and ensure they are securely fastened to the apparatus.

   • Fill the disintegration vessels with the appropriate disintegration medium, ensuring each vessel is at the same level (if using multiple vessels).

2. Setting up the Tablets for Testing:

   • Place the tablets to be tested into the appropriate disintegration baskets.

   • Ensure that the number of tablets corresponds with the test requirements (typically, 6 tablets per test).

   • Make sure the tablets are properly placed in the baskets and are not touching each other or the sides of the vessels.

3. Initiating the Test:

   • Start the apparatus, ensuring the baskets move up and down in the medium in a consistent manner.

   • Set the timer according to the specified disintegration time (typically 30 minutes, depending on the tablet type).

   • Observe the tablets during the test for any signs of non-compliance, such as incomplete disintegration.

4. Test Completion:

   • At the specified time, stop the apparatus and check if the tablets have disintegrated completely.

   • Record the disintegration time and the condition of the tablets.

   • If necessary, remove the tablets and inspect them according to the requirements of the pharmacopeia (e.g., visual inspection, testing for residues).

5. Documentation:

   • Document the results of the test in the laboratory notebook or electronic system, including the tablet batch number, test conditions, and outcome of the disintegration test.

   • If the test is passed, record the passing result. If the test fails, initiate an investigation according to the failure protocol.

5.2 Calibration of Tablet Disintegration Apparatus

1. Frequency of Calibration:

   • Calibrate the tablet disintegration apparatus before its first use and on a regular basis (e.g., quarterly, or as per company protocol).

   • Calibrate after any repair, maintenance, or if there are signs of malfunction.

2. Calibration Standards:

   • Use a calibration tablet or a standardized tablet of known characteristics, such as a tablet with a known disintegration time (e.g., a tablet with a specific disintegration time of 30 minutes).

   • Alternatively, use an apparatus-specific calibration method (e.g., displacement calibration, or using an accuracy verification device).

3. Perform Calibration:

   • Set up the disintegration apparatus as described in Section 5.1 (ensure the apparatus is at the correct temperature).

   • Place the calibration tablet into the disintegration basket.

   • Run the test and compare the observed disintegration time to the expected value (e.g., 30 minutes for the standard calibration tablet).

   • If the disintegration time does not match the expected value, check the apparatus for calibration issues.

4. Adjustment of Apparatus:

   • If the calibration test fails, adjust the disintegration apparatus according to the manufacturer’s instructions.

   • Common adjustments may include altering the stroke rate, adjusting the basket height, or checking for mechanical issues in the apparatus.

5. Verification:

   • After adjustments, perform a second calibration test to ensure the apparatus is functioning within specifications.

   • If the apparatus is still out of specification after adjustment, report the issue to the maintenance team.

6. Recording Calibration Data:

   • Document the results of the calibration process, including the date, calibration tablet used, and results of the calibration test.

   • Include any adjustments made to the apparatus during calibration in the calibration log.

5.3 Maintenance of Tablet Disintegration Apparatus

1. Routine Maintenance:

   • Clean the apparatus, including the disintegration vessels, baskets, and any associated parts, after each use.

   • Inspect the apparatus for any signs of wear or damage, including checking the movement of the baskets and the alignment of the temperature control unit.

2. Scheduled Maintenance:

   • Perform scheduled maintenance at regular intervals (e.g., quarterly) to ensure the apparatus is operating correctly.

   • Check the electrical and mechanical components, including the motor, temperature control, and movement mechanism.

3. Repair and Calibration Records:

   • Keep records of all maintenance and repairs performed on the apparatus, including the date, nature of the work, and personnel involved.

   • If repairs are necessary, ensure the apparatus is calibrated again after maintenance before use.

6. Precautions

• Always check the temperature of the disintegration medium before starting the test to ensure it is within the required range.

• Never overload the disintegration vessels with tablets beyond the specified quantity (typically 6 tablets per vessel).

• Avoid any manual handling of the tablet baskets during the test to prevent interference with the disintegration process.

• Ensure that the apparatus is regularly calibrated and maintained to avoid any discrepancies in test results.

7. Documentation and Records

• Operational Log: Record all tablet disintegration tests, including the sample details, date, and outcome of the test.

• Calibration Log: Document all calibration results, including the calibration tablet used, observed results, adjustments made, and any issues encountered during calibration.

• Maintenance Log: Record details of maintenance and repairs, including the date, work performed, and any parts replaced.

8. Reference Documents

• USP Chapter <701>: Disintegration Tests

• Manufacturer’s manual for the tablet disintegration apparatus

• Pharmacopoeias guidelines for disintegration testing (e.g., USP, EP)

🎓 Discover one of the best Quality Assurance courses available — click below to explore the course that’s shaping future QA skills.

https://trcjw.on-app.in/app/oc/306166/trcjw