Standard Operating Procedure (SOP) for Operational Check of Disintegration Test Apparatus

1.0 Purpose:

To ensure the proper functioning and accuracy of the Disintegration Test Apparatus in accordance with regulatory standards.

2.0 Scope:

This SOP applies to all personnel involved in the operation and maintenance of the Disintegration Test Apparatus.

3.0 Responsibilities:

3.1 Quality Control (QC) Personnel

Responsibilities:

3.1 Pre-Check Preparation:

• 3.1.1 QC personnel are responsible for ensuring that the Disintegration Test Apparatus is clean and free from any residues from previous tests.
• 3.1.2 Verify the calibration status of the apparatus and check the calibration certificate.

3.2 Start-up Procedure:

• 3.2.1 Initiate the warming up of the apparatus for a minimum of 30 minutes.
• 3.2.2 Verify the proper functioning of the temperature control system.

3.3 Mechanical Checks:

• 3.3.1 Inspect the condition of the disintegration test baskets, reporting any defects or damage.
• 3.3.2 Evaluate the motorized drive for smooth operation, identifying and reporting any unusual noise.
• 3.3.3 Confirm the lifting mechanism’s functionality, ensuring even lifting of the baskets.

3.4 Operational Check:

• 3.4.1 Place disintegration test discs in each basket according to standard specifications.
• 3.4.2 Fill the dissolution medium as specified in the test procedure.
• 3.4.3 Set the stopwatch timer to the predetermined disintegration time.
• 3.4.4 Observe the test discs continuously and record the time of disintegration.

3.5 Post-Operational Checks:

• 3.5.1 Verify that the disintegration test meets the specified time limit.
• 3.5.2 Record any deviations from the standard procedure and report them to the laboratory supervisor.
• 3.5.3 Collaborate with maintenance personnel to address identified issues.

4.0 Documentation:

QC personnel are responsible for accurately documenting all observations, deviations, and corrective actions in the Disintegration Test Apparatus Logbook.

3.2 Laboratory supervisor

Responsibilities:

3.1 Pre-Check Preparation:

• 3.1.1 Verify that QC personnel have ensured the cleanliness of the Disintegration Test Apparatus and validated the calibration status.
• 3.1.2 Confirm that all required materials and equipment are available for the operational check.

3.2 Start-up Procedure:

• 3.2.1 Supervise the initiation of the warming-up process, ensuring it aligns with the recommended duration.
• 3.2.2 Confirm the proper functioning of the temperature control system.

3.3 Mechanical Checks:

• 3.3.1 Review the inspection reports on the condition of disintegration test baskets, motorized drive, and lifting mechanism.
• 3.3.2 Address any reported defects, damages, or irregularities in collaboration with QC personnel.

3.4 Operational Check:

• 3.4.1 Oversee the placement of disintegration test discs in each basket, verifying compliance with standard specifications.
• 3.4.2 Monitor the filling of the dissolution medium as per the specified test procedure.
• 3.4.3 Ensure the stopwatch timer is set correctly, and the operational check is initiated per the predetermined disintegration time.
• 3.4.4 Review continuous observations of the test discs, providing guidance if needed.

3.5 Post-Operational Checks:

• 3.5.1 Validate that the disintegration test meets the specified time limit.
• 3.5.2 Review QC personnel’s documentation of any deviations and collaborate with them to address issues.
• 3.5.3 Coordinate with maintenance personnel for necessary repairs or adjustments.

4.0 Documentation:

Supervise the accurate documentation of all observations, deviations, and corrective actions in the Disintegration Test Apparatus Logbook.

3.3 Maintenance personnel

Responsibilities:

3.1 Pre-Check Preparation:

• 3.1.1 Collaborate with QC and Laboratory Supervisor to review any reported defects or issues from previous tests.
• 3.1.2 Ensure availability of necessary tools and spare parts for potential repairs.

3.2 Start-up Procedure:

• 3.2.1 Check the power supply and electrical connections to ensure stability.
• 3.2.2 Verify the proper functioning of the apparatus during the warm-up phase.

3.3 Mechanical Checks:

• 3.3.1 Conduct a thorough inspection of the disintegration test baskets, motorized drive, and lifting mechanism.
• 3.3.2 Address any identified defects or irregularities promptly and report them to the Laboratory Supervisor.

3.4 Operational Check:

• 3.4.1 Monitor the operational check process for any signs of malfunction or unusual noise.
• 3.4.2 Collaborate with QC personnel and the Laboratory Supervisor to troubleshoot and rectify issues during the test.

3.5 Post-Operational Checks:

• 3.5.1 Collaborate with QC personnel to review documentation of deviations and issues.
• 3.5.2 Schedule and perform routine maintenance based on operational check findings.
• 3.5.3 Ensure that the Disintegration Test Apparatus is left in a clean and operational state after use.

4.0 Documentation:

• 4.1 Document all maintenance activities, including repairs and adjustments made during the operational check.
• 4.2 Maintain a record of spare parts used and their stock levels.

4.0 Equipment and Materials:

• 4.1 Disintegration Test Apparatus
• 4.2 Stopwatch
• 4.3 Calibration weights (if applicable)
• 4.4 Manufacturer’s manual

5.0 Procedure:

5.1 Pre-Check Preparation:

• 5.1.1 Ensure that the Disintegration Test Apparatus is clean and free from any residues from previous tests.
• 5.1.2 Check the electrical connections and ensure that the power supply is stable.
• 5.1.3 Verify that the apparatus is properly calibrated (if applicable) by checking the calibration certificate.

5.2 Start-up Procedure:

• 5.2.1 Turn on the power switch and allow the apparatus to warm up for a minimum of 30 minutes.
• 5.2.2 Check that the temperature control system is functioning properly.

5.3 Mechanical Checks:

• 5.3.1 Inspect the condition of the disintegration test baskets, ensuring there are no defects or damage.
• 5.3.2 Check that the motorized drive is operating smoothly without any unusual noise.
• 5.3.3 Verify that the lifting mechanism is functioning correctly and lifting the baskets evenly.

5.4 Operational Check:

• 5.4.1 Place disintegration test discs in each basket as per standard specifications.
• 5.4.2 Fill the dissolution medium as specified in the test procedure.
• 5.4.3 Set the timer on the stopwatch to the predetermined disintegration time.
• 5.4.4 Start the apparatus and initiate the disintegration test.
• 5.4.5 Observe the test discs continuously and record the time at which disintegration occurs.

5.5 Post-Operational Checks:

• 5.5.1 Ensure that the disintegration test meets the specified time limit.
• 5.5.2 Record any deviations from the standard procedure and report them to the supervisor.
• 5.5.3 Turn off the power switch and clean the apparatus thoroughly after use.

6.0 Documentation:

6.1 Documentation Requirements:

6.1.1 Pre-Check Documentation:

• QC personnel must document the cleanliness verification of the Disintegration Test Apparatus.
• Record the calibration status and check for the calibration certificate.

6.1.2 Start-up Procedure Documentation:

• Document the initiation of the warming-up process, including the start time and duration.
• Record the verification of the temperature control system’s proper functioning.

6.1.3 Mechanical Checks Documentation:

• Maintain inspection reports on the condition of disintegration test baskets, motorized drive, and lifting mechanism.
• Document any defects, damages, or irregularities reported by QC personnel.

6.1.4 Operational Check Documentation:

• Record the placement of disintegration test discs in each basket, ensuring compliance with standard specifications.
• Document the filling of the dissolution medium according to the specified test procedure.
• Note the stopwatch timer settings and record the time of disintegration.

6.1.5 Post-Operational Checks Documentation:

• Document the validation of disintegration test results meeting the specified time limit.
• Record any deviations reported by QC personnel and collaborative efforts to address them.
• Document maintenance activities, repairs, or adjustments made during or after the operational check.

6.2 Record Keeping:

• Maintain a Disintegration Test Apparatus Logbook for centralized documentation.
• Include details such as date, time, personnel involved, and any observed deviations.

6.3 Training Records:

• Document the training records of personnel involved in the operational check procedures.

7.0 Training:

All personnel involved in the operational check must undergo proper training on the use and maintenance of the Disintegration Test Apparatus.

8.0 References:

Refer to the manufacturer’s manual for specific instructions and guidelines.

9.0 Revision History:

Document any changes or updates made to this SOP.

10.0 Approval:

This SOP is to be reviewed and approved by the Quality Assurance department.

11.0 Distribution:

Distribute this SOP to all relevant personnel and ensure they are aware of and trained on its contents.

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