SOP Guide for Pharma

Tablets: SOP for Cleaning and Calibration of Dissolution Apparatus – V 2.0

Auditor

Tablets: SOP for Cleaning and Calibration of Dissolution Apparatus – V 2.0

Standard Operating Procedure for Cleaning and Calibration of Dissolution Apparatus

Department Tablet
SOP No. SOP/TAB/088/2025
Supersedes SOP/TAB/088/2022
Page No. Page 1 of 7
Issue Date 01/03/2026
Effective Date 06/03/2026
Review Date 01/03/2027

1. Purpose

To establish the procedure for cleaning and calibrating dissolution apparatus to ensure that the dissolution testing is accurate and reproducible, in compliance with regulatory standards and GMP.

2. Scope

This SOP applies to the cleaning, calibration, and maintenance of dissolution apparatus used for testing the release characteristics of tablet formulations. It ensures the apparatus is clean, calibrated, and ready for accurate use.

3. Responsibilities

4. Accountability

The QC Manager is accountable for ensuring the dissolution apparatus is cleaned and calibrated in accordance with this SOP. The QA Manager is responsible for reviewing the results and ensuring the apparatus meets the specifications for use.

See also  Tablets: SOP for Disintegration Testing for Immediate Release Tablets - V 2.0

5. Procedure

5.1 Cleaning of Dissolution Apparatus

  1. Turn off and unplug the dissolution apparatus before starting the cleaning process.
  2. Remove all components such as baskets, paddles, and shafts from the apparatus.
  3. Clean all removable parts using distilled water and an appropriate detergent (e.g., non-abrasive lab detergent). Use a soft brush if needed to remove any residue.
  4. Clean the vessel chambers using a lint-free cloth soaked in distilled water. Ensure there is no residue left behind.
  5. For any stubborn residues, use an appropriate solvent that will not affect the functionality of the apparatus. Follow manufacturer recommendations for any specialized cleaning agents.
  6. Dry all components thoroughly before reassembling the apparatus.
  7. Check for any damage, corrosion, or wear on the components. Replace any damaged parts immediately.

5.2 Calibration of Dissolution Apparatus

  1. Ensure that the apparatus is clean and dry before starting the calibration process.
  2. Check the general condition of the apparatus and verify that all components are correctly installed and functioning.
  3. Use a certified calibration standard for the dissolution medium (e.g., a standard volume and temperature) to check the apparatus’ accuracy.
  4. For paddle speed calibration, use a tachometer to measure the rotation speed and adjust as necessary to ensure it is within the specified range (usually 100–200 rpm depending on the apparatus model and testing guidelines).
  5. For temperature calibration, use a calibrated thermometer or temperature probe to verify that the dissolution medium is maintained at the required temperature (usually 37°C ± 0.5°C).
  6. For the vessel alignment check, verify that the vessels are properly aligned and centered. Check that they are positioned at the correct height for uniform stirring.
  7. Document the calibration results in the calibration log (Annexure-1). Note any adjustments made and if any components were replaced or repaired.
See also  Tablets: SOP for Accelerated Stability Testing of Tablets - V 2.0

5.3 Routine Maintenance

  1. Perform a visual inspection of the apparatus daily to ensure that no parts are worn out or damaged.
  2. Check the integrity of the apparatus and replace any parts that show signs of wear or damage (e.g., corroded baskets, paddles with missing blades).
  3. Record all maintenance activities, including repairs or parts replacements, in the maintenance log (Annexure-2).
  4. Schedule a detailed calibration and cleaning at least once a month or as per the manufacturer’s guidelines.

5.4 Documentation and Record-Keeping

  1. Record all cleaning, calibration, and maintenance activities in the respective logs (Calibration Log – Annexure-1, Maintenance Log – Annexure-2).
  2. Ensure that all logs are signed and dated by the personnel performing the activities and reviewed by the supervisor.
  3. Maintain records according to the company’s record retention policy for future audits and inspections.

5.5 Post-Test Cleanup

  1. After each dissolution test, clean the apparatus as per the cleaning procedure outlined in this SOP.
  2. Ensure that the dissolution apparatus is properly dried and stored in a clean, dry environment to prevent contamination and corrosion.
See also  Tablets: SOP for Dissolution Testing of Film-Coated Tablets - V 2.0

6. Abbreviations

7. Documents

  1. Calibration Log (Annexure-1)
  2. Maintenance Log (Annexure-2)

8. References

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Calibration Log

Calibration Date Apparatus ID Test Conducted Result Action Taken Signature
10/12/2025 Apparatus 001 Paddle Speed 100 rpm No action needed John Doe

Annexure-2: Maintenance Log

Maintenance Date Apparatus ID Activity Parts Replaced Responsible Person
12/12/2025 Apparatus 001 Cleaning None Jane Smith

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP Creation QA Head
01/02/2025 2.0 Updated Calibration and Cleaning Frequency Refined cleaning and calibration protocols QA Head
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