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
- Manufacturing Personnel: Responsible for preparing the apparatus for use, ensuring it is clean and functional before each dissolution test.
- Quality Control (QC): Responsible for performing cleaning, calibration, and routine maintenance of the dissolution apparatus, and ensuring that the apparatus meets the required specifications.
- Quality Assurance (QA): Ensures the cleaning and calibration procedures are followed correctly and reviews records for compliance.
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.
5. Procedure
5.1 Cleaning of Dissolution Apparatus
- Turn off and unplug the dissolution apparatus before starting the cleaning process.
- Remove all components such as baskets, paddles, and shafts from the apparatus.
- 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.
- Clean the vessel chambers using a lint-free cloth soaked in distilled water. Ensure there is no residue left behind.
- 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.
- Dry all components thoroughly before reassembling the apparatus.
- Check for any damage, corrosion, or wear on the components. Replace any damaged parts immediately.
5.2 Calibration of Dissolution Apparatus
- Ensure that the apparatus is clean and dry before starting the calibration process.
- Check the general condition of the apparatus and verify that all components are correctly installed and functioning.
- Use a certified calibration standard for the dissolution medium (e.g., a standard volume and temperature) to check the apparatus’ accuracy.
- 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).
- 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).
- 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.
- Document the calibration results in the calibration log (Annexure-1). Note any adjustments made and if any components were replaced or repaired.
5.3 Routine Maintenance
- Perform a visual inspection of the apparatus daily to ensure that no parts are worn out or damaged.
- 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).
- Record all maintenance activities, including repairs or parts replacements, in the maintenance log (Annexure-2).
- Schedule a detailed calibration and cleaning at least once a month or as per the manufacturer’s guidelines.
5.4 Documentation and Record-Keeping
- Record all cleaning, calibration, and maintenance activities in the respective logs (Calibration Log – Annexure-1, Maintenance Log – Annexure-2).
- Ensure that all logs are signed and dated by the personnel performing the activities and reviewed by the supervisor.
- Maintain records according to the company’s record retention policy for future audits and inspections.
5.5 Post-Test Cleanup
- After each dissolution test, clean the apparatus as per the cleaning procedure outlined in this SOP.
- Ensure that the dissolution apparatus is properly dried and stored in a clean, dry environment to prevent contamination and corrosion.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- API: Active Pharmaceutical Ingredient
- rpm: Revolutions Per Minute
7. Documents
- Calibration Log (Annexure-1)
- Maintenance Log (Annexure-2)
8. References
- USP <711> – Dissolution Testing
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- European Pharmacopoeia (EP) – Dissolution Testing
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 |