Standard Operating Procedure for Cleaning Verification of Coating Pans Between Batches
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/139/2025 |
| Supersedes | SOP/TAB/139/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 01/03/2026 |
| Effective Date | 06/03/2026 |
| Review Date | 01/03/2027 |
1. Purpose
To define the procedure for cleaning and verifying the cleanliness of coating pans between batches to prevent cross-contamination and ensure product quality.
2. Scope
This SOP applies to the cleaning and verification of coating pans used in tablet manufacturing, ensuring that all residues from previous batches are removed before starting a new batch.
3. Responsibilities
- Quality Control (QC): Responsible for verifying the cleanliness of the coating pans and ensuring that cleaning procedures are effective.
- Coating Operator: Responsible for performing the cleaning process of the coating pans and ensuring the pans are cleaned properly before use in the next batch.
- Quality Assurance (QA): Ensures that the cleaning verification process is followed and reviews the results of cleaning inspections to ensure compliance with quality standards.
4. Accountability
The QC Manager is accountable for ensuring that the cleaning verification process is conducted properly and that all coating pans are verified as clean before use. The QA Manager is responsible for ensuring compliance with the SOP and reviewing the cleaning records.
5. Procedure
5.1 Cleaning Process
- After each batch, disassemble the coating pan as needed, including all parts that come into contact with the coating material.
- Use an appropriate cleaning solution based on the type of residue, such as a detergent solution or solvent, as specified in the cleaning guidelines for the coating pan.
- Ensure that all areas of the coating pan, including the interior, spray nozzles, and any parts in direct contact with the tablet coating, are thoroughly cleaned.
- Rinse the coating pan thoroughly with water to remove any cleaning solution or residue from previous batches.
- Wipe down all parts of the coating pan with clean, lint-free cloths or wipes to remove any remaining residue.
- If applicable, use an appropriate cleaning method such as ultrasonic cleaning or mechanical scrubbing for difficult-to-remove residues.
5.2 Cleaning Verification
- After cleaning, perform a visual inspection of the coating pan to ensure that all residues have been removed, and the pan appears clean and free from any debris or foreign material.
- Use a “swab test” to verify the cleanliness of the pan. Swab critical areas, such as the interior surface, spray nozzles, and other parts that come into contact with the tablets.
- Swabs should be analyzed for any residual contamination using an appropriate analytical method, such as a residue test, to ensure no contamination remains.
- Record the results of the swab tests and visual inspection in the cleaning log (Annexure-2). If any residue is detected, repeat the cleaning procedure until the swab tests show no contamination.
5.3 Documentation and Approval
- Document the cleaning verification results, including the swab test results, visual inspection findings, and any corrective actions taken, in the cleaning log (Annexure-2).
- Ensure that all documentation is signed and dated by the responsible personnel, including the coating operator and QC inspector.
- QA must review and approve the cleaning verification documentation before the coating pan can be used for the next batch.
5.4 Recleaning Actions
- If any residue or contamination is found during the cleaning verification process, perform a recleaning procedure and retest the pan.
- For persistent contamination, consider using stronger cleaning agents or different cleaning methods, such as a different solvent or mechanical cleaning tools.
- Once the pan passes the cleaning verification, proceed with the next batch production.
5.5 Frequency of Cleaning
- The cleaning and verification procedure must be performed between every batch of tablets, especially when different tablet formulations or coatings are used.
- If the coating pan is used for the same formulation without any changes to the coating material, a less stringent cleaning verification may be performed, based on risk assessment.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
7. Documents
- Cleaning Log (Annexure-2)
- Deviation Report (Annexure-1)
8. References
- USP <1053> – Cleaning and Cleaning Validation
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- European Pharmacopoeia (EP) – Cleaning and Cleaning Verification Guidelines
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Deviation Report
| Deviation Date | Batch Number | Deviation Description | Corrective Action | Responsible Person |
|---|---|---|---|---|
| 15/12/2025 | Batch 001 | Contamination detected in coating pan | Recleaned pan using stronger solvent | John Doe |
Annexure-2: Cleaning Log
| Cleaning Date | Coating Pan ID | Swab Test Results | Visual Inspection Result | Action Taken |
|---|---|---|---|---|
| 15/12/2025 | Pan 123 | Pass (No contamination) | Pass (Clean) | Accepted |
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 cleaning verification process | Improved cleaning verification methods | QA Head |