Standard Operating Procedure for Cleaning of Packing Machines Between Batches
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/245/2025 |
| Supersedes | SOP/TAB/245/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 01/07/2026 |
| Effective Date | 06/07/2026 |
| Review Date | 01/07/2027 |
1. Purpose
The purpose of this SOP is to outline the procedures for cleaning packing machines between batches to ensure they are free from product residues, contaminants, and foreign substances. This ensures the quality and safety of the tablets being packaged and complies with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to the cleaning of all packing machines used in the packaging process for tablets. The cleaning procedure should be followed between batches, after any machine malfunction, or when a change in packaging material occurs.
3. Responsibilities
- Packaging Operators: Responsible for performing the cleaning of packing machines, following the SOP and documenting the cleaning process.
- Quality Control (QC) Inspectors: Verify that cleaning is performed as per the SOP and that machines are free from residues before the next batch begins.
- Maintenance Personnel: Ensure that the machines are in good working condition and assist with any repairs required during the cleaning process.
- Production Manager: Ensure that the SOP is followed and that the equipment is cleaned in a timely manner to prevent production delays.
4. Accountability
The Production Manager is accountable for ensuring that the cleaning process is carried out between each batch. QC is responsible for inspecting the machine before production resumes to ensure the machine is cleaned thoroughly.
5. Procedure
5.1 Preparation for Cleaning
- Ensure the packing machine is turned off and isolated from the power source.
- Gather the required cleaning materials, including approved cleaning agents, brushes, cloths, and gloves (Annexure-1).
- Check the cleaning instructions for the machine and any specific recommendations from the manufacturer (Annexure-2).
- Prepare a cleaning solution that is compatible with the machine materials and product residues (Annexure-3).
5.2 Cleaning the Machine
- Begin by wiping down the external surfaces of the machine to remove any dust or visible residue (Annexure-4).
- Disassemble the machine components that come into contact with the product (e.g., hoppers, conveyors, sealing equipment) and soak them in the cleaning solution (Annexure-5).
- Use brushes and cloths to scrub all internal parts to remove any remaining product residues (Annexure-6).
- Ensure that all product contact surfaces are thoroughly cleaned to prevent cross-contamination (Annexure-7).
- Rinse all machine parts with water to remove any cleaning solution residue (Annexure-8).
- Allow the parts to air dry completely before reassembling the machine (Annexure-9).
5.3 Cleaning Validation
- QC must inspect the cleaned machine for any visible residues or contamination (Annexure-10).
- If any contamination is found, repeat the cleaning process and inspect again (Annexure-11).
- Once the inspection confirms that the machine is clean, document the results in the cleaning log (Annexure-12).
5.4 Final Reassembly and Start-Up
- Reassemble the packing machine once the parts have dried and are free from contaminants (Annexure-13).
- Run the machine empty for a short period to ensure everything is functioning properly and that no residual cleaning agents are left behind (Annexure-14).
- After the test run, check for any issues such as improper sealing or uneven product placement, and resolve them before starting production (Annexure-15).
5.5 Documentation and Record-Keeping
- Document each cleaning process, including the machine name, date, cleaning personnel, and inspection results (Annexure-16).
- Maintain cleaning logs for the required retention period according to company policies (Annexure-17).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- FIFO: First In, First Out
7. Documents
- Cleaning Log (Annexure-1)
- Cleaning Instructions (Annexure-2)
- Cleaning Solution Preparation Record (Annexure-3)
- External Surface Cleaning Log (Annexure-4)
- Machine Disassembly Log (Annexure-5)
- Internal Cleaning Log (Annexure-6)
- Product Contact Surface Cleaning Log (Annexure-7)
- Rinsing Record (Annexure-8)
- Drying Log (Annexure-9)
- Machine Inspection Log (Annexure-10)
- Re-cleaning Report (Annexure-11)
- Cleaning Validation Log (Annexure-12)
- Machine Reassembly Log (Annexure-13)
- Test Run Report (Annexure-14)
- Final Inspection Report (Annexure-15)
- Cleaning Documentation Log (Annexure-16)
- Cleaning Records Retention Log (Annexure-17)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (FDA)
- USP <1079> – Good Storage and Distribution Practices
- ISO 9001 – Quality Management Systems
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Cleaning Log
| Machine | Cleaning Date | Operator | Cleaning Status |
|---|---|---|---|
| Strip Packing Machine | 01/07/2026 | John Doe | Completed |
Annexure-2: Cleaning Instructions
| Machine | Instructions |
|---|---|
| Strip Packing Machine | Follow manufacturer’s cleaning procedure, use compatible cleaning solution. |
Annexure-3: Cleaning Solution Preparation Record
| Solution Type | Preparation Date | Prepared By | Concentration | Used For |
|---|---|---|---|---|
| Alkaline Cleaner | 01/07/2026 | John Doe | 5% solution | External surface cleaning |
| Acidic Cleaner | 01/07/2026 | Jane Smith | 2% solution | Internal surface cleaning |
Annexure-4: External Surface Cleaning Log
| Machine | Cleaning Date | Operator | Cleaning Method | Cleaning Status |
|---|---|---|---|---|
| Strip Packing Machine | 01/07/2026 | John Doe | Manual wipe down with cleaning solution | Completed |
Annexure-5: Machine Disassembly Log
| Machine | Disassembly Date | Disassembled By | Parts Disassembled | Disassembly Status |
|---|---|---|---|---|
| Strip Packing Machine | 01/07/2026 | Jane Smith | Hopper, Sealing Mechanism, Conveyor | Completed |
Annexure-6: Internal Cleaning Log
| Machine | Cleaning Date | Operator | Cleaning Solution Used | Cleaning Method | Cleaning Status |
|---|---|---|---|---|---|
| Strip Packing Machine | 01/07/2026 | John Doe | Alkaline Cleaner | Scrubbed with brush and soaked for 15 minutes | Completed |
Annexure-7: Product Contact Surface Cleaning Log
| Machine | Cleaning Date | Operator | Surface Area | Cleaning Solution Used | Cleaning Status |
|---|---|---|---|---|---|
| Strip Packing Machine | 01/07/2026 | Jane Smith | Sealing Mechanism | Acidic Cleaner | Completed |
Annexure-8: Rinsing Record
| Machine | Rinsing Date | Rinsing Agent | Operator | Rinsing Status |
|---|---|---|---|---|
| Strip Packing Machine | 01/07/2026 | Water | John Doe | Completed |
Annexure-9: Drying Log
| Machine | Drying Date | Drying Method | Operator | Drying Status |
|---|---|---|---|---|
| Strip Packing Machine | 01/07/2026 | Air Drying | Jane Smith | Completed |
Annexure-10: Machine Inspection Log
| Machine | Inspection Date | Inspector | Inspection Result | Corrective Action (if any) |
|---|---|---|---|---|
| Strip Packing Machine | 01/07/2026 | John Doe | Pass | None |
Annexure-11: Re-cleaning Report
| Issue | Re-cleaning Date | Action Taken | Responsible Person |
|---|---|---|---|
| Residue found after initial cleaning | 02/07/2026 | Re-cleaned and re-verified | John Doe |
Annexure-12: Cleaning Validation Log
| Machine | Validation Date | Validation Method | Validator | Validation Status |
|---|---|---|---|---|
| Strip Packing Machine | 01/07/2026 | Visual Inspection and Sampling | Jane Smith | Pass |
Annexure-13: Machine Reassembly Log
| Machine | Reassembly Date | Reassembled By | Reassembly Status |
|---|---|---|---|
| Strip Packing Machine | 01/07/2026 | John Doe | Completed |
Annexure-14: Test Run Report
| Machine | Test Run Date | Tested By | Test Run Result | Comments |
|---|---|---|---|---|
| Strip Packing Machine | 01/07/2026 | Jane Smith | Pass | No issues observed |
Annexure-15: Final Inspection Report
| Machine | Inspection Date | Inspector | Final Status | Comments |
|---|---|---|---|---|
| Strip Packing Machine | 01/07/2026 | John Doe | Pass | All checks completed successfully |