The Production Manager is accountable for ensuring the proper execution of the cleaning procedure for tablet compression equipment. The QA Manager is responsible for verifying the cleanliness and proper documentation of the equipment cleaning process.

5. Procedure

5.1 Pre-Cleaning Setup

1. Ensure that the tablet compression machine has been turned off and disconnected from the power source before cleaning begins.
2. Verify that the necessary cleaning materials, such as cleaning solvents, brushes, wipes, and lint-free cloths, are available and appropriate for the task.
3. Wear the appropriate protective equipment (e.g., gloves, masks) to maintain hygiene during the cleaning process.
4. Check the equipment and verify that it is cool and free from any residual heat before beginning the cleaning procedure.

5.2 Cleaning of Compression Tooling (Dies and Punches)

1. Remove all dies and punches from the compression machine using the appropriate tools and place them on a clean, designated surface.
2. Clean each die and punch individually using a lint-free cloth and the recommended cleaning solvent. If necessary, use a brush to remove any powder or residue from the tooling surfaces.
3. Check the dies and punches for wear and tear during cleaning. If any tool is damaged, it must be reported to the maintenance team for replacement.
4. After cleaning, dry the dies and punches completely before reinstalling them in the compression machine.

5.3 Cleaning of Compression Machine Components

1. Remove any remaining powder or residue from the machine’s hopper, feed chute, and compression area using a vacuum cleaner or air blower.
2. Wipe down all surfaces with a lint-free cloth dampened with an approved cleaning solution. Ensure that all surfaces are free from any tablet residues, powders, or contaminants.
3. Pay special attention to areas where powders may accumulate, such as corners and crevices. Use a brush if necessary to clean hard-to-reach areas.
4. Clean the machine’s control panel and other electronic components with a dry cloth. Avoid using excessive moisture to prevent damage to electrical parts.

5.4 Cleaning of Surrounding Areas

1. Clean the surrounding work area to ensure no powder or debris has spread during the cleaning process.
2. Use a vacuum cleaner with HEPA filters to remove any loose powder from the floor and nearby equipment.
3. Ensure that the cleaning area is kept dry to avoid any cross-contamination with moisture-sensitive materials.

5.5 Post-Cleaning Inspection

1. After cleaning, perform a visual inspection of the tablet compression machine and all components to ensure that all residues have been removed and that no cleaning agents remain on the surfaces.
2. Check for any signs of damage, such as cracks or wear, on the compression tooling or machine components.
3. If any issues are found during the inspection, report them to the maintenance team for immediate action before the equipment is used for the next batch.

5.6 Documentation and Record-Keeping

1. Record all details of the cleaning procedure, including the date, time, personnel involved, and any issues encountered, in the cleaning log (Annexure-1).
2. Document the results of the inspection and any corrective actions taken in the deviation report (Annexure-2).
3. Ensure that all records are reviewed and signed off by the appropriate personnel, including the QC and QA teams, to confirm that the cleaning process has been completed properly.
4. Store all cleaning records and deviation reports for future audits and regulatory inspections.

5.7 Equipment Cleaning Frequency

1. Clean the tablet compression machine and tooling after every batch to prevent cross-contamination between different tablet formulations.
2. Perform a thorough cleaning whenever there is a change in the tablet formula or before starting production with a new batch to ensure that no residues are left behind.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• API: Active Pharmaceutical Ingredient

7. Documents

1. Cleaning Log (Annexure-1)
2. Deviation Report (Annexure-2)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
• ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

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

Cleaning Date	Equipment	Cleaning Method	Checked By	Comments
01/09/2025	Compression Machine	Solvent wipe, vacuum cleaning	John Doe	No issues found
02/09/2025	Compression Tooling	Brush, solvent wipe	Jane Smith	Minor residue on dies removed

Annexure-2: Deviation Report

Deviation Date	Batch Number	Deviation Description	Corrective Action	Responsible Person
03/09/2025	Batch 003	Residual powder found on tooling	Re-cleaned tooling and replaced wipes	John Doe

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 Methodology	Improved Cleaning Efficiency	QA Head