during cleaning.

Quality Control (QC) Team: Responsible for verifying that the cleaning procedures do not affect the quality of the product and that the machines are ready for use in subsequent batches.

Health and Safety Officer: Ensures that all safety protocols related to the use of cleaning agents and machine operation are adhered to during the cleaning process.

4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed and that crimping machines are cleaned as prescribed. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Pre-Cleaning Preparation

1. Before starting the cleaning process, ensure that the crimping machine is turned off, disconnected from the power supply, and isolated from any compressed air or gas supply to prevent accidental activation.
2. Remove all aerosol cans from the machine, ensuring that no product is left in the machine’s components.
3. Gather all necessary cleaning materials, including:
   • Cleaning agents approved for aerosol production
   • Water or rinsing solvents
   • Cleaning cloths, brushes, sponges
   • Compressed air or blowers for drying
   • PPE such as gloves, safety glasses, and aprons
4. Ensure that all cleaning tools are clean and in proper working condition.
5. Verify that the cleaning agents to be used are compatible with the crimping machine components and are suitable for removing product residues and lubricants.

5.2. Cleaning the Crimping Machine

1. Start by wiping down the exterior of the crimping machine to remove dust, dirt, and any visible product residues.
2. Disassemble any removable parts, such as crimping heads, seals, and valves, following the manufacturer’s guidelines for safe disassembly.
3. Clean the disassembled parts with an appropriate cleaning agent. Use brushes, sponges, or cloths to scrub away any product residues or contaminants. For stubborn residues, allow the parts to soak in the cleaning solution for a recommended period.
4. For components that are not easily removed, such as internal parts or hard-to-reach areas, use compressed air or a brush to remove product residue and contaminants.
5. After cleaning, thoroughly rinse all cleaned components with clean water or another solvent to ensure that no cleaning agent residue is left behind.
6. Dry all cleaned components using compressed air or clean, lint-free cloths to ensure they are completely dry before reassembly. Ensure that no moisture is left, as this could cause damage or product contamination.

5.3. Reassembling the Crimping Machine

1. After all components have been cleaned and dried, carefully reassemble the crimping machine, ensuring that all parts are properly aligned and seated according to the manufacturer’s specifications.
2. Check that all seals, gaskets, and components are correctly fitted to avoid leaks or operational issues during the next production run.
3. Ensure that all screws, bolts, and connectors are securely fastened to prevent malfunctions during machine operation.
4. Reattach any power, air, or gas connections that were disconnected during the cleaning process. Ensure that all connections are secure before turning on the machine.

5.4. Post-Cleaning Inspection and Testing

1. Once the crimping machine is reassembled, conduct a thorough visual inspection to ensure that all components are correctly assembled, clean, and free from contamination.
2. Check for any remaining residues or dirt in the machine components, especially in areas that are difficult to reach.
3. Run the machine through a short test cycle to ensure that it is functioning properly. Monitor the machine for unusual noises, vibrations, or malfunctions during this test cycle.
4. After the test run, verify that the crimping pressure and other machine settings are within the required specifications. Document the machine performance and any observations in the Post-Cleaning Inspection Log (Annexure-1).

5.5. Safety and Environmental Considerations

1. Ensure that all cleaning activities are performed in accordance with safety guidelines and the manufacturer’s instructions for handling cleaning agents and machine parts.
2. Wear the appropriate PPE, including gloves, goggles, and protective aprons, during the cleaning process to avoid exposure to cleaning agents or machine parts.
3. Ensure proper ventilation when using cleaning agents or solvents, especially if they emit fumes or vapors that could be harmful to health.
4. Dispose of used cleaning materials, solvents, and waste according to company policies and environmental regulations to prevent contamination and ensure safe disposal.

5.6. Documentation and Record-Keeping

1. Document all cleaning activities in the Cleaning Log (Annexure-2), including the machine ID, operator name, cleaning agents used, parts cleaned, and any issues encountered during the cleaning process.
2. Ensure that the Cleaning Log is completed thoroughly and accurately for each cleaning session.
3. Store cleaning records in accordance with the company’s document retention policy. These records must be available for audits, quality control checks, and regulatory inspections as needed.
4. Review cleaning logs periodically to ensure compliance with the SOP and to identify any recurring issues or areas for improvement.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• PPE: Personal Protective Equipment
• SOP: Standard Operating Procedure

7. Documents

1. Cleaning Log (Annexure-2)
2. Post-Cleaning Inspection Log (Annexure-1)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001:2015 – 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: Post-Cleaning Inspection Log

Machine ID	Parts Cleaned	Operator Name	Inspection Date	Remarks
F-12345	Crimping Heads	Rajesh Patel	06/02/2025	Inspection completed, no issues found

Annexure-2: Cleaning Log

Machine ID	Cleaning Agent Used	Operator Name	Date
F-12345	Solvent A	Rajesh Patel	06/02/2025

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated cleaning procedure for crimping machines	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures