Control (QC) Team: Responsible for verifying that the cleaning process does not interfere with product quality, and that cleaning activities meet the required standards for hygiene and safety.

Health and Safety Officer: Ensures that all safety protocols related to cleaning agents, machine operation, and PPE use are followed to prevent accidents or exposure to hazardous materials.

4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed and that all aerosol filling machines are cleaned according to the prescribed schedule. 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 beginning the cleaning process, ensure that the filling machine is turned off, disconnected from the power supply, and isolated from the compressed air or gas supply to avoid accidental operation.
2. Remove any remaining aerosol containers, materials, and components from the machine, ensuring that no product remains in the system.
3. Gather all necessary cleaning materials and equipment, including:
   • Cleaning agents (approved for use in aerosol production)
   • Water or other rinsing solvents
   • Cleaning cloths, brushes, or sponges
   • Air blowers or compressed air for drying
   • PPE such as gloves, safety glasses, and aprons
4. Check that all required cleaning tools are in proper working condition and clean before use.
5. Ensure that the cleaning agents used are compatible with the materials of the machine and meet regulatory standards.

5.2. Cleaning the Filling Machine

1. Start by cleaning the exterior of the filling machine, wiping down surfaces, removing dust and debris, and cleaning any exposed areas using a damp cloth.
2. Disassemble any removable parts, such as filling nozzles, hoppers, or filling chambers, according to the manufacturer’s guidelines.
3. Clean all disassembled parts using an appropriate cleaning agent and scrubbing tools to remove product residues and contaminants. Ensure all parts are thoroughly cleaned to prevent contamination in future batches.
4. If any parts are heavily soiled or clogged, soak them in a cleaning solution for the recommended time before scrubbing and rinsing.
5. Once the machine parts are clean, rinse them thoroughly with clean water or other suitable solvent to remove any cleaning agents. Ensure that no residues are left that could affect product quality.
6. Dry all cleaned parts using air blowers or clean, lint-free cloths. Ensure that parts are completely dry before reassembling them to avoid moisture buildup in the machine.
7. Clean all inaccessible areas of the machine using brushes, compressed air, or other cleaning methods to ensure that no residue is left inside the machine.

5.3. Reassembling the Filling Machine

1. Once all parts have been cleaned and dried, carefully reassemble the machine, following the manufacturer’s guidelines for correct assembly and alignment of components.
2. Check that all seals, gaskets, and other parts are properly seated to ensure that the machine operates safely and effectively.
3. Ensure that all parts are securely fastened to prevent malfunctions or leaks during operation.
4. Reattach any electrical, air, or gas connections that were disconnected during the cleaning process, ensuring that all connections are secure and functioning correctly.

5.4. Post-Cleaning Inspection and Testing

1. Once the machine is reassembled, conduct a thorough visual inspection to ensure that it is clean and free of any foreign objects or cleaning residues.
2. Check that all components are properly aligned, and verify that the machine is reassembled correctly to avoid operational issues.
3. Run the machine through a short cycle to verify its functionality and ensure that no issues arise during operation.
4. Perform a product quality check after the test cycle to ensure that the cleaning process has not affected the machine’s ability to fill correctly.
5. Document the inspection results in the Post-Cleaning Inspection Log (Annexure-1) and confirm that all tasks were completed satisfactorily.

5.5. Safety and Environmental Considerations

1. Ensure that all cleaning and maintenance activities are performed in accordance with safety regulations, including proper handling of cleaning agents, solvents, and waste disposal.
2. Wear appropriate PPE, including gloves, goggles, and aprons, during the cleaning process to prevent exposure to harmful chemicals or contaminants.
3. Dispose of cleaning waste, including used rags, solvents, and empty containers, according to company policies and environmental regulations.
4. Ensure that the cleaning agents used are non-toxic and environmentally safe for disposal.

5.6. Documentation and Record-Keeping

1. Document all cleaning activities in the Cleaning Log (Annexure-2), including the date, operator name, cleaning agents used, machine parts cleaned, and any observations made during the cleaning process.
2. Ensure that the Cleaning Log is completed thoroughly and accurately for each cleaning session.
3. Maintain cleaning records in accordance with the company’s document retention policy, ensuring they are available for internal audits and regulatory inspections.
4. Review cleaning records periodically to ensure compliance with cleaning procedures and identify any trends 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	Filling Chamber	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 procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures