after cleaning, particularly for mechanical cleaning systems.

Quality Control (QC) Team: Ensures that cleaning procedures are properly implemented, verifies the cleanliness of the tanks, and ensures that cleaning records are accurately maintained.

Health and Safety Officer: Ensures that safety protocols for handling cleaning agents, solvents, and other materials are followed to prevent accidents or exposure to hazardous substances.

4. Accountability

The Manufacturing Manager is accountable for ensuring that the storage tanks are cleaned as per this SOP. Compliance with this SOP is overseen by the Quality Assurance (QA) Manager, who is responsible for ensuring that cleaning and documentation practices meet GMP and regulatory standards.

5. Procedure

5.1. Pre-Cleaning Preparation

1. Before starting the cleaning process, ensure that the storage tank is isolated from the rest of the production system and disconnected from any product transfer lines, pumps, and other connected equipment.
2. Ensure that the tank is empty and all formulation material has been removed from the tank.
3. Ensure that all safety measures are in place, such as proper lockout/tagout procedures to prevent accidental activation of the system during cleaning.
4. Gather the required cleaning materials, including:
   • Approved cleaning agents
   • Water or other suitable solvents for rinsing
   • Cleaning brushes, sponges, and other tools for scrubbing
   • Compressed air or blowers for drying
   • PPE, including gloves, goggles, and aprons
5. Verify that all cleaning equipment and tools are clean and in good condition before use.
6. Inspect the tank for any visible signs of damage or contamination that may require repairs before proceeding with cleaning.

5.2. Cleaning Process

1. Start by manually removing any visible product residues from the internal surfaces of the tank using a dry cloth or brush.
2. For the main cleaning process, apply an appropriate cleaning agent to the tank surfaces. Use cleaning agents that are approved for use with aerosol formulation ingredients and that will not leave harmful residues.
3. Scrub the internal surfaces of the tank with a brush to remove any residues that may have adhered to the surfaces during formulation storage.
4. Rinse the tank thoroughly with clean water or an appropriate solvent to remove any cleaning agent residues and contaminants. Ensure that all areas of the tank, including difficult-to-reach surfaces, are properly rinsed.
5. For tanks with heavy residues or that have been in service for extended periods, consider using a soak cleaning method, where the cleaning solution is allowed to sit in the tank for a specified time before being scrubbed and rinsed.
6. After rinsing, ensure that the tank is completely dried using compressed air or clean, lint-free cloths. This is especially important for preventing microbial growth or mold due to trapped moisture.

5.3. Post-Cleaning Inspection

1. Once the tank is cleaned and dried, conduct a thorough visual inspection to ensure that all product residues, cleaning agents, and solvents have been completely removed.
2. Inspect the tank for signs of damage, wear, or leaks. Report any issues to the Maintenance Team for repairs before using the tank again.
3. Conduct a sample test, such as a swab or rinse water test, to verify that no residual product or cleaning agents remain in the tank. Test results must meet established acceptance criteria before the tank can be used again.
4. Document the inspection results in the Cleaning Validation Log (Annexure-1), including the operator name, inspection date, and any findings during the inspection process.

5.4. Documentation and Record-Keeping

1. Document all cleaning activities in the Cleaning Log (Annexure-2), including the date, operator name, cleaning agents used, and any problems encountered during the cleaning process.
2. Document all test results, including rinse water or swab tests, and ensure that the test results meet the acceptable limits for cleaning verification.
3. Ensure that all documentation is signed and approved by the relevant personnel (Production, QC, QA) to ensure compliance with internal and regulatory standards.
4. Maintain cleaning and inspection records according to the company’s document retention policy to ensure that they are available for audits and inspections.

5.5. Environmental and Safety Considerations

1. Ensure that all cleaning agents used in the process are disposed of according to the company’s waste management procedures and environmental regulations.
2. Ensure that all personnel involved in the cleaning process wear the appropriate PPE to protect against exposure to cleaning agents or propellants.
3. Follow all relevant safety procedures when handling cleaning agents and solvents, ensuring that they are used in well-ventilated areas and stored according to safety data sheets (SDS).
4. Dispose of waste cleaning materials, such as used rags, solvents, or cleaning solutions, in accordance with company policies and environmental regulations.

6. Abbreviations

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

7. Documents

1. Cleaning Validation Log (Annexure-1)
2. Cleaning Log (Annexure-2)

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: Cleaning Validation Log

Sample ID	Test Method	Test Results	Acceptance Criteria	Remarks
SV-001	HPLC	Pass	< 5 ppm	No deviation

Annexure-2: Cleaning Log

Machine ID	Cleaning Agent Used	Operator Name	Date
T-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 process for storage tanks	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures