used in production.

Health and Safety Officer: Ensures that all safety protocols for handling cleaning agents and sanitizers are followed, and that personal protective equipment (PPE) is used during cleaning and sanitization.

Maintenance Team: Inspects and repairs small tools if necessary and assists in ensuring that tools are in proper working condition after cleaning.

4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed and that all small tools are cleaned and sanitized according to the prescribed procedure. 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 cleaning, remove any product residues from the small tools by gently scraping or wiping the tools to prevent contamination of the cleaning solution.
2. Ensure that all small tools are properly disassembled, if applicable, to ensure thorough cleaning (e.g., removing detachable parts from dispensers or mixing devices).
3. Gather the required cleaning materials, including:
   • Approved cleaning agents (non-toxic and compatible with aerosol formulations)
   • Sanitizers suitable for food-grade or pharmaceutical manufacturing
   • Water or appropriate rinsing solvent
   • Cleaning brushes, sponges, cloths, and disposable wipes
   • Personal Protective Equipment (PPE), including gloves, goggles, and aprons
4. Inspect all cleaning tools to ensure they are clean and in good working condition.
5. Ensure that the cleaning agents used are compatible with the tools and will not damage the surfaces of the tools.

5.2. Cleaning the Tools

1. Clean each small tool by scrubbing with an appropriate cleaning agent and brush to remove any product residues. Ensure all surfaces, including hard-to-reach areas, are thoroughly cleaned.
2. If necessary, soak the tools in an appropriate cleaning solution for a set period to loosen stubborn residues before scrubbing.
3. Rinse the cleaned tools thoroughly with clean water or another approved solvent to remove any cleaning agent residues.
4. For tools that come into contact with propellants or other hazardous chemicals, ensure that the cleaning process removes all traces of these materials before sanitization.

5.3. Sanitizing the Tools

1. After cleaning, sanitize the tools using an approved sanitizer that is suitable for use in aerosol manufacturing. Ensure that the sanitizer is applied to all surfaces of the tools, paying particular attention to any areas where contamination could remain.
2. If necessary, use a soaking method to ensure thorough sanitization, following the manufacturer’s instructions for the sanitizer’s concentration and contact time.
3. After sanitizing, rinse the tools with clean water or a suitable rinsing solution to remove any excess sanitizer. Ensure that no sanitizer residues remain on the tools.
4. Allow the tools to air dry or dry them using compressed air or clean, lint-free cloths to ensure no moisture remains.

5.4. Post-Cleaning Inspection

1. Once the tools are cleaned and sanitized, perform a visual inspection to ensure that there are no visible residues, dirt, or contaminants remaining on the tools.
2. Check for any signs of damage or wear during cleaning and sanitization. Report any issues to the Maintenance Team for repair or replacement.
3. Ensure that all tools are completely dry before being stored or used again in production, as moisture could lead to microbial growth or rust.
4. Document the inspection results in the Tool Inspection Log (Annexure-1), noting the condition of the tools, any problems found, and corrective actions taken.

5.5. Documentation and Record-Keeping

1. Document all cleaning and sanitization activities in the Cleaning and Sanitization Log (Annexure-2), including the date, operator name, cleaning agents used, sanitizers used, and any deviations or issues encountered.
2. Ensure that the Tool Inspection Log (Annexure-1) is completed after each cleaning cycle to record the condition of the tools and any repairs or replacements made.
3. Ensure that all records are reviewed by the QC team and signed off by the relevant personnel to ensure compliance with this SOP.
4. Store all cleaning and inspection records in accordance with the company’s document retention policy to ensure that they are available for audits and regulatory inspections.

5.6. Safety and Environmental Considerations

1. Ensure that all cleaning and sanitization activities are conducted in accordance with safety guidelines, particularly with regard to handling cleaning agents, sanitizers, and any waste materials.
2. Ensure that all personnel handling cleaning agents and sanitizers wear appropriate PPE to prevent exposure to hazardous chemicals.
3. Dispose of used cleaning materials, such as cleaning agents and contaminated wipes, according to the company’s waste disposal policies and environmental regulations.
4. Ensure that the cleaning and sanitization process does not create any safety or environmental risks, and take appropriate measures to mitigate any hazards identified during the process.

6. Abbreviations

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

7. Documents

1. Cleaning and Sanitization Log (Annexure-2)
2. Tool 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: Tool Inspection Log

Tool ID	Inspection Date	Condition	Operator Name	Remarks
T-12345	06/02/2025	Good	Rajesh Patel	No issues found

Annexure-2: Cleaning and Sanitization Log

Tool ID	Cleaning Agent Used	Sanitizer Used	Operator Name	Date
T-12345	Solvent A	Sanitizer B	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 and sanitization process	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures