SOP for Cleaning Propellant Filling Lines

Department	Aerosol
SOP No.	SOP/Aerosol/056/2025
Supersedes	SOP/Aerosol/056/2022
Page No.	Page 1 of Y
Issue Date	06/02/2025
Effective Date	16/02/2025
Review Date	06/02/2028

1. Purpose

This Standard Operating Procedure (SOP) outlines the process for cleaning propellant filling lines in aerosol manufacturing. The purpose of this SOP is to ensure the effective removal of product residues, propellant remnants, and contaminants from the filling lines after each production run. Proper cleaning of the propellant filling lines is essential to prevent cross-contamination between product batches and ensure compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to the cleaning of all propellant filling lines used in aerosol manufacturing at [Company Name]. It covers the steps for cleaning propellant lines between production runs, especially when changing between different formulations or when different propellants are used. This SOP does not cover cleaning procedures for other equipment, such as filling machines or crimping machines, which are covered under separate SOPs.

3. Responsibilities

• Production Team: Responsible for cleaning the propellant filling lines after each production run and ensuring all procedures are followed to meet cleanliness standards.
• Maintenance Team: Responsible for assisting in the cleaning process, particularly when disassembling and reassembling parts of the filling lines. They also ensure that cleaning tools and equipment are in proper working condition.
• Quality Control (QC) Team: Responsible for verifying that cleaning processes meet the required standards and that there are no residues left in the lines that could affect product quality.
• Health and Safety Officer: Ensures that cleaning procedures are carried out in compliance with health and safety regulations, particularly with regards to handling cleaning agents and any propellant gases.

4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed, and that the propellant filling lines are properly cleaned. 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 propellant filling lines are turned off and that all power and compressed air connections are safely disconnected.
2. Ensure that the lines are depressurized and that any remaining propellant has been safely purged from the system.
3. Gather the required cleaning materials, including:
   • Cleaning agents approved for use in propellant systems
   • Water or solvent for rinsing
   • Cleaning tools, including brushes, cloths, and sponges
   • Air blowers or compressed air for drying
   • PPE, such as gloves, goggles, and aprons
4. Inspect all cleaning tools and equipment to ensure they are clean and in good condition.
5. Verify that all cleaning agents used are compatible with propellant chemicals and are approved for use in manufacturing operations.

5.2. Cleaning Process

1. Begin by cleaning the external parts of the propellant filling lines, including pipes, connectors, and valves, using a damp cloth to remove any visible dust, dirt, or product residue.
2. For internal cleaning, flush the lines with an appropriate solvent or cleaning agent to remove product residues and any remaining propellant chemicals.
3. Use a brush to scrub any stubborn residues from internal surfaces, paying special attention to areas where propellant or product might have accumulated.
4. After the initial cleaning, rinse the lines thoroughly with clean water or another appropriate solvent to remove any remaining cleaning agents and residues.
5. For sensitive components, such as valves or pressure regulators, clean these using non-abrasive methods to avoid damage.
6. Once the lines have been rinsed, dry them thoroughly using compressed air or clean, lint-free cloths to ensure that no moisture remains inside the system.

5.3. Reassembly and Inspection

1. Once all parts have been cleaned and dried, carefully reassemble the propellant filling lines, ensuring that all components are correctly aligned and securely attached.
2. Inspect the lines for any signs of wear or damage during the cleaning process, particularly seals, gaskets, and valves. Replace any worn or damaged parts as necessary.
3. Conduct a visual inspection to ensure that all cleaning agents have been removed from the system and that the lines are clean and dry.
4. Run the lines through a short cycle with water or a test solution to check for leaks or operational issues before starting production. Ensure that all connections are secure and that there is no risk of contamination.

5.4. Post-Cleaning Testing

1. After the cleaning and reassembly, perform a test to ensure that the propellant lines are free of any cleaning agents or contaminants. This can include:
   • Sampling rinse water or testing for residue on internal surfaces of the lines
   • Conducting a pressure test to ensure that the lines are functioning correctly without leaks
2. Ensure that the results of the post-cleaning tests meet the established acceptance criteria. If the test results fail to meet the criteria, repeat the cleaning process until the required standards are achieved.
3. Document the results of the testing, including any corrective actions taken, in the Cleaning Validation Log (Annexure-1).

5.5. Safety and Environmental Considerations

1. Ensure that all cleaning activities are performed following safety guidelines and proper handling procedures for cleaning agents and propellants.
2. Ensure that all personnel involved in the cleaning process are wearing the appropriate PPE, including gloves, goggles, and protective aprons.
3. Dispose of any waste materials, including used cleaning agents and solvents, in compliance with environmental regulations and company policies.
4. Ensure that the cleaning process does not cause any environmental contamination, especially regarding the release of cleaning agents or solvents into the waste system or environment.

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 issues encountered during the cleaning process.
2. Ensure that all testing results, including sampling and pressure tests, are documented in the Cleaning Validation Log (Annexure-1) and are reviewed by the QC team.
3. Maintain cleaning and testing records according to the company’s document retention policy, ensuring that they are accessible for audits and inspections.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• PPE: Personal Protective Equipment
• SOP: Standard Operating Procedure
• HPLC: High-Performance Liquid Chromatography

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
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 propellant filling lines	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures