properly maintained, and that all equipment settings are correct before production begins.

Health and Safety Officer: Ensures that safety protocols are followed during line clearance, particularly when handling chemicals or hazardous materials during cleaning procedures.

4. Accountability

The Manufacturing Manager is accountable for ensuring that line clearance is conducted according to this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Pre-Line Clearance Preparation

1. Verify that the production line is idle and no products are in the process of being produced.
2. Ensure that the production team is aware of the line clearance procedure and that they are equipped with the necessary tools and cleaning materials for the process.
3. Prepare the cleaning tools and materials, including cleaning agents, brushes, and disposable wipes. Ensure that the materials are approved for use in aerosol manufacturing.
4. Confirm that all necessary equipment for the new batch is ready for installation (e.g., new raw materials, aerosol cans, propellants, etc.).

5.2. Line Clearance Process

1. Remove all products, materials, and packaging from the production line that were used in the previous batch. Ensure that all items are properly disposed of according to safety and environmental guidelines.
2. Inspect the line for any residual product, materials, or foreign objects. This includes checking the conveyor belts, filling machines, crimping machines, and other equipment.
3. Clean the entire production line, including all equipment and work surfaces, using approved cleaning agents. This should include:
   • Cleaning conveyors, filling machines, valves, and actuators.
   • Wiping down all surfaces that came into contact with the previous product or materials.
   • Ensuring that cleaning agents are thoroughly removed to avoid contamination of the new batch.
4. Check and clean any raw material storage areas or stations where materials may have been stored or handled during the previous batch. Ensure that no material residue remains from the previous batch.
5. Inspect all equipment for wear and tear, and ensure that all components are in good working condition before starting the new batch. If any equipment requires maintenance, it should be addressed by the maintenance team.

5.3. Documentation of Line Clearance

1. Document all steps taken during the line clearance process in the Line Clearance Log (Annexure-1). Include details such as:
   • Time and date of line clearance
   • Names of personnel involved in the process
   • Inspection of equipment and areas
   • Cleaning methods and agents used
2. Ensure that the log is reviewed and signed off by the QC team to confirm that line clearance has been completed successfully and that the line is ready for production.
3. If any issues or deviations are identified during the line clearance process:
   • Document the issue in the Deviation Log (Annexure-2).
   • Take corrective actions, such as additional cleaning or equipment maintenance, and document them in the Corrective Action Log (Annexure-3).

5.4. Final Verification and Approval

1. After cleaning and inspection, the production line must be inspected and approved by the QC team before the start of production. The QC team should verify:
   • That all equipment has been properly cleaned and inspected.
   • That all materials have been removed from the line, and the line is free from contamination.
   • That no previous product residues remain on the line.
2. Once approved by QC, the production line is cleared for the next batch, and the manufacturing process can begin.

5.5. Calibration and Maintenance of Equipment

1. Ensure that all equipment used for aerosol manufacturing, including filling machines, crimping machines, and other critical equipment, is calibrated and properly maintained before production starts.
2. Document all calibration and maintenance activities in the Equipment Calibration Log (Annexure-4) and the Equipment Maintenance Log (Annexure-5).

5.6. Documentation and Record-Keeping

1. Ensure that all records related to line clearance, including the Line Clearance Log (Annexure-1), Deviation Log (Annexure-2), and Corrective Action Log (Annexure-3), are completed and stored in the document management system.
2. All records should be available for future reference, including audits and inspections by regulatory authorities.

5.7. Safety and Environmental Considerations

1. Ensure that all personnel involved in line clearance follow safety protocols, including wearing appropriate PPE (e.g., gloves, goggles, lab coats).
2. Follow environmental guidelines for the disposal of cleaning agents and any waste generated during the line clearance process.
3. Ensure that all cleaning agents used are approved for use in the aerosol manufacturing process and are effective at removing residues without leaving harmful traces.

6. Abbreviations

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

7. Documents

1. Line Clearance Log (Annexure-1)
2. Deviation Log (Annexure-2)
3. Corrective Action Log (Annexure-3)
4. Equipment Calibration Log (Annexure-4)
5. Equipment Maintenance Log (Annexure-5)

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: Line Clearance Log

Batch Number	Line Clearance Date	Operator Name	Inspection Details	Remarks
Batch-001	06/02/2025	Rajesh Patel	Line cleared, cleaned, and inspected	No issues found

Annexure-2: Deviation Log

Deviation Description	Corrective Action	Operator Name	Remarks
Residue found on filling machine	Cleaned machine again	Rajesh Patel	Machine cleared

Annexure-3: Corrective Action Log

Batch Number	Issue Date	Issue Description	Corrective Action	Operator Name
Batch-001	06/02/2025	Residue detected on line	Re-cleaned line, adjusted machine settings	Rajesh Patel

Annexure-4: Equipment Calibration Log

Equipment ID	Calibration Date	Calibration Results	Operator Name	Remarks
FILL-001	06/02/2025	Pass	Rajesh Patel	No adjustments required

Annexure-5: Equipment Maintenance Log

Equipment ID	Maintenance Date	Tasks Performed	Operator Name	Remarks
FILL-001	06/02/2025	Cleaned and calibrated	Rajesh Patel	No issues found

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 line clearance process	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures