Aerosol: SOP for Line Clearance Between Manufacturing Stages – V 2.0
SOP for Line Clearance Between Manufacturing Stages
| Department |
Aerosol |
| SOP No. |
SOP/Aerosol/037/2025 |
| Supersedes |
SOP/Aerosol/037/2022 |
| 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 performing line clearance between manufacturing stages of aerosol products. The objective of this SOP is to ensure that all equipment, tools, and materials are properly cleared of any leftover product, contaminants, or debris before transitioning to the next stage of production. This procedure ensures that cross-contamination is prevented and that the product quality and safety standards are maintained across all stages of manufacturing.
2. Scope
This SOP applies to all aerosol manufacturing lines at [Company Name]. It covers the line clearance procedure between key manufacturing stages, including formulation, filling, packaging, and other critical stages. This SOP does not cover routine cleaning, which is addressed in separate cleaning procedures.
3. Responsibilities
- Production Team: Responsible for carrying out the line clearance procedure between manufacturing stages, ensuring all equipment and work areas are cleared of product residues and contaminants.
- Quality Control (QC) Team: Responsible for verifying that line clearance has been properly performed and that no product residues are present before the line is approved for the next stage of production.
- Maintenance Team: Responsible for assisting in the clearing and maintenance of equipment as required, ensuring that equipment is properly cleaned and prepared for the next manufacturing phase.
- Health and Safety Officer: Ensures that safety protocols are followed during the line clearance process, particularly when handling hazardous materials or waste.
4. Accountability
The Manufacturing Manager is accountable for ensuring that this SOP is followed and that line clearance is effectively carried out. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.
5. Procedure
5.1. Preparation for Line Clearance
- Before performing line clearance, ensure that the manufacturing area is free from any hazards. All personnel should wear the required personal protective equipment (PPE), including gloves, safety goggles, and lab coats.
- Review the production batch records to verify that the previous manufacturing stage has been completed, and the product has been successfully processed.
- Ensure that all equipment, utensils, and tools used in the previous stage are identified and ready for cleaning or storage.
- Prepare a checklist for line clearance, which includes all areas and equipment that need to be cleared, cleaned, and inspected (Annexure-1).
5.2. Equipment and Work Area Clearance
- Remove any remaining raw materials, components, or finished products from the manufacturing line and equipment.
- Clean all equipment and tools thoroughly according to the cleaning procedures, ensuring that no residues remain from the previous batch.
- Inspect all equipment, including mixing vessels, filling machines, valves, and conveyors, to ensure that they are completely free from any product residues or contaminants.
- Ensure that all waste materials, including empty containers, product residues, and packaging materials, are properly disposed of in designated waste bins according to company guidelines.
- Once the equipment is cleared and cleaned, label it to indicate that the line is ready for the next phase of production. The label should include the date and time of clearance and the operator’s name (Annexure-2).
5.3. Area Clearance
- Clear the production area of any extraneous materials such as leftover packaging, spilled products, or waste.
- Inspect the area for cleanliness and ensure that there is no cross-contamination risk. Wipe down all surfaces and equipment as necessary to remove any residual product.
- Ensure that all product storage areas are emptied of materials related to the previous batch and that they are properly cleaned and sanitized if required.
- Ensure that any labels, batch tags, or other identifiers from the previous stage are removed from the work area and properly disposed of or archived as necessary.
5.4. Verification of Line Clearance
- Once the line clearance process is completed, the Quality Control team should verify that all areas have been cleared properly.
- Conduct a final visual inspection of all equipment, tools, and work areas to ensure that no residues or contaminants are present.
- Use the Line Clearance Verification Checklist (Annexure-3) to confirm that all required steps have been completed. The checklist should be signed off by both the Production Team and QC Team.
- If any discrepancies or issues are found during the inspection, the line clearance process should be repeated for the affected areas until the clearance is verified as satisfactory.
5.5. Documentation and Record-Keeping
- Document the line clearance process in the Line Clearance Log (Annexure-4), including the date and time, the batch number, the operator’s name, and any discrepancies found during the clearance process.
- Ensure that the Line Clearance Verification Checklist (Annexure-3) is completed and signed by the appropriate personnel, including both the Production and QC teams.
- Store all records according to the company’s document retention policy and ensure that they are available for future audits or inspections.
6. Abbreviations
- GMP: Good Manufacturing Practice
- QC: Quality Control
- PPE: Personal Protective Equipment
- SOP: Standard Operating Procedure
7. Documents
- Line Clearance Checklist (Annexure-1)
- Line Clearance Label (Annexure-2)
- Line Clearance Verification Checklist (Annexure-3)
- Line Clearance Log (Annexure-4)
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
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Prepared By |
Checked By |
Approved By |
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11. Annexures
Annexure-1: Line Clearance Checklist
| Area/Equipment |
Action Taken |
Operator Name |
Date & Time |
| Filling Machine |
Cleaned and cleared of residues |
Rajesh Patel |
06/02/2025 |
Annexure-2: Line Clearance Label
| Batch Number |
Date & Time of Clearance |
Operator Name |
Verified By |
| 12345 |
06/02/2025 |
Rajesh Patel |
Quality Control |
Annexure-3: Line Clearance Verification Checklist
| Area/Equipment |
Verification Completed |
Remarks |
Verified By |
| Filling Machine |
Yes |
No residues found |
Rajesh Patel |
Annexure-4: Line Clearance Log
| Batch No. |
Operator Name |
Clearance Date |
Discrepancies Found |
Corrective Action Taken |
| 12345 |
Rajesh Patel |
06/02/2025 |
No |
None |
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 procedure |
To comply with updated GMP regulations |
Anjali Sharma |
Page 1 |
[Ref Point] |
Updated procedures |