and ensuring the proper alignment of the can’s valve and lid.

Health and Safety Officer: Ensures that safety protocols are followed during the operation and maintenance of the crimping machine, particularly in relation to the pressurized nature of aerosol cans.

4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed, and that the crimping machine operates effectively and efficiently. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Pre-Operation Checks

1. Before operating the crimping machine, verify that all components are clean and free from any debris, product residues, or foreign material.
2. Ensure that the machine is properly calibrated and set to the correct specifications for the aerosol can being processed (e.g., crimping pressure, speed, and positioning).
3. Check the pressure settings on the crimping machine and ensure that the machine is receiving the proper air supply to function effectively.
4. Inspect the crimping die for signs of wear or damage and ensure it is clean and aligned correctly. Verify that the sealing ring is in place and functioning properly.
5. Ensure that all safety guards and covers are in place, and that the emergency stop button is functional.
6. Check that the can alignment system is properly adjusted to ensure that cans are positioned correctly during crimping.
7. Record the results of the pre-operation check in the Crimping Machine Pre-Operation Log (Annexure-1).

5.2. Operating the Crimping Machine

1. Start the machine by activating the power supply and pressing the “Start” button. The machine should enter the “Standby” mode first, and then automatically move into the “Active” mode when production begins.
2. Place the filled aerosol cans into the crimping machine’s loading system, ensuring that the cans are correctly positioned under the crimping head.
3. As the machine operates, the crimping head should press the valve onto the can and create a secure seal. Observe the machine’s operation to ensure that the sealing is consistent and that no cans are misaligned or improperly crimped.
4. Monitor the machine’s cycle time and ensure that it remains consistent with the desired production speed. Any irregularities should be documented and investigated.
5. If a malfunction occurs during operation, immediately stop the machine using the emergency stop button and troubleshoot the issue according to the manufacturer’s instructions.
6. Record the production data (batch number, start time, operator name, and number of cans processed) in the Batch Production Log (Annexure-2).

5.3. Post-Operation Checks

1. Once the production run is complete, turn off the machine’s power supply and ensure that all components are in the “Safe” position.
2. Inspect the finished cans for proper sealing. Check for any signs of leakage, improper crimping, or damaged valves. Reject any cans that do not meet quality standards.
3. Remove any unused materials, such as crimping rings or labels, and clean the machine to remove any product residue or debris from the crimping process.
4. Record the number of acceptable and rejected cans in the Post-Operation Report (Annexure-3), along with any corrective actions taken during the operation.

5.4. Routine Maintenance

1. Perform daily maintenance tasks as per the machine’s maintenance schedule, which may include lubricating moving parts, cleaning crimping dies, and inspecting the air pressure system.
2. Check the alignment and calibration of the crimping machine regularly to ensure consistent and accurate crimping. Recalibrate if necessary.
3. Inspect the crimping machine for any signs of wear or damage, particularly the crimping die, and replace any worn parts before the machine is used for production.
4. Log all maintenance activities, including repairs, parts replacement, and inspections, in the Crimping Machine Maintenance Log (Annexure-4).

5.5. Troubleshooting

1. If the crimping machine produces defective seals, check the following:
   • Ensure that the crimping die is properly aligned and free from debris.
   • Verify that the sealing pressure and speed are within the correct parameters.
   • Check the machine for signs of wear on the crimping components.
   • Inspect the aerosol cans for deformities or misalignments.
2. If the machine stops unexpectedly, check the power supply, air pressure, and machine settings. Investigate any error codes displayed on the control panel and refer to the troubleshooting guide in the machine manual.
3. Document any issues and corrective actions taken in the Troubleshooting Log (Annexure-5).

5.6. Documentation and Record-Keeping

1. Ensure that all logs related to machine operation, maintenance, and troubleshooting are accurately completed and stored according to the company’s document retention policy.
2. These records should be available for internal and external audits, as well as for regulatory inspections.

6. Abbreviations

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

7. Documents

1. Crimping Machine Pre-Operation Log (Annexure-1)
2. Batch Production Log (Annexure-2)
3. Post-Operation Report (Annexure-3)
4. Crimping Machine Maintenance Log (Annexure-4)
5. Troubleshooting 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: Crimping Machine Pre-Operation Log

Machine ID	Check Description	Operator Name	Date & Time	Remarks
CM-001	Checked crimping die alignment	Rajesh Patel	06/02/2025	No issues

Annexure-2: Batch Production Log

Batch No.	Start Time	Operator Name	Seals Produced	Test Results
12345	06/02/2025	Rajesh Patel	5000	Pass

Annexure-3: Post-Operation Report

Batch No.	Stop Time	Operator Name	Issues Encountered	Corrective Actions
12345	06/02/2025	Rajesh Patel	None	None

Annexure-4: Crimping Machine Maintenance Log

Maintenance Type	Details	Performed By	Date
Lubrication	Lubricated crimping die	Rajesh Patel	06/02/2025

Annexure-5: Troubleshooting Log

Batch No.	Issue	Action Taken	Operator Name
12345	Crimping misalignment	Adjusted die alignment	Rajesh Patel

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 operation and maintenance procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures