can is properly sealed.

Maintenance Team: Responsible for maintaining and calibrating the crimping equipment to ensure optimal performance and prevent malfunctions during the process.

Health and Safety Officer: Ensures that all safety protocols are followed during the crimping process, including the use of personal protective equipment (PPE) and proper handling of aerosol cans.

4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed during the valve crimping process. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparation for the Crimping Process

1. Ensure that the following items are available and ready for the crimping process:
   • Aerosol cans filled with the formulation and propellant
   • Valves and actuators
   • Crimping equipment (manual or automated machines)
   • Personal protective equipment (PPE) for operators
2. Inspect all aerosol cans to ensure that they are free from defects such as dents, cracks, or any other form of damage that could affect the crimping process or lead to leakage.
3. Verify that the valves are properly aligned with the aerosol cans and that there is no contamination in the valve area.

5.2. Crimping Process

1. Load the aerosol cans into the crimping machine, ensuring that they are positioned correctly and securely held in place. The cans should be oriented in such a way that the valve is facing the crimping head.
2. Activate the crimping machine to begin the crimping process. The machine should securely attach the valve to the aerosol can by applying sufficient pressure to the crimping surface, forming a tight seal.
3. Monitor the crimping process to ensure that the valve is securely crimped to the can. The crimp should be uniform and free from any defects, such as crooked or incomplete crimps, which could lead to leakage.
4. If the crimping machine is automated, verify that the machine settings (pressure, speed, etc.) are correctly adjusted according to the specifications for the aerosol product.

5.3. In-Process Inspection and Testing

1. Perform regular in-process inspections to ensure that the crimping process is carried out correctly. The inspection should include:
   • Visual inspection of the crimped valve to ensure that it is evenly and securely attached to the can
   • Checking the can for any signs of leakage around the valve area
   • Ensuring that the valve is properly seated and not misaligned
2. Conduct functional testing on a sample of filled cans to verify that the valve is operating as intended. This may include actuating the valve to ensure that it dispenses the product correctly and that there are no issues with the spray pattern.
3. Record the results of in-process checks in the Crimping Inspection Log (Annexure-1). If any defects are found (e.g., misaligned valves or incomplete crimps), stop the process and take corrective actions.

5.4. Post-Crimping Procedure

1. After the valve is crimped, inspect the aerosol cans for any visible defects, such as improper sealing, damage to the can, or valve misalignment. Reject any defective cans for reprocessing.
2. Transfer the crimped cans to the next stage of the manufacturing process, which may include labeling, packaging, or further testing.
3. If the cans pass inspection, record the batch number, production date, and other relevant details in the Batch Record and the Crimping Log (Annexure-2).

5.5. Safety and Environmental Considerations

1. Ensure that the crimping area is well-ventilated to avoid the accumulation of flammable vapors from propellants or solvents.
2. Operators must wear the appropriate PPE, including gloves, safety goggles, and lab coats, to prevent exposure to propellants and other hazardous materials.
3. Ensure that the crimping equipment is regularly maintained and calibrated to avoid equipment malfunction or failure during the crimping process.
4. Ensure that the work area is kept clean and free from any potential hazards, such as spilled propellants or aerosols.

5.6. Documentation and Record-Keeping

1. Document all crimping activities in the Crimping Log (Annexure-1), including the batch number, operator name, machine settings, and any deviations from the standard procedure.
2. Ensure that any defects found during the inspection process are recorded in the Defective Product Log (Annexure-2) and that corrective actions are taken.
3. Store all batch records, inspection logs, and related documentation according to the company’s document retention policy and ensure they are available for review during audits or inspections.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• CAPA: Corrective and Preventive Actions
• PPE: Personal Protective Equipment
• R&D: Research and Development

7. Documents

1. Crimping Inspection Log (Annexure-1)
2. Crimping Log (Annexure-2)
3. Defective Product Log (Annexure-3)

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
• International Pharmacopoeia (Ph. Int.) – Aerosol Delivery

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 Inspection Log

Batch No.	Crimping Machine	Operator Name	Crimping Result	Comments
12345	Machine 1	Rajesh Patel	Pass	No issues

Annexure-2: Crimping Log

Batch No.	Machine Settings	Operator Name	Date	Comments
12345	Pressure: 10 psi	Rajesh Patel	06/02/2025	Normal operation

Annexure-3: Defective Product Log

Batch No.	Defect Description	Action Taken	Operator Name
12345	Misaligned valve	Rejected and reprocessed	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 crimping process	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures