process, particularly when handling pressurized containers and crimping equipment.

Maintenance Team: Responsible for ensuring that crimping equipment is calibrated and properly maintained to perform the crimping process consistently and accurately.

4. Accountability

The Manufacturing Manager is accountable for ensuring that crimp diameter checks are performed on all aerosol cans in compliance with this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Pre-Test Preparation

1. Ensure that aerosol cans are filled, crimped, and ready for inspection after the filling process is complete.
2. Prepare the necessary equipment, including:
   • Crimp diameter measuring tools (e.g., calipers, micrometers)
   • Calibration standards to verify measurement accuracy
   • PPE, including gloves, goggles, and lab coats
3. Ensure that the crimping machine is properly calibrated and operating correctly according to the product specifications for crimp diameter.
4. Ensure that the production line is free from obstructions and that all necessary safety measures are in place for handling aerosol cans.

5.2. Measuring the Crimp Diameter

1. Measure the crimp diameter of the aerosol cans using calibrated measuring tools (e.g., calipers or micrometers) at specified intervals during the production process (e.g., every 10th can or every 30 minutes).
2. For each measurement, record the crimp diameter and compare it against the specified target value for the crimp diameter.
3. Check the crimping area for uniformity, ensuring that the crimp is evenly applied around the perimeter of the valve.
4. Ensure that the crimp diameter is within the acceptable tolerance range specified for the product.
5. For automated systems:
   • Monitor the automated system’s output to ensure that it is accurately measuring and recording the crimp diameter.
   • Review the system’s data for consistency and compliance with the crimping specifications.

5.3. Post-Test Actions

1. If the crimp diameter is within the acceptable tolerance range:
   • Continue the crimping process and document the results in the Crimp Diameter Monitoring Log (Annexure-1).
   • Ensure that all recorded data is reviewed by the QC team to verify that the measurements are accurate and in compliance.
2. If the crimp diameter is outside the acceptable tolerance limits:
   • Remove the affected cans from the production line and label them as “non-conforming.”
   • Investigate the cause of the deviation (e.g., improper machine settings, defective valves, or irregular crimping force).
   • Take corrective actions as necessary, such as adjusting machine settings, recalibrating the crimping equipment, or replacing faulty components.
   • Document the corrective actions in the Corrective Action Log (Annexure-2).

5.4. Calibration and Maintenance of Equipment

1. Ensure that all measuring tools used for checking crimp diameter are calibrated regularly according to the manufacturer’s specifications and company procedures.
2. Perform routine maintenance on crimping equipment, ensuring that all components are clean, functional, and free from defects that could affect the crimping process.
3. Document all calibration and maintenance activities in the Equipment Calibration Log (Annexure-3) and the Equipment Maintenance Log (Annexure-4).

5.5. Documentation and Record-Keeping

1. Document all crimp diameter monitoring activities, including the can ID, test date, measurement results, operator name, and any corrective actions taken, in the Crimp Diameter Monitoring Log (Annexure-1).
2. Ensure that all records are reviewed by the QC team to confirm that the aerosol products meet the required crimp diameter specifications.
3. Store all records in the document management system, ensuring they are available for future reference and audits.

5.6. Safety and Environmental Considerations

1. Ensure that all personnel involved in the crimp diameter checking process wear the appropriate PPE, including gloves, goggles, and lab coats, to prevent exposure to aerosol products and equipment.
2. Follow safety guidelines for handling aerosol containers, including ensuring that pressurized cans are handled properly during inspection and measurement.
3. Ensure proper disposal of any non-conforming aerosol containers and other waste materials in accordance with environmental and safety regulations.

6. Abbreviations

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

7. Documents

1. Crimp Diameter Monitoring Log (Annexure-1)
2. Corrective Action Log (Annexure-2)
3. Equipment Calibration Log (Annexure-3)
4. Equipment Maintenance 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

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Crimp Diameter Monitoring Log

Can ID	Test Date	Crimp Diameter (mm)	Result	Operator Name	Remarks
C-12345	06/02/2025	4.8 mm	Pass	Rajesh Patel	No issues found

Annexure-2: Corrective Action Log

Can ID	Issue Date	Issue Description	Corrective Action	Operator Name
C-12346	06/02/2025	Improper crimp	Recalibrated crimping machine	Rajesh Patel

Annexure-3: Equipment Calibration Log

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

Annexure-4: Equipment Maintenance Log

Equipment ID	Maintenance Date	Tasks Performed	Operator Name	Remarks
CRIMP-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 crimp diameter procedure	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures