and associated equipment.

Maintenance Team: Responsible for ensuring that the equipment used for spray performance monitoring, such as spray testers and pressure gauges, is calibrated and maintained for accurate results.

4. Accountability

The Manufacturing Manager is accountable for ensuring that in-line spray performance monitoring is conducted during the aerosol manufacturing process. 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, sealed, and ready for spray performance monitoring.
2. Set up the spray performance monitoring system, including the following equipment:
   • Spray tester or spray pattern analyzer
   • Pressure gauge and flow measurement devices
   • PPE, including gloves, goggles, and lab coats
3. Verify that the spray performance monitoring system is calibrated according to the manufacturer’s specifications and company procedures.
4. Ensure that the production line is free from obstructions and that all necessary safety measures are in place for handling aerosol cans during testing.

5.2. Conducting In-Line Spray Performance Monitoring

1. Begin the in-line spray performance monitoring as soon as aerosol cans are filled and sealed. Use the spray tester to monitor key spray parameters, including:
   • Spray Pattern: Ensure that the spray pattern is consistent and meets the required specifications (e.g., conical, fan-shaped).
   • Flow Rate: Measure the flow rate of the aerosol, ensuring it is within the acceptable limits (e.g., in mL/sec).
   • Droplet Size Distribution: Monitor the droplet size of the aerosol to ensure it is within the specified range for effective delivery.
   • Spray Duration: Measure how long the aerosol dispenses during each spray event to ensure that the product delivers the correct amount per use.
2. For automated systems:
   • Ensure that the automated spray performance monitoring system is properly configured to detect deviations and alert operators in case of out-of-spec conditions.
   • Monitor the system’s output to verify that it is accurately recording the spray performance data.
3. For manual systems:
   • Perform visual and/or mechanical checks of the spray pattern and droplet size, using spray pattern analyzers or measuring devices, at specified intervals (e.g., every 10th can).
   • Record the results for each aerosol can and ensure that they fall within the predefined performance criteria.

5.3. Post-Test Actions

1. If the spray performance is within the required specifications:
   • Proceed with the next stage in the production process, ensuring that only conforming aerosol products are released for packaging and distribution.
   • Document the spray performance results in the Spray Performance Monitoring Log (Annexure-1), including the spray pattern, flow rate, droplet size, and any deviations from the target values.
2. If the spray performance is outside the acceptable limits (e.g., improper spray pattern, incorrect flow rate):
   • Remove the non-conforming aerosol cans from the production line and label them as “non-conforming.”
   • Investigate the cause of the deviation (e.g., incorrect formulation, machine malfunction, defective valve).
   • Take corrective actions as necessary, such as adjusting the filling machine settings, recalibrating the spray system, or replacing faulty valves.
   • Document the corrective actions taken and the test results in the Corrective Action Log (Annexure-2).

5.4. Calibration and Maintenance of Equipment

1. Ensure that all spray performance monitoring equipment, including spray testers, flow measurement devices, and pressure gauges, are calibrated at regular intervals according to the manufacturer’s specifications.
2. Perform routine maintenance on spray performance monitoring systems, ensuring that all components are clean, functional, and free from defects that could affect measurement accuracy.
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 spray performance monitoring activities, including the test date, can ID, spray pattern, flow rate, droplet size, operator name, and any corrective actions taken, in the Spray Performance Monitoring Log (Annexure-1).
2. Ensure that all records are reviewed by the QC team to confirm that the aerosol products meet the required spray performance 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 spray performance monitoring process wear appropriate PPE to prevent exposure to aerosols and other hazardous materials.
2. Conduct all monitoring activities in a safe environment, ensuring that safety guidelines are followed for handling pressurized cans and operating the monitoring equipment.
3. Ensure proper disposal of any waste generated during the monitoring process, including non-conforming cans and other materials, according to safety and environmental regulations.

6. Abbreviations

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

7. Documents

1. Spray Performance 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: Spray Performance Monitoring Log

Can ID	Test Date	Spray Pattern	Flow Rate (mL/sec)	Droplet Size	Result	Operator Name	Remarks
C-12345	06/02/2025	Fan-shaped	0.5 mL/sec	Medium	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	Inconsistent spray pattern	Recalibrated spray nozzle	Rajesh Patel

Annexure-3: Equipment Calibration Log

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

Annexure-4: Equipment Maintenance Log

Equipment ID	Maintenance Date	Tasks Performed	Operator Name	Remarks
SPRAY-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 spray performance monitoring procedure	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures