to confirm that aerosol products meet the required spray rate specifications.

Maintenance Team: Ensures that the equipment used for spray rate testing, such as the spray rate apparatus, is properly calibrated and maintained in working condition.

Health and Safety Officer: Ensures that all safety protocols are followed during the spray rate measurement process, particularly with respect to handling pressurized cans and ensuring the proper use of personal protective equipment (PPE).

4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed, and that aerosol spray rates are accurately measured as part of the quality control 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 the aerosol can to be tested is fully filled, sealed, and crimped, and that it is representative of the product batch being produced.
2. Gather the necessary equipment for spray rate measurement, including:
   • Spray rate apparatus (e.g., spray rate testing machine or collection tray)
   • Stopwatch or timer for measuring spray duration
   • Measuring container or balance to record the collected amount of product
   • PPE, including gloves and goggles, to ensure safety during testing
3. Inspect the spray rate apparatus to ensure it is clean, calibrated, and functioning correctly.

5.2. Conducting the Spray Rate Test

1. Position the aerosol can in the spray rate apparatus, ensuring that the can is held securely and that the nozzle is properly aligned for testing.
2. Activate the aerosol can for a set time (e.g., 10 seconds) while measuring the amount of product dispensed. The amount dispensed should be collected in a pre-weighed container or recorded directly by the apparatus.
3. Repeat the test three times to ensure consistency in spray rate measurements. The results should fall within the acceptable range specified for the product.
4. If using a collection tray, ensure that the tray is large enough to collect the entire spray without overflow and that it is placed on a surface that will not be affected by the aerosol spray (e.g., a non-absorbent, level surface).

5.3. Post-Test Actions

1. Record the results of each spray rate test, including the amount of product dispensed, the duration of the spray, and any deviations from the expected spray rate in the Spray Rate Test Log (Annexure-1).
2. Analyze the results to confirm that the measured spray rate falls within the product specification range. If the spray rate falls outside the acceptable limits, investigate the cause of the discrepancy and take corrective action.
3. If the spray rate is out of specification, notify the QC Team or Maintenance Team to address any issues with the valve, actuator, or can pressure, and retest after any corrective action is taken.

5.4. Calibration and Maintenance of Equipment

1. Regularly calibrate the spray rate apparatus according to the manufacturer’s guidelines or company procedures. Ensure that calibration is performed at specified intervals or after any major maintenance.
2. Inspect the spray rate testing equipment before each test to ensure that it is functioning properly. If any malfunction is observed, report it to the Maintenance Team for repair.
3. Document all calibration activities in the Calibration Log (Annexure-2) to ensure that the equipment is consistently providing accurate results.

5.5. Documentation and Record-Keeping

1. Document the results of all spray rate measurements, including the can ID, test date, operator name, and measured spray rate, in the Spray Rate Test Log (Annexure-1).
2. Ensure that all records are reviewed and approved by the QC team to confirm that the aerosol product meets the required spray rate specifications.
3. Store all spray rate test logs and calibration records in the document management system in accordance with the company’s document retention policy for future reference and audits.

5.6. Safety and Environmental Considerations

1. Ensure that all personnel conducting spray rate tests wear appropriate PPE, including gloves and goggles, to protect against exposure to propellants and product formulations.
2. Perform all testing in a well-ventilated area to prevent the buildup of propellant vapors or other potentially hazardous fumes.
3. Dispose of any waste materials generated during the testing process, such as used testing containers or waste aerosol, in accordance with the company’s waste disposal procedures and environmental regulations.

6. Abbreviations

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

7. Documents

1. Spray Rate Test Log (Annexure-1)
2. Calibration Log (Annexure-2)

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 Rate Test Log

Can ID	Test Date	Test Duration	Amount Dispensed (ml)	Operator Name	Remarks
C-12345	06/02/2025	10 seconds	30 ml	Rajesh Patel	No issues found

Annexure-2: Calibration Log

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

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 rate measurement procedure	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures