the required specifications for particle size.

Health and Safety Officer: Ensures that all safety protocols are followed during particle size testing, especially in relation to handling aerosols and the testing equipment.

Maintenance Team: Responsible for ensuring that the particle size testing equipment is properly maintained, calibrated, and functioning as intended.

4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed and that aerosol products meet the required particle size distribution specifications. Compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Pre-Test Preparation

1. Ensure that the aerosol product to be tested is representative of the batch and is fully prepared for testing (i.e., the product has been filled and sealed in the appropriate container).
2. Prepare the particle size testing equipment according to the manufacturer’s instructions. This may include calibration, checking the settings, and verifying the correct sample holders or accessories are in place.
3. Ensure that the testing environment is free from contamination and that all instruments are clean and in good working condition.
4. Gather the necessary tools, including sample collection equipment, personal protective equipment (PPE), and the appropriate testing apparatus (e.g., laser diffraction analyzer or cascade impactor).

5.2. Conducting the Particle Size Test

1. For laser diffraction analysis:
   • Place a representative sample of the aerosol product in the sample chamber of the analyzer.
   • Activate the aerosol can and collect the sample using the appropriate sampling device, such as a vacuum or aspiration system, to ensure a consistent sample is collected.
   • The laser diffraction analyzer will measure the particle size distribution by analyzing the diffraction pattern produced by the aerosol particles.
   • Ensure that the sample is adequately dispersed to avoid aggregation of particles, as this could affect the accuracy of the results.

For cascade impactor analysis:

• Set up the cascade impactor according to the manufacturer’s instructions.
• Place the aerosol product into the impactor and activate the product for a specified duration, ensuring the aerosol plume is directed through the impactor stages for particle collection.
• Collect the particles on the appropriate stages of the impactor, and weigh the particles collected on each stage after the test is completed.
• Record the collected particle mass and the corresponding particle size range for each stage.

Repeat the test three times to ensure consistent results and obtain a reliable particle size distribution profile.

5.3. Post-Test Actions

1. After testing, ensure that the particle size analyzer or cascade impactor is cleaned and calibrated, as required by the manufacturer’s instructions, to maintain the accuracy of future tests.
2. Analyze the data from the particle size test to determine if the aerosol product meets the required specifications. The data should include parameters such as the median particle size (D50), particle size distribution range, and the percentage of particles within the required size range.
3. If the results fall within the acceptable range, proceed with the next steps in the production process. If the particle size distribution is out of specification, investigate potential causes and take corrective actions, such as adjusting the formulation or valve specifications.

5.4. Documentation and Record-Keeping

1. Document all particle size testing results in the Particle Size Distribution Log (Annexure-1), including the test date, operator name, sample ID, and particle size data (e.g., D50, size range, and percentage distribution).
2. Ensure that the results are reviewed by the QC team and that any deviations are addressed and documented in the Deviation Log (Annexure-2).
3. Maintain records of particle size testing for each batch according to the company’s document retention policy for future reference and audits.

5.5. Calibration and Maintenance of Equipment

1. Calibrate the particle size testing equipment at regular intervals according to the manufacturer’s guidelines or company procedures.
2. Ensure that the particle size testing equipment is checked for proper functioning before and after each test and that any malfunctions or inaccuracies are addressed by the Maintenance Team.
3. Document calibration and maintenance activities in the Equipment Calibration Log (Annexure-3) and the Equipment Maintenance Log (Annexure-4).

5.6. Safety and Environmental Considerations

1. Ensure that all personnel involved in particle size testing are trained in the proper use of PPE, including gloves, goggles, and lab coats, to prevent exposure to aerosol formulations.
2. Conduct all tests in a well-ventilated area or fume hood to prevent the buildup of propellant vapors and maintain safety during aerosol testing.
3. Dispose of any waste generated during particle size testing, such as used sampling equipment or product residues, according to 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
• D50: Median Particle Size

7. Documents

1. Particle Size Distribution Log (Annexure-1)
2. Deviation 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: Particle Size Distribution Log

Sample ID	Test Date	Test Type	Particle Size Distribution	Operator Name	Remarks
PS-12345	06/02/2025	Laser Diffraction	D50: 5 µm	Rajesh Patel	No issues found

Annexure-2: Deviation Log

Deviation ID	Deviation Description	Corrective Action Taken	Operator Name	Test Date
DV-001	Particle size out of spec	Adjusted formulation	Rajesh Patel	06/02/2025

Annexure-3: Equipment Calibration Log

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

Annexure-4: Equipment Maintenance Log

Equipment ID	Maintenance Date	Tasks Performed	Operator Name	Remarks
PSD-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 particle size testing procedure	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures