Procedure for Determining Spray Angle and Coverage of Aerosol Products
| Department | Aerosol |
|---|---|
| SOP No. | SOP/Aerosol/194/2025 |
| Supersedes | SOP/Aerosol/194/2022 |
| Page No. | Page 1 of Y |
| Issue Date | 06/02/2025 |
| Effective Date | 16/02/2025 |
| Review Date | 06/02/2028 |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a validated method for measuring the spray angle and coverage of aerosol products to ensure uniform dispersion and product efficacy.
2. Scope
This SOP applies to all aerosol formulations tested for spray pattern, angle, and coverage within the Quality Control (QC) laboratory and during in-process monitoring.
3. Responsibilities
- Quality Control (QC) Analysts: Responsible for conducting spray angle and coverage tests.
- Quality Assurance (QA) Team: Responsible for reviewing and approving test results.
- Laboratory Supervisor: Responsible for ensuring compliance with the validated test method.
- Production Team: Responsible for providing representative samples for testing.
4. Accountability
The Quality Control Manager is accountable for ensuring the accuracy and reliability of spray angle and coverage testing.
5. Procedure
5.1. Sample Preparation
- Randomly select aerosol cans from the batch.
- Ensure cans are conditioned at room temperature before testing.
- Record sample details in the Spray Test Sample Log (Annexure-1).
5.2. Spray Angle Measurement
- Use a calibrated spray pattern analysis system or a protractor-based setup.
- Spray the aerosol onto a flat surface from a standard distance (e.g., 15 cm).
- Measure the angle of dispersion from
the central axis.
Record results in the Spray Angle Test Log (Annexure-2).
5.3. Spray Coverage Assessment
- Apply spray to a pre-marked surface with grid lines.
- Allow the formulation to settle and measure the coverage area.
- Compare the results against product specifications.
- Record measurements in the Spray Coverage Test Log (Annexure-3).
5.4. Data Analysis and Acceptance Criteria
- Compare test results with predefined specifications.
- Identify any deviations and assess potential impact on product performance.
- Document findings in the Spray Performance Report (Annexure-4).
5.5. Corrective Actions for Non-Conforming Results
- Investigate root causes for abnormal spray angles or uneven coverage.
- Recommend corrective actions such as valve adjustment or formulation modification.
- Document corrective measures in the Spray Test Corrective Action Log (Annexure-5).
6. Abbreviations
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- SOP: Standard Operating Procedure
7. Documents
- Spray Test Sample Log (Annexure-1)
- Spray Angle Test Log (Annexure-2)
- Spray Coverage Test Log (Annexure-3)
- Spray Performance Report (Annexure-4)
- Spray Test Corrective Action Log (Annexure-5)
8. References
- Good Manufacturing Practice (GMP) Guidelines
- ISO Standards for Aerosol Spray Performance
- FDA Guidelines on Aerosol Dispersion Testing
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 Test Sample Log
| Batch No. | Sample ID | Test Date | Analyst |
|---|---|---|---|
| BN-235 | SPL-201 | 07/02/2025 | Rahul Mehta |
Annexure-2: Spray Angle Test Log
| Sample ID | Spray Distance (cm) | Spray Angle (°) | Checked By |
|---|---|---|---|
| SPL-201 | 15 cm | 45° | QA Team |
Annexure-3: Spray Coverage Test Log
| Sample ID | Coverage Area (cm²) | Test Method | Reviewed By |
|---|---|---|---|
| SPL-202 | 120 cm² | Grid Marking | QA Team |
Annexure-4: Spray Performance Report
| Batch No. | Test Parameter | Specification | Result | Approved By |
|---|---|---|---|---|
| BN-236 | Spray Angle | 40°-50° | 45° | QA Team |
Annexure-5: Spray Test Corrective Action Log
| Issue Identified | Corrective Action | Implementation Date | Approved By |
|---|---|---|---|
| Spray Angle Out of Range | Valve Adjustment | 08/02/2025 | Anjali Sharma |
12. Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | V 1.0 | Initial Release | First Issue | Anjali Sharma |
| 01/01/2025 | V 2.0 | Updated spray testing parameters | GMP Compliance | Anjali Sharma |