Procedure for Aerosol Emission Rate Testing
| Department | Aerosol |
|---|---|
| SOP No. | SOP/Aerosol/198/2025 |
| Supersedes | SOP/Aerosol/198/2022 |
| 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 determining the emission rate of aerosol products to ensure consistent performance, product efficacy, and compliance with regulatory requirements.
2. Scope
This SOP applies to all aerosol products tested for emission rate in the Quality Control (QC) laboratory, as well as in-process testing during production.
3. Responsibilities
- Quality Control (QC) Analysts: Responsible for conducting emission rate testing.
- Quality Assurance (QA) Team: Responsible for reviewing and approving test results.
- Production Team: Responsible for providing representative samples for testing.
- Regulatory Affairs Team: Responsible for ensuring compliance with global aerosol performance standards.
4. Accountability
The Quality Control Manager is accountable for ensuring the accuracy and compliance of aerosol emission rate testing.
5. Procedure
5.1. Sample Preparation
- Select aerosol cans randomly from the batch.
- Ensure samples are conditioned at room temperature before testing.
- Record sample details in the Emission Rate Sample Log (Annexure-1).
5.2. Testing Setup
- Place the aerosol can on an analytical balance.
- Ensure the can is positioned vertically and secured in place.
- Record setup details in the Testing Setup Log (Annexure-2).
5.3. Determining Aerosol Emission Rate
- Record the initial weight of the aerosol can.
- Actuate the
spray for a fixed time (e.g., 10 seconds).
Weigh the can immediately after spraying.
Calculate the emission rate using the formula:
Emission Rate (g/sec) = (Initial Weight – Final Weight) / Spray Time
Record results in the Emission Rate Test Log (Annexure-3).
5.4. Data Analysis and Acceptance Criteria
- Compare the measured emission rate with the product specifications.
- Identify any deviations from acceptable limits.
- Document findings in the Emission Rate Analysis Report (Annexure-4).
5.5. Corrective Actions for Non-Conforming Results
- Investigate potential causes such as valve defects, propellant issues, or formulation inconsistencies.
- Implement corrective actions as required.
- Record corrective measures in the Emission Rate Corrective Action Log (Annexure-5).
6. Abbreviations
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- SOP: Standard Operating Procedure
7. Documents
- Emission Rate Sample Log (Annexure-1)
- Testing Setup Log (Annexure-2)
- Emission Rate Test Log (Annexure-3)
- Emission Rate Analysis Report (Annexure-4)
- Emission Rate Corrective Action Log (Annexure-5)
8. References
- Good Manufacturing Practice (GMP) Guidelines
- ISO 16000-13 Standard for Aerosol Emissions Testing
- FDA Guidance on Aerosol Product Performance
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Emission Rate Sample Log
| Batch No. | Sample ID | Test Date | Checked By |
|---|---|---|---|
| BN-260 | SPL-501 | 07/02/2025 | QA Team |
Annexure-2: Testing Setup Log
| Sample ID | Setup Details | Test Method | Reviewed By |
|---|---|---|---|
| SPL-501 | Secured on balance | Weighing Method | QA Team |
Annexure-3: Emission Rate Test Log
| Sample ID | Initial Weight (g) | Final Weight (g) | Emission Rate (g/sec) | Checked By |
|---|---|---|---|---|
| SPL-501 | 150.2 | 148.5 | 0.17 | QA Team |
Annexure-4: Emission Rate Analysis Report
| Batch No. | Emission Rate (g/sec) | Specification | Approved By |
|---|---|---|---|
| BN-261 | 0.17 | 0.15 – 0.20 | QA Team |
Annexure-5: Emission Rate Corrective Action Log
| Issue Identified | Corrective Action | Implementation Date | Approved By |
|---|---|---|---|
| Emission Rate Below Limit | 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 emission rate test procedure | GMP Compliance | Anjali Sharma |