SOP for Dissolution Testing of Aerosol-Delivered Products
| Department | Aerosol |
|---|---|
| SOP No. | SOP/Aerosol/070/2025 |
| Supersedes | SOP/Aerosol/070/2022 |
| Page No. | Page 1 of Y |
| Issue Date | 06/02/2025 |
| Effective Date | 16/02/2025 |
| Review Date | 06/02/2028 |
1. Purpose
This Standard Operating Procedure (SOP) defines the process for conducting dissolution testing of aerosol-delivered products. The objective is to evaluate the release profile of active ingredients from aerosol products into the air or target area, ensuring that the product delivers the intended dose consistently and effectively. Dissolution testing helps assess the product’s performance, stability, and consistency over time.
2. Scope
This SOP applies to all aerosol-delivered products manufactured at [Company Name]. It includes the procedure for conducting dissolution testing, monitoring the release of active ingredients, and ensuring that the aerosol products meet the required specifications for dissolution and release performance.
3. Responsibilities
- Quality Control (QC) Team: Responsible for performing dissolution tests on aerosol-delivered products and ensuring that they meet the required dissolution profile. QC is also responsible for documenting the results and initiating corrective actions if the product fails to meet specifications.
- Production Team: Responsible for providing representative samples of aerosol products for testing and ensuring that the products are manufactured according to the specifications.
- Health and Safety Officer: Ensures that all safety protocols are followed during the dissolution testing process, particularly regarding the handling of aerosol products and the release of propellants or chemicals.
- Research and Development (R&D) Team: Involved in the development of new aerosol formulations and adjusting the dissolution testing parameters to meet the specific characteristics of each formulation.
4. Accountability
The Manufacturing Manager is accountable for ensuring that dissolution tests are conducted on aerosol products to verify the performance and release characteristics. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.
5. Procedure
5.1. Pre-Test Preparation
- Ensure that the aerosol products to be tested are fully manufactured, filled, and sealed according to product specifications.
- Prepare the dissolution testing equipment, including:
- Dissolution chamber or apparatus designed for aerosol-delivered products
- Appropriate dissolution medium (e.g., simulated lung fluid or air) to simulate real-world conditions
- PPE, including gloves, goggles, and lab coats
- Verify that the testing environment is clean, sterile, and free from contamination. Calibrate the dissolution testing equipment according to the manufacturer’s specifications and company procedures.
5.2. Conducting the Dissolution Test
- Place the aerosol product (e.g., spray can or inhaler) into the dissolution chamber according to the type of test being performed.
- Activate the aerosol product under controlled conditions to release the active ingredient(s). Ensure that the test conditions, such as air flow, temperature, and humidity, replicate real-world usage scenarios.
- Monitor the amount of active ingredient released over time. For aerosol products, this may involve collecting a specified volume of aerosol or measuring the concentration of active ingredients in the air over a given time period.
- Record the amount of active ingredient released at specified intervals (e.g., 5, 10, 15, 30 minutes) to construct a dissolution profile.
- Ensure that the dissolution profile matches the predefined release specifications (e.g., the percentage of the active ingredient released within a certain time frame).
5.3. Post-Test Actions
- If the aerosol product passes the dissolution test:
- Proceed with the next step in the production process, ensuring that all products meet the dissolution requirements.
- Document the test results, including the test date, sample ID, operator name, and dissolution profile, in the Dissolution Test Log (Annexure-1).
- If the aerosol product fails the dissolution test (e.g., insufficient release, incomplete dissolution), investigate potential causes (e.g., formulation issues, actuator malfunction) and take corrective action.
- Notify the QC team and relevant personnel of the failure, and document corrective actions taken in the Corrective Action Log (Annexure-2).
5.4. Calibration and Maintenance of Equipment
- Ensure that all dissolution testing equipment is calibrated according to the manufacturer’s specifications and company procedures.
- Perform routine maintenance on the dissolution testing apparatus, including cleaning, checking for wear, and replacing any faulty components to ensure accurate results.
- 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
- Document all dissolution testing activities, including the test results, sample details, operator name, and any corrective actions taken, in the Dissolution Test Log (Annexure-1).
- Ensure that all records are reviewed by the QC team to confirm that the aerosol product meets the required dissolution specifications.
- Store all records in the document management system, ensuring they are available for future reference and audits.
5.6. Safety and Environmental Considerations
- Ensure that all personnel involved in dissolution testing wear appropriate PPE, including gloves, goggles, and lab coats, to prevent exposure to aerosols and propellants.
- Conduct all testing in a well-ventilated area, preferably in a fume hood or with proper exhaust systems, to prevent the buildup of propellant vapors or other potentially harmful gases.
- Dispose of any waste generated during testing, including used formulations, contaminated equipment, and aerosols, according to safety and environmental regulations.
6. Abbreviations
- GMP: Good Manufacturing Practice
- QC: Quality Control
- PPE: Personal Protective Equipment
- SOP: Standard Operating Procedure
- LOD: Limit of Detection
7. Documents
- Dissolution Test Log (Annexure-1)
- Corrective Action Log (Annexure-2)
- Equipment Calibration Log (Annexure-3)
- 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
- International Conference on Harmonisation (ICH) Guidelines
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Dissolution Test Log
| Formulation ID | Test Date | Test Method | Result | Operator Name | Remarks |
|---|---|---|---|---|---|
| FORM-12345 | 06/02/2025 | Spray Test | Pass | Rajesh Patel | No issues found |
Annexure-2: Corrective Action Log
| Can ID | Issue Date | Issue Description | Corrective Action | Operator Name |
|---|---|---|---|---|
| FORM-12346 | 06/02/2025 | Inconsistent release rate | Reformulated to improve release profile | Rajesh Patel |
Annexure-3: Equipment Calibration Log
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| Equipment ID | Calibration Date | Calibration Results | Operator Name | Remarks |
|---|---|---|---|---|
| TEST-001 | 06/02/2025 | Pass | Rajesh Patel | No adjustments required |
Annexure-4: Equipment Maintenance Log
| Equipment ID | Maintenance Date | Tasks Performed | Operator Name | Remarks |
|---|---|---|---|---|
| TEST-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 dissolution testing procedure | To comply with updated GMP regulations | Anjali Sharma | Page 1 | [Ref Point] | Updated procedures |