that may affect product performance.

Packaging Development Team: Responsible for selecting and sourcing valves and actuators that are suitable for the formulation and ensuring that they meet all functional and compatibility requirements.

Production Personnel: Ensures that proper valve and actuator systems are used during the filling process and that no defects are observed during manufacturing.

4. Accountability

The R&D Manager is accountable for ensuring that this SOP is followed during the valve and actuator compatibility testing process. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Selection of Valve and Actuator Systems

1. Select the valve and actuator systems based on the formulation’s requirements, including the desired spray pattern, delivery rate, and ease of use.
2. Ensure that the selected valve and actuator system are compatible with the specific formulation, including active ingredients, excipients, and propellants.
3. Review technical specifications from suppliers to ensure that the materials used in the valve and actuator system do not react with the formulation components.

5.2. Sample Preparation

1. Prepare the aerosol formulation sample for compatibility testing by filling the selected valve and actuator system with the formulation. Ensure that the formulation is properly homogenized before filling to avoid any phase separation or instability during testing.
2. Label each sample with batch numbers, formulation details, and the specific valve and actuator system used.

5.3. Testing Valve and Actuator Compatibility

1. Conduct the following tests to evaluate the compatibility of the valve and actuator system with the formulation:
   • Leakage Testing: Test the filled aerosol canister for leakage by applying pressure to the valve system and inspecting for any signs of leakage at the valve seal or actuator interface.
   • Actuation Testing: Test the functionality of the actuator by actuating the valve multiple times. Check for consistent spray pattern, proper discharge rate, and ease of use.
   • Performance Testing: Measure the spray pattern, droplet size, and uniformity of the aerosol discharge. Verify that the performance meets the product specifications.
   • Corrosion Resistance Testing: Evaluate the valve and actuator system for any signs of corrosion or degradation due to interaction with the formulation, especially if the formulation contains solvents, acids, or other reactive ingredients.
   • Compatibility with Packaging: Check for any interaction between the formulation and the valve or actuator materials that could lead to the degradation of the packaging components, such as plasticizers leaching from plastic components.
2. Record all observations and measurements, including any defects, deviations from expected performance, or compatibility issues, in the Valve and Actuator Compatibility Test Log (Annexure-1).

5.4. Data Analysis and Interpretation

1. Analyze the test results to determine if the valve and actuator system is compatible with the formulation. The system should be able to deliver the formulation consistently and without issues such as leakage, clogging, or uneven spray.
2. If any compatibility issues are identified, investigate the cause and assess whether the formulation or packaging system needs to be adjusted to resolve the issue.
3. Interpret the results based on the specific requirements of the product, such as consistent spray pattern and proper droplet size for effective delivery.

5.5. Documentation and Reporting

1. Prepare a comprehensive Valve and Actuator Compatibility Report (Annexure-2) documenting all test results, observations, and conclusions. The report should include:
   • Details of the valve and actuator system tested
   • Test conditions (e.g., temperature, pressure, formulation type)
   • Results of all tests, including performance, leakage, and corrosion testing
   • Any deviations from expected performance and corrective actions taken
2. The report should be reviewed and approved by the Quality Control and Packaging Development teams.

5.6. Corrective and Preventive Actions (CAPA)

1. If any issues are found during testing (e.g., leakage, poor performance), initiate corrective actions to resolve the issue. This could include reformulating the product, selecting alternative packaging components, or modifying the filling process.
2. Implement preventive actions to prevent recurrence of the same issues, such as improving the formulation, packaging materials, or testing procedures.
3. Document all corrective and preventive actions in the CAPA Log (Annexure-3) and ensure that follow-up testing is performed to confirm the effectiveness of the actions taken.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• CAPA: Corrective and Preventive Actions
• R&D: Research and Development

7. Documents

1. Valve and Actuator Compatibility Test Log (Annexure-1)
2. Valve and Actuator Compatibility Report (Annexure-2)
3. CAPA Log (Annexure-3)

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 Pharmacopoeia (Ph. Int.) – Aerosol Delivery

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Valve and Actuator Compatibility Test Log

Test Parameter	Test Date	Test Result	Observations	Tested By
Leakage	06/02/2025	Pass	No leakage observed	Rajesh Patel

Annexure-2: Valve and Actuator Compatibility Report

Batch No.	Formulation	Valve and Actuator Tested	Test Results	Approval Date
12345	Example Aerosol	Valve A, Actuator B	Pass	06/02/2025

Annexure-3: CAPA Log

Issue	Root Cause	Corrective Action	Preventive Action	Follow-up Date
Valve leakage	Poor seal quality	Replaced seal material	Improved supplier quality control	06/03/2025

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