making adjustments to formulations or actuators based on compatibility testing results.

Maintenance Team: Ensures that testing equipment is calibrated and in proper working condition before conducting the compatibility tests.

4. Accountability

The Manufacturing Manager is accountable for ensuring that compatibility testing is performed on all aerosol formulations and actuators. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Pre-Test Preparation

1. Ensure that the aerosol formulation is fully prepared and the actuator is sourced according to product specifications.
2. Gather the necessary equipment for compatibility testing, including:
   • Actuators (sample units to be tested)
   • Aerosol formulation (sample units to be tested)
   • Testing apparatus such as spray chambers or testing rigs
   • PPE, including gloves, goggles, and lab coats
3. Verify that the testing environment is clean, sterile, and free from contamination to avoid external factors influencing the results.

5.2. Conducting the Compatibility Test

1. Attach the actuator to the aerosol can filled with the formulation to simulate real-world usage conditions.
2. Perform the following compatibility tests:
   • Spray Pattern Test: Activate the actuator and observe the spray pattern. The spray should be consistent, uniform, and without clogging or sputtering.
   • Valve Performance Test: Ensure that the actuator does not cause leakage or malfunction. The valve should function correctly under pressure.
   • Stability Test: Check if the actuator’s performance is consistent over time when exposed to the formulation. The actuator should not corrode, degrade, or react adversely with the formulation.
   • Formulation Degradation Test: Monitor the formulation for any signs of degradation or chemical reactions, such as color change, separation, or reduced efficacy due to contact with the actuator.
3. Document the test observations, including the spray pattern, valve function, any degradation or reactions, and overall compatibility in the Compatibility Test Log (Annexure-1).

5.3. Post-Test Actions

1. If the actuator and formulation are compatible:
   • Proceed with the production process, ensuring that the formulation and actuator pairing meets all quality control standards.
   • Mark the tested actuator and formulation combination as approved in the Compatibility Test Log (Annexure-1).
2. If any incompatibility is found (e.g., leaking, degradation, poor spray performance), identify the root cause (e.g., improper formulation or actuator malfunction) and take corrective action:
   • Adjust the formulation or actuator design as needed.
   • Retest after making adjustments to ensure compatibility.
3. Notify the Quality Assurance (QA) team and relevant personnel about the incompatibility, and document any corrective actions taken in the Compatibility Test Log (Annexure-1).

5.4. Documentation and Record-Keeping

1. Document all compatibility test results in the Compatibility Test Log (Annexure-1), including the formulation ID, actuator model, test observations, and results.
2. Ensure that the results are reviewed and approved by the QC team and are available for future reference and audits.
3. Store all records in the document management system in accordance with the company’s document retention policy.

5.5. Calibration and Maintenance of Equipment

1. Ensure that all equipment used for compatibility testing (e.g., spray chambers, testing rigs) is calibrated regularly according to the manufacturer’s guidelines.
2. Perform routine maintenance on testing equipment, including cleaning and replacing any parts that may degrade or become damaged.
3. Document all calibration and maintenance activities in the Equipment Calibration Log (Annexure-2) and the Equipment Maintenance Log (Annexure-3).

5.6. Safety and Environmental Considerations

1. Ensure that all personnel conducting compatibility testing wear the appropriate PPE, including gloves, goggles, and lab coats, to prevent exposure to potentially harmful substances.
2. Conduct all testing in a well-ventilated area or fume hood to minimize exposure to aerosols and propellants.
3. Dispose of any waste generated during testing, including used formulations, actuators, or contaminated testing equipment, according to safety and environmental regulations.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• PPE: Personal Protective Equipment
• SOP: Standard Operating Procedure

7. Documents

1. Compatibility Test Log (Annexure-1)
2. Equipment Calibration Log (Annexure-2)
3. Equipment Maintenance 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

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Compatibility Test Log

Formulation ID	Actuator Model	Test Date	Test Results	Operator Name	Corrective Actions
FORM-12345	ACT-001	06/02/2025	Pass	Rajesh Patel	No issues found

Annexure-2: Equipment Calibration Log

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

Annexure-3: Equipment Maintenance Log

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