actions if necessary.

Validation Team: Responsible for ensuring that the swab testing method is validated and that the test results are documented properly in accordance with GMP standards.

Regulatory Affairs Team: Ensures that swab testing procedures meet regulatory requirements for aerosol manufacturing.

4. Accountability

The Manufacturing Manager is accountable for ensuring that swab testing is conducted as part of the cleaning validation process. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparing for Swab Testing

1. Before conducting swab testing, ensure that the cleaning process has been completed and that all equipment surfaces are accessible for testing.
2. Ensure that all necessary materials and equipment for swab testing are available, including sterile swabs, solvent for swabbing (e.g., water or alcohol), sample collection containers, and labeling materials.
3. Prepare the swab testing kit by ensuring that swabs are sterile, and the solvent used for swabbing is compatible with the residue being tested (e.g., cleaning agent or product residues).
4. Verify that appropriate lighting and magnification tools are available to inspect the equipment surfaces during the testing process.
5. Review the cleaning validation protocol to identify the specific surfaces to be swabbed, ensuring that critical areas are included in the swab testing process.

5.2. Selecting Swab Sampling Points

1. Identify the critical surfaces of the equipment that must be swabbed. These include surfaces that directly contact the product and those that are difficult to clean.
2. Common sampling points include:
   • Filling nozzles, pumps, and valves
   • Internal surfaces of containers, tubes, and chambers
   • Surfaces that may retain product residues or cleaning agents after cleaning
3. Ensure that the sampling plan is followed, including the number of swabs per equipment unit and the frequency of swabbing, as outlined in the cleaning validation protocol.

5.3. Performing Swab Sampling

1. Using a sterile swab, moisten the swab with an appropriate solvent (e.g., water or alcohol), ensuring that the swab is adequately wetted but not overly saturated.
2. Swab the identified surfaces in a consistent manner, ensuring that all critical areas are covered. Use a systematic approach to swabbing, including making sure that the swab is applied evenly to the surface.
3. After swabbing, place the swab in a sterile container and seal it to prevent contamination. Label the container with relevant information, including the batch number, sampling point, equipment cleaned, and the date and time of the sampling.
4. Ensure that the swabbed surfaces are inspected for any visible residues before proceeding with the next sampling location.

5.4. Analyzing the Swab Samples

1. Once the swab samples are collected, they should be sent to the laboratory for analysis using validated methods. Common methods for analyzing swab samples include:
   • High-Performance Liquid Chromatography (HPLC): Used to detect and quantify product residues or cleaning agents.
   • Spectrophotometry: Used to detect cleaning agents or other contaminants based on their light absorption properties.
   • Titration: A method for measuring the concentration of cleaning agents or residual active ingredients on swabbed surfaces.
   • pH Measurement: Used to detect residual acidic or alkaline cleaning agents.
2. Once the analysis is complete, compare the results to the established acceptance criteria, including residue limits and microbial contamination levels.
3. If the results show that the residue levels exceed the acceptance criteria, further corrective actions should be taken as described in the Deviation Log (Annexure-2).

5.5. Documenting the Swab Testing Results

1. Document all swab testing activities in the Swab Testing Report (Annexure-1). The report should include:
   • The equipment cleaned and the specific sampling points swabbed
   • The solvent used for swabbing and the amount of solvent applied
   • The results of the swab sample analysis, including residue levels and any deviations from acceptance criteria
   • Any corrective actions taken if residue levels exceed the acceptance criteria
2. Each swab testing report should be signed and dated by the person performing the testing and the person reviewing the results.
3. The Swab Testing Report should be reviewed and approved by the QA team. Once approved, the report should be stored as part of the cleaning validation documentation.

5.6. Corrective Actions for Deviations

1. If the swab testing results show that the equipment does not meet the established cleanliness criteria, corrective actions should be taken. These may include:
   • Re-cleaning the equipment using the appropriate cleaning procedures.
   • Adjusting the cleaning process or agents to achieve better residue removal.
   • Performing additional sampling and testing to verify the effectiveness of the corrective actions.
2. The corrective actions should be documented in the Deviation Log (Annexure-2), including the steps taken to address the deviation and the results of any subsequent testing.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• HPLC: High-Performance Liquid Chromatography
• CAPA: Corrective and Preventive Action

7. Documents

1. Swab Testing Report (Annexure-1)
2. Deviation Log (Annexure-2)

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
• International Council for 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: Swab Testing Report

Batch Number	Test Date	Residue Level	Acceptance Criteria	Result
Batch-001	10/02/2025	Detergent	Less than 5 ppm	Pass

Annexure-2: Deviation Log

Deviation ID	Deviation Description	Corrective Action	Assigned To	Status
DEV-12345	Residue above limit	Adjusted cleaning procedure	Rajesh Patel	Completed

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