Aerosol: SOP for Cleaning Validation of Aerosol Filling Machines – V 2.0

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Aerosol: SOP for Cleaning Validation of Aerosol Filling Machines – V 2.0

SOP for Cleaning Validation of Aerosol Filling Machines

Department Aerosol
SOP No. SOP/Aerosol/121/2025
Supersedes SOP/Aerosol/121/2022
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) outlines the process for cleaning validation of aerosol filling machines. The objective of this SOP is to ensure that cleaning procedures effectively remove residues from the filling machines, preventing cross-contamination and ensuring that the machine is suitable for use in subsequent production runs. Cleaning validation helps confirm that the cleaning process consistently meets predefined standards for cleanliness and that it complies with Good Manufacturing Practices (GMP) and regulatory requirements.

2. Scope

This SOP applies to all aerosol filling machines at [Company Name]. It covers the cleaning process for filling machines used in the production of aerosol products. The SOP applies to routine cleaning as well as the validation of cleaning procedures whenever changes are made to the equipment, cleaning procedures, or formulation.

3. Responsibilities

  • Production Team: Responsible for performing the cleaning procedures on the aerosol filling machines and ensuring that they are followed according to the cleaning validation protocol.
  • Quality Assurance (QA) Team: Responsible for overseeing the cleaning validation process, reviewing validation results, and ensuring compliance with GMP and regulatory standards.
  • Validation Team: Responsible for developing the cleaning validation protocol, conducting the validation runs, and analyzing the results.
  • Regulatory Affairs Team: Ensures that the cleaning validation process complies with regulatory requirements and supports regulatory inspections or submissions.
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4. Accountability

The Manufacturing Manager is accountable for ensuring that cleaning validation is conducted according to this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Developing the Cleaning Validation Protocol

  1. The cleaning validation protocol should include the following components:
    • Objective: To validate the cleaning process of the aerosol filling machines, ensuring that all residues are effectively removed.
    • Scope: The machines and components to be cleaned, including filling nozzles, pumps, and other parts that come into direct contact with the product.
    • Cleaning Procedure: A detailed description of the cleaning steps, including cleaning agents, water, and the method of cleaning (manual, automated, etc.).
    • Acceptance Criteria: Defined limits for residue levels (e.g., active ingredients, cleaning agents) that must be achieved after cleaning, typically based on established thresholds or regulatory guidelines.
    • Sampling Plan: A plan for collecting samples from cleaned surfaces to verify that no residues remain. This may include rinse water sampling or swab testing.
    • Methodology: Step-by-step instructions for conducting the cleaning validation, including sample collection, analysis, and data recording procedures.
  2. The protocol should be reviewed and approved by the QA team and relevant departments.

5.2. Performing the Cleaning Validation

  1. Cleaning validation should be performed by following the protocol, including the cleaning procedure, sampling plan, and testing methods. The following steps should be taken:
    • Conduct the cleaning procedure as outlined in the cleaning validation protocol.
    • Collect samples from cleaned surfaces using appropriate techniques (e.g., swab sampling, rinse water sampling).
    • Send the collected samples for analysis to determine residue levels of any active ingredients, cleaning agents, or contaminants.
  2. Once cleaning is complete, ensure that the machines are allowed to dry properly before proceeding with the validation tests.
  3. Cleaning validation should be repeated until the residue levels are within acceptable limits, and all sampling data is documented in the Cleaning Validation Report (Annexure-1).
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5.3. Analyzing Cleaning Validation Data

  1. After the samples are analyzed, the results should be compared to the predefined acceptance criteria. The analysis should include:
    • Evaluation of residue levels in samples to ensure they meet the acceptable limits.
    • Identification of any contamination or non-compliance issues.
    • Investigation of any deviations or anomalies, and corrective actions if necessary.
  2. If the cleaning procedure is deemed ineffective or does not meet acceptance criteria, further investigation and corrective actions should be taken to adjust the cleaning process or improve the cleaning procedure.
  3. Once all results are reviewed and validated, the Cleaning Validation Report should be finalized and submitted for approval by the QA team and relevant departments.

5.4. Documenting Cleaning Validation Results

  1. The following documentation should be completed:
    • Cleaning Validation Report: A comprehensive report summarizing the cleaning process, sampling results, data analysis, and conclusions regarding the effectiveness of the cleaning procedure. This report should include all test results and any deviations that were observed (Annexure-1).
    • Deviation Log: A log documenting any deviations from the cleaning protocol and the corrective actions taken (Annexure-2).
  2. All documentation must be reviewed and approved by the QA team. Once approved, the documentation should be archived for future reference and regulatory inspections.
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5.5. Revalidation of Cleaning Process

  1. Cleaning validation should be re-performed if any changes occur that could affect the cleaning process, such as:
    • Changes in cleaning agents or procedures
    • Modification of the equipment or parts being cleaned
    • Changes in raw materials or formulations
  2. Revalidation should follow the same steps as outlined in the cleaning validation protocol, ensuring that all changes are documented and verified for compliance with cleaning standards.

6. Abbreviations

  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • SOP: Standard Operating Procedure
  • CPP: Critical Process Parameter
  • CFR: Code of Federal Regulations

7. Documents

  1. Cleaning Validation 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: Cleaning Validation Report

Batch Number Test Date Test Parameters Result Remarks
Batch-001 10/02/2025 Filling nozzles, pumps Pass Residue levels within acceptable limits

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