SOP Guide for Pharma

Aerosol: SOP for Troubleshooting Aerosol Filling Machines – V 2.0

Aerosol: SOP for Troubleshooting Aerosol Filling Machines – V 2.0

SOP for Troubleshooting Aerosol Filling Machines

Department Aerosol
SOP No. SOP/Aerosol/171/2025
Supersedes SOP/Aerosol/171/2022
Page No. Page 1 of Y
Issue Date 06/02/2025
Effective Date 16/02/2025
Review Date 06/02/2028

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach for troubleshooting aerosol filling machines. Effective troubleshooting helps minimize downtime, maintain product quality, and improve production efficiency.

2. Scope

This SOP applies to all aerosol filling machines used in production, including propellant filling systems, crimping machines, and product dosing systems. It covers troubleshooting of mechanical, pneumatic, and electrical issues.

3. Responsibilities

  • Production Operators: Responsible for identifying and reporting machine faults.
  • Maintenance Team: Responsible for diagnosing and resolving mechanical, pneumatic, and electrical issues.
  • Quality Assurance (QA) Team: Responsible for verifying machine performance after troubleshooting.
  • Engineering Team: Responsible for major repairs and preventive maintenance planning.

4. Accountability

The Maintenance Manager is accountable for ensuring timely troubleshooting, repair, and documentation of aerosol filling machine issues.

5. Procedure

5.1. Identifying Common Machine Issues

  1. Operators should monitor machine performance and identify issues such as:
    • Propellant Filling Issues: Inconsistent fill weight, gas leakage, or valve malfunction.
    • Product Dosing Problems: Underfilling, overfilling, or clogging.
    • Crimping Malfunctions: Loose or improperly sealed valves.
    • Machine Stoppages: Pneumatic or electrical failure.
    • Conveyor System Failures: Misalignment or jamming.
  2. All issues should be recorded in the Machine Fault Log (Annexure-1).

5.2. Initial Troubleshooting

  1. The operator should
perform basic troubleshooting before calling the maintenance team.
  • For minor issues:
    • Check air pressure settings and ensure they match machine specifications.
    • Inspect machine sensors and clear any obstructions.
    • Verify that product and propellant supply lines are not blocked.
  • If the issue persists, escalate to the maintenance team.
  • 5.3. Mechanical and Pneumatic Troubleshooting

    1. Maintenance personnel should inspect:
      • Seals, gaskets, and O-rings for wear and tear.
      • Crimping dies and filling nozzles for alignment.
      • Compressed air pressure and lines for leaks.
    2. If components are damaged, replace them as per the Equipment Repair Log (Annexure-2).
    3. Test machine functionality after repairs.

    5.4. Electrical Troubleshooting

    1. For machines experiencing power failures or sensor malfunctions:
      • Check fuses and circuit breakers.
      • Inspect wiring connections for loose or damaged wires.
      • Reset the control panel and check software settings.
    2. All electrical troubleshooting activities must be documented in the Electrical Maintenance Log (Annexure-3).

    5.5. Quality Assurance Verification

    1. After repairs, the QA team should verify machine performance.
    2. Conduct test runs to ensure proper filling, crimping, and propellant charging.
    3. Record observations in the Machine Performance Verification Log (Annexure-4).

    5.6. Preventive Maintenance

    1. Schedule regular machine inspections to reduce the frequency of breakdowns.
    2. Maintain an inventory of spare parts to minimize downtime.
    3. Update preventive maintenance records in the Maintenance Schedule Log (Annexure-5).

    6. Abbreviations

    • GMP: Good Manufacturing Practice
    • QA: Quality Assurance
    • SOP: Standard Operating Procedure
    • PPE: Personal Protective Equipment

    7. Documents

    1. Machine Fault Log (Annexure-1)
    2. Equipment Repair Log (Annexure-2)
    3. Electrical Maintenance Log (Annexure-3)
    4. Machine Performance Verification Log (Annexure-4)
    5. Maintenance Schedule Log (Annexure-5)

    8. References

    • Good Manufacturing Practice (GMP) Guidelines
    • OEM Machine Troubleshooting Manuals
    • ISO 9001 – 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: Machine Fault Log

    Machine ID Fault Description Date Reported Reported By Status
    FILL-001 Low gas pressure 06/02/2025 Rajesh Patel Resolved

    Annexure-2: Equipment Repair Log

    Machine ID Repaired Component Repair Date Performed By Verification Status
    FILL-001 Sealing gasket 07/02/2025 Amit Sharma Passed

    Annexure-3: Electrical Maintenance Log

    Machine ID Issue Description Repair Date Technician Remarks
    FILL-002 Wiring short circuit 07/02/2025 Sunil Verma Fixed and tested

    Annexure-4: Machine Performance Verification Log

    Machine ID Verification Date Performed By Test Results Status
    FILL-001 08/02/2025 Rahul Mehta Proper filling and crimping observed Passed

    Annexure-5: Maintenance Schedule Log

    Machine ID Scheduled Maintenance Date Performed By Maintenance Type Remarks
    FILL-003 10/03/2025 Amit Sharma Preventive Lubrication and part replacement

    12. Revision History:

    Revision Date Revision No. Revision Details Reason for Revision Approved By
    01/01/2024 V 1.0 Initial Release First Issue Anjali Sharma
    01/01/2025 V 2.0 Updated troubleshooting methods GMP Compliance Anjali Sharma
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