SOP for Preventive Maintenance of Cleaning Equipment
| Department | Aerosol |
|---|---|
| SOP No. | SOP/Aerosol/060/2025 |
| Supersedes | SOP/Aerosol/060/2022 |
| 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) defines the process for performing preventive maintenance on cleaning equipment used in aerosol manufacturing. The objective is to ensure that all cleaning equipment, including washers, brushes, and other cleaning systems, are functioning optimally to maintain the cleanliness of machines and equipment. Regular preventive maintenance minimizes equipment downtime, ensures consistent cleaning performance, and helps maintain compliance with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all cleaning equipment used in aerosol manufacturing, including cleaning machines, scrubbers, and washing stations. It covers the routine maintenance tasks that need to be performed on cleaning equipment to prevent malfunctions, reduce wear and tear, and extend the life of the equipment. This SOP does not cover the cleaning process itself, which is addressed separately.
3. Responsibilities
- Maintenance Team: Responsible for performing the preventive maintenance tasks on cleaning equipment according to this SOP, including lubrication, parts inspection, and adjustments.
- Production Team: Responsible for notifying the Maintenance Team of any issues or malfunctions related to the cleaning equipment and for following the SOP during cleaning activities.
- Quality Control (QC) Team: Ensures that the preventive maintenance program is being followed correctly and that equipment performance meets the necessary standards for cleaning.
- Health and Safety Officer: Ensures that maintenance work is conducted following safety protocols and that proper PPE is used to prevent injury.
4. Accountability
The Manufacturing Manager is accountable for ensuring that preventive maintenance is conducted according to this SOP and that cleaning equipment is maintained in good working condition. Compliance with this SOP is overseen by the Quality Assurance (QA) Manager.
5. Procedure
5.1. Maintenance Schedule
- Develop and maintain a preventive maintenance schedule for all cleaning equipment. The schedule should be based on the manufacturer’s recommendations and the frequency of use of the equipment.
- The schedule should include tasks such as equipment inspection, lubrication, calibration, and part replacement.
- Review the schedule annually and update it as needed based on equipment usage, wear, or operational changes.
- Ensure that the schedule is clearly communicated to the Maintenance and Production Teams, and ensure that all required tasks are performed on time.
5.2. Routine Maintenance Tasks
- Inspect all cleaning equipment components for signs of wear or damage. Key components to inspect include:
- Motors and electrical components
- Pumps and hoses
- Valves and seals
- Filters and air systems
- Brushes and cleaning heads
- Clean equipment components to prevent buildup of dirt or debris that could affect performance.
- Lubricate moving parts according to the manufacturer’s guidelines to reduce friction and wear.
- Test equipment to ensure that it is operating within the required specifications, such as pressure, temperature, or flow rate.
- Check and replace any worn or damaged parts, such as seals, hoses, or filters, and document the replacement in the maintenance log (Annexure-1).
5.3. Equipment Calibration
- For equipment that requires calibration, follow the manufacturer’s instructions to verify that the equipment is within the specified operating range.
- If calibration results are outside the acceptable range, adjust the equipment as necessary or replace any faulty components.
- Document the calibration results and any adjustments made in the calibration log (Annexure-2).
5.4. Cleaning Equipment Testing
- Test the cleaning equipment after maintenance to ensure that it is functioning properly. This includes:
- Running the equipment through a cycle to check for leaks or malfunctions.
- Verifying that cleaning solutions or water flow properly through the system and that all components are operating smoothly.
- Checking for proper pressure or vacuum levels in the cleaning systems.
- Ensure that any issues identified during testing are documented and addressed before the equipment is put back into service.
5.5. Documentation and Record-Keeping
- Document all preventive maintenance activities in the Preventive Maintenance Log (Annexure-1), including the date, tasks performed, parts replaced, and any issues encountered.
- Ensure that the Maintenance Team signs off on all completed tasks and that the records are reviewed by the Quality Control (QC) Team.
- Maintain a copy of the maintenance log in the document management system for future reference and audits.
5.6. Safety and Environmental Considerations
- Ensure that all maintenance work is performed following the company’s health and safety policies, including lockout/tagout procedures to prevent accidental equipment activation during maintenance.
- Ensure that maintenance personnel are equipped with the appropriate Personal Protective Equipment (PPE), including gloves, goggles, and hearing protection, where necessary.
- Dispose of any waste generated during maintenance (e.g., used lubricants, filters, parts) according to the company’s waste disposal procedures and environmental regulations.
6. Abbreviations
- GMP: Good Manufacturing Practice
- QC: Quality Control
- PPE: Personal Protective Equipment
- SOP: Standard Operating Procedure
7. Documents
- Preventive Maintenance Log (Annexure-1)
- Calibration 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
- 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: Preventive Maintenance Log
| Equipment ID | Maintenance Date | Tasks Performed | Parts Replaced | Operator Name |
|---|---|---|---|---|
| CLE-123 | 06/02/2025 | Lubrication, filter replacement | Filter, hose | Rajesh Patel |
Annexure-2: Calibration Log
| Equipment ID | Calibration Date | Calibration Results | Operator Name | Remarks |
|---|---|---|---|---|
| CLE-123 | 06/02/2025 | Pass | Rajesh Patel | No adjustments required |
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 preventive maintenance procedures | To comply with updated GMP regulations | Anjali Sharma | Page 1 | [Ref Point] | Updated procedures |