Standard Operating Procedure for Preventive Maintenance of Tube Filling Machine in Gel Manufacturing
| Department | Gel Manufacturing |
|---|---|
| SOP No. | SOP/GM/159/2025 |
| Supersedes | SOP/GM/159/2022 |
| Page No. | Page 1 of 12 |
| Issue Date | 09/06/2025 |
| Effective Date | 11/06/2025 |
| Review Date | 09/06/2027 |
1. Purpose
To lay down the procedure for preventive maintenance of the tube filling machine in the gel manufacturing area to ensure its optimum performance and prevent any breakdown during production.
2. Scope
This SOP applies to the preventive maintenance activities performed on the tube filling machine used in the gel manufacturing unit of the pharmaceutical formulation facility.
3. Responsibilities
- Maintenance Engineer: Carries out the scheduled preventive maintenance as per plan.
- Production Supervisor: Ensures availability of machine and coordinates during maintenance.
- QA Executive: Verifies
the maintenance activity and reviews the completed records.
4. Accountability
Head – Engineering is accountable for execution and documentation of preventive maintenance activities as per schedule. QA is accountable for compliance oversight.
5. Procedure
5.1 General Guidelines
- Refer to the Equipment Preventive Maintenance Schedule for planned maintenance dates.
- Notify production at least 24 hours in advance before maintenance activity.
- Ensure the machine is switched off and tagged as “Under Maintenance.”
- Wear appropriate PPE and follow safety protocols while performing maintenance.
5.2 Preventive Maintenance Steps
- Disconnect the machine from power supply.
- Inspect and clean the lubrication system, apply fresh lubricant to moving parts.
- Check for wear and tear of major components like:
- Filling nozzles
- Piston and cylinder unit
- Heating jaws and sealing bars
- Conveyor belt
- Tube holder grippers
- Tighten any loose bolts, nuts, and couplings.
- Inspect and replace filters if clogged or damaged.
- Check air pressure settings and validate pneumatic connections.
- Inspect electrical wiring, switches, emergency stop button functionality.
- Clean the sensors and optical/photoelectric components.
5.3 Post-Maintenance Checks
- Reconnect the machine and perform a dry run with empty tubes.
- Verify that the machine functions as per design specifications.
- Record the readings of temperature, filling volume accuracy, and sealing quality.
5.4 Documentation
- Enter maintenance details in the Preventive Maintenance Logbook – Annexure-1.
- Document replaced parts using the Spare Parts Replacement Sheet – Annexure-2.
- Get the record reviewed by QA and approved by Engineering Head.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- PPE: Personal Protective Equipment
- GMP: Good Manufacturing Practice
7. Documents
- Preventive Maintenance Schedule
- Preventive Maintenance Logbook – Annexure-1
- Spare Parts Replacement Sheet – Annexure-2
- QA Verification Checklist – Annexure-3
8. References
- GMP Guidelines – Schedule M
- Manufacturer’s Equipment Maintenance Manual
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | Jr. Production Chemist | QA Executive | Head – Manufacturing |
| Department | Gel Manufacturing | Quality Assurance | Manufacturing |
11. Annexures
Annexure-1: Preventive Maintenance Logbook Format
| Date | Performed By | Activity Performed | Remarks | Reviewed By |
|---|---|---|---|---|
Annexure-2: Spare Parts Replacement Sheet
| Part Name | Part Number | Date Replaced | Reason | Performed By |
|---|---|---|---|---|
Annexure-3: QA Verification Checklist
Checklist for verifying completion of preventive maintenance including date, parts replaced, performance verification, and QA signature.
Revision History
| Revision Date | Revision No. | Change Description | Reason | Approved By |
|---|---|---|---|---|
| 20/04/2022 | 1.0 | Initial issue | New equipment added | QA Head |
| 09/06/2025 | 2.0 | Included QA checklist and updated annexures | Periodic review | QA Head |