Standard Operating Procedure for Maintenance of Mixing Vessels in Gel Manufacturing
| Department | Gel Manufacturing |
|---|---|
| SOP No. | SOP/GM/131/2025 |
| Supersedes | SOP/GM/131/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 09/06/2025 |
| Effective Date | 11/06/2025 |
| Review Date | 09/06/2027 |
1. Purpose
To establish a standardized procedure for routine and preventive maintenance of mixing vessels used in the gel manufacturing process, ensuring operational efficiency and regulatory compliance.
2. Scope
This SOP is applicable to all mixing vessels utilized in the production of gel formulations in the Gel
Manufacturing department.
3. Responsibilities
- Maintenance Technician: Execute maintenance as per schedule and document findings.
- Production Supervisor: Initiate maintenance request and coordinate vessel availability.
- QA Executive: Review maintenance records and provide clearance post-maintenance.
4. Accountability
Head – Gel Manufacturing and Head – Engineering
5. Procedure
5.1 Scheduling
- Prepare and maintain an annual preventive maintenance (PM) calendar for all mixing vessels.
- Ensure minimum disruption to production schedule during PM activities.
5.2 Maintenance Activities
- Switch off power supply and affix “Under Maintenance” tag.
- Inspect vessel body for physical integrity, dents, or corrosion.
- Check internal agitator blades, seals, gaskets, and shaft condition.
- Clean motor housing, inspect electrical connectors, and tighten loose terminals.
- Lubricate bearings and agitator shaft as per manufacturer’s recommendation.
- Check calibration of temperature probes or load cells, if integrated.
5.3 Post-Maintenance Checks
- QA to perform a visual and functional inspection.
- Record results in Annexure-1 and obtain QA approval.
- Affix “Ready for Use” label after clearance.
5.4 Breakdown Maintenance
- Report equipment failure immediately to Engineering and QA.
- Tag the vessel as “Out of Order” and isolate from production.
- Document incident and corrective action in Annexure-2.
5.5 Documentation
- Maintain logbooks of maintenance schedules and checklists.
- Retain maintenance reports for a minimum of 5 years or as per regulatory requirements.
5.6 Safety Precautions
- Use PPE including gloves, safety shoes, and insulated tools.
- Ensure cleaning after maintenance to remove grease or residues.
6. Abbreviations
- QA: Quality Assurance
- PM: Preventive Maintenance
- PPE: Personal Protective Equipment
7. Documents
- Preventive Maintenance Checklist – Annexure-1
- Breakdown Maintenance Report – Annexure-2
- Maintenance Calendar
8. References
- WHO TRS 1010 Annex 3 – GMP Requirements
- Equipment Manufacturer’s Maintenance Manual
- Schedule M – Equipment Maintenance Guidelines
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 Checklist
| Item | Checked (Y/N) | Remarks | Technician Initials |
|---|---|---|---|
| Agitator Blades | |||
| Seals & Gaskets | |||
| Motor & Wiring | |||
| Vessel Body | |||
| Lubrication |
Annexure-2: Breakdown Maintenance Report
| Date | Issue Description | Action Taken | Technician | QA Approval |
|---|---|---|---|---|
Revision History
| Revision Date | Revision No. | Change Description | Reason | Approved By |
|---|---|---|---|---|
| 04/02/2022 | 1.0 | Initial Release | New SOP | QA Head |
| 09/06/2025 | 2.0 | Revised Annexures and updated PM calendar reference | Annual Review | QA Head |