Standard Operating Procedure for Preventive Maintenance of Solvent Recovery System in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/047/2025 |
| Supersedes | SOP/API/047/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To define a systematic approach for the preventive maintenance of solvent recovery systems used in API manufacturing, ensuring consistent functionality, operational safety, and regulatory compliance.
2. Scope
This SOP applies to all solvent recovery systems, including distillation units, condensers, and associated utilities, installed in the API manufacturing facility.
3. Responsibilities
- Maintenance Team: Perform scheduled
maintenance activities as per plan.
Engineering Head: Approve and update maintenance checklists and schedules.
Production Team: Support isolation, cleaning, and preparation for maintenance.
QA Department: Review maintenance records and ensure compliance.
4. Accountability
The Engineering Head is accountable for the execution and documentation of preventive maintenance. QA Head ensures that maintenance practices meet GMP and audit standards.
5. Procedure
5.1 Maintenance Schedule and Planning
- Create a preventive maintenance calendar for each solvent recovery system with:
- Daily checks
- Weekly inspections
- Monthly preventive tasks
- Quarterly servicing
- Annual shutdown overhauls
- Record all planned activities in the “Solvent Recovery Maintenance Plan” (Annexure-1).
5.2 Pre-Maintenance Checklist
- Ensure the solvent recovery unit is shut down and isolated from utility lines.
- Drain all residual solvents safely using grounding procedures.
- Verify availability of tools, PPE, lockout-tagout (LOTO) tags, and cleaning materials.
- Use the “Pre-Maintenance Safety Checklist” (Annexure-2) before starting work.
5.3 Component-Wise Maintenance Activities
- Distillation Vessel: Check inner linings, gaskets, agitator alignment, and thermal jacket.
- Condenser: Inspect for fouling, corrosion, and coolant flow pressure.
- Pumps and Valves: Lubricate mechanical parts, check for leakages, replace worn seals.
- Filters and Traps: Clean or replace solvent traps, filters, and vents.
- Instrumentation: Calibrate pressure gauges, temperature sensors, and flow meters.
- Pipelines and Fittings: Inspect for blockages, joint leaks, and flexible hose wear.
5.4 Post-Maintenance and Restart
- Clean and reassemble all parts.
- Conduct dry-run test and leak check.
- Record observations in “Maintenance Execution Log” (Annexure-3).
- Ensure QA review and sign-off before releasing the system for reuse.
6. Abbreviations
- SOP: Standard Operating Procedure
- PPE: Personal Protective Equipment
- QA: Quality Assurance
- LOTO: Lockout-Tagout
7. Documents
- Solvent Recovery Maintenance Plan (Annexure-1)
- Pre-Maintenance Safety Checklist (Annexure-2)
- Maintenance Execution Log (Annexure-3)
8. References
- ICH Q7 – GMP for Active Pharmaceutical Ingredients
- OSHA Maintenance Safety Guidelines
- Company Engineering Manual for Solvent Recovery Units
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Solvent Recovery Maintenance Plan
| System ID | Frequency | Task | Planned Date | Remarks |
|---|---|---|---|---|
| SRU-101 | Monthly | Condenser Cleaning | 10/04/2025 | Scheduled |
Annexure-2: Pre-Maintenance Safety Checklist
| Check Item | Status (Y/N) | Remarks |
|---|---|---|
| LOTO Applied | Y | Verified |
| Solvent Drained | Y | Clean |
Annexure-3: Maintenance Execution Log
| Date | System ID | Maintenance Performed | Performed By | Verified By |
|---|---|---|---|---|
| 10/04/2025 | SRU-101 | Pump Seal Replacement |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial SOP Release | GMP Implementation | QA Head |
| 13/04/2025 | 2.0 | Detailed Maintenance Plan and Checklists Added | Audit Observation | QA Head |