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

1. Create a preventive maintenance calendar for each solvent recovery system with:
   • Daily checks
   • Weekly inspections
   • Monthly preventive tasks
   • Quarterly servicing
   • Annual shutdown overhauls
2. Record all planned activities in the “Solvent Recovery Maintenance Plan” (Annexure-1).

5.2 Pre-Maintenance Checklist

1. Ensure the solvent recovery unit is shut down and isolated from utility lines.
2. Drain all residual solvents safely using grounding procedures.
3. Verify availability of tools, PPE, lockout-tagout (LOTO) tags, and cleaning materials.
4. Use the “Pre-Maintenance Safety Checklist” (Annexure-2) before starting work.

5.3 Component-Wise Maintenance Activities

1. Distillation Vessel: Check inner linings, gaskets, agitator alignment, and thermal jacket.
2. Condenser: Inspect for fouling, corrosion, and coolant flow pressure.
3. Pumps and Valves: Lubricate mechanical parts, check for leakages, replace worn seals.
4. Filters and Traps: Clean or replace solvent traps, filters, and vents.
5. Instrumentation: Calibrate pressure gauges, temperature sensors, and flow meters.
6. Pipelines and Fittings: Inspect for blockages, joint leaks, and flexible hose wear.

5.4 Post-Maintenance and Restart

1. Clean and reassemble all parts.
2. Conduct dry-run test and leak check.
3. Record observations in “Maintenance Execution Log” (Annexure-3).
4. 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

1. Solvent Recovery Maintenance Plan (Annexure-1)
2. Pre-Maintenance Safety Checklist (Annexure-2)
3. 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