Standard Operating Procedure for Solvent Transfer Using Pumps in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/056/2025 |
| Supersedes | SOP/API/056/2022 |
| 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 the procedure for the safe and controlled transfer of solvents using pumps in API manufacturing, ensuring prevention of spills, cross-contamination, and exposure while maintaining GMP and safety compliance.
2. Scope
This SOP is applicable to all solvent transfers using mechanical, diaphragm, peristaltic, or centrifugal pumps within the API manufacturing facility, including between drums, tanks, reactors, and pipelines.
3. Responsibilities
- Operators: Ensure correct setup, operation, and cleaning of pumps used for solvent transfer.
- Maintenance Team: Maintain pumps in working condition and respond to breakdowns.
- EHS Team: Ensure transfer complies with safety standards and spill containment procedures.
- QA Team: Review logs and verify GMP compliance.
4. Accountability
The Production Head is accountable for ensuring all solvent transfers via pumps are carried out as per this SOP. The EHS Head is accountable for safety compliance.
5. Procedure
5.1 Pre-Transfer Checklist
- Verify the pump type is compatible with the solvent (e.g., explosion-proof for flammable solvents).
- Ensure grounding and bonding cables are connected to prevent static discharge.
- Check the availability of:
- Appropriate PPE (gloves, goggles, antistatic shoes, face shield)
- Spill kits and fire extinguishers nearby
- Solvent transfer logbook
5.2 Solvent Transfer Process
- Connect inlet hose from solvent container (drum or tank) to the pump suction port securely.
- Connect discharge hose to receiving vessel, ensuring tight clamps and leak-free joints.
- Prime the pump if required (refer equipment manual).
- Switch on the pump and begin transfer slowly.
- Monitor solvent level and flow rate throughout the transfer.
- Do not leave the pump unattended during operation.
- Upon completion:
- Switch off the pump
- Drain remaining solvent in hoses to avoid wastage
- Disconnect and clean hoses
5.3 Post-Transfer Activities
- Document transfer details in the “Solvent Transfer Log” (Annexure-1).
- Check for any leakage, spills, or abnormalities and report immediately.
- If cross-contamination risk exists, clean pump as per cleaning SOP before reuse.
5.4 Emergency Handling
- In case of leakage/spill:
- Stop the pump immediately
- Use spill kit to contain and clean
- Ventilate the area
- Report incident to shift in-charge and EHS
- Record all such incidents in “Solvent Spill and Incident Log” (Annexure-2).
6. Abbreviations
- SOP: Standard Operating Procedure
- PPE: Personal Protective Equipment
- EHS: Environment, Health and Safety
- QA: Quality Assurance
7. Documents
- Solvent Transfer Log (Annexure-1)
- Solvent Spill and Incident Log (Annexure-2)
8. References
- ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- OSHA Flammable Liquid Transfer Safety Guidelines
- Company EHS Manual
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 Transfer Log
| Date | Solvent | Source Vessel | Destination Vessel | Volume (L) | Operator |
|---|---|---|---|---|---|
| 13/04/2025 | Methanol | DRM-101 | RX-202 | 120 |
Annexure-2: Solvent Spill and Incident Log
| Date | Solvent | Location | Description | Action Taken | Reported By |
|---|---|---|---|---|---|
| 10/04/2025 | Acetone | Tank Farm | Leak from hose clamp | Clamp replaced, area cleaned |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial Release | New Pumping Protocol | QA Head |
| 13/04/2025 | 2.0 | Spill Log and Cross-Contamination Precautions Added | Audit Feedback | QA Head |