Standard Operating Procedure for Safety Measures in Solvent Recovery Operations in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/046/2025 |
| Supersedes | SOP/API/046/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To establish safety protocols and preventive measures for solvent recovery operations in API manufacturing, minimizing risks of fire, explosion, chemical exposure, and environmental contamination.
2. Scope
This SOP applies to all personnel, equipment, and operations involved in solvent recovery processes, including distillation, collection, and handling of recovered solvents in the API facility.
3. Responsibilities
- Operators: Follow safety protocols and wear appropriate PPE during all solvent handling operations.
- Shift Supervisor: Monitor compliance and report any unsafe conditions immediately.
- EHS Officer: Conduct regular inspections, provide training, and investigate incidents.
4. Accountability
The EHS Head is accountable for ensuring the implementation of all safety controls in solvent recovery operations. The Production Head is responsible for safe execution at the operational level.
5. Procedure
5.1 Personal Protective Equipment (PPE)
- Mandatory PPE for all personnel in solvent recovery area:
- Flame-resistant overalls or lab coats
- Chemical-resistant gloves (nitrile or neoprene)
- Antistatic safety footwear
- Chemical splash goggles or face shield
- Respiratory protection if solvent fumes exceed limits
- Ensure PPE is in good condition before entry into recovery area.
5.2 Equipment and Area Safety
- Use only flameproof-rated equipment and motors in solvent recovery areas.
- Verify proper earthing and bonding of distillation vessels, pipelines, and storage drums to prevent static discharge.
- Install gas detection alarms for flammable vapor monitoring.
- Use closed systems for solvent transfer to minimize vapor release.
- Label all pipelines, valves, and vessels clearly for correct identification.
5.3 Operational Safety
- Do not allow mobile phones, matchsticks, lighters, or unauthorized electrical equipment in the solvent recovery area.
- Check for solvent compatibility before starting distillation or mixing.
- Maintain solvent recovery logs, and inspect for leaks or corrosion before and after operations.
- Ensure emergency exits are unobstructed at all times.
- Prohibit eating, drinking, or smoking in solvent recovery zones.
5.4 Emergency Preparedness
- Equip area with fire extinguishers (foam, CO₂) and spill control kits.
- Train personnel in:
- Fire safety and evacuation
- Solvent spill control
- First aid response
- Display Material Safety Data Sheets (MSDS) for all solvents used.
- Conduct emergency drills at least once every six months and document results in the “Safety Drill Log” (Annexure-1).
5.5 Incident Reporting
- Report any fire, spill, injury, or near-miss event immediately to the shift supervisor and EHS department.
- Record details in the “Solvent Safety Incident Log” (Annexure-2).
- Implement corrective actions and preventive measures (CAPA) for each incident.
6. Abbreviations
- SOP: Standard Operating Procedure
- PPE: Personal Protective Equipment
- EHS: Environment, Health, and Safety
- MSDS: Material Safety Data Sheet
- CAPA: Corrective and Preventive Action
7. Documents
- Safety Drill Log (Annexure-1)
- Solvent Safety Incident Log (Annexure-2)
8. References
- ICH Q7 – GMP Guidelines for API
- OSHA 1910.106 – Flammable and Combustible Liquids
- NFPA 30 – Flammable Liquids Code
- MSDS and company safety 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: Safety Drill Log
| Date | Type of Drill | Conducted By | No. of Participants | Outcome | Remarks |
|---|---|---|---|---|---|
| 10/04/2025 | Solvent Spill Drill | EHS | 15 | Satisfactory | Improved response time |
Annexure-2: Solvent Safety Incident Log
| Date | Type of Incident | Location | Reported By | Immediate Action | CAPA Reference |
|---|---|---|---|---|---|
| 05/04/2025 | Minor Spill | Recovery Room-1 | Cleaned with absorbent | CAPA-0425 |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial SOP Release | New Operation Safety Protocol | QA Head |
| 13/04/2025 | 2.0 | Added Emergency Drills and Static Protection | Audit & EHS Compliance | QA Head |