Standard Operating Procedure for Emergency Handling in Solvent Area in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/059/2025 |
| Supersedes | SOP/API/059/2022 |
| 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 emergency handling procedures for solvent-related incidents in the API manufacturing plant, ensuring quick response, protection of personnel and property, and compliance with safety standards.
2. Scope
This SOP applies to all solvent storage, transfer, handling, and recovery operations conducted within the API manufacturing area, including incidents like fire, spills, inhalation, and equipment failure.
3. Responsibilities
- All Employees: Immediately report and respond to solvent emergencies as trained.
- Shift In-charge: Supervise emergency actions and initiate communication with EHS and Security.
- EHS Team: Lead containment, evacuation, and incident analysis.
- Security Personnel: Activate alarms and control area access during emergencies.
4. Accountability
The EHS Head is accountable for ensuring timely and effective emergency handling in solvent areas. The Site Head is responsible for post-incident CAPA and compliance reporting.
5. Procedure
5.1 Immediate Actions in Case of Solvent Leak or Spill
- Evacuate non-essential personnel from the area.
- Stop all sources of ignition and isolate equipment involved.
- Wear appropriate PPE (gloves, goggles, face mask, antistatic coverall).
- Use spill kit (absorbent pads, sand, neutralizer) to contain and absorb spill.
- Ventilate the area if vapors are present.
- Collect waste in designated hazardous waste containers.
- Record the spill in the “Solvent Spill Log” (Annexure-1).
5.2 In Case of Fire
- Activate the nearest fire alarm switch immediately.
- Use fire extinguishers (foam or CO₂) only if trained and safe to do so.
- Evacuate as per fire evacuation plan and move to assembly point.
- Close fire doors and isolate power supply where applicable.
- Contact firefighting team and EHS immediately.
- Document incident in “Fire Incident Register” (Annexure-2).
5.3 Solvent Inhalation or Skin Exposure
- Move affected person to fresh air or safety shower area.
- In case of eye or skin contact:
- Flush with running water for at least 15 minutes
- Remove contaminated clothing
- Call First Aid Officer and shift person to medical center if required.
- Record exposure in “First Aid Register” (Annexure-3).
5.4 Reporting and Escalation
- Shift in-charge must inform:
- EHS Department
- QA Head (if batch impact exists)
- Security Officer
- Fill “Emergency Incident Report” (Annexure-4) and submit to EHS within 2 hours.
- Root cause analysis and CAPA to be completed within 5 working days.
5.5 Training and Mock Drill
- All employees must be trained in solvent emergency response annually.
- Conduct mock emergency drills every six months and maintain “Mock Drill Report” (Annexure-5).
6. Abbreviations
- SOP: Standard Operating Procedure
- EHS: Environment, Health and Safety
- CAPA: Corrective and Preventive Action
- PPE: Personal Protective Equipment
7. Documents
- Solvent Spill Log (Annexure-1)
- Fire Incident Register (Annexure-2)
- First Aid Register (Annexure-3)
- Emergency Incident Report (Annexure-4)
- Mock Drill Report (Annexure-5)
8. References
- OSHA Standard 1910 – Hazardous Materials
- Factory Act, 1948 – Emergency and Safety Rules
- ICH Q9 – Quality Risk Management
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 Spill Log
| Date | Location | Solvent | Volume (L) | Action Taken | Reported By |
|---|---|---|---|---|---|
| 13/04/2025 | Tank Farm | Toluene | 10 | Neutralized and Collected |
Annexure-2: Fire Incident Register
| Date | Location | Cause | Damage | Action Taken |
|---|---|---|---|---|
| 12/04/2025 | Solvent Recovery | Electrical Spark | None | Panel Repaired |
Annexure-3: First Aid Register
| Date | Employee Name | Exposure Type | Action Taken | Doctor Recommendation |
|---|---|---|---|---|
| 11/04/2025 | Rajesh Kumar | Inhalation | Oxygen Support | Observation for 4 hrs |
Annexure-4: Emergency Incident Report
| Date | Time | Type | Description | Immediate Response | Root Cause | CAPA Ref. |
|---|---|---|---|---|---|---|
| 13/04/2025 | 09:15 | Spill | Solvent Leak from Valve | Isolated and Cleaned | Worn gasket | CAPA-059 |
Annexure-5: Mock Drill Report
| Date | Type | Location | No. of Participants | Observations |
|---|---|---|---|---|
| 05/04/2025 | Evacuation | Solvent Warehouse | 28 | Evacuation within 2 mins |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial SOP Release | Regulatory Requirement | QA Head |
| 13/04/2025 | 2.0 | Included Spill, Fire, and Exposure Protocols | Updated Emergency Response Plan | QA Head |