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

1. Evacuate non-essential personnel from the area.
2. Stop all sources of ignition and isolate equipment involved.
3. Wear appropriate PPE (gloves, goggles, face mask, antistatic coverall).
4. Use spill kit (absorbent pads, sand, neutralizer) to contain and absorb spill.
5. Ventilate the area if vapors are present.
6. Collect waste in designated hazardous waste containers.
7. Record the spill in the “Solvent Spill Log” (Annexure-1).

5.2 In Case of Fire

1. Activate the nearest fire alarm switch immediately.
2. Use fire extinguishers (foam or CO₂) only if trained and safe to do so.
3. Evacuate as per fire evacuation plan and move to assembly point.
4. Close fire doors and isolate power supply where applicable.
5. Contact firefighting team and EHS immediately.
6. Document incident in “Fire Incident Register” (Annexure-2).

5.3 Solvent Inhalation or Skin Exposure

1. Move affected person to fresh air or safety shower area.
2. In case of eye or skin contact:
   • Flush with running water for at least 15 minutes
   • Remove contaminated clothing
3. Call First Aid Officer and shift person to medical center if required.
4. Record exposure in “First Aid Register” (Annexure-3).

5.4 Reporting and Escalation

1. Shift in-charge must inform:
   • EHS Department
   • QA Head (if batch impact exists)
   • Security Officer
2. Fill “Emergency Incident Report” (Annexure-4) and submit to EHS within 2 hours.
3. Root cause analysis and CAPA to be completed within 5 working days.

5.5 Training and Mock Drill

1. All employees must be trained in solvent emergency response annually.
2. 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

1. Solvent Spill Log (Annexure-1)
2. Fire Incident Register (Annexure-2)
3. First Aid Register (Annexure-3)
4. Emergency Incident Report (Annexure-4)
5. 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