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API Manufacturing: SOP for Emergency Handling in Solvent Area – V 2.0

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API Manufacturing: SOP for Emergency Handling in Solvent Area – V 2.0

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
    See also  API Manufacturing: SOP for Handling and Labeling of Retest Samples - V 2.0
    API Manufacturing V 2.0 Tags:API batch record, API BMR, API calibration, API centrifuge, API cleaning, API crystallization, API deviation, API documentation, API drying, API equipment cleaning, API filtration, API GMP compliance, API granulation, API hold time, API impurities, API line clearance, API manufacturing, API process, API quality control, API reactor, API sampling, API solvent handling, API validation, API waste disposal, API yield

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    Standard Operating Procedures V 1.0

    • Aerosols
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    NEW! Revised SOPs – V 2.0

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