SOP Guide for Pharma

SOP for Use of Explosion-Proof Storage Cabinets for Flammable Raw Materials – V 2.0

SOP for Use of Explosion-Proof Storage Cabinets for Flammable Raw Materials – V 2.0

Standard Operating Procedure for Use of Explosion-Proof Storage Cabinets for Flammable Raw Materials

Department Warehouse / Quality Assurance
SOP No. SOP/RM/113/2025
Supersedes SOP/RM/113/2022
Page No. Page 1 of 15
Issue Date 13/02/2025
Effective Date 17/02/2025
Review Date 13/02/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the safe use, handling, and maintenance of explosion-proof storage cabinets for flammable raw materials to ensure workplace safety and regulatory compliance.

2. Scope

This SOP applies to all flammable raw materials, including solvents, chemicals, and reagents, stored in explosion-proof cabinets within the warehouse and laboratory environments.

3. Responsibilities

  • Warehouse Personnel: Store and handle flammable materials in designated explosion-proof cabinets and monitor storage conditions.
  • Quality Assurance (QA): Conduct audits to ensure compliance with safety standards for flammable materials.
  • Warehouse Manager: Oversee the proper use of explosion-proof cabinets and ensure staff are trained on safety procedures.

4. Accountability

The Warehouse Manager is accountable for the safe storage of flammable materials in explosion-proof cabinets, while the QA Manager ensures compliance with safety and regulatory requirements.

5. Procedure

5.1 Selection and Installation of Explosion-Proof Cabinets

  1. Cabinet Selection:
    • Select
explosion-proof cabinets that meet OSHA and NFPA standards for the storage of flammable liquids.
  • Ensure cabinets have self-closing doors, grounding connections, and ventilation options.
  • Installation Guidelines:
    • Install cabinets in well-ventilated areas, away from ignition sources, and maintain clear access for emergency response.
    • Document installation details in the Cabinet Installation Log (Annexure-1).
  • 5.2 Storage of Flammable Raw Materials

    1. Labeling and Segregation:
      • Clearly label all flammable materials with hazard symbols and store them in appropriate containers (e.g., safety cans).
      • Segregate incompatible substances, such as acids and bases, to prevent chemical reactions.
      • Document storage arrangements in the Flammable Material Storage Log (Annexure-2).
    2. Capacity Limits:
      • Do not exceed the maximum storage capacity of the cabinet as specified by the manufacturer.
      • Document capacity checks in the Capacity Monitoring Log (Annexure-3).

    5.3 Handling Procedures for Flammable Materials

    1. Personal Protective Equipment (PPE):
      • Wear appropriate PPE, including flame-resistant gloves, goggles, and protective clothing, while handling flammable materials.
      • Document PPE checks in the PPE Usage Log (Annexure-4).
    2. Safe Handling Practices:
      • Use bonding and grounding procedures to prevent static discharge during material transfer.
      • Handle materials in designated flammable liquid storage areas, away from open flames and heat sources.
      • Document handling activities in the Material Handling Log (Annexure-5).

    5.4 Monitoring and Maintenance of Cabinets

    1. Regular Inspections:
      • Inspect explosion-proof cabinets monthly for signs of damage, corrosion, or malfunction.
      • Ensure that the self-closing mechanisms and venting systems are functional.
      • Document inspection results in the Cabinet Inspection Log (Annexure-6).
    2. Maintenance Schedule:
      • Perform routine maintenance, including lubrication of hinges and cleaning of vent filters, as per the manufacturer’s instructions.
      • Document maintenance activities in the Maintenance Log (Annexure-7).

    5.5 Handling of Deviations and Spills

    1. Deviation Detection:
      • Identify deviations in storage conditions or cabinet functionality through regular monitoring.
      • Isolate affected materials immediately and initiate corrective actions.
      • Document deviations in the Deviation Log (Annexure-8).
    2. Spill Response:
      • In case of a spill, evacuate the area, use appropriate spill containment kits, and notify the emergency response team.
      • Ventilate the area and ensure safe disposal of contaminated materials according to hazardous waste protocols.
      • Document spill responses in the Spill Response Log (Annexure-9).

    5.6 Periodic Review and Compliance Monitoring

    1. Warehouse Inspections:
      • Conduct routine inspections to ensure compliance with storage and safety protocols.
      • Document inspection findings in the Warehouse Inspection Log (Annexure-10).
    2. QA Compliance Audits:
      • QA will perform audits to verify compliance with safety and regulatory standards for flammable material storage.
      • Document audit findings in the Compliance Audit Log (Annexure-11).

    6. Abbreviations

    • SOP: Standard Operating Procedure
    • GMP: Good Manufacturing Practice
    • QA: Quality Assurance
    • PPE: Personal Protective Equipment
    • OSHA: Occupational Safety and Health Administration
    • NFPA: National Fire Protection Association

    7. Documents

    1. Cabinet Installation Log (Annexure-1)
    2. Flammable Material Storage Log (Annexure-2)
    3. Capacity Monitoring Log (Annexure-3)
    4. PPE Usage Log (Annexure-4)
    5. Material Handling Log (Annexure-5)
    6. Cabinet Inspection Log (Annexure-6)
    7. Maintenance Log (Annexure-7)
    8. Deviation Log (Annexure-8)
    9. Spill Response Log (Annexure-9)
    10. Warehouse Inspection Log (Annexure-10)
    11. Compliance Audit Log (Annexure-11)

    8. References

    • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
    • OSHA 29 CFR 1910.106 – Flammable Liquids
    • NFPA 30 – Flammable and Combustible Liquids Code
    • WHO GMP Guidelines

    9. SOP Version

    Version: 2.0

    10. Approval Section

    Prepared By Checked By Approved By
    Signature
    Date
    Name
    Designation
    Department

    11. Annexures

    Annexure-1: Cabinet Installation Log

    Date Cabinet ID Location Installed By
    13/02/2025 EXP-CAB-001 Flammable Storage Area 1 Ravi Kumar

    Annexure-2: Flammable Material Storage Log

    Date Material Name Batch Number Cabinet ID Stored By
    13/02/2025 Toluene TOL-2025-001 EXP-CAB-001 Sunita Sharma

    Annexure-3: Capacity Monitoring Log

    Date Cabinet ID Capacity Utilization (%) Checked By
    13/02/2025 EXP-CAB-001 75% Ravi Kumar

    Annexure-4: PPE Usage Log

    Date Material Handled PPE Used Issued By
    13/02/2025 Toluene Gloves, Goggles, Flame-Resistant Clothing Anjali Mehta

    Annexure-5: Material Handling Log

    Date Material Name Batch Number Handling Activity Handled By
    13/02/2025 Toluene TOL-2025-001 Transferred to QC Lab Sunita Sharma

    Annexure-6: Cabinet Inspection Log

    Date Cabinet ID Inspection Findings Inspected By
    13/02/2025 EXP-CAB-001 No issues detected Anjali Mehta

    Annexure-7: Maintenance Log

    Date Cabinet ID Maintenance Activity Performed By
    12/02/2025 EXP-CAB-001 Lubricated hinges and checked seals Ravi Kumar

    Annexure-8: Deviation Log

    Date Deviation Action Taken Reported By
    12/02/2025 Cabinet door not sealing properly Repaired door mechanism Ravi Kumar

    Annexure-9: Spill Response Log

    Date Material Spilled Spill Size Action Taken Handled By
    12/02/2025 Toluene 250 ml Used spill kit, ventilated area Sunita Sharma

    Annexure-10: Warehouse Inspection Log

    Date Area Inspected Inspector Findings Corrective Actions
    13/02/2025 Flammable Storage Area 1 Anjali Mehta No deviations found N/A

    Annexure-11: Compliance Audit Log

    Date Audit Type Findings Corrective Actions Audited By
    14/02/2025 Explosion-Proof Cabinet Compliance Audit Compliant N/A Anjali Mehta

    Revision History:

    Revision Date Revision No. Revision Details Reason for Revision Approved By
    01/01/2024 1.0 Initial Version New SOP QA Head
    13/02/2025 2.0 Updated Handling and Storage Procedures Regulatory Compliance QA Head
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