SOP Guide for Pharma

Elixir Department: SOP for Cleaning Flammable Solvent Equipment – V 2.0

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Elixir Department: SOP for Cleaning Flammable Solvent Equipment – V 2.0

Standard Operating Procedure for Cleaning Flammable Solvent Equipment in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/187/2025
Supersedes SOP/ELX/187/2022
Page No. Page 1 of 10
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To define a safe, validated, and compliant procedure for cleaning of equipment used in handling, transferring, or storing flammable solvents during elixir manufacturing.

2. Scope

This SOP applies to all tanks, pipelines, hoses, valves, and accessories exposed to flammable solvents (e.g., ethanol, isopropanol) within the Elixir Manufacturing Department.

3. Responsibilities

  • Production Operator:
    • Perform cleaning using flameproof equipment and methods described herein.
  • Engineering Department:
    • Ensure flameproof and explosion-proof compliance of cleaning infrastructure.
  • QA & EHS Officers:
    • Ensure all safety and validation requirements are fulfilled during cleaning.

4. Accountability

The Production Head is accountable for the implementation of this SOP. The QA Head ensures validation, and EHS Head ensures safety compliance and hazardous area classification adherence.

See also  Elixir Department: SOP for Transfer of Materials to Quarantine Area Post Dispensing - V 2.0

5. Procedure

5.1 Safety Precautions

  1. Ensure no ignition source is present in the vicinity of cleaning operations.
  2. Use intrinsically
safe or flameproof equipment only.
  • Wear antistatic PPE: coveralls, footwear, and gloves.
  • Ensure area ventilation is active. Use gas detector for flammable vapor levels.

    • 5.2 Materials and Tools

    • Approved flameproof pumps and cleaning equipment
    • Purified water and 1% neutral detergent solution
    • Solvent recovery drum (earthing required)
    • Lint-free cloths, non-sparking tools

    5.3 Cleaning Process

    1. Draining: Ensure all flammable solvent is drained and transferred to a labeled recovery drum with grounding wire attached.
    2. Initial Rinse: Rinse with purified water to remove solvent residues. Collect rinse in flammable waste container.
    3. Detergent Cleaning: Circulate 1% neutral detergent solution for 10–15 minutes through pipelines and tank jackets using CIP system or manual scrubbing for smaller parts.
    4. Rinse: Rinse twice with purified water until pH and conductivity meet acceptable limits. Check for odor to confirm absence of residual solvent.
    5. Drying: Dry using compressed HEPA-filtered air or drying cabinet, avoiding heat-based methods that could pose ignition risk.

    5.4 Verification and Labeling

    1. QA to inspect cleaned equipment for absence of solvent odor and visible residues.
    2. If required, perform rinse sampling and send for GC analysis for residual solvents.
    3. Label equipment with “CLEANED – READY FOR USE” after QA clearance.

    5.5 Documentation

    1. Enter cleaning details in the Flammable Solvent Equipment Cleaning Logbook (Annexure-1).
    2. Attach solvent disposal record and rinse sample report if applicable.

    6. Abbreviations

    • SOP: Standard Operating Procedure
    • QA: Quality Assurance
    • EHS: Environment, Health & Safety
    • CIP: Clean-In-Place

    7. Documents

    1. Flammable Solvent Equipment Cleaning Logbook (Annexure-1)
    2. Solvent Recovery Record
    3. Residual Solvent Rinse Report (if applicable)

    8. References

    • 21 CFR Part 211.67 – Cleaning and Maintenance
    • ICH Q7 – GMP Guidelines for Active Pharmaceutical Ingredients
    • NFPA 30 – Flammable and Combustible Liquids Code

    9. SOP Version

    Version: 2.0

    10. Approval Section

    Prepared By Checked By Approved By
    Signature
    Date
    Name
    Designation
    Department

    11. Annexures

    Annexure-1: Flammable Solvent Equipment Cleaning Logbook

    Date Equipment ID Solvent Handled Cleaning Method Cleaned By QA Verified Remarks
    11/04/2025 TK-ELX-15 Ethanol Manual + CIP Rajesh Kumar Sunita Reddy Odor-free, Ready

    Revision History:

    Revision Date Revision No. Revision Details Reason for Revision Approved By
    01/01/2024 1.0 Initial Release New SOP QA Head
    11/04/2025 2.0 Added GC testing step for residue Audit Compliance QA Head
    See also  Elixir Department: SOP for Deviation Management - V 2.0
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