Elixir Department: SOP for Cleaning Equipment in Explosion-Proof Areas – V 2.0

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Elixir Department: SOP for Cleaning Equipment in Explosion-Proof Areas – V 2.0

Standard Operating Procedure for Cleaning Equipment in Explosion-Proof Areas in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/182/2025
Supersedes SOP/ELX/182/2022
Page No. Page 1 of 9
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To define the safe and compliant procedure for cleaning equipment located in explosion-proof (hazardous) areas within the Elixir Manufacturing Department, particularly where flammable solvents and vapors are handled.

2. Scope

This SOP applies to all production equipment, tanks, valves, and associated components present in classified explosion-proof areas (Zone 1 and Zone 2) of the Elixir Department, especially where alcohol-based or volatile ingredients are processed.

3. Responsibilities

  • Production Operator:
    • Carry out cleaning using flame-proof tools and approved techniques.
  • Engineering Department:
    • Ensure all electrical and utility systems in the zone comply with explosion-proof standards.
  • EHS & QA Personnel:
    • Review and verify adherence to safety measures and cleaning compliance.

4. Accountability

The Production Head is accountable for ensuring compliance with cleaning in hazardous areas. The QA Head is responsible for cleaning verification. The EHS Officer ensures adherence to safety protocols.

See also  Elixir Department: SOP for Verification of Final Product Volume - V 2.0

5. Procedure

5.1 General Safety Precautions

  1. Obtain cleaning clearance from EHS before entering the zone.
  2. Ensure area is well ventilated and free of vapor accumulation.
  3. Use only flame-proof lighting, electrical connections, and non-sparking tools.
  4. Prohibit smoking, welding, or use of mobile phones inside the area.

5.2 PPE Requirements

  • Antistatic overalls
  • Flame-retardant gloves
  • Anti-static footwear
  • Face shield and safety goggles

5.3 Cleaning Materials and Tools

  • Approved non-sparking brushes and scrapers
  • Lint-free cloths
  • Detergent solution (non-flammable)
  • 70% IPA or other approved alcohols (used with caution and in small volumes)

5.4 Cleaning Procedure

  1. Switch off all equipment and disconnect from power where safe and allowed.
  2. Wipe external surfaces with detergent and water using lint-free cloth.
  3. Use non-sparking brushes for residue on flanges and corners.
  4. For interior parts:
    • Use minimum volume of 70% IPA only where validated and allowed.
    • Wipe off residual IPA using dry cloth. Allow air drying in ventilated zone.
  5. Do not spray IPA or solvent directly onto equipment or electrical panels.
  6. Document time of entry and exit from zone in the hazardous area access register.
See also  Elixir Department: SOP for Final Mixing Tank Clean-in-Place (CIP) Operations - V 2.0

5.5 Post-Cleaning Checks

  1. Inspect cleaned equipment visually for residues, dust, or product remains.
  2. QA to sign off cleaning completion checklist (Annexure-1).
  3. Report any signs of leakage, vapor release, or loose connections to Engineering.

5.6 Documentation

  1. Record all cleaning activity in the Explosion-Proof Area Cleaning Logbook (Annexure-2).
  2. Note safety observations in EHS Checklist (Annexure-3) and retain records as per retention policy.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • EHS: Environment, Health and Safety
  • IPA: Isopropyl Alcohol

7. Documents

  1. Explosion-Proof Area Cleaning Logbook (Annexure-2)
  2. Cleaning Verification Checklist (Annexure-1)
  3. EHS Safety Checklist (Annexure-3)

8. References

  • National Building Code – Hazardous Area Classification
  • 21 CFR Part 211.67 – Cleaning and Maintenance
  • WHO TRS 957 Annex 5 – GMP for Hazardous Pharmaceutical Manufacturing
See also  Elixir Department: SOP for Transfer of Final Bulk for Bottling - V 2.0

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Cleaning Verification Checklist

Equipment ID Date Area Cleaned Visually Clean QA Verified By Remarks
MXR-ELX-05 11/04/2025 Tank Outer Surface Yes Sunita Reddy Approved

Annexure-2: Cleaning Logbook

Date Operator Name Equipment Cleaned Cleaning Agent Used Time In Time Out QA Verified
11/04/2025 Rajesh Kumar Alcohol Transfer Line 1% Neutraclean 09:30 10:15 Yes

Annexure-3: EHS Safety Checklist

Date Area Ventilation OK Flameproof Tools Used Spark Risk Observed EHS Verified
11/04/2025 Zone 1 – Solvent Room Yes Yes No Neha Patil

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial SOP Release New SOP QA Head
11/04/2025 2.0 Added EHS safety checklist and solvent handling cautions Compliance Update QA Head
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