SOP Guide for Pharma

Elixir Department: SOP for Use of Explosion-Proof Control Panels – V 2.0

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Elixir Department: SOP for Use of Explosion-Proof Control Panels – V 2.0

Standard Operating Procedure for Use of Explosion-Proof Control Panels in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/159/2025
Supersedes SOP/ELX/159/2022
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 the procedure for safe operation, inspection, and maintenance of explosion-proof control panels used in classified hazardous areas within the Elixir Department to prevent ignition of flammable vapors and ensure personnel and equipment safety.

2. Scope

This SOP applies to all explosion-proof (Ex-rated) control panels installed in areas where alcohol-based elixirs or volatile solvents are handled, including mixing rooms, filling areas, and solvent storage zones.

3. Responsibilities

  • Production Operator:
    • Operate explosion-proof panels as per instructions.
    • Check enclosure integrity and signage before each use.
  • Engineering Department:
    • Ensure compliance with ATEX/IECEx/IS standards.
    • Conduct preventive maintenance and certify panels.
  • QA Officer:
    • Verify panel calibration, inspection records, and logbook entries.

4. Accountability

The Engineering Head is accountable for panel certification and safety. The Production Head ensures correct operation. The QA Head is responsible for ensuring compliance with GMP and regulatory expectations.

See also  Elixir Department: SOP for CIP System Operation - V 2.0

5. Procedure

5.1 Description and Construction

  1. Explosion-proof panels are sealed, rigid enclosures that prevent internal sparks or arcs from igniting external gases.
  2. Panels are designed per IS/IEC 60079 or equivalent ATEX/UL standards with flame paths, flameproof glands, and special sealing gaskets.
  3. Common control functions include motor start/stop, lighting, valve actuation, and temperature control.

5.2 Pre-Use Checklist

  1. Ensure the panel is located in a marked hazardous area (Zone 1 or Zone 2).
  2. Check panel label for Ex-rating such as “Ex d IIB T4” or equivalent IS certification.
  3. Inspect for:
    • No visible cracks or deformation
    • All bolts fastened tightly
    • No unauthorized cables or openings
    • Functional emergency shutoff (if present)
  4. Sign off in Explosion-Proof Panel Checklist (Annexure-1) before starting batch.

5.3 Safe Operating Practices

  1. Only trained operators are permitted to use the panel.
  2. Do not open the enclosure unless:
    • Power is switched off and tagged out
    • Area is purged or declared gas-free
    • QA and Engineering approval is received
  3. Operate toggle switches, push buttons, and selector switches with care.
  4. In case of system alarm or emergency, press emergency shutdown if applicable and report immediately.
See also  Elixir Department: SOP for Volume Reconciliation During Manufacturing - V 2.0

5.4 Maintenance and Certification

  1. Monthly:
    • Check panel earthing resistance < 1 ohm.
    • Inspect flame path and gasket for wear or damage.
  2. Quarterly:
    • Test enclosure for IP integrity using air pressure or soap bubble test.
    • Inspect cable glands and conduit threads.
  3. Annually:
    • Calibration of control systems inside the panel (temperature, RPM, etc.).
    • Renewal of flameproof certificate by licensed authority.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • Ex: Explosion-Proof
  • IS: Indian Standards
  • ATEX: Atmosphères Explosibles (EU Directive)
  • IECEx: IEC System for Certification to Standards Relating to Equipment for Use in Explosive Atmospheres

7. Documents

  1. Explosion-Proof Panel Checklist (Annexure-1)
  2. Panel Maintenance Logbook (Annexure-2)
  3. Calibration Certificate (Annexure-3)

8. References

  • IS/IEC 60079 – Explosive Atmospheres Standard
  • 21 CFR Part 211 – Equipment Safety
  • WHO TRS 1010 – Environmental Controls and Utilities
See also  Elixir Department: SOP for Light Protection Measures in Manufacturing - 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: Explosion-Proof Panel Checklist

Date Panel ID Area Visual Inspection Seals/Gaskets Signed By Remarks
11/04/2025 EX-ELX-02 Mixing Room A OK OK Rajesh Kumar None

Annexure-2: Panel Maintenance Logbook

Date Panel ID Activity Findings Corrective Action Engineer
10/04/2025 EX-ELX-02 Gasket Inspection Intact None Ramesh Nair

Annexure-3: Calibration Certificate (Sample Entry)

Certificate No. Date Instrument Range Calibration Agency Due Date
CAL-2025/093 10/04/2025 Temperature Controller 0–100°C ABC Calibration Lab 10/04/2026

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial SOP Release New Equipment Implementation QA Head
11/04/2025 2.0 Added maintenance & certification details Compliance Enhancement QA Head
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