Elixir Department: SOP for Use of Flameproof Equipment in Alcohol-Based Elixirs – V 2.0

Posted on By

Elixir Department: SOP for Use of Flameproof Equipment in Alcohol-Based Elixirs – V 2.0

Standard Operating Procedure for Use of Flameproof Equipment in Alcohol-Based Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/142/2025
Supersedes SOP/ELX/142/2022
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 the safe use, handling, and maintenance of flameproof (explosion-proof) equipment in the manufacturing of alcohol-based elixirs to prevent fire hazards, ensure regulatory compliance, and protect personnel and property.

2. Scope

This SOP applies to all flameproof motors, control panels, pumps, mixers, and weighing balances used in the alcohol-handling areas of the Elixir Department, especially where alcohol vapors may be present.

3. Responsibilities

  • Production Operator:
    • Operate flameproof equipment only after verifying its safety status.
    • Report any sparks, abnormal noise, or malfunction immediately.
  • Engineering Department:
    • Maintain flameproof integrity and perform routine inspections.
    • Ensure junction boxes and enclosures are sealed properly.
  • QA Officer:
    • Ensure the use of validated and compliant equipment in classified zones.
    • Verify logbooks and review maintenance records during audits.
See also  Elixir Department: SOP for Control and Use of Primary Containers During Dispensing - V 2.0

4. Accountability

The Production Head is accountable for implementing this SOP. The Engineering Head is responsible for

the mechanical and electrical integrity of flameproof systems.

5. Procedure

5.1 Identification of Flameproof Equipment

  1. All flameproof equipment must have certified markings (e.g., ATEX, IECEx, PESO) and be suitable for use in Zone 1/Zone 2 hazardous areas.
  2. Ensure the equipment has a label indicating its gas group and temperature class (e.g., IIB, T3).

5.2 Pre-Use Checks

  1. Check for damage or corrosion on the enclosure, seals, cable glands, and earthing points.
  2. Ensure covers and access panels are tightly closed with proper flameproof bolts.
  3. Verify equipment is labeled “CLEANED” and “CERTIFIED FOR USE.”
  4. Do not use any open or modified flameproof device without Engineering clearance.

See also  Elixir Department: SOP for Electronic Batch Record Systems - V 2.0

5.3 Operating Procedures

  1. Ensure that no alcohol transfer or handling is initiated before activating the exhaust ventilation system.
  2. Turn on flameproof equipment using designated explosion-proof switches or pushbuttons only.
  3. Maintain temperature and pressure parameters within validated operational limits.
  4. Operate only one alcohol-handling activity in the classified area at a time to avoid vapor accumulation.

5.4 Maintenance and Handling

  1. Only authorized Engineering personnel trained in flameproof equipment may perform maintenance.
  2. Never open the enclosures while the equipment is live. Follow lock-out/tag-out (LOTO) procedures.
  3. Use only certified flameproof spare parts for replacement and repairs.
  4. Record every maintenance activity in the Equipment Maintenance Log (Annexure-1).

5.5 Emergency Handling

  1. In case of any abnormal sound, smoke, or spark, immediately switch off the equipment using emergency stop and evacuate the area.
  2. Inform the Engineering and Safety Officer immediately.
  3. Tag the equipment as “DO NOT USE – UNDER INVESTIGATION.”

6. Abbreviations

  • SOP: Standard Operating Procedure
  • LOTO: Lock-Out Tag-Out
  • PESO: Petroleum and Explosives Safety Organisation
  • QA: Quality Assurance
See also  Elixir Department: SOP for Line Clearance Before Manufacturing - V 2.0

7. Documents

  1. Equipment Maintenance Log (Annexure-1)
  2. Flameproof Equipment Verification Checklist
  3. Calibration and Certification Records

8. References

  • Explosives Rules, 2008 (India) – PESO Guidelines
  • 21 CFR Part 211 – Equipment Maintenance and Use
  • IEC 60079 – Electrical Equipment in Hazardous Areas

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Equipment Maintenance Log

Date Equipment ID Area Activity Performed Engineer Name Remarks
11/04/2025 FLM-MTR-01 Alcohol Mixing Room Terminal Tightening and Visual Inspection Sunil Yadav OK – No Fault Detected

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 PESO compliance and emergency section GMP & Safety Update QA Head
Elixers V 2.0 Tags:, , , , , , , , , , , , , , , , , , , , , , , ,