Elixir Department: SOP for Safety Measures in Alcohol-Based Elixir Production – V 2.0

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Elixir Department: SOP for Safety Measures in Alcohol-Based Elixir Production – V 2.0

Standard Operating Procedure for Safety Measures in Alcohol-Based Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/116/2025
Supersedes SOP/ELX/116/2022
Page No. Page 1 of 10
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To establish standardized safety measures for the handling, processing, and storage of alcohol-based elixirs in the Elixir Department. This SOP ensures the protection of personnel, prevention of fire and explosion hazards, and compliance with statutory and GMP requirements.

2. Scope

This SOP applies to all activities involving the receipt, storage, dispensing, mixing, and transfer of alcohol and alcohol-containing formulations within the Elixir manufacturing areas.

3. Responsibilities

  • Production Operator:
    • Follow all safety protocols while handling alcohol-based substances.
    • Use appropriate PPE and operate within approved safety zones only.
  • Production Supervisor:
    • Monitor adherence to safety measures and report deviations.
    • Ensure that flammable materials are handled as per guidelines.
  • Engineering Department:
    • Maintain flameproof equipment, ensure proper ventilation systems are functional, and verify grounding/earthing.
  • QA Officer:
    • Conduct safety audits and reviews of alcohol-handling procedures.

See also  Elixir Department: SOP for Sampling During Elixir Manufacturing - V 2.0

4. Accountability

The Head of Production and Engineering are jointly accountable for ensuring adherence to safety

protocols during alcohol-based elixir production.

5. Procedure

5.1 Alcohol Handling Zones

  1. Designate specific areas for alcohol dispensing, mixing, and transfer—labelled as “FLAMMABLE ZONE.”
  2. Ensure restricted access to authorized personnel only with proper PPE.
  3. Equip zones with alcohol-rated flameproof lighting and exhaust ventilation systems.

5.2 Personal Protective Equipment (PPE)

  1. All personnel must wear:
    • Flame-retardant lab coat
    • Anti-static footwear
    • Chemical-resistant gloves
    • Safety goggles or face shield
    • Respirator (if vapour concentration is high)

5.3 Fire and Explosion Prevention

  1. Use only flameproof equipment and intrinsically safe instrumentation in alcohol zones.
  2. Prohibit use of mobile phones, lighters, or open flames.
  3. Ensure all containers, vessels, and pipelines are properly grounded and bonded to prevent static buildup.
  4. Maintain minimum distance of 5 meters between electrical panels and flammable materials.
  5. Install flame arrestors and explosion-proof motors for agitators and pumps.

5.4 Storage and Dispensing

  1. Store alcohols in designated flameproof storage rooms equipped with fire detection systems and spill containment.
  2. Keep Material Safety Data Sheets (MSDS) of all alcohols readily accessible.
  3. Dispense only under fume hoods or localized exhaust ventilation systems.
  4. Label all containers clearly with “FLAMMABLE,” product name, and batch number.
See also  Elixir Department: SOP for Agitator Blade Changeover Procedure - V 2.0

5.5 Environmental Controls

  1. Maintain relative humidity between 40% to 60% to minimize static charge.
  2. Ensure ambient temperature does not exceed 30°C in storage and production zones.
  3. Run exhaust fans continuously during alcohol-related operations.

5.6 Emergency Handling

  1. Install ABC-type and CO2 fire extinguishers in all alcohol-handling zones.
  2. Provide safety showers and eyewash stations near alcohol processing areas.
  3. Train staff on fire drill response, evacuation procedures, and emergency shutdown systems.
  4. Report all spills or near-miss events immediately using the Incident Reporting Form.

5.7 Documentation

  1. Maintain records of:
    • Alcohol usage and dispensing
    • PPE issuance logs
    • Daily area checks and ventilation system status
    • Emergency drills and training
  2. Update Safety Measures Checklist (Annexure-1) for each operation involving alcohol.

5.8 Audits and Monitoring

  1. QA shall conduct monthly audits to verify compliance with safety protocols.
  2. Engineering shall inspect flameproof equipment quarterly and document results.
  3. Any deviation from safety norms shall be documented and investigated.
See also  Elixir Department: SOP for Identification and Traceability of Manufacturing Tanks - V 2.0

6. Abbreviations

  • SOP: Standard Operating Procedure
  • MSDS: Material Safety Data Sheet
  • PPE: Personal Protective Equipment
  • QA: Quality Assurance

7. Documents

  1. Safety Measures Checklist (Annexure-1)
  2. Alcohol Usage and Dispensing Log
  3. Incident Reporting Form

8. References

  • NFPA 30 – Flammable and Combustible Liquids Code
  • 21 CFR Part 211 – Current Good Manufacturing Practice
  • WHO TRS 1010 – GMP for Pharmaceutical Production

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Safety Measures Checklist for Alcohol-Based Elixir Production

Date Batch No. Area PPE Verified Ventilation Status Labeling Checked Fire Extinguishers OK Checked By
11/04/2025 ELX-1051 Mixing Room 1 Yes Operational Yes Yes Rajesh Kumar

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 Expanded environmental and emergency protocols Regulatory Compliance QA Head
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