Elixir Department: SOP for Use of Nitrogen Blanketing for Volatile Elixirs – V 2.0

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Elixir Department: SOP for Use of Nitrogen Blanketing for Volatile Elixirs – V 2.0

Standard Operating Procedure for Use of Nitrogen Blanketing in Volatile Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/078/2025
Supersedes SOP/ELX/078/2022
Page No. Page 1 of 8
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To define the procedure for using nitrogen blanketing during the manufacturing, storage, and transfer of volatile elixirs to prevent oxidation, evaporation loss, and contamination due to exposure to atmospheric air.

2. Scope

This SOP is applicable to all volatile elixir formulations containing alcohols or other volatile solvents that require nitrogen blanketing in stainless steel vessels, holding tanks, and pipelines in the Elixir Department.

3. Responsibilities

  • Production Operator:
    • Perform nitrogen blanketing as per instructions and ensure proper flow rate and pressure.
    • Check integrity of connections and safety of nitrogen supply line.
  • Production Supervisor:
    • Verify nitrogen source, monitor consumption, and ensure proper venting post-operation.
  • Engineering Department:
    • Maintain and calibrate nitrogen regulators, pressure gauges, and ensure uninterrupted supply.
  • QA Officer:
    • Ensure compliance and review nitrogen blanketing log for batch records.
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4. Accountability

The Head of Production is accountable for implementing and maintaining nitrogen blanketing

procedures for volatile elixirs to ensure product quality and regulatory compliance.

5. Procedure

5.1 Prerequisite Checks

  1. Ensure nitrogen gas cylinder is connected with pressure regulator and supply hose in good condition.
  2. Confirm that nitrogen is of pharmaceutical grade (minimum 99.9% purity).
  3. Check vessel is cleaned, labeled as “CLEANED,” and validated for blanketing.

5.2 Setup and Operation

  1. Open nitrogen cylinder valve slowly and adjust regulator to maintain 0.5 to 1.0 kg/cm² pressure.
  2. Open the inlet valve to the tank/vessel and allow nitrogen gas to displace atmospheric air in the headspace.
  3. Maintain a positive nitrogen pressure throughout mixing, transfer, and storage.
  4. Close nitrogen inlet after operation and purge line before disconnection.
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5.3 Monitoring

  1. Record inlet pressure and flow rate at start and end of blanketing operation.
  2. Ensure the pressure does not exceed vessel design limit.
  3. Log parameters in the Nitrogen Blanketing Log (Annexure-1).

5.4 Safety Measures

  1. Ensure nitrogen is used in a well-ventilated area to prevent oxygen depletion.
  2. Label nitrogen lines clearly and use flame-proof fittings in alcohol handling areas.
  3. Do not use compressed air in place of nitrogen for blanketing purposes.

5.5 Post-Operation

  1. Turn off regulator and close cylinder valve securely.
  2. Detach hose and store equipment in designated safe area.
  3. Record operation closure details in the logbook and verify integrity of residual product.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • kg/cm²: Kilogram per square centimeter

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7. Documents

  1. Nitrogen Blanketing Log (Annexure-1)
  2. Equipment Calibration Certificate
  3. Batch Manufacturing Record (BMR)

8. References

  • 21 CFR Part 211.63 – Equipment Design, Size, and Location
  • ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
  • WHO GMP Annex 2 – Handling of Gases in Pharmaceutical Manufacturing

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Nitrogen Blanketing Log

Date Batch No. Start Time End Time Pressure (kg/cm²) Operator Remarks
11/04/2025 ELX-1017 10:00 AM 12:30 PM 0.8 Rajesh Kumar Operation completed successfully

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 Safety and Post-Operation Checks Process Control Enhancement QA Head
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