Elixir Department: SOP for Operating Vacuum Transfer Systems – V 2.0

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Elixir Department: SOP for Operating Vacuum Transfer Systems – V 2.0

Standard Operating Procedure for Operating Vacuum Transfer Systems in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/125/2025
Supersedes SOP/ELX/125/2022
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 standard procedure for the safe and effective operation of vacuum transfer systems used in elixir manufacturing for transferring raw materials, solvents, or liquid intermediates under reduced pressure conditions. This ensures efficiency, containment, and minimization of product exposure.

2. Scope

This SOP is applicable to all vacuum transfer systems used in the Elixir Department, including fixed-line systems and mobile vacuum pumps, for transferring materials from storage drums or containers to mixing or holding vessels.

3. Responsibilities

  • Production Operator:
    • Execute vacuum transfer operations following defined procedures.
    • Monitor vacuum levels and ensure containment is maintained.
  • Production Supervisor:
    • Ensure correct setup, readiness of equipment, and verify log entries.
  • Engineering Department:
    • Maintain and calibrate vacuum gauges, sensors, and vacuum pumps.
  • QA Officer:
    • Ensure operational verification and compliance with GMP during batch review.
See also  Elixir Department: SOP for Cleaning During Campaign Manufacturing - V 2.0

4. Accountability

The Production Head is accountable for the correct use and documentation of vacuum

transfer systems, and the Engineering Head is responsible for system maintenance.

5. Procedure

5.1 Pre-Operation Checks

  1. Ensure the vacuum transfer line and system are labeled as “CLEANED” and released for use by QA.
  2. Check that all gaskets, clamps, valves, and hoses are properly installed and intact.
  3. Inspect the receiving vessel to confirm it is properly grounded and suitable for vacuum transfer.
  4. Verify that the vacuum pump and control panel are functional and calibrated.

5.2 Setup Procedure

  1. Connect the suction line to the source container (e.g., drum or holding tank).
  2. Connect the discharge line to the receiving vessel.
  3. Ensure that all valves are in the correct position as per the transfer flow path.
  4. Use a sight glass or flow indicator to observe flow during operation.
See also  Elixir Department: SOP for Identification and Labeling of Clean Equipment - V 2.0

5.3 Vacuum Transfer Operation

  1. Start the vacuum pump using the control panel.
  2. Gradually open the suction valve to initiate material transfer.
  3. Monitor vacuum level (typically between -0.6 to -0.9 bar) and flow rate.
  4. Ensure that the transfer occurs without interruptions, cavitation, or leaks.
  5. Observe for foam formation or backflow and stop transfer if any deviation occurs.
  6. Record the start time, end time, and total volume transferred in the Vacuum Transfer Log (Annexure-1).

5.4 Shutdown and Cleaning

  1. Close all valves and switch off the vacuum pump.
  2. Disconnect hoses and drain any residual material using suitable collection containers.
  3. Clean the vacuum lines, valves, and accessories using the validated cleaning SOP.
  4. Label the system as “TO BE CLEANED” or “CLEANED” after cleaning completion.

5.5 Safety and Precautions

  1. Always wear PPE including gloves, goggles, and apron during transfer.
  2. Ensure the system is leak-free and vacuum-rated before applying negative pressure.
  3. Use anti-foam agents if specified in the BMR to avoid frothing during transfer.
  4. Never bypass safety interlocks or operate the system with broken seals.
See also  Elixir Department: SOP for Bulk Filtration Before Packing - V 2.0

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • BMR: Batch Manufacturing Record
  • PPE: Personal Protective Equipment

7. Documents

  1. Vacuum Transfer Log (Annexure-1)
  2. Preventive Maintenance Record
  3. BMR/Transfer Sheet

8. References

  • 21 CFR Part 211.65 – Equipment Construction
  • WHO GMP Guidelines – Liquid Transfer Systems
  • ICH Q8 – Pharmaceutical Development

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Vacuum Transfer Log

Date Batch No. Source Container Receiving Vessel Volume Transferred (L) Start Time End Time Operator
11/04/2025 ELX-1058 Drum-002 MIX-305 200 09:00 09:25 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 Added foam control and flow monitoring steps Operational Improvement QA Head
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