Elixir Department: SOP for Operation of Transfer Pumps – V 2.0

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Elixir Department: SOP for Operation of Transfer Pumps – V 2.0

Standard Operating Procedure for Operation of Transfer Pumps in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/123/2025
Supersedes SOP/ELX/123/2022
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 a standardized procedure for the safe and effective setup, operation, monitoring, and cleaning of transfer pumps used in the manufacturing of elixirs for transferring bulk liquids between vessels, tanks, and filling equipment.

2. Scope

This SOP applies to all transfer pumps (peristaltic, centrifugal, diaphragm, or rotary lobe) used in the Elixir Department during batch production and transfer activities involving solutions, syrups, and volatile/elixir preparations.

3. Responsibilities

  • Production Operator:
    • Perform setup, operation, and cleaning of pumps as per SOP.
  • Production Supervisor:
    • Verify setup integrity, operating parameters, and record entries.
  • Engineering Department:
    • Calibrate pressure gauges, check motor alignment, and maintain pump systems.
  • QA Officer:
    • Approve equipment before use and ensure proper documentation.
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4. Accountability

The Production Head is accountable for ensuring that transfer pump operations comply with GMP, safety, and process requirements.

5. Procedure

5.1 Pre-Operation Checks

  1. Check that the pump is labeled as “CLEANED” and approved by QA.
  2. Verify compatibility of pump type with the product (e.g., use flameproof pump for alcohol-based elixirs).
  3. Ensure that gaskets, hoses, and clamps are intact and correctly connected.
  4. Check electrical grounding and motor connections before starting.

5.2 Setup Procedure

  1. Connect suction hose from the source tank to the pump inlet.
  2. Connect discharge hose from the pump outlet to the receiving vessel.
  3. Secure all clamps and fittings using sterile gloves and sanitization spray.
  4. Prime the pump if required (especially for rotary and centrifugal pumps).

5.3 Operation Procedure

  1. Switch on the pump and set speed/pressure as per BMR specifications.
  2. Begin product transfer, ensuring smooth and continuous flow.
  3. Monitor the discharge hose for leaks, kinks, or blockages.
  4. Observe flow rate and motor noise for any abnormalities.
  5. Record start time, end time, and any observations in the Transfer Pump Log (Annexure-1).
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5.4 Shutdown and Cleaning

  1. After transfer is complete, switch off the pump and disconnect hoses.
  2. Drain residual product from hoses and pump housing using designated collection containers.
  3. Clean internal and external parts of the pump using validated cleaning procedures and detergents.
  4. Dry with sterile compressed air (if required), and label the pump as “TO BE CLEANED” or “CLEANED.”

5.5 Safety and Precautions

  1. Use only flameproof pumps in alcohol-handling processes.
  2. Do not operate pumps at dry-run conditions unless specified.
  3. Wear PPE (gloves, goggles, apron) during setup and cleaning operations.
  4. Report any pump malfunction or vibration to Engineering immediately.

6. Abbreviations

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

  1. Transfer Pump Log (Annexure-1)
  2. Preventive Maintenance Record
  3. Cleaning Checklist

8. References

  • 21 CFR Part 211.67 – Equipment Cleaning and Maintenance
  • WHO GMP Guidelines – Equipment Operation
  • Internal SOP for Pump Cleaning (Reference SOP/ELX/201/2025)

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Transfer Pump Log

Date Batch No. Pump ID Start Time End Time Product Operator Remarks
11/04/2025 ELX-1056 PMP-12 10:00 10:25 Flavored Elixir A Rajesh Kumar Normal flow

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 safety and equipment compatibility checks Process Control QA Head
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