Elixir Department: SOP for Operation of Filter Press – V 2.0

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Elixir Department: SOP for Operation of Filter Press – V 2.0

Standard Operating Procedure for Operation of Filter Press in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/128/2025
Supersedes SOP/ELX/128/2022
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, efficient, and GMP-compliant operation of the filter press used during elixir manufacturing for clarification, particulate removal, and polishing filtration of bulk liquids.

2. Scope

This SOP applies to all filter press operations carried out in the Elixir Department involving the transfer and filtration of bulk liquids including syrups, extracts, alcohol-based elixirs, and volatile formulations.

3. Responsibilities

  • Production Operator:
    • Set up, operate, and monitor the filter press during batch processing.
    • Ensure proper cleaning and integrity of filter media before use.
  • Production Supervisor:
    • Verify setup, operational parameters, and filter integrity.
  • Engineering Department:
    • Maintain the filter press, perform mechanical servicing, and support troubleshooting.
  • QA Officer:
    • Verify cleaning status and review batch documentation for compliance.
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4. Accountability

The Production Head is accountable for proper operation and documentation of filter press activities, and the Engineering Head is accountable for its mechanical performance and

calibration (if applicable).

5. Procedure

5.1 Pre-Operation Checks

  1. Ensure the filter press is labeled as “CLEANED” and released by QA for use.
  2. Inspect all filter plates, frames, gaskets, and the frame closure mechanism for cleanliness and functionality.
  3. Check that the filter media (filter paper, cloth, or membranes) is undamaged and correctly placed between plates.
  4. Ensure all valves, hoses, and the filtrate outlet lines are properly connected and leak-proof.

5.2 Setup and Priming

  1. Align and tighten the plate pack manually or using the hydraulic system to prevent leakage during operation.
  2. Connect the inlet to the source vessel and the outlet to the receiving tank.
  3. Prime the system using purified water or initial product to remove air from the filter chamber.

5.3 Filtration Operation

  1. Start the feed pump at low pressure and gradually increase to the defined operating range (e.g., 1 to 2.5 bar).
  2. Monitor:
    • Inlet and outlet pressure
    • Flow rate
    • Clarity of the filtrate
  3. If the pressure exceeds the limit or flow slows down, inspect for clogging and replace filter media if necessary.
  4. Continue filtration until the entire batch is processed or specified volume is filtered.
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5.4 Completion and Cleaning

  1. Shut off the pump and close all valves.
  2. Drain residual material from the filter and lines into appropriate containers.
  3. Open the filter press and remove used filter media using gloves and PPE.
  4. Clean all internal and external parts of the press using validated cleaning agents.
  5. Rinse thoroughly with purified water and allow to dry completely.
  6. Label as “TO BE CLEANED” or “CLEANED” as applicable.

5.5 Safety and Precautions

  1. Always wear gloves, apron, mask, and goggles while handling filters and during operation.
  2. Never open the filter press while under pressure.
  3. Ensure pressure release before disassembling the unit.
  4. Dispose of used filter media as per waste handling SOP.
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6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • GMP: Good Manufacturing Practice
  • BMR: Batch Manufacturing Record

7. Documents

  1. Filter Press Log (Annexure-1)
  2. Cleaning Checklist
  3. Preventive Maintenance Record

8. References

  • 21 CFR Part 211.67 – Equipment Cleaning and Maintenance
  • WHO TRS 986 – GMP Equipment Guidelines
  • 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: Filter Press Log

Date Batch No. Filter ID Start Time End Time Inlet Pressure (bar) Operator Remarks
11/04/2025 ELX-1060 FP-01 11:00 11:45 2.2 Rajesh Kumar Normal Operation

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 Included enhanced safety and leak test steps Process Control Enhancement QA Head
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