SOP Guide for Pharma

Elixir Department: SOP for Use of Volumetric Filling Machine – V 2.0

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Elixir Department: SOP for Use of Volumetric Filling Machine – V 2.0

Standard Operating Procedure for Use of Volumetric Filling Machine in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/132/2025
Supersedes SOP/ELX/132/2022
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 setup, operation, and cleaning of volumetric filling machines used for accurate filling of elixir formulations into primary containers such as bottles and jars under controlled conditions.

2. Scope

This SOP applies to all volumetric filling machines used in the Elixir Department for batch-wise filling of oral liquid products including sugar-based, alcohol-based, and aqueous elixirs.

3. Responsibilities

  • Production Operator:
    • Set up, operate, monitor, and clean the filling machine.
  • Production Supervisor:
    • Verify volume accuracy, oversee line clearance, and maintain records.
  • Engineering Department:
    • Perform preventive maintenance, servicing, and calibration.
  • QA Officer:
    • Verify cleanliness, review BMR entries, and ensure GMP compliance.

4. Accountability

The Production Head is accountable for machine operation and documentation. The Engineering Head is responsible for equipment upkeep and calibration.

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5. Procedure

5.1 Pre-Operation Checks

  1. Ensure
the machine is labeled “CLEANED” and released by QA.
  • Check that the volumetric pistons, cylinders, valves, and nozzles are properly assembled and clean.
  • Verify calibration status of the machine and ensure it is within the due date.
  • Ensure containers (e.g., bottles) are clean and ready for filling.

    • 5.2 Setup and Trial Run

    1. Connect the inlet to the bulk tank or storage vessel using sanitized hoses.
    2. Set the desired filling volume using the control panel or manual dial (e.g., 100 mL, 200 mL).
    3. Perform trial fills on 10 containers and weigh the filled volume using a calibrated balance.
    4. If variation is within ±2% of target volume, proceed with batch filling. If not, readjust settings.
    5. Record trial run results in the Filling Machine Calibration Log (Annexure-1).

    5.3 Batch Filling Operation

    1. Start the filling process and monitor container placement, nozzle movement, and volume consistency.
    2. Collect filled containers onto the conveyor or collection tray for capping.
    3. Continuously check 1 container every 15 minutes or 1000 units for volume verification.
    4. Document all observations in the BMR and Filling Activity Log (Annexure-2).

    5.4 Post-Filling Cleaning

    1. Switch off the machine and disconnect hoses.
    2. Drain remaining liquid from the machine into a recovery container.
    3. Disassemble filling nozzles, pistons, and valves.
    4. Clean all parts using validated cleaning solutions, rinse with purified water, and dry.
    5. Reassemble and label the machine “TO BE CLEANED” or “CLEANED.”

    5.5 Safety and Precautions

    1. Ensure machine guards and covers are in place during operation.
    2. Do not attempt to adjust pistons or remove nozzles while the machine is running.
    3. Wear gloves, mask, and eye protection when handling filled products or cleaning solutions.
    4. Do not bypass safety interlocks or sensors.

    6. Abbreviations

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

    7. Documents

    1. Filling Machine Calibration Log (Annexure-1)
    2. Filling Activity Log (Annexure-2)
    3. BMR/Batch Sheet

    8. References

    • 21 CFR Part 211 – cGMP for Finished Pharmaceuticals
    • 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: Filling Machine Calibration Log

    Date Machine ID Set Volume (mL) Avg. Actual Volume (mL) Deviation (%) Status Checked By
    11/04/2025 VMF-03 100 99.6 -0.4% Pass Sunita Reddy

    Annexure-2: Filling Activity Log

    Date Batch No. Start Time End Time Volume/Container No. of Containers Operator Remarks
    11/04/2025 ELX-1062 09:00 10:20 100 mL 5000 Rajesh Kumar Operation Normal

    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 trial fill verification and cleaning steps Process Standardization QA Head
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