SOP Guide for Pharma

Elixir Department: SOP for Operation of Foot Pedal-Controlled Fillers – V 2.0

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Elixir Department: SOP for Operation of Foot Pedal-Controlled Fillers – V 2.0

Standard Operating Procedure for Operation of Foot Pedal-Controlled Fillers in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/150/2025
Supersedes SOP/ELX/150/2022
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 efficient operation of foot pedal-controlled fillers used for dispensing elixirs into containers, ensuring accuracy, hygiene, and operator safety.

2. Scope

This SOP applies to all foot pedal-operated semi-automatic liquid filling machines used in the Elixir Department for filling bottles, jars, and vials with elixir formulations.

3. Responsibilities

  • Production Operator:
    • Operate the foot pedal-controlled filler as per instructions.
    • Ensure container alignment, volume setting, and cleanliness.
    • Log batch-wise filling records and deviations.
  • Engineering Department:
    • Maintain and calibrate the filling volume and foot pedal mechanism.
    • Ensure air and power supply are stable.
  • QA Officer:
    • Verify equipment readiness and review filled sample weights.
See also  Elixir Department: SOP for Light Protection Measures in Manufacturing - V 2.0

4. Accountability

The Production Head is accountable for execution and training. The Engineering Head is responsible for equipment functionality and maintenance.

5. Procedure

5.1 Pre-Use

Checks
  1. Ensure that the filler has been cleaned and labeled as “READY FOR USE.”
  2. Check that all machine parts—nozzles, hoppers, tubes—are assembled correctly.
  3. Inspect the foot pedal for smooth operation and no obstruction.
  4. Switch on the machine and verify that compressed air and electricity are connected.

5.2 Volume Setting

  1. Use the calibration mode or mechanical gauge to set the target fill volume (e.g., 100 ml).
  2. Perform 5 trial fills using water and measure the output using a volumetric flask or weighing scale.
  3. If variation exceeds ±1.5%, adjust the piston stroke length or timer and retest.
  4. Once validated, lock the setting using the control knob or digital lockout feature.

5.3 Filling Process

  1. Place the cleaned and labeled container under the nozzle.
  2. Press the foot pedal firmly to initiate the fill cycle.
  3. Ensure the container remains centered and steady during dispensing.
  4. Once filled, remove the container and place the next one immediately.
  5. Repeat the process for the entire batch, ensuring rhythmic and consistent operation.

5.4 In-Process Checks

  1. Every 30 minutes or after every 100 containers (whichever is earlier), perform a weight/volume check of 3 random containers.
  2. Record these values in the Filling In-Process Check Log (Annexure-1).
  3. If deviation is detected, stop the filling and inform QA and Engineering.

5.5 Post-Operation Activities

  1. Switch off the machine and disconnect power and air supply.
  2. Flush the filler using WFI or approved cleaning agent to remove residue.
  3. Clean and disassemble the parts for further washing and sanitization.
  4. Label the machine as “CLEANED” or “TO BE CLEANED” depending on completion status.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • WFI: Water for Injection

7. Documents

  1. Filling In-Process Check Log (Annexure-1)
  2. Calibration Certificate
  3. BMR for relevant batch

8. References

  • 21 CFR Part 211 – cGMP for Finished Pharmaceuticals
  • WHO TRS 986 – Equipment Operation and Cleaning
  • 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 In-Process Check Log

Date Batch No. Container No. Target Volume (ml) Actual Volume Operator Remarks
11/04/2025 ELX-B-2025-17 153 100 99.7 Sunita Reddy Within Limit

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 calibration and deviation handling Compliance Update QA Head
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