Standard Operating Procedure for Operation of Flow Meter for Liquid Transfer in Elixir Manufacturing

Department	Elixir Department
SOP No.	SOP/ELX/131/2025
Supersedes	SOP/ELX/131/2022
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 use of flow meters during the transfer of liquid materials in elixir manufacturing to ensure accurate volume measurement and batch traceability.

2. Scope

This SOP applies to all electromagnetic, ultrasonic, and turbine-type flow meters used for transferring solvents, syrups, or finished elixirs within the Elixir Department.

3. Responsibilities

• Production Operator:
  • Perform setup, operation, and volume verification using the flow meter.
• Engineering Department:
  • Maintain and calibrate flow meters as per schedule.
• Production Supervisor:
  • Ensure correct readings are logged and verify transferred volumes.
• QA Officer:
  • Verify calibration status and review transfer records during batch review.

4. Accountability

The Production Head is accountable for the implementation and documentation of flow meter usage. The Engineering Head is accountable for calibration and maintenance.

5. Procedure

5.1 Pre-Operation Checks

1. Ensure the flow meter is labeled as “CALIBRATED” and the due date is not lapsed.
2. Check all connections and ensure the flow meter is securely installed in the transfer line.
3. Confirm the power supply or battery backup is functional.

5.2 Setup and Zeroing

1. Ensure the transfer line is clean and free from air pockets.
2. Reset the flow meter totalizer to zero before initiating transfer.
3. Verify unit settings (liters, kilograms, etc.) as per BMR instructions.

5.3 Liquid Transfer Operation

1. Open the source valve and start the pump to initiate the flow.
2. Monitor the flow rate and total volume displayed on the meter screen.
3. Maintain the flow rate within specified limits (e.g., 10–15 LPM for syrup transfer).
4. Once the target volume is reached, stop the pump and close all valves.
5. Record the final volume transferred in the Flow Meter Log (Annexure-1) and in the BMR.

5.4 Post-Operation

1. Rinse the flow meter and lines with purified water or solvent if required.
2. Drain and dry the meter if not used for an extended period.
3. Update the equipment status label as “TO BE CLEANED” or “CLEANED.”

5.5 Maintenance and Troubleshooting

1. Check calibration once every 6 months or after 10,000 L cumulative usage (whichever is earlier).
2. For erratic readings:
   • Check sensor alignment and cable connections
   • Inspect for clogged sensors or scaling in flow path
3. Notify the Engineering department if repair is required and document downtime.

5.6 Safety and Precautions

1. Do not expose flow meters to direct impact or moisture unless rated IP65/IP67.
2. Do not bypass grounding connections, especially during alcohol-based liquid transfer.
3. Always wear appropriate PPE during line connection or disconnection.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• BMR: Batch Manufacturing Record
• LPM: Liters Per Minute

7. Documents

1. Flow Meter Log (Annexure-1)
2. Calibration Certificate
3. BMR/Batch Sheet

8. References

• 21 CFR Part 211 – cGMP for Finished Pharmaceuticals
• WHO GMP Guidelines – Equipment Operation and Calibration
• ICH Q9 – Quality Risk Management

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Flow Meter Log

Date	Batch No.	Flow Meter ID	Start Time	End Time	Volume Transferred (L)	Operator	Remarks
11/04/2025	ELX-1061	FM-12	10:05	10:35	500	Rajesh Kumar	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 zeroing and troubleshooting procedures	Process Control Enhancement	QA Head