SOP Guide for Pharma

Elixir Department: SOP for Operation of PLC-Controlled Blending System – V 2.0

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Elixir Department: SOP for Operation of PLC-Controlled Blending System – V 2.0

Standard Operating Procedure for Operation of PLC-Controlled Blending System in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/141/2025
Supersedes SOP/ELX/141/2022
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 operation, monitoring, and recording of activities associated with the PLC-controlled blending system used in the manufacturing of elixirs to ensure uniform mixing, process consistency, and product quality.

2. Scope

This SOP applies to all programmable logic controller (PLC)-based automated blending systems used for large-scale manufacturing of elixirs in the Elixir Department.

3. Responsibilities

  • Production Operator:
    • Operate the PLC system as per approved batch manufacturing records (BMR).
    • Record operational parameters and notify deviations immediately.
  • Production Supervisor:
    • Verify settings and review panel activity logs and system reports.
  • Engineering Department:
    • Maintain the PLC system, sensors, alarms, and automation controls.
  • QA Officer:
    • Review data logs and ensure compliance with GMP standards.
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4. Accountability

The Production Head is accountable for SOP implementation. The Engineering Head is accountable for equipment programming, performance, and maintenance of the PLC system.

5. Procedure

5.1 System Start-Up

  1. Ensure the system is labeled “CLEANED” and all tanks and pipelines are ready for use.
  2. Verify that power supply, compressed air, and utilities are available and stable.
  3. Log in using secure operator credentials on the PLC HMI (Human Machine Interface).
  4. Select the corresponding recipe for the batch from the BMR or Master Control File.

5.2 Parameter Entry

  1. Enter the required parameters:
    • Blending time
    • Agitation speed (RPM)
    • Temperature (if heating/cooling is required)
    • Recirculation mode (if applicable)
  2. Verify values and press “START CYCLE.”
  3. Observe and confirm that the agitator, pumps, and recirculation loops operate as programmed.

5.3 Monitoring and Documentation

  1. Monitor the screen for live status of each parameter.
  2. Print interim logs (if printer is connected) or download digital log at batch completion.
  3. Record all observed values and times in the PLC Operation Logbook (Annexure-1).
  4. If an alarm is triggered (e.g., temperature deviation, power failure), pause operation and notify Engineering and QA immediately.
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5.4 End of Blending Cycle

  1. Once the cycle completes, confirm status as “COMPLETED” on the display.
  2. Stop the operation and shut off utilities like the agitator and heating system.
  3. Save the cycle log, logout of the HMI panel, and label the equipment as “TO BE CLEANED.”

5.5 Panel Maintenance and Safety

  1. Only Engineering personnel shall access the PLC backend or software configuration.
  2. Do not bypass safety interlocks, overload protection, or programmed alarms.
  3. In case of screen freeze or communication failure, report to Engineering immediately without tampering.

6. Abbreviations

  • PLC: Programmable Logic Controller
  • HMI: Human Machine Interface
  • BMR: Batch Manufacturing Record
  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
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7. Documents

  1. PLC Operation Logbook (Annexure-1)
  2. Control Panel Calibration/Service Record
  3. BMR for respective batch

8. References

  • 21 CFR Part 11 – Electronic Records and Signatures
  • ICH Q9 – Quality Risk Management
  • WHO GMP Guidelines – Equipment and Automation

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: PLC Operation Logbook

Date Batch No. System ID Cycle Start Cycle End RPM Temp (°C) Operator Remarks
11/04/2025 ELX-1067 PLC-BLND-02 10:00 11:20 120 65 Rajesh Kumar Cycle Completed Successfully

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 HMI safety protocols and logging frequency System Enhancement QA Head
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