SOP Guide for Pharma

Elixir Department: SOP for Sequential Logic Programming for Batch Mixers – V 2.0

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Elixir Department: SOP for Sequential Logic Programming for Batch Mixers – V 2.0

Standard Operating Procedure for Sequential Logic Programming for Batch Mixers in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/155/2025
Supersedes SOP/ELX/155/2022
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 design, validation, and use of sequential logic programming in batch mixers to ensure accurate, automated control of manufacturing steps for elixir formulations.

2. Scope

This SOP applies to all programmable logic controller (PLC) and human machine interface (HMI)-based batch mixers operated in the Elixir Department where predefined sequences are used to manage operations such as mixing, heating, cooling, and transfer.

3. Responsibilities

  • Automation Engineer:
    • Design and program the sequence logic as per the approved functional specification.
    • Validate and troubleshoot the logic implementation.
  • Production Supervisor:
    • Ensure sequence runs as intended during batch execution.
    • Report abnormalities or interruptions in sequence flow.
  • QA Officer:
    • Verify that validated logic is in use and review change controls if modified.
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4. Accountability

The Engineering Head is accountable for control system programming. The Production Head ensures correct usage during operation. QA

ensures compliance with validation and documentation requirements.

5. Procedure

5.1 Logic Programming Design

  1. Automation engineer shall prepare a functional requirement specification (FRS) for each batch mixer based on process requirements.
  2. Develop the sequential function chart (SFC) including:
    • Tank fill initiation
    • Agitation start with speed control
    • Heating or cooling loop activation
    • Holding time and process checks
    • Transfer or discharge sequence
  3. Program the logic using validated PLC software and upload to control panel.

5.2 Validation of Logic

  1. Perform initial dry run using simulated inputs and review event logs.
  2. Conduct Integration Test (IQ/OQ) for actual equipment using water batch.
  3. Document logic validation results and obtain QA approval before batch use.

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5.3 Batch Execution with Sequential Logic

  1. Load the approved logic recipe from the HMI or SCADA interface.
  2. Confirm batch parameters (batch size, product code, operator ID) before initiation.
  3. Press “Start” on the control panel and allow the system to run through programmed steps.
  4. Monitor status indicators on the screen and log any operator interventions.

5.4 Handling Abnormalities

  1. If sequence halts mid-operation due to error or alarm:
    • Record the error code and screen status in the Alarm Logbook.
    • Notify Automation and QA for investigation.
  2. Do not attempt to resume the sequence without corrective action and QA clearance.

5.5 Logic Change Control

  1. Any modification in logic requires formal change control approval with impact assessment.
  2. Updated logic must be validated again before reactivation.
  3. Maintain backup of previous validated version on secure server with audit trail.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • PLC: Programmable Logic Controller
  • HMI: Human Machine Interface
  • SFC: Sequential Function Chart
  • IQ/OQ: Installation Qualification / Operational Qualification
  • QA: Quality Assurance
See also  Elixir Department: SOP for Agitator Operation and RPM Calibration - V 2.0

7. Documents

  1. Logic Validation Protocol and Report
  2. Alarm Logbook (Annexure-1)
  3. Change Control Form (if applicable)

8. References

  • 21 CFR Part 11 – Electronic Records and Signatures
  • GAMP 5 – A Risk-Based Approach to Compliant GxP Computerized Systems
  • WHO TRS 1019 – Good Practices for Automation in Manufacturing

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Alarm Logbook

Date Batch No. Alarm Code Description Operator Corrective Action Engineer
11/04/2025 ELX-2025-030 SEQ-ERR-05 Step Skipped – Agitation Time Mismatch Sunita Reddy Logic Restarted Post Review Rakesh Nair

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial SOP Release New Logic Introduction QA Head
11/04/2025 2.0 Included SFC and deviation handling logic System Upgrade QA Head
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