SOP Guide for Pharma

Elixir Department: SOP for Alarm Handling on Mixing Equipment – V 2.0

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Elixir Department: SOP for Alarm Handling on Mixing Equipment – V 2.0

Standard Operating Procedure for Alarm Handling on Mixing Equipment in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/152/2025
Supersedes SOP/ELX/152/2022
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 identifying, responding to, documenting, and resolving alarms triggered by mixing equipment during elixir manufacturing, ensuring continuity of operation and product quality while maintaining safety and compliance.

2. Scope

This SOP applies to all programmable and semi-automatic mixing equipment with integrated alarm systems used in the Elixir Department, including systems equipped with PLCs, HMIs, or SCADA controls.

3. Responsibilities

  • Production Operator:
    • Monitor for alarms during mixing operations and respond as per procedure.
    • Record all alarm incidents in the Alarm Logbook.
  • Engineering Department:
    • Investigate and resolve technical causes of alarms.
    • Document root cause and corrective action in Maintenance Log.
  • QA Officer:
    • Evaluate impact of alarms on product quality.
    • Approve restart of operations post-verification.
See also  Elixir Department: SOP for Transfer of Materials to Quarantine Area Post Dispensing - V 2.0

4. Accountability

The Production Head is accountable for operator training and alarm compliance. The Engineering Head is responsible for alarm diagnostics and resolution. The QA Head is

responsible for product release decisions after alarm events.

5. Procedure

5.1 Types of Alarms

  1. Temperature Alarm: Triggered if setpoint is exceeded or drops below threshold.
  2. Agitation RPM Alarm: Indicates deviation from target speed range.
  3. Power Supply Alarm: Loss of main or backup power supply to mixer.
  4. Mechanical Fault Alarm: Shaft misalignment, impeller jam, or motor overload.
  5. Emergency Stop Trigger: Manual emergency stop pressed.

5.2 Immediate Operator Actions

  1. Pause operation by pressing STOP or E-STOP depending on the nature of the alarm.
  2. Visually inspect control panel or HMI for alarm message and code.
  3. Record alarm details in Alarm Logbook (Annexure-1), including time, code, and brief observation.
  4. Notify Production Supervisor and Engineering immediately.
See also  Elixir Department: SOP for Preparation of Manufacturing Tank - V 2.0

5.3 Engineering Troubleshooting Procedure

  1. Access the alarm history from PLC/HMI or SCADA to confirm the root cause.
  2. Inspect mechanical and electrical components as applicable.
  3. Perform required maintenance or replace faulty parts.
  4. Conduct dry run post-correction and validate that the alarm is cleared.
  5. Record resolution and preventive action in the Maintenance Logbook (Annexure-2).

5.4 QA Evaluation and Restart

  1. QA shall assess whether the product was impacted during the alarm event (e.g., temperature excursion, agitation stoppage).
  2. If product quality is unaffected, QA shall approve continuation of the batch.
  3. If impacted, QA shall raise a deviation report and evaluate the disposition of the batch.
  4. Post-approval, operator may resume operation from the step where alarm occurred.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • HMI: Human Machine Interface
  • PLC: Programmable Logic Controller
  • QA: Quality Assurance
  • SCADA: Supervisory Control and Data Acquisition
  • E-STOP: Emergency Stop

7. Documents

  1. Alarm Logbook (Annexure-1)
  2. Maintenance Logbook (Annexure-2)
  3. Deviation Report (if applicable)
See also  Elixir Department: SOP for Handling Damaged Raw Material Packs - V 2.0

8. References

  • 21 CFR Part 211 – Equipment Malfunction and Deviation Management
  • ICH Q9 – Quality Risk Management
  • WHO TRS 1010 – Pharmaceutical Engineering Systems

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 Equipment ID Alarm Code Alarm Description Operator Time Remarks
11/04/2025 MXR-ELX-04 TEMP-HI-01 Temperature exceeded 70°C Sunita Reddy 11:22 Paused & informed Engineering

Annexure-2: Maintenance Logbook

Date Equipment ID Issue Corrective Action Engineer Remarks
11/04/2025 MXR-ELX-04 High Temp Alarm Recalibrated sensor Ramesh Nair Issue resolved

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Release New SOP QA Head
11/04/2025 2.0 Added QA evaluation and alarm classification GMP Compliance QA Head
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