Elixir Department: SOP for Backup Power Supply Systems for Critical Equipment – V 2.0

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Elixir Department: SOP for Backup Power Supply Systems for Critical Equipment – V 2.0

Standard Operating Procedure for Backup Power Supply Systems for Critical Equipment in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/157/2025
Supersedes SOP/ELX/157/2022
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 standard procedure for the operation, monitoring, and maintenance of backup power supply systems including UPS (Uninterruptible Power Supply) and DG (Diesel Generator) sets used to support critical equipment during power interruptions in the Elixir Department.

2. Scope

This SOP applies to all backup power infrastructure supporting critical pharmaceutical manufacturing equipment such as mixers, transfer pumps, control systems, HVAC panels, and cleanroom lighting within the Elixir Department.

3. Responsibilities

  • Engineering Department:
    • Ensure readiness, regular testing, and preventive maintenance of UPS and DG systems.
    • Log all events, faults, and test results in the Power Backup Logbook.
  • Production Department:
    • Report power interruptions or backup activation.
    • Ensure proper shutdown or restart of connected systems post-restoration.
  • QA Department:
    • Review impact of power events on in-process batches and approve continuation or deviation management.
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4. Accountability

The Engineering Head is accountable for

uninterrupted power supply to critical systems. The QA Head is responsible for impact assessment of power interruptions. The Production Head ensures controlled operation of equipment during such events.

5. Procedure

5.1 Backup Power Systems Overview

The Elixir Department is supported by:

  • UPS System: Installed for SCADA servers, HMI panels, control systems, and QA workstations. Provides power for up to 30 minutes.
  • Diesel Generator (DG) Set: Auto-start enabled system for supplying power to all critical loads, including HVAC, mixers, lighting, and compressors.

5.2 UPS System Monitoring and Testing

  1. Daily check:
    • UPS load level and battery status (should be above 90%).
    • Input/output voltage range and inverter condition.
  2. Monthly:
    • Conduct a 15-minute load test by simulating power failure.
    • Document battery performance and time to recovery.

5.3 DG Set Operation and Maintenance

  1. Ensure auto-start function is enabled via ATS (Automatic Transfer Switch).
  2. Fuel level must be ≥ 75% and checked daily.
  3. Weekly:
    • Start DG manually for 15 minutes to ensure functionality.
    • Check oil level, coolant level, belt condition, and noise levels.
  4. Record all operational data in the DG Maintenance Log (Annexure-2).
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5.4 Action During Power Failure

  1. UPS instantly supplies power to connected loads (no manual action needed).
  2. DG Set starts automatically within 30 seconds to take over critical systems.
  3. Operator must verify equipment status and document start time in Annexure-1.
  4. QA must assess if the in-process batch is affected (agitation pause, heating halt, etc.).

5.5 Post-Restoration Activities

  1. Verify return of main power supply.
  2. ATS will transfer load back to main supply and stop the DG set automatically.
  3. UPS will switch to charging mode automatically.
  4. Engineering shall log transition details and battery recharge status.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • UPS: Uninterruptible Power Supply
  • DG: Diesel Generator
  • QA: Quality Assurance
  • ATS: Automatic Transfer Switch

7. Documents

  1. Power Failure and Backup Activation Logbook (Annexure-1)
  2. DG Maintenance Logbook (Annexure-2)
  3. UPS Performance Test Report
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8. References

  • 21 CFR Part 211 – Equipment and Utility Controls
  • WHO TRS 961 – Utility and Facility Requirements in Pharma
  • Electrical Safety Standards IS 3043 and IEC 60364

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Power Failure and Backup Activation Logbook

Date Time Power Failure Duration UPS Active DG Active Batch Status Operator Remarks
11/04/2025 14:15 12 mins Yes Yes Holding Agitation Sunita Reddy Normal switch back

Annexure-2: DG Maintenance Logbook

Date DG ID Oil Level Coolant Level Battery Voltage Fuel Level Remarks Technician
10/04/2025 DG-ELX-01 Normal Full 12.5 V 85% Test Run OK Ramesh Nair

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 Updated preventive checks and auto-start configuration System Upgrade QA Head
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