SOP Guide for Pharma

Elixir Department: SOP for Preventive Maintenance of Mixing Vessels – V 2.0

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Elixir Department: SOP for Preventive Maintenance of Mixing Vessels – V 2.0

Standard Operating Procedure for Preventive Maintenance of Mixing Vessels in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/105/2025
Supersedes SOP/ELX/105/2022
Page No. Page 1 of 8
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To outline the procedure for scheduled preventive maintenance of mixing vessels used in elixir manufacturing, ensuring continuous and efficient operation in compliance with GMP and safety standards.

2. Scope

This SOP applies to all stainless-steel mixing vessels, with or without agitators, used for manufacturing elixirs in the Elixir Department.

3. Responsibilities

  • Maintenance Technician:
    • Perform preventive maintenance tasks according to the checklist and schedule.
  • Production Supervisor:
    • Ensure vessels are made available for maintenance and verify completion of tasks.
  • QA Officer:
    • Review maintenance records and approve equipment readiness post-maintenance.

See also  Elixir Department: SOP for Cleaning Equipment in Explosion-Proof Areas - V 2.0

4. Accountability

The Engineering Head is accountable for implementation and documentation of preventive maintenance of mixing vessels, and ensuring operational reliability.

5. Procedure

5.1 Maintenance Frequency

  1. Preventive maintenance shall be performed:
    • Monthly
    • Quarterly
    • Annually (comprehensive check)
  2. Refer to the Equipment Maintenance Calendar approved by QA and Engineering.

5.2 Preparation Before Maintenance

  1. Ensure vessel is empty, cleaned, and labeled “UNDER MAINTENANCE.”
  2. Disconnect utilities like steam, water, compressed air, and power supply.
  3. Wear appropriate PPE and follow Lockout/Tagout (LOTO) procedures.

5.3 Monthly Maintenance Checklist

  1. Check vessel body and weld joints for corrosion, leakage, or cracks.
  2. Inspect agitator shaft, seals, and blade for wear or alignment issues.
  3. Lubricate moving parts as per manufacturer’s instruction.
  4. Check and clean vent filters and temperature probes.

5.4 Quarterly Maintenance Checklist

  1. Check motor alignment and belt tension (if applicable).
  2. Test motor RPM and compare with standard setting.
  3. Verify function of pressure gauges, valves, and safety interlocks.
  4. Calibrate temperature and level sensors.
See also  Elixir Department: SOP for Equipment Breakdown Handling in Manufacturing - V 2.0

5.5 Annual Maintenance Checklist

  1. Conduct complete vessel dismantling and visual inspection.
  2. Replace worn-out seals, gaskets, and fittings.
  3. Test and inspect CIP/SIP connections and clean spray balls.
  4. Perform hydrostatic pressure test (if scheduled).

5.6 Post-Maintenance Procedure

  1. Reconnect all utilities and perform a dry run of the mixing vessel.
  2. Verify that all parameters are within standard limits.
  3. Affix “READY TO USE” label and update status in the Equipment Status Board.
  4. Complete Maintenance Checklist and get it reviewed by Production and QA.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • PPE: Personal Protective Equipment
  • QA: Quality Assurance
  • CIP: Clean-in-Place
  • SIP: Steam-in-Place
  • LOTO: Lockout Tagout

7. Documents

  1. Monthly/Quarterly/Annual Maintenance Checklist (Annexure-1)
  2. Maintenance Logbook (Annexure-2)
  3. Equipment Maintenance Calendar
See also  Elixir Department: SOP for Risk Assessment During Manufacturing - V 2.0

8. References

  • WHO TRS 1010 – GMP Guidelines
  • 21 CFR Part 211.67 – Equipment Cleaning and Maintenance
  • OEM Maintenance Manuals

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Maintenance Checklist

Date Frequency Checklist Item Status (OK/Not OK) Remarks Technician
11/04/2025 Monthly Agitator Seal OK – Rajesh Kumar

Annexure-2: Maintenance Logbook

Date Equipment ID Batch No. (if applicable) Work Done Performed By Reviewed By
11/04/2025 MIX-012 NA Seal Replacement & Belt Check Sunita Reddy Meena Sharma

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 annual checklist and hydro test step Preventive Maintenance Standardization QA Head
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