SOP Guide for Pharma

Gel Manufacturing: SOP for Maintenance of Mixing Vessels – V 2.0

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Gel Manufacturing: SOP for Maintenance of Mixing Vessels – V 2.0

Standard Operating Procedure for Maintenance of Mixing Vessels in Gel Manufacturing


Department Gel Manufacturing
SOP No. SOP/GM/131/2025
Supersedes SOP/GM/131/2022
Page No. Page 1 of 10
Issue Date 09/06/2025
Effective Date 11/06/2025
Review Date 09/06/2027

1. Purpose

To establish a standardized procedure for routine and preventive maintenance of mixing vessels used in the gel manufacturing process, ensuring operational efficiency and regulatory compliance.

2. Scope

This SOP is applicable to all mixing vessels utilized in the production of gel formulations in the Gel

Manufacturing department.

3. Responsibilities

  • Maintenance Technician: Execute maintenance as per schedule and document findings.
  • Production Supervisor: Initiate maintenance request and coordinate vessel availability.
  • QA Executive: Review maintenance records and provide clearance post-maintenance.
See also  Gel Manufacturing: SOP for Documentation of Dispensing Operations for Gels - V 2.0

4. Accountability

Head – Gel Manufacturing and Head – Engineering

5. Procedure

5.1 Scheduling

  1. Prepare and maintain an annual preventive maintenance (PM) calendar for all mixing vessels.
  2. Ensure minimum disruption to production schedule during PM activities.

5.2 Maintenance Activities

  1. Switch off power supply and affix “Under Maintenance” tag.
  2. Inspect vessel body for physical integrity, dents, or corrosion.
  3. Check internal agitator blades, seals, gaskets, and shaft condition.
  4. Clean motor housing, inspect electrical connectors, and tighten loose terminals.
  5. Lubricate bearings and agitator shaft as per manufacturer’s recommendation.
  6. Check calibration of temperature probes or load cells, if integrated.

5.3 Post-Maintenance Checks

  1. QA to perform a visual and functional inspection.
  2. Record results in Annexure-1 and obtain QA approval.
  3. Affix “Ready for Use” label after clearance.
See also  Gel Manufacturing: SOP for Conducting Analytical Studies During Gel Development - V 2.0

5.4 Breakdown Maintenance

  1. Report equipment failure immediately to Engineering and QA.
  2. Tag the vessel as “Out of Order” and isolate from production.
  3. Document incident and corrective action in Annexure-2.

5.5 Documentation

  1. Maintain logbooks of maintenance schedules and checklists.
  2. Retain maintenance reports for a minimum of 5 years or as per regulatory requirements.

5.6 Safety Precautions

  • Use PPE including gloves, safety shoes, and insulated tools.
  • Ensure cleaning after maintenance to remove grease or residues.

6. Abbreviations

  • QA: Quality Assurance
  • PM: Preventive Maintenance
  • PPE: Personal Protective Equipment

7. Documents

  1. Preventive Maintenance Checklist – Annexure-1
  2. Breakdown Maintenance Report – Annexure-2
  3. Maintenance Calendar

8. References

  • WHO TRS 1010 Annex 3 – GMP Requirements
  • Equipment Manufacturer’s Maintenance Manual
  • Schedule M – Equipment Maintenance Guidelines
See also  Gel Manufacturing: SOP for Environmental Monitoring in Gel Production Areas - V 2.0

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation Jr. Production Chemist QA Executive Head – Manufacturing
Department Gel Manufacturing Quality Assurance Manufacturing

11. Annexures

Annexure-1: Preventive Maintenance Checklist

Item Checked (Y/N) Remarks Technician Initials
Agitator Blades
Seals & Gaskets
Motor & Wiring
Vessel Body
Lubrication

Annexure-2: Breakdown Maintenance Report

Date Issue Description Action Taken Technician QA Approval

Revision History

Revision Date Revision No. Change Description Reason Approved By
04/02/2022 1.0 Initial Release New SOP QA Head
09/06/2025 2.0 Revised Annexures and updated PM calendar reference Annual Review QA Head
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