Ointments: SOP for Lubricating Moving Parts of Equipment – V 2.0

SOP for Lubricating Moving Parts of Equipment – V 2.0

Procedure for Lubricating Moving Parts of Equipment

Department Engineering/Maintenance/Production
SOP No. SOP/Ointment/048
Supersedes V 1.0
Page No. Page X of Y
Issue Date [Insert Issue Date]
Effective Date [Insert Effective Date]
Review Date [Insert Review Date]

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define a standardized method for lubricating moving parts of equipment used in ointment manufacturing. Proper lubrication reduces friction, prevents wear, and ensures smooth operation of machinery.

2. Scope

This SOP applies to all personnel responsible for the maintenance, lubrication, and servicing of manufacturing equipment in the ointment production facility.

3. Responsibilities

  • Maintenance Supervisor: Oversees lubrication schedules and ensures compliance.
  • Machine Operator: Identifies parts requiring lubrication and reports issues.
  • Quality Assurance (QA) Personnel: Verifies lubrication procedures and records.
  • Engineering Technician: Performs lubrication tasks and maintains equipment logs.
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4. Accountability

The Engineering and QA Managers are accountable for ensuring that lubrication is performed as per GMP standards and properly documented.

5. Procedure

5.1 Pre-Lubrication Checks

  • Ensure the equipment is turned off and locked out before lubrication.
  • Identify lubrication points from the equipment manual.
  • Verify that the correct type of lubricant is being used.
  • Check for any worn-out or damaged parts before applying lubrication.

5.2 Selecting the Lubricant

  • Use only FDA-approved, food-grade lubricants for contact parts.
  • For non-contact areas, use standard industrial-grade lubricants.
  • Refer to the equipment manufacturer’s specifications for recommended
lubricants.

5.3 Lubrication Process

5.3.1 Manual Lubrication

  • Apply lubricant using an appropriate applicator (e.g., grease gun, oil dropper).
  • Avoid over-lubrication to prevent contamination.
  • Ensure even distribution across moving components.

5.3.2 Automated Lubrication

  • Check that automatic lubrication systems are functioning properly.
  • Refill lubricant reservoirs as per the scheduled maintenance plan.
  • Monitor for any leaks or blockages in the lubrication system.

5.4 Post-Lubrication Checks

  • Wipe off any excess lubricant from external surfaces.
  • Ensure all parts are securely reassembled before restarting the equipment.
  • Run a test operation to confirm smooth functionality.
  • Record lubrication details in the Lubrication Log.

5.5 Maintenance and Monitoring

  • Follow the lubrication schedule as per the preventive maintenance plan.
  • Monitor wear and tear of lubricated components.
  • Replace or upgrade lubricants based on performance analysis.

6. Abbreviations

  • GMP – Good Manufacturing Practices
  • QA – Quality Assurance
  • QC – Quality Control
  • BMR – Batch Manufacturing Record

7. Documents

  • Lubrication Log (Annexure-1)
  • Preventive Maintenance Schedule (Annexure-2)

8. References

  • WHO GMP Guidelines for Pharmaceutical Manufacturing
  • 21 CFR Part 211 – Current Good Manufacturing Practices
  • Equipment Manufacturer Guidelines

9. SOP Version

Version 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Lubrication Log

Date Equipment ID Lubrication Type Lubricant Used Next Due Date Verified By
01/02/2025 LB-101 Manual Food-grade Grease 15/02/2025 QA Officer
02/02/2025 LB-102 Automated Industrial Oil 16/02/2025 QA Officer

Annexure-2: Preventive Maintenance Schedule

Equipment ID Lubrication Interval Type of Lubricant Last Lubrication Date Next Due Date Verified By
LB-101 Bi-Weekly Food-grade Grease 01/02/2025 15/02/2025 Maintenance Head
LB-102 Monthly Industrial Oil 02/02/2025 02/03/2025 Maintenance Head

12. Revision History:

Revision Date Revision No. Details of Revision Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP QA Head
01/02/2025 2.0 Updated SOP Format Standardization of Document QA Head
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