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.
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 |