Standard Operating Procedure for Lubrication and Greasing of Equipment

1) Purpose

The purpose of this SOP is to establish the procedures for the proper lubrication and greasing of equipment to ensure optimal performance and longevity in pharmaceutical manufacturing facilities.

2) Scope

This SOP applies to all equipment requiring lubrication and greasing within pharmaceutical manufacturing facilities, including production machinery, laboratory instruments, and utilities.

3) Responsibilities

The Facility Management Department is responsible for implementing and adhering to this SOP. The Maintenance Team is responsible for executing lubrication and greasing activities.

4) Procedure

1. Maintenance Schedule Planning
   1. Develop a comprehensive lubrication and greasing schedule based on equipment type, usage frequency, manufacturer recommendations, and operational conditions.
   2. Assign specific lubrication tasks to qualified personnel.
   3. Document the schedule and ensure it is communicated to relevant departments.
2. Lubrication and Greasing Process
   1. Identify lubrication points on equipment using manufacturer-provided diagrams and instructions.
   2. Select appropriate lubricants and greases based on equipment specifications and operating conditions.
   3. Clean lubrication points before applying grease or oil to prevent contamination.
   4. Apply lubricants in specified quantities and intervals to ensure proper equipment lubrication.
3. Corrective Maintenance Procedures
   1. Address any equipment issues related to lubrication promptly.
   2. Investigate the cause of lubrication failures and implement corrective actions.
   3. Replace lubricants or adjust lubrication schedules as necessary.
   4. Verify equipment functionality post-maintenance to ensure proper lubrication.
4. Record Keeping
   1. Maintain detailed records of all lubrication and greasing activities.
   2. Document lubrication schedules, quantities used, equipment condition before and after lubrication, and any corrective actions taken.
   3. Archive records for future reference and regulatory inspections.

5) Abbreviations, if any

None

6) Documents, if any

Lubrication Schedules, Lubricant Specifications, Maintenance Records, Equipment Manuals

7) Reference, if any

Relevant regulatory guidelines such as FDA, EMA, and WHO GMP requirements for maintenance and lubrication practices in pharmaceutical manufacturing facilities.

8) SOP Version

Version 1.0