Standard Operating Procedure for Preventive Maintenance of All Production Equipment
1) Purpose
This SOP outlines the procedures for conducting preventive maintenance of all production equipment used in the manufacturing of nasal formulations. Preventive maintenance ensures the proper functioning of equipment and helps prevent unexpected downtime or malfunctions during production.
2) Scope
This SOP applies to all personnel responsible for maintaining production equipment, including mixing machines, spray dryers, filling machines, and HVAC systems, at [Company Name].
3) Responsibilities
- Operators: Perform routine maintenance checks, clean equipment after use, and report any abnormalities to the maintenance team.
- Maintenance Team: Responsible for scheduling and performing preventive maintenance, including repairs, part replacements, and calibration.
- Quality Assurance (QA): Ensures that all maintenance activities are recorded and that equipment meets operational standards before use.
4) Procedure
4.1 Routine Maintenance Activities
4.1.1 Daily Equipment Inspections
- At the beginning and end of each shift, inspect all production equipment for cleanliness, proper operation, and any signs of wear or malfunction. Document the inspection results in the maintenance log.
- If any equipment shows signs of malfunction, report the issue to the maintenance team for immediate repair.
4.1.2 Cleaning and Lubrication
- After each production run, disassemble any removable parts, clean them thoroughly with an approved cleaning agent, and lubricate moving parts according to the manufacturer’s specifications.
- Ensure all parts are reassembled correctly, and document the cleaning and lubrication activities in the cleaning log.
4.2 Monthly Preventive Maintenance
4.2.1 Equipment Checks
- Once a month, perform detailed checks on critical production equipment, including motors, belts, sensors, and heating elements. Replace any worn parts and document the replacements in the maintenance log.
- Check for any unusual noise, vibration, or signs of overheating during equipment operation and address any issues as needed.
4.2.2 HVAC System Maintenance
- Check the HVAC system filters, ducts, and pressure differentials monthly. Clean or replace filters as necessary to ensure that the system is operating within acceptable parameters.
- Document all HVAC system maintenance activities in the HVAC maintenance log and submit for QA review.
4.3 Quarterly Preventive Maintenance
4.3.1 Calibration of Equipment
- Once every three months, calibrate all critical production equipment, including mixing machines, filling machines, and temperature control systems. Record the calibration results in the calibration log.
- Ensure that all calibrated equipment meets the specified accuracy and operational standards before use.
4.3.2 Spray Dryer Maintenance
- Inspect the spray dryer’s atomizer, nozzles, and air filtration system quarterly. Clean and replace any parts that show signs of clogging or wear.
- Document all maintenance activities in the spray dryer maintenance log.
4.4 Annual Preventive Maintenance
4.4.1 Full System Overhaul
- Once per year, perform a full system overhaul on each piece of production equipment. Replace any worn-out parts, recalibrate the equipment, and perform a complete safety check.
- Document the results of the full system overhaul in the annual maintenance log and submit for QA approval.
4.4.2 HVAC System Overhaul
- Perform a full overhaul of the HVAC system annually, including cleaning and replacing filters, checking ductwork, and recalibrating pressure control systems. Ensure that the system meets cleanroom standards and is operating efficiently.
- Submit the HVAC system overhaul report to QA for approval.
5) Abbreviations, if any
- HVAC: Heating, Ventilation, and Air Conditioning
- QA: Quality Assurance
6) Documents, if any
- Maintenance Log
- Cleaning Log
- Calibration Log
- HVAC Maintenance Log
- Annual Maintenance Log
7) References, if any
- Manufacturer’s equipment manuals
- Internal SOP for cleaning and maintenance
8) SOP Version
Version 1.0
Annexure
1. Maintenance Log Template
| Date | Equipment ID | Maintenance Performed | Operator Initials | QA Approval |
|---|---|---|---|---|
| DD/MM/YYYY | Equipment Name | Maintenance Description | Operator Name | QA Name |