SOP for Preventive Maintenance of All Production Equipment

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

Date	Equipment ID	Maintenance Performed	Operator Initials	QA Approval
DD/MM/YYYY	Equipment Name	Maintenance Description	Operator Name	QA Name