SOP Guide for Pharma

SOP for Cleaning and Maintenance of Nebulizer Filling Machines

Auditor

SOP for Cleaning and Maintenance of Nebulizer Filling Machines

Standard Procedure for Maintaining and Cleaning Nebulizer Filling Machines

1) Purpose

The purpose of this SOP is to provide a detailed guideline for cleaning and maintaining nebulizer filling machines to ensure optimal functionality, compliance with regulatory standards, and consistent product quality.

2) Scope

This SOP applies to all nebulizer filling machines used in the production facility, including both manual and automated systems, covering cleaning, basic upkeep, and periodic maintenance tasks.

3) Responsibilities

Operators: Perform routine cleaning and report any issues to the maintenance team.
Maintenance Team: Conduct scheduled and unscheduled maintenance activities.
Quality Assurance (QA): Verify and document cleaning and maintenance activities to ensure compliance with this SOP.

See also  SOP for Cleaning of Nebulizer Air Handling Units

4) Procedure

4.1 Preparation for Cleaning

  • Ensure the filling machine is powered off and unplugged from the main power supply.
  • Wear the appropriate personal protective equipment (PPE), such as gloves, masks, and safety glasses.
  • Clear the work area of unrelated materials or items to minimize contamination risk.

4.2 Cleaning Process

  • Carefully disassemble removable components such as nozzles, filling tubes, and hoppers following the manufacturer’s guidelines.
  • Wash the dismantled components using a mild detergent solution and a soft, lint-free cloth.
  • Rinse thoroughly with distilled water to ensure no detergent residues remain.
  • Dry all parts completely
using clean wipes or compressed air.

4.3 Maintenance Steps

  • Inspect moving parts such as conveyor belts and rollers for wear and tear; lubricate if needed.
  • Check for loose or damaged components and tighten or replace as necessary.
  • Calibrate measurement sensors using standard calibration solutions to ensure accuracy.
  • Run a test cycle without the product to ensure proper functioning.

4.4 Reassembly and Post-Cleaning Check

  • Reassemble the components in the reverse order of disassembly, ensuring all parts are secured.
  • Conduct a dry run of the machine to verify all components function as intended.
  • Document the cleaning and maintenance activities in the designated logbook.

4.5 Cleaning Frequency

  • Daily: General cleaning after every shift.
  • Weekly: Deep cleaning and detailed inspection.
  • Monthly: Comprehensive maintenance and calibration.

5) Abbreviations

  • PPE: Personal Protective Equipment
  • QA: Quality Assurance

6) Documents

The following documents should be maintained:

  • Cleaning and Maintenance Record
  • Equipment Calibration Log

7) References

Relevant regulatory guidelines and references include:

  • Equipment Manufacturer’s Manual
  • ISO 13485: Medical Devices Quality Management Systems

8) SOP Version

Version: 1.0

Annexure

Annexure Title: Cleaning and Maintenance Record for Nebulizer Filling Machines
Date Time Operator Initials Cleaning Duration Remarks
DD/MM/YYYY HH:MM Operator Name Duration in minutes Cleaning completed as per SOP
         
         

Annexure Title: Equipment Calibration Log
Date Equipment Name Calibration Status Operator Initials Remarks
DD/MM/YYYY Filling Machine Pass/Fail Operator Name Details of calibration status
         
See also  SOP for Operation of Nebulizer Cap Sealing Machines
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