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.

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

Date	Time	Operator Initials	Cleaning Duration	Remarks
DD/MM/YYYY	HH:MM	Operator Name	Duration in minutes	Cleaning completed as per SOP

Date	Equipment Name	Calibration Status	Operator Initials	Remarks
DD/MM/YYYY	Filling Machine	Pass/Fail	Operator Name	Details of calibration status