SOP for Operation of Nebulizer Product Transfer Systems

Standard Operating Procedure for Operating Nebulizer Product Transfer Systems

1) Purpose

The purpose of this SOP is to define a standardized procedure for operating nebulizer product transfer systems to ensure efficient and contamination-free movement of products between production stages.

2) Scope

This SOP applies to all transfer systems used for handling nebulizer components, semi-finished products, and finished goods within the facility.

3) Responsibilities

Operators: Operate the transfer system and monitor its performance.
Maintenance Team: Perform routine and preventive maintenance on the system.
Quality Assurance (QA): Validate operational performance and approve related records.
Supervisors: Oversee operations to ensure adherence to this SOP.

4) Procedure

4.1 Pre-Operation Checks

Inspect the transfer system for cleanliness and functionality.
Ensure all belts, rollers, and conveyor components are intact and securely fastened.
Verify the system is free of debris or obstructions.
Check that the control panel and emergency stop buttons are operational.
Document pre-operation checks in the Transfer System Log.

4.2 Starting the Transfer System

Switch on the main power supply to the transfer system.
Set the system parameters, such as speed and load capacity, according to the batch requirements.
Conduct a trial run with an empty system to ensure smooth operation.
Address any issues identified during the trial run

before proceeding.

4.3 Operating the Transfer System

Load products onto the transfer system in a secure and organized manner to prevent spillage or damage.
Monitor the system continuously during operation to ensure smooth and consistent product movement.
Inspect transferred products periodically to confirm they remain undamaged.
Record operational details, including batch number and operator initials, in the Operation Log.

4.4 Post-Operation Activities

Turn off the transfer system and disconnect it from the power supply.
Clean the belts, rollers, and other components using approved cleaning agents.
Inspect the system for any wear or damage and report findings to the maintenance team.
Document post-operation activities in the Transfer System Log.

4.5 Handling System Malfunctions

Stop the transfer system immediately if any malfunctions occur.
Notify the maintenance team and document the issue in the System Malfunction Report.
Resume operation only after the issue has been resolved and the system has been tested.

4.6 Preventive Maintenance

Inspect belts, rollers, and motor components monthly and replace worn parts as necessary.
Lubricate moving parts as per the manufacturer’s guidelines to ensure smooth operation.
Calibrate the system quarterly to verify speed and load capacity settings.
Document all maintenance activities in the Maintenance Log.

4.7 Safety Precautions

Wear appropriate personal protective equipment (PPE), such as gloves and safety shoes, during operation and maintenance.
Ensure no unauthorized personnel are near the system during operation.
Keep hands and tools away from moving parts while the system is operational.
Follow lockout/tagout procedures when performing maintenance activities.

5) Abbreviations

QA: Quality Assurance
PPE: Personal Protective Equipment

6) Documents

The following documents should be maintained:

Transfer System Log
Operation Log
System Malfunction Report
Maintenance Log

7) References

Relevant regulatory guidelines and references include:

ISO 13485: Medical Devices Quality Management Systems
Good Manufacturing Practices (GMP) Guidelines
Equipment Manufacturer’s Manual

8) SOP Version

Version: 1.0

Annexure

Annexure Title: Transfer System Log

   Date  System ID  Pre-Operation Check  Post-Operation Check  Operator Initials  Remarks  
  DD/MM/YYYY  System Identifier  Pass/Fail  Pass/Fail  Operator Name  Details of operation

Date	System ID	Pre-Operation Check	Post-Operation Check	Operator Initials	Remarks
DD/MM/YYYY	System Identifier	Pass/Fail	Pass/Fail	Operator Name	Details of operation

Annexure Title: System Malfunction Report

   Date  System ID  Issue Identified  Corrective Action  Performed By  QA Approval  
  DD/MM/YYYY  System Identifier  Description of issue  Details of corrective action  Technician Name  QA Name

Date	System ID	Issue Identified	Corrective Action	Performed By	QA Approval
DD/MM/YYYY	System Identifier	Description of issue	Details of corrective action	Technician Name	QA Name

Annexure Title: Maintenance Log

   Date  System ID  Maintenance Type  Performed By  QA Approval  Remarks  
  DD/MM/YYYY  System Identifier  Routine/Corrective  Technician Name  QA Name  Details of activity