SOP for Operation of Nebulizer Control Panels

Standard Operating Procedure for Operating Nebulizer Control Panels

1) Purpose

The purpose of this SOP is to provide standardized instructions for the operation of nebulizer control panels to ensure accurate settings, consistent performance, and safety during production.

2) Scope

This SOP applies to all control panels used in nebulizer production equipment within the facility, including mixing, filling, sealing, and packaging systems.

3) Responsibilities

Operators: Operate the control panels as per the instructions and report any anomalies.
Maintenance Team: Conduct routine checks and address any issues with the control panels.
Quality Assurance (QA): Validate operational settings and approve production records.
Supervisors: Ensure adherence to this SOP and oversee panel operations during shifts.

4) Procedure

4.1 Pre-Operation Checks

Ensure the power supply to the control panel is stable and properly connected.
Inspect the control panel for visible damage, loose connections, or malfunctioning indicators.
Verify that the panel’s emergency stop button is functional.
Clean the control panel surface using a lint-free cloth and an approved cleaning agent.
Record pre-operation inspection details in the Control Panel Log.

4.2 Starting the Control Panel

Switch on the control panel using the main power button.
Wait for the system to initialize and display the main menu or dashboard.
Check that all

system indicators, such as temperature, pressure, and flow rate, are within acceptable limits.

Enter the required parameters, such as batch size, processing time, and machine settings, according to the batch record.

4.3 Operating the Control Panel

Monitor the real-time data displayed on the control panel during operation.
Use the control panel’s interface to start, pause, or stop equipment as required.
Adjust operational parameters, such as speed or pressure, using the panel’s input options if necessary.
Log any changes to the parameters in the Operation Log.

4.4 Emergency Situations

Press the emergency stop button immediately in case of equipment malfunction or safety concerns.
Report the issue to the maintenance team and document the incident in the Control Panel Incident Report.
Do not resume operations until the problem has been resolved and approved by QA.

4.5 Post-Operation Activities

Switch off the control panel and disconnect it from the power supply after the production run.
Clean the control panel and surrounding area to remove any dust or debris.
Inspect the panel for any new damage or wear and report findings to the maintenance team.
Record post-operation activities in the Control Panel Log.

4.6 Preventive Maintenance

Perform a comprehensive inspection of control panel components, such as buttons, displays, and wiring, monthly.
Calibrate control panel sensors and indicators annually or as specified by the manufacturer.
Document all maintenance activities in the Maintenance Log and submit them to QA.

4.7 Safety Precautions

Wear appropriate personal protective equipment (PPE), including gloves and safety glasses, while operating or inspecting the control panel.
Ensure hands are dry and clean before touching the control panel to avoid electrical hazards.
Follow lockout/tagout procedures during maintenance to prevent accidental start-up.

5) Abbreviations

QA: Quality Assurance
PPE: Personal Protective Equipment

6) Documents

The following documents should be maintained:

Control Panel Log
Operation Log
Control Panel Incident 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: Control Panel Log

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

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

Annexure Title: Control Panel Incident Report

   Date  Panel ID  Incident Description  Action Taken  Performed By  QA Approval  
  DD/MM/YYYY  Control Panel Identifier  Details of incident  Details of corrective action  Technician Name  QA Name

Date	Panel ID	Incident Description	Action Taken	Performed By	QA Approval
DD/MM/YYYY	Control Panel Identifier	Details of incident	Details of corrective action	Technician Name	QA Name

Annexure Title: Maintenance Log

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

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