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
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 |
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 |
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 |