Standard Operating Procedure for Calibrating Nebulizer Flow Rate Monitors

1) Purpose

The purpose of this SOP is to establish a standardized procedure for calibrating nebulizer flow rate monitors to ensure accurate and reliable performance during quality control and production processes.

2) Scope

This SOP applies to all flow rate monitoring equipment used in the production and testing of nebulizers within the manufacturing facility.

3) Responsibilities

Operators: Assist with the calibration process and document results.
Maintenance Team: Perform calibration and ensure proper functioning of flow rate monitors.
Quality Assurance (QA): Validate calibration results and approve calibration records.

4) Procedure

4.1 Pre-Calibration Checks

• Inspect the flow rate monitor for physical damage or wear and ensure it is clean.
• Verify the calibration equipment (e.g., reference flow meters) is within its calibration validity period.
• Ensure the monitor is properly connected to the power supply and any required accessories are available.
• Document the monitor details, such as model and serial number, in the Calibration Log.

4.2 Setting Up the Calibration

• Connect the nebulizer flow rate monitor to a certified reference flow meter or a traceable calibration device.
• Prepare the setup by ensuring a stable power source and the absence of environmental disturbances, such as vibrations or air drafts.
• Input the required calibration parameters, such as flow range and units of measurement, into the monitor.

4.3 Calibration Process

• Start the calibration process by allowing the reference device to generate a series of controlled flow rates within the operating range of the monitor.
• Record the flow rate readings displayed on the monitor for each reference value provided by the calibration device.
• Compare the recorded readings with the reference values and calculate deviations.
• If deviations exceed the acceptable tolerance limits, adjust the monitor settings and recalibrate.

4.4 Post-Calibration Verification

• Repeat the calibration process after adjustments to confirm accuracy and stability of the monitor.
• Label the flow rate monitor with the calibration status, date, next due date, and technician initials.
• Submit calibration data to the QA team for review and approval.

4.5 Frequency of Calibration

• Routine Calibration: Performed quarterly or as recommended by the manufacturer.
• Post-Maintenance Calibration: Conducted after repairs or part replacements.
• Annual Calibration: Comprehensive calibration by an external certified agency.

4.6 Handling Calibration Failures

• If calibration fails, isolate the equipment and report the issue to the maintenance team.
• Document the failure and initiate corrective actions in the Calibration Failure Report.
• Do not use the monitor until recalibration is successfully completed and approved by QA.

4.7 Safety Precautions

• Wear personal protective equipment (PPE), such as gloves and safety glasses, during the calibration process.
• Handle electrical connections and equipment components with care to avoid accidents.
• Follow the manufacturer’s guidelines for using calibration equipment.

5) Abbreviations

• QA: Quality Assurance
• PPE: Personal Protective Equipment

6) Documents

The following documents should be maintained:

• Calibration Log
• Calibration Report
• Calibration Failure Report

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: Calibration Log

Date	Monitor ID	Reference Device ID	Deviation (%)	Performed By	Remarks
DD/MM/YYYY	Monitor Identifier	Reference Device Identifier	Deviation Percentage	Technician Name	Details of calibration

Annexure Title: Calibration Report

Date	Monitor ID	Pre-Calibration Reading	Post-Calibration Reading	Performed By	QA Approval
DD/MM/YYYY	Monitor Identifier	Pre-Reading (L/min)	Post-Reading (L/min)	Technician Name	QA Name

Annexure Title: Calibration Failure Report

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