Standard Operating Procedure for Calibrating Nebulizer Pressure Relief Valves

1) Purpose

The purpose of this SOP is to define the procedure for calibrating pressure relief valves used in nebulizer systems to ensure their reliability, safety, and compliance with operational standards.

2) Scope

This SOP applies to all pressure relief valves used in nebulizer manufacturing systems within the facility.

3) Responsibilities

Operators: Assist in calibration setup and document readings.
Maintenance Team: Perform calibration and ensure proper functioning of the valves.
Quality Assurance (QA): Validate calibration results and approve calibration records.
Supervisors: Ensure compliance with this SOP and oversee calibration activities.

4) Procedure

4.1 Pre-Calibration Checks

• Ensure the calibration equipment, such as pressure gauges and reference valves, is within its calibration validity period.
• Inspect the pressure relief valve for physical damage, dirt, or wear.
• Verify that the valve is correctly installed in the system and isolated for calibration purposes.
• Document the valve details, such as model and serial number, in the Calibration Log.

4.2 Calibration Setup

• Connect the pressure relief valve to the calibration test bench or setup as specified in the manufacturer’s guidelines.
• Attach the pressure source to the valve inlet and the pressure gauge to monitor the applied pressure.
• Ensure all connections are secure and free of leaks.

4.3 Calibration Procedure

• Gradually increase the pressure using the test setup until the valve begins to release pressure (the set-point).
• Record the pressure at which the valve opens and compare it with the manufacturer’s specifications.
• Adjust the valve set-point if it deviates from the acceptable range using the adjustment mechanism provided by the manufacturer.
• Repeat the process three times to confirm consistent performance.
• Document the results of each trial in the Calibration Report.

4.4 Post-Calibration Activities

• Reinstall the calibrated pressure relief valve onto the nebulizer system.
• Label the valve with the calibration status, date, and next due date.
• Submit the calibration records to QA for validation and approval.
• Document the calibration activity in the Calibration Log.

4.5 Frequency of Calibration

• Routine Calibration: Annually or as per the manufacturer’s recommendations.
• Post-Maintenance Calibration: After repairs, replacements, or major adjustments.

4.6 Handling Calibration Failures

• Isolate the valve and report the issue to the maintenance team if calibration fails.
• Document the failure details in the Calibration Failure Report and notify QA.
• Replace or repair faulty valves and repeat the calibration process.

4.7 Safety Precautions

• Wear appropriate personal protective equipment (PPE), including gloves and safety goggles, during calibration activities.
• Handle pressurized systems carefully to avoid accidents or equipment damage.
• Ensure proper grounding and follow lockout/tagout procedures where necessary.

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	Valve ID	Set-Point Pressure	Measured Pressure	Performed By	Remarks
DD/MM/YYYY	Valve Identifier	Specified Value	Measured Value	Technician Name	Details of calibration

Annexure Title: Calibration Report

Date	Valve ID	Pre-Calibration Reading	Post-Calibration Reading	Performed By	QA Approval
DD/MM/YYYY	Valve Identifier	Pre-Calibration Value	Post-Calibration Value	Technician Name	QA Name

Annexure Title: Calibration Failure Report

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