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
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 |