Standard Operating Procedure for Calibrating Nebulizer Temperature Sensors
1) Purpose
The purpose of this SOP is to provide a standardized method for calibrating temperature sensors used in nebulizer manufacturing to ensure accurate temperature readings and compliance with quality standards.
2) Scope
This SOP applies to all temperature sensors utilized in nebulizer production equipment, including mixing tanks, storage units, and sterilization chambers, within the facility.
3) Responsibilities
Operators: Assist with calibration setup and documentation.
Maintenance Team: Perform calibration and ensure proper functioning of temperature sensors.
Quality Assurance (QA): Validate calibration results and approve calibration records.
Supervisors: Ensure adherence to this SOP during calibration activities.
4) Procedure
4.1 Pre-Calibration Checks
- Ensure the calibration equipment, such as standard thermometers or temperature calibrators, is within its calibration validity period.
- Inspect the temperature sensor for visible damage, dirt, or corrosion.
- Verify that the sensor is properly connected to the equipment and power supply.
- Document the sensor details, including model, serial number, and location, in the Calibration Log.
4.2 Calibration Setup
- Disconnect the temperature sensor from the production equipment if required.
- Connect the sensor to a certified temperature calibrator or immerse it in a temperature-controlled bath.
- Set the calibrator or bath to a known reference temperature.
- Allow the sensor to
4.3 Calibration Procedure
- Record the temperature reading displayed by the sensor and compare it with the reference temperature.
- Repeat the measurement at multiple reference temperatures within the sensor’s operating range (e.g., 0°C, 25°C, 50°C).
- Calculate the deviation for each measurement and ensure it is within the acceptable range specified by the manufacturer.
- If deviations exceed the acceptable limits, adjust the sensor settings or recalibrate using the manufacturer’s instructions.
4.4 Post-Calibration Activities
- Reinstall the temperature sensor onto the production equipment, ensuring proper connections.
- Label the sensor with the calibration status, date, and next due date.
- Submit the calibration results and supporting documents to QA for validation and approval.
- Record the calibration activity in the Calibration Log and retain the Calibration Report.
4.5 Frequency of Calibration
- Routine Calibration: Semi-annually or as per the manufacturer’s recommendations.
- Post-Maintenance Calibration: After repairs or replacement of critical components.
- Annual Calibration: Comprehensive calibration by an external certified agency.
4.6 Handling Calibration Failures
- Isolate the equipment if the sensor fails calibration and report the issue to the maintenance team.
- Document the failure details in the Calibration Failure Report and notify QA.
- Replace or repair the faulty sensor and repeat the calibration process before resuming production.
4.7 Safety Precautions
- Wear appropriate personal protective equipment (PPE), including gloves and safety goggles, during calibration activities.
- Handle calibration equipment and temperature sensors carefully to avoid damage.
- Ensure all electrical connections are secure and follow lockout/tagout procedures if 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 | Sensor ID | Reference Temperature | Measured Temperature | Deviation (%) | Performed By |
|---|---|---|---|---|---|
| DD/MM/YYYY | Sensor Identifier | Reference Value | Measured Value | Deviation Value | Technician Name |
Annexure Title: Calibration Report
| Date | Sensor ID | Pre-Calibration Reading | Post-Calibration Reading | Performed By | QA Approval |
|---|---|---|---|---|---|
| DD/MM/YYYY | Sensor Identifier | Details of pre-readings | Details of post-readings | Technician Name | QA Name |
Annexure Title: Calibration Failure Report
| Date | Sensor ID | Issue Identified | Corrective Action | Performed By | QA Approval |
|---|---|---|---|---|---|
| DD/MM/YYYY | Sensor Identifier | Details of issue | Details of corrective action | Technician Name | QA Name |