SOP for Calibration of Nebulizer Temperature Sensors

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 stabilize at the reference temperature for a specified duration.

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

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

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

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