Standard Operating Procedure for Using Digital Thermometer
1) Purpose
The purpose of this SOP is to describe the procedure for the proper use and calibration of the digital thermometer in the pharmaceutical manufacturing of otic dosage forms to ensure accurate temperature measurements.
2) Scope
This SOP applies to all personnel involved in the use and calibration of digital thermometers in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly using the digital thermometer as per this SOP.
Quality Control (QC) Personnel: Responsible for verifying temperature measurements for accuracy.
Maintenance Personnel: Responsible for calibrating and maintaining digital thermometers in proper working condition.
4) Procedure
4.1 Calibration
4.1.1 Initial Calibration
4.1.1.1 Verify the accuracy of the digital thermometer against a certified thermometer.
4.1.1.2 Adjust the digital thermometer if necessary to ensure readings are within acceptable limits.
4.1.1.3 Record calibration results in the equipment log.
4.1.2 Daily Use
4.1.2.1 Ensure the digital thermometer is clean and free from any contaminants before use.
4.1.2.2 Insert the thermometer probe into the sample or environment to be measured.
4.1.2.3 Wait for the temperature
4.1.3 Accuracy Check
4.1.3.1 Periodically check the accuracy of the digital thermometer using a certified reference thermometer.
4.1.3.2 Compare readings and adjust the digital thermometer if discrepancies are found.
4.1.3.3 Document all accuracy checks and adjustments in the equipment log.
4.2 Maintenance
4.2.1 Routine Maintenance
4.2.1.1 Clean the digital thermometer probe with a suitable disinfectant before and after each use.
4.2.1.2 Inspect the thermometer casing and probe for damage or wear.
4.2.1.3 Replace batteries as needed and ensure the thermometer is stored correctly.
4.2.2 Troubleshooting
4.2.2.1 If the digital thermometer displays errors or malfunctions, refer to the manufacturer’s manual for troubleshooting steps.
4.2.2.2 Contact maintenance personnel for repairs or replacement if necessary.
5) Abbreviations, if any
QC: Quality Control
SOP: Standard Operating Procedure
6) Documents, if any
Calibration log
Temperature measurement records
7) Reference, if any
Manufacturer’s manual for the digital thermometer
Regulatory guidelines for temperature monitoring in pharmaceutical manufacturing
8) SOP Version
Version 1.0