ISO/TR 20461:2023 Compliance in Pharmaceutical Pipette Calibration

 

Selecting lab calibration providers for your pipettes is not a trivial decision. Ensuring that your pipette calibration provider delivers accurate, reliable, and consistent results is crucial to the continued success of your pharmaceutical operations. This article will demonstrate the enhancements Bio Calibration Company, Inc. has made to its capabilities for calibrating pipettes in the pharmaceutical industry. Bio Calibration Company now accounts for all the environmental variables that affect the accuracy of your pipettes. They also include these factors in the total estimated measurement uncertainty of your pipettes, as specified in ISO/TR 20461:2023.

 

What is ISO/TR 20461:2023?

ISO/TR 20461:2023 is a technical report that guides the measurement of volume using piston-operated volumetric apparatus, such as pipettes. It details a gravimetric method, which means determining the volume of liquid delivered by weighing it under controlled conditions. This report outlines the necessary corrections, measurement steps, and contributors to uncertainty that affect calibration results. In short, it sets a recognized international framework for achieving high accuracy in pipette calibration.

 

What are the typical variables that most pipette calibration companies consider in their environment?

Most pipette calibration providers recognize a few key environmental factors during lab calibration, such as:

  • Temperature of the lab environment
  • Air pressure (altitude or barometric conditions)
  • Humidity levels

These are important, but they are only part of the picture when it comes to accurately calibrating pipettes gravimetrically. Bio Calibration Company will now consider all these variables when calibrating pipettes.

Bio Calibration Company has expanded beyond the basics. In addition to temperature, pressure, and humidity, they now account for:

  • Evaporation effects during weighing
  • Density of water based on temperature
  • Air buoyancy corrections
  • Balance performance and readability
  • Repeatability of measurements

By including all these contributors, Bio Calibration Company provides a more realistic and comprehensive estimate of uncertainty. This ensures that pipette calibration reflects the actual conditions under which your lab operates, ultimately leading to greater confidence in your results.

 

Conclusion

Pharmaceutical laboratories cannot afford uncertainty when it comes to measurement accuracy. By adopting ISO/TR 20461:2023 as a foundation and thoroughly considering all environmental and methodological variables, Bio Calibration Company delivers pipette calibration that meets the highest industry standards. This approach provides pharmaceutical businesses with the confidence that their pipettes are performing exactly as intended, thereby reducing risk, supporting compliance, and protecting patient safety.

 

 

Pipette Calibration for the Pharmaceutical Industry – Using ISO/TR 20461:2023