Measurement Uncertainty Analysis of Single-Use Flow Sensors

Niclas Ludolph ^* Julian Haller Andreas Prediger

• Sartorius, Goettingen, Germany

The increased application of single-use (SU) equipment and sensor technology in Biopharma and Bioprocess has a significant impact on development and production. The question also arises for users as to how sensor uncertainties due to SU devices can be handled and estimated to ensure process reliability. The classical methods for verification by means of calibration and resulting uncertainty determination are only transferable to SU sensors to a limited extent. Sensor elements are usually delivered to the user sterile and without possibilities of (multiple) in-process calibration. Manufacturers' specifications do not use strictly defined terms but constructions such as (1-sigma) accuracy, which makes it even more difficult for the end customer to classify the sensor in a process with various measurement techniques and quantities. The purpose of this paper is to demonstrate the determination of measurement uncertainty using a 1/2-inch BioPAT®Flow SU sensor as an example to accomplish a comparison of the determined measurement uncertainty with the accuracy specification given in the sensor data sheet. A linear regression could be determined as the upper limit of the combined measurement uncertainty: 𝑢(𝑄) = 0.0114 𝑄 + 0,182 𝐿/𝑚𝑖𝑛