Measurement uncertainty analysis of single-use flow sensors

Area of Science:

• Biotechnology
• Process Engineering
• Measurement Science

Background:

• Single-use (SU) equipment and sensor technology are increasingly used in biopharma and bioprocesses, impacting development and production.
• Classical calibration methods for uncertainty determination are limited for SU sensors due to pre-assembly and lack of in-process calibration.
• Vague manufacturer specifications like '1-sigma accuracy' complicate end-user determination of sensor uncertainties.

Purpose of the Study:

• To demonstrate a method for determining measurement uncertainty in single-use (SU) sensors.
• To compare the determined uncertainty with manufacturer accuracy specifications for SU sensors.
• To provide a framework for handling and estimating sensor uncertainties in SU devices for reliable bioprocessing.

Main Methods:

• Utilized a 1/2-inch BioPAT®Flow SU sensor as a case study for uncertainty determination.
• Employed linear regression analysis to establish the upper limit of combined measurement uncertainty.
• Compared the experimentally determined measurement uncertainty against the accuracy specifications provided in the sensor's data sheet.

Main Results:

• A method for determining measurement uncertainty in SU sensors was successfully demonstrated.
• The study established a linear regression as the upper limit of the combined measurement uncertainty.
• The determined uncertainty provided a basis for comparison with the manufacturer's stated accuracy.

Conclusions:

• Accurate determination of measurement uncertainty is essential for ensuring process reliability with SU sensors.
• The developed method offers a practical approach to quantify SU sensor uncertainties.
• This work aids bioprocess engineers in better understanding and managing sensor performance in SU systems.