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一次性流量传感器的测量不确定度分析

Measurement uncertainty analysis of single-use flow sensors.

作者信息

Ludolph Niclas, Haller Julian, Prediger Andreas

机构信息

PD PAT and Flow Kits, Sartorius Stedim Biotech GmbH, Goettingen, Germany.

Metrology, Sartorius Lab Instruments GmbH & Co. KG, Goettingen, Germany.

出版信息

Front Bioeng Biotechnol. 2025 Mar 26;13:1455336. doi: 10.3389/fbioe.2025.1455336. eCollection 2025.

DOI:10.3389/fbioe.2025.1455336
PMID:40206830
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11979247/
Abstract

The increased application of single-use (SU) equipment and sensor technology in biopharma and bioprocesses has a significant impact on development and production. User are faced with the question how sensor uncertainties of SU devices can be handled and estimated to ensure process reliability. The classical methods by means of calibration and resulting uncertainty determination are only transferable to SU sensors to a limited extent. Sensor elements are often delivered pre-assembled and without the possibility of in-process calibrations. Moreover, 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 determine sensor uncertainties. The purpose of this article is to demonstrate the determination of measurement uncertainty using a 1/2-inch BioPAT®Flow SU sensor as an example to accomplish a comparison 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: .

摘要

一次性（SU）设备和传感器技术在生物制药和生物工艺中的应用日益增加，这对研发和生产产生了重大影响。用户面临着如何处理和估计SU设备的传感器不确定性以确保过程可靠性的问题。通过校准和确定由此产生的不确定性的经典方法仅在有限程度上可转移到SU传感器。传感器元件通常是预先组装好交付的，无法进行过程中校准。此外，制造商的规格并未使用严格定义的术语，而是使用诸如“1-西格玛精度”之类的表述，这使得最终客户更难确定传感器的不确定性。本文的目的是以1/2英寸BioPAT®Flow SU传感器为例，演示测量不确定度的确定，以便与传感器数据手册中给出的精度规格进行比较。可以确定线性回归作为组合测量不确定度的上限： 。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7337/11979247/e200181c5eb0/fbioe-13-1455336-g014.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7337/11979247/d043da91a2ed/fbioe-13-1455336-g010.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7337/11979247/e200181c5eb0/fbioe-13-1455336-g014.jpg

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