对一次性流量传感器的测量不确定性分析
Niclas Ludolph1, Julian Haller2, Andreas Prediger1
1PD PAT and Flow Kits, Sartorius Stedim Biotech GmbH, Goettingen, Germany.
Frontiers in bioengineering and biotechnology
|April 10, 2025
概括
在一次性使用 (SU) 生物处理设备中估计传感器不确定性对于可靠的生产至关重要. 本研究展示了一种方法来确定SU传感器的测量不确定性,将其与制造商规格进行比较.
科学领域:
- 生物技术是生物技术.
- 工艺工程是过程工程.
- 测量科学 测量科学 测量科学
背景情况:
- 单一用途 (SU) 设备和传感器技术越来越多地用于生物制药和生物工艺,影响开发和生产.
- 对于SU传感器来说,用于确定不确定性的经典校准方法是有限的,原因是预先组装和缺乏工艺校准.
- 模糊的制造商规格,如"1-sigma准确度",使最终用户难以确定传感器的不确定性.
研究的目的:
- 展示一种方法来确定一次性 (SU) 传感器的测量不确定性.
- 为了将确定不确定性与SU传感器的制造商准确性规格进行比较.
- 提供一个框架来处理和估计SU设备中的传感器不确定性,以实现可靠的生物处理.
主要方法:
- 使用1/2英寸的BioPAT®Flow SU传感器作为不确定性确定性的案例研究.
- 采用线性回归分析来确定组合测量不确定性的上限.
- 将实验确定的测量不确定性与传感器数据表中提供的精度规格进行了比较.
主要成果:
- 成功演示了一种用于确定SU传感器测量不确定性的方法.
- 该研究确定了线性回归作为综合测量不确定性的上限.
- 确定的不确定性提供了与制造商声明的准确性进行比较的基础.
结论:
- 准确确定测量不确定性对于确保SU传感器的过程可靠性至关重要.
- 开发的方法提供了一个实用的方法来量化SU传感器的不确定性.
- 这项工作有助于生物工艺工程师更好地理解和管理SU系统中的传感器性能.
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