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Development of a Tool for Verifying Leakage Detection in Microfluidic Systems.

Ali Bozorgnezhad1, Luke Herbertson1, Suvajyoti Guha1

  • 1Division of Applied Mechanics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.

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Summary

A new tool accurately measures microfluidic device leaks from 0.1% to 10%. This method aids in verifying microfluidic leakage detection systems and preventing failures in medical devices.

Keywords:
failure modesleakage testingmedical devicesmicrofluidicsverification

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Area of Science:

  • Biomedical Engineering
  • Materials Science
  • Fluid Dynamics

Background:

  • Microfluidic devices are increasingly submitted to regulatory bodies like the Food and Drug Administration (FDA).
  • Leakage is a prevalent and challenging failure mode in microfluidic systems, impacting device reliability and safety.
  • Accurate detection and quantification of microfluidic leaks are crucial for medical device development.

Purpose of the Study:

  • To develop and validate a sensitive tool for measuring and verifying microfluidic leakages.
  • To establish a bench test method for assessing leak rates from 0.1% to 10% in microfluidic systems.
  • To provide a verification tool for developers of microfluidic medical devices to detect flow-mediated leakage failures.

Main Methods:

  • An analytical model was developed applying hydrodynamic resistance principles to fluid-contacting elements (tubing, junctions, connectors).
  • Leakage rates were tuned based on application-specific acceptance criteria.
  • Three polymer-based microfluidic systems (PEEK, PEEKsil, COC) were used to target and experimentally verify leakages at approximately 0.1%, 1.0%, and 10% levels.

Main Results:

  • The PEEKsil tubing system demonstrated high accuracy with experimental uncertainties of 0.00% to 1.59% across target leak rates.
  • Polyether Ether Ketone (PEEK) tubing showed higher uncertainties, ranging from 1.16% to 23.08%.
  • Cyclic Olefin Copolymer (COC) microfluidic chips exhibited errors of 7.69% and 5.05% for specific target leakages.

Conclusions:

  • The proposed bench test method offers a sensitive and reliable approach for leakage detection in microfluidic devices.
  • The methodology allows for precise tuning of leakage rates, aiding in the verification of leakage detection systems.
  • This tool can significantly assist device developers in assessing and mitigating leakage-related failures in microfluidic medical applications.