A new USP Class VI-compliant substrate for manufacturing disposable microfluidic devices

Area of Science:

• Materials Science
• Biomedical Engineering
• Chemical Engineering

Background:

• Microfluidic systems are increasingly used in clinical diagnostics, demanding new materials for disposable devices.
• Existing materials often face challenges in meeting regulatory requirements, manufacturing economics, and performance standards.
• There is a need for advanced substrate materials that are suitable for mass production and medical applications.

Purpose of the Study:

• To introduce and characterize a novel UV-curable polyurethane-methacrylate (PUMA) substrate for microfluidic devices.
• To assess PUMA's suitability for medical applications and disposable diagnostic devices.
• To demonstrate manufacturing compatibility and performance of PUMA-based microfluidic devices.

Main Methods:

• Development of a UV-curable polyurethane-methacrylate (PUMA) formulation.
• Medical-grade qualification of the PUMA substrate.
• Characterization of PUMA's optical, biocompatibility, and electroosmotic properties.
• Implementation of two production processes compatible with rapid prototyping.

Main Results:

• PUMA was successfully qualified for medical use, meeting regulatory and economic demands for disposable devices.
• PUMA exhibits excellent optical transparency, biocompatibility, and high electroosmotic mobility without surface modification.
• Two viable production processes were demonstrated, integrating with existing rapid prototyping methods.

Conclusions:

• UV-curable PUMA is a promising material for the cost-effective manufacturing of disposable microfluidic diagnostic devices.
• PUMA's properties satisfy the critical requirements for clinical applications, including optical clarity, biocompatibility, and fluidic performance.
• The developed production methods enable scalable manufacturing of PUMA microfluidic devices.