Establishing metrology standards in microfluidic devices

Microfluidics, concerned with fluid-handling in the nano-to-millilitre scale, is used in medical applications for on-spot diagnosis, including pregnancy, glucose, and pH tests.
In 2019 Europe companies had a 26 % global share in microfluidics devices, a market expected to value €50 billion by 2025. Although microfluidics is helping to boost innovation in medical diagnostics and drug development products on the market are not traceable to reference standards nor do they rely on well-established metrology or calibration procedures. This is a huge obstacle for wider implementation of reliable microfluidics devices.

Building on the work of the EMPIR project Metrology for drug delivery II (MeDDII) this project focussed on the metrology necessary to support standardisation for microfluids. Factors such as flow rate and liquid properties were examined for microfluidics devices for pharmaceuticals, biomedical and mechanobiology applications and the most appropriate protocols incorporated into a EURAMET guide. Standards and guidelines for interfaces and connectivity between fluidic passages and optical-electrical connections of microfluidics components and corresponding measurement standards, from micro to macro size scales, have also been defined. Data obtained on such things as dimensioning tolerances, leakage and burst pressure will allow better comparability and connectivity of microfluidic components made between different manufactures. Results will input into standards development groups including ISO/TC 48 and ISO IWA23 for inclusion into new technical guides such as ISO-10991. Project outputs will help provide the standardisation and help accelerate the use of microfluidic devices in healthcare, pharmaceutical and innovative diagnostics applications.