MFMET II - Flyer

WP4 OBJECTIVE 4 Development and characterisation of a new setup and performance evaluation of integrated microfluidic systems ▪ identify the set of functional and metrological requirements by assessing user needs and current sensing and actuation technologies; ▪ design microfluidic prototype setups through conceptualization, sourcing, optioneering, and performance evaluation guidelines; ▪ create the prototype setups and qualify through interlaboratory comparisons of selected physical and biological measurements; ▪ validate the microfluidic prototype setups through experimental tests and producing protocols for their performance evaluation. WP5 OBJECTIVE 5 EARLY IMPACT: ▪ Establish new microfluidic standards to enhance product reliability and quality control, facilitating industry-wide adoption and economic growth; ▪ Devise new traceable calibration methods for particle-laden flows and particle-free flows; ▪ Fabricate and validate new standardmicrofluidic prototype setups; ▪ Promote Knowledge Transfer and Exchange between players and Standards Committees. WIDER IMPACT: ▪ Design new traceable calibration services for microfluidic devices, in particular organ-on-chip technology, to underline the reliability of the products; ▪ Knowledge Transfer and Exchange of Best Practices for the integration of elements in microfluidic devices, and quality control and validation in industrial settings. DISSEMINATION: International conferences; Peer-reviewed publications; Workshops; Training Courses; Best Practice Guide; Update of EURAMET Technical Guide 4 on the Evaluation of flowrelated quantities in microfluidic devices. WP6 Management & Coordination CONSORTIUM Metrology Institutes: IPQ – Portugal, CETIAT – France, CMI – Czech Republic, INRIM – Italy, LEI – Lithuania, LNEC – Portugal, PTB – Germany and RISE – Sweden, DTI-Denmark Companies: FOG – France, microfluidic ChipShop – Germany, Micronit – The Netherlands, IMT – Switzerland Research Institutions: Universität Freiburg – Germany, B/MSC University of Twente – The Netherlands, CEA – France, METU – Türkiye, and University of Glasgow – United Kingdom, INESC MN - Portugal Chief Stakeholder: Advisory Board: Darwin Reyes (NIST), Hiroki Nakae (JMAC), Bertrand Cinquin (ESPCI Paris), Julia Sepulveda (Microfluidics Innovation Center), Rui Martins (NOVA FCT), Mariëlle Wouters (MaterialsXpertise), Auke Kronemeijer (TNO), Nan Zhang (University College Dublin), Alexis Paul Tzannis (HSE•AG), John Crabtree (HJC consulting), Hugo Bissig (METAS), Dries Braeken (IMEC) MFMET II ESTABLISHING METROLOGY STANDARDS IN MICROFLUIDIC DEVICES Coordination: Rua António Gião, 2 2829-513 Caparica Portugal www.ipq.pt v.01 2025-10-14 SUMMARY NEEDS WP2 OBJECTIVE 2 This project aims to advance metrology research for standardization in biomedical technology, pharmaceutical and chemical industries, focusing on microfluidics, while also expanding the existing metrological infrastructure. The documents prepared within this project will be used in the standards prepared or revised by ISO/TC 48/WG 3 and other specific ISO and CEN committees. MOTIVATION ▪ Lack of metrological standards tailored for microfluidics applications → lack of harmonization of measurement procedures and results; ▪ Lack of protocols for quality control and validation of microfluidic devices → fail to guarantee safe and accurate applicability; slower replacement of animal testing; ▪ Wide range of applications including Organon-Chip, a rapidly growing market. ▪ total volume, dead volume ▪ flow resistance, pressure ▪ shear stress ▪ adsorption, absorption, leeching ▪ biocompatibility ▪ particle counting ▪ sterilization, contamination prevention ▪ bonding strength, interfacial properties Standardisation will help define common terminology, specifications, protocols, and criteria for microfluidic system design, fabrication, characterization, validation, traceability, operation, analysis, and reporting. WP1 OBJECTIVE 1 Establishment of standard procedures to metrologically assess and characterise microfluidic devices ▪ define and establish concepts and procedures for characterizing particle-laden flows, focusing on velocity, shear stress, and particle counting; ▪ assess pressure drop and flow resistance in microfluidic devices using particle-free liquids, with plans to adapt the methodologies to particle-laden flows; ▪ develop accurate measurement methods for dead volume and total volume in microfluidic systems and improve EURAMET technical guide 4. Development of protocols for the integration of elements and material characterisation in microfluidic devices ▪ integrate sensors, actuators, and fluidic components and update the 20NRM02 MFMET database. Define specifications for a universal connector; ▪ develop test protocols for evaluating absorption, adsorption, and biocompatibility of materials, especially for Organ-onChip applications. Quantify surface properties and establish coating procedures; ▪ evaluate sterilization and contamination prevention methods; ▪ develop a detailed resource for materials, emphasizing their properties and sustainability. Create guidelines for assessing material deformation during manufacturing. WP3 OBJECTIVE 3 General guidelines for quality control, validation and characterisation of microfluidic devices ▪ overview of the most relevant microfluidic components, devices and equipment. Assess current QC and validation protocols, emphasizing the differences in testing fluids (liquid vs. gas); ▪ create new leak detection methods using liquids vs gas, and develop guidelines for leakage measurements at high temperatures; ▪ develop Standardized protocols and a Good Practice Guide for burst pressure (liquids vs. gases); ▪ develop test protocols for bonding strength and produce a white paper. The specific objectives of the project are to develop: ▪ new calibration procedures to assess and characterize metrological quantities in microfluidics (e.g. flow, pressure, volume, shear stress, particle counting, biocompatibility, adsorption, absorption, leeching, etc.); ▪ new protocols for integration of components and material characterization in microfluidic devices; ▪ standards and guidelines for quality control and validation of microfluidic systems; ▪ setups for performance evaluation of integrated microfluidic devices. Validated metrological infrastructure for traceable measurements and testing Crucial for wider adoption