14 Jan 2021 Publications

NextGenMicrofluidics Safe-by-Design concept and (nano-)safety strategy

Safe-by-Design concept and (nano-)safety strategy

Project Deliverable by BNN
Project: NextGenMicrofluidics (Grant Agreement No. 862092) Topic: DT-NMBP-03-2019 – Open Innovation Test Beds for nano-enabled surfaces and membranes (IA)
Date of publication: January 2021
Area: DfTD
BNN team involvement: Clemens Wolf, Susanne Resch


The H2020 project NextGenMicrofluidics (NGM) addresses the production of nano-enabled surfaces (NES) and nano-enabled membranes (NEMs) based on microfluidics on large area polymer foils, aiming for high-throughput upscaling of 1 million devices per year and more.

As part of the project, BNN oversaw the development of a Safe-by-Design concept. The resulting report provided an overview of the Safe-by-Design (SbD) concept, its core principles, and its relationship with traditional chemical risk assessment. It emphasizes the adoption of SbD within the NextGenMicrofluidics OITB and its various Demo Cases, with a specific focus on safety issues related to nanotechnology.

Through the implementation of the SbD concept, safety concerns are proactively addressed right from the design phase. This approach aims to create a real-life relevant risk profile for a given material/process, identify potential exposure scenarios, reduce uncertainty related to potential hazards, analyze occupational and environmental exposure, and prioritize them. It also pursues maximizing safety along the entire value chain of the used materials. This ensures that innovative materials, processes, and products are optimized for safety. Drawing insights from state-of-the-art literature, the report examines the essential elements of risk assessment and the SbD concept, considering cross-cutting issues such as regulation, standardization, and sustainability. By incorporating the SbD concept from the outset, i.e., while specifying the development steps in the Demo Cases, it allows for creation of innovative materials/processes/products that are as safe as possible, while keeping the technical requirements, complying with current and future regulations, and keeping costs at the lowest possible level. These factors fundamentally contribute to the prevention of late development failures.

These concepts built the basis of all discussions with all partners and led to the successful achievement of safety related milestones in all applications throughout the project. It has been shown that timely addressing of safety-related issues, which is traditionally done at the end of an innovation cycle, contributes to the success of new developments.

The original deliverable is confidential and can only be viewed by project beneficiaries.

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