Integrated Risk Management in Biomaterials Design and Manufacture

The Electrospinning Company was invited into the BIORIMA European H2020 funded project as an industrial partner due to their experience in the design, development, and manufacture of nanoscale biomaterials. As a member of the BIORIMA consortium, The Electrospinning Company contributed to the development of the Integrated Risk Management (IRM) framework and is now applying it to its processes to ensure the design and manufacture of safe nano-biomaterials.

What is BIORIMA?

BIORIMA stands for BIOmaterial RIsk MAnagement and is a project to develop a risk assessment framework for nano-biomaterials used in Advanced Therapy Medicinal Products and Medical Devices. It covers occupational, environmental, and patient health and safety risks. The consortium, made up of 41 partnering organisations from 16 different countries, came together to enable industries and regulators to develop, test and use tools for high-quality data acquisition and informed decision-making. This framework will help establish validated test methods and schemes for appropriate future safety measures for nano-biomaterials, contributing to regulatory and standardisation activities.

BIORIMA and Electrospinning Collaboration

The Electrospinning Company has worked actively with the BIORIMA consortium members since the project started in 2017. As manufacturers of medical nano-biomaterials, the Electrospinning Company contributed practical advice and applied the principles to the fabrication of a range of biomaterials that were supplied to consortium members for different applications and analyses.

One of the reference materials provided by the Electrospinning Company was a silver nanoparticle encapsulating micro-composite fibre scaffold. As part of a “Safer by Design” work package, Istituto di Scienza e Tecnologia dei Materiali Ceramici (ISTEC-CRN) (University of Bologna), a consortium member based in Italy, developed a nano silver – hydroxyethyl cellulose (nAgHEC) substitute for the particles used in the reference material. This new approach adds a cellulose tail to the silver nano particle, lowering it’s mobility and decreasing risks associated with the silver leaching out of the composite. The Electrospinning Company developed a protocol, based on their experience making the original reference material, to successfully incorporate ISTEC-CRN’s modified silver particle into a nano-biomaterial.

JOANNEUM RESEARCH HEALTH, based in Austria, are also consortium members and are the developers of the Open Flow Microperfusion (OFM) test method. OFM is a probe-based sampling method used to evaluate the pharmacokinetics and pharmacodynamics of drugs directly through the skin. The Electrospinning Company provided electrospun nanobiomaterials of the polymer PLLA with silver nanoparticles and the nAgHEC silver particles described above. The nano-biomaterials were evaluated in two tests. In the first test, they were placed on the skin to detect whether the incorporated active ingredients would leave the scaffolds and penetrate the outermost layer of the skin.

In the second test, the particles were applied directly into the skin via OFM micro-dosing to test for substance mobility in the skin.


Preliminary results indicated:

  • the silver nanoparticles from all samples did not penetrate through the intact skin barrier;
  • the pharmacodynamic effects (inflammation) of the material introduced directly into the dermal tissue (bypassing the skin barrier) were not significant;
  • the intradermal mobility of substances introduced directly into the skin was low.

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Decision Support System (DSS) Case Study

The Electrospinning Company participated in the BIORIMA case study as early testers of their Decision Support System (DSS). The DSS is a web-based system that can help screen for risks and benefits associated with new or existing nanomaterials and nano-enabled consumer products. The Electrospinning Company provided feedback and significant input to help test and improve the system.

Next Steps

The Electrospinning Company is applying the BIORIMA IRM framework to its planning for cleanroom expansion, ensuring that future workflows minimise environmental, occupational and product safety risks.

The BioRima project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 760928. To learn more about BIORIMA visit:

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