EMRP-HLT07: Metrology for Drug Delivery

• Forschungsstelle: METAS
• Projektnummer: F-5135.30012
• Projekttitel Englisch: EMRP-HLT07: Metrology for Drug Delivery

Schlüsselwörter (Englisch)

Drug delivery devices, traceability, pulsation effect

Kurzbeschreibung (Englisch)

This project will provide traceable calibration services for drug delivery systems for flow rates down to 1 nl/min with a target uncertainty of 0.5 %. This is several orders of magnitude lower than the lowest calibration service available in Europe today which is at a flow rate of 10 µl/min with an uncertainty of 4 %. This will help to improve the reliability and accuracy of drug delivery, thereby increasing the safety of infusion technology. Hence, the ultimate goal of this project is to make drug delivery more reliable, especially for multi-pump infusion and ap-plications with very low flow rates.
The world’s first traceability chain for liquid flow rates from 150 µl/min to 1 nl/min with a target uncertainty of 0.5% will be developed. A robust micro-flow meter will be developed as well and metrological assessment of commercially available flow meters and various types of drug delivery devices will be performed. One of the focal points will be the effect of pulsation on meter performance.

This project is part of the European Metrology Research Programme (EMRP, http://www.euramet.org/index.php?id=emrp); it is partly funded by the European Union on the basis of Decision No 912/2009/EC.

Projektziele (Englisch)

The aim of the project for METAS is an improvement of the calibration services for liquid flow by means of the development of a primary standard for flow rates from 1 ml/min down to 100 nl/min with the aim of reaching 10 nl/min and a target uncertainty of 0.5 %. Moreover, the installation will be able to test the performance of flow meters for pulsating flow.

Abstract (Englisch)

In the framework of the Project, a primary standard was developed to cover the flow rate range from 1 ml/min down to 100 nl/min with uncertainties in the range from 0.1 % to 0.6 % (k=2) for steady flow and from 1 ml/min down to 1 µl/min with uncertainties in the range from 0.2 % to 2.7 % for pulsating flow.
The calibration capabilities and the corresponding uncertainties of the primary standard have been validated by means of the research inter-comparison (EURAMET.M.FF-S7). The calibration and measurement capabilities (CMC) have been submitted to EURAMET to be approved and published in the BIPM key comparison database.

Umsetzung und Anwendungen (Englisch)

The calibration facility is used for calibration of commercially available flow sensors and flow generators and for testing the influence of physical parameters as the viscosity and the back pressure downstream the flow sensor or the flow generator. The calibration facility is fully operational for testing and for calibration of flow sensors and flow generators.

Publikationen / Ergebnisse (Englisch)

• Bissig H., Tschannen M., Mikrofluidik - Kein Tropfen auf den heissen Stein, METinfo, Vol. 20, No. 1/2013, S. 23
• Bissig H., Tschannen M., Mikrofluidik - Kein Tropfen auf den heissen Stein, Laborscope, No. 6/13, S. 11
• Bissig H., Tschannen M., de Huu M., Micro flow facility for traceability in steady and pulsating flow,, Flomeko, Paris, 24. - 26. September 2013, conference proceeding
• Bissig H., Tschannen M., de Huu M., Micro Flow Standard for Steady and Pulsating Flow, 2nd International Conference on Micro Fluidic Handling Systems (MFHS), Freiburg, 8. – 10. Oktober 2014, conference proceeding
• H. Bissig (METAS), M. Tschannen (METAS), M. de Huu (METAS), Micro-flow facility for traceability in steady an pulsating flow, Journal of Flow Measurement and Instrumentation (2014), doi: 10.1016/j.flowmeasinst.2014.11.008
• Bissig H., Tschannen M., Durchflussbestimmung im Nanoliterbereich – Kein Tropfen auf den heissen Stein, CHEMIEXTRA, No. 4/15, S. 31
• Bissig H., Tschannen M., de Huu M., Primary Standard in Micro Flow for Traceability in Steady and Pulsating Flow Regime, 9th International Symposium of Fluid Flow Measure-ments (ISFFM), Arlington, 14. - 17. April 2015, conference proceeding
• Bissig H. et al., Primary Standards for Flow Rates from 100 nL/min to 1 mL/min – Gravimetric Principle, Journal of Biomedical Engineering – proceedings of the 8th workshop on ‘Low flows in medical technology’, Lübeck, September 2014, submitted