Until 2012, micro- and nano-flow rate measurements traceability was a problem, due to the lack of references at and below 1 mL·h-1. For drug delivery by infusion, uncertainty on real delivered flow rate can cause injuries or even death. Quality of volumetric dosing has to be closely controlled. Exact delivered volume and stability are critical parameters, particularly for drugs requiring low blood concentration for toxicity reasons, such as vasoactive and anesthetics. To meet this need, the national metrology laboratories LNE-CETIAT, DTI, IPQ, METAS and VSL have developed, in the scope of the European Research Project in Metrology “EMRP/HLT07 MeDD – Metrology for Drug Delivery”, calibration benches for flow rates from 600 mL·h-1 down to 600 nL·h-1. This article presents the work done at LNE-CETIAT in the scope of this project, including qualification of a calibration facility for flow rates from 1 mL·h-1 to 10 L·h-1, and temperature assessment of microflowmeters and drug delivery devices.

Key words

drug delivery devices
liquid micro-flow
gravimetric calibration
metrology for drug delivery