Antonio Nicolucci1, Luca Leonardi2. 1. Center for Outcomes Research and Clinical Epidemiology (CORESEARCH Srl), Pescara (PE), Italy. 2. Pikdare S.p.A., Casnate Con Bernate (CO), Italy.
Abstract
Purpose: To test the compatibility of PiC Insupen needles with a broad range of pens produced by different manufacturers for the injection of subcutaneously administered drugs. Patients and Methods: The "extreme" products in PiC pen needles range were considered (G33x4 mm and G29x12 mm), to verify that the compatibility was not affected by the cannula diameter and length. Following the launch of the G34x3.5mm needle, additional tests were performed comparing G33x4 and G34x3.5 pen needles. A test medium with viscosity similar to insulin was used. Additional tests were performed with a liquid with a much higher viscosity. All the requirements of the technical standard ISO 11608-2 were satisfied, and the differences between G29, G33 and G34 were negligible. Therefore, the PiC Insupen needle G33x4mm was chosen as representative of the PiC pen needles. Dose accuracy and needle hub torque were assessed, according to the ISO 11608-2:2012 norms. For pens with variable volume, two different volumes were tested (Vlow and Vhigh) in random order, testing 60 needles with Vlow and 60 with Vhigh. Results: Overall, 50 different pens were tested. Dose accuracy acceptance criteria were met for all the pens tested, with the only exception of Vhigh for Berlipen Precision pen. The removal torque was adequate for all pens, with the only exception of Berlipen 301 and Berlipen 302 pens. Conclusion: We documented that Pikdare needles are compatible with a large array of different pens for the injection of insulin and other drugs administered subcutaneously.
Purpose: To test the compatibility of PiC Insupen needles with a broad range of pens produced by different manufacturers for the injection of subcutaneously administered drugs. Patients and Methods: The "extreme" products in PiC pen needles range were considered (G33x4 mm and G29x12 mm), to verify that the compatibility was not affected by the cannula diameter and length. Following the launch of the G34x3.5mm needle, additional tests were performed comparing G33x4 and G34x3.5 pen needles. A test medium with viscosity similar to insulin was used. Additional tests were performed with a liquid with a much higher viscosity. All the requirements of the technical standard ISO 11608-2 were satisfied, and the differences between G29, G33 and G34 were negligible. Therefore, the PiC Insupen needle G33x4mm was chosen as representative of the PiC pen needles. Dose accuracy and needle hub torque were assessed, according to the ISO 11608-2:2012 norms. For pens with variable volume, two different volumes were tested (Vlow and Vhigh) in random order, testing 60 needles with Vlow and 60 with Vhigh. Results: Overall, 50 different pens were tested. Dose accuracy acceptance criteria were met for all the pens tested, with the only exception of Vhigh for Berlipen Precision pen. The removal torque was adequate for all pens, with the only exception of Berlipen 301 and Berlipen 302 pens. Conclusion: We documented that Pikdare needles are compatible with a large array of different pens for the injection of insulin and other drugs administered subcutaneously.
Authors: Michael Grabner; James Chu; Swetha Raparla; Ralph Quimbo; Steve Zhou; Joseph Conoshenti Journal: Postgrad Med Date: 2013-05 Impact factor: 3.840