RT Journal Article
SR Electronic
T1 A Novel Combined Approach to Better Predict Sealing Performance of Luer Lock Connectivity
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 514
OP 515
DO 10.5731/pdajpst.2024.012966
VO 78
IS 4
A1 Singer, Julien
A1 Gontard, Lucile
A1 Daroji, Yetirajendra
A1 Voniez, Jimmy
A1 Rodriguez, Nestor
A1 Koschel, Diana
A1 Leverd, William
YR 2024
UL http://journal.pda.org/content/78/4/514.abstract
AB Luer systems, for example Luer-needle hub with syringe’s Luer cone tip and its Luer lock Adapter, are common interface on medical devices. One of the key questions in this application is about the safety guaranty and dose accuracy. It is then crucial to study the sealing between these elements. In this study we combine the use of Finite Element Analysis (FEA) and Multiscale Contact Mechanics (MCM) to analyze the connectivity and sealing performance of a glass syringe and a plastic needle Luer hub.This methodology has been applied before to the contact between glass and rubber and this is the first time that it is used for the contact between glass and plastic materials. The use of FEA allows to calculate the contact pressures and the nominal area of contact. The surface topographies of the two surfaces were measured, over a wide wavelength range (mm to nm). Subsequently, the air and liquid interfacial flow (leakage) is calculated using Persson’s MCM theory which considers the roughness and elasto-plasticity of the interfacial surfaces. The theoretical predictions are compared to experimental leak measurements by pressure decay method. Further analysis is conducted, evidencing the key features that are responsible for a good sealing.