A medical device manufacturer required 100% testing of several models of solvent bonded Drug Infusion Sets comprised of tubing, various connectors and a specific ranges of flow restrictors. Each model had a different flow restricting orifice designed to limit the drug delivery rate. They had been using a simple analog “floating-bead” variable area flow meter read visually by an operator who observes the meter to ensure the flow was within a band as measured by graduated lines on the meter. After the flow test, the outlet of the Set would be plugged and a pressure decay test was performed using a simple coarse analog gauge watching for a drop of 1 psig in 1 minute.
The manufacturer was having issues with the following:
Air mass flow each Set at 12 psig with part models nominally measuring 600 sccm, 800 sccm, 1400 sccm and 2700 sccm followed sequentially by a pressure decay leak test at 25 psig rejecting –0.015 psig or more in 5.0 seconds.
CTS utilized the Sentinel Blackbelt leak test instrument with 0-30 psig pressure range and 0-3000 sccm mass flow capability to complete both tests in single combination test sequence of mass flow followed by pressure decay - ?P. Using this high-resolution digital instrument, the tolerance range of each model could be much tighter (+-5% of target flow range or less). Each test generated quantified data (up to the last 5000 test results could be stored within instrument memory) which the customer could collect and utilize for trending purposes.