College - Author 1
College of Engineering
Department - Author 1
Biomedical Engineering Department
Degree Name - Author 1
BS in Biomedical Engineering
College - Author 2
College of Engineering
Department - Author 2
Biomedical Engineering Department
Degree - Author 2
BS in Biomedical Engineering
College - Author 3
College of Engineering
Department - Author 3
Biomedical Engineering Department
Degree - Author 3
BS in Biomedical Engineering
Date
3-2023
Primary Advisor
Christopher Heylman, College of Engineering, Biomedical Engineering Department
Abstract/Summary
The scope of our project involved choosing existing testing procedures and determining a viable sample size to determine an accurate leakage rate of single-use system connections (SUS). Another goal was to assess the effects of gamma irradiation on the material integrity of the hose barb to tubing connections.
Our key customer requirements included: being able to determine an overall leakage rate and making a repeatable testing process. The importance of these requirements was determined through our house of quality and Pugh charts. To achieve the requirements, we tested the leakage in low-pressure and high-pressure scenarios with a large enough sample size to meet the requirements of the central limit theorem (n=30), in order to get an accurate estimate. For a repeatable testing process, there was nothing to be changed with the hydrostatic burst test since it already included calibrated machinery and a strict SOP the operator must follow. On the flip side, Meissner’s SOP for the low-pressure gas test was vague and unclear on instructions to “manipulate” the testing sample. We decided to define “manipulation” of the sample to strictly apply the 90-degree bend, 90-degree twist, pulling in a straight line, and holding the middle and end of the tube (opposite sides of the connection). Additionally, we implemented the alternation between operators to minimize or eliminate operator bias. For specifications we looked into decreasing the observation time for testing for the low-pressure gas test. The modifications were finalized to delegating at least 2 personnel to operate the testing which reduces testing time, and the SOP was modified to shorten the waiting time from 2 minutes down to 1.5 minutes.
The result of our project was an improved SOP that made testing quicker and less susceptible to operator bias. Our testing performed with the modified SOP showed that there was no significant sign of operator bias. The data we gathered provided us with leakage rates for several hose barb connection configurations that we then compared to understand whether gamma-irradiation affects leakage. Our data indicates that gamma-irradiation negatively impacts the hose barb connection’s performance in terms of leakage and maximum allowable pressure.
URL: https://digitalcommons.calpoly.edu/bmedsp/169