Umbilicus Leak Tester
A large medical manufacturer required a machine to automatically leak test a five-lumen (port) tube, called an umbilicus, used for blood component separation.
The specification required testing the umbilicus for lumen-to-lumen and external leakage. The threshold for lumen-to-lumen leakage was 2.15 cm3/minute. The specification for external leakage was an overall pressure drop of 1 psi over a five second test period from a starting pressure of 20 psi.
The team worked with the customer to design a machine for testing the umbilicus. They had to design custom valve manifold plates. Due to the large number of connections required, small valves were mounted to an internally ported plate. This allowed an extremely compact package. The machine also utilized flow meters to detect the lumen-to-lumen leakage, and pressure transducers to monitor the pressure drop during the external leakage test. Custom spring-loaded fixtures held the umbilicus in place and accurate positioned during testing, while custom designed sealing heads and fittings were used to make a leak free seal onto both ends of the umbilicus.
outcomes and benefits
Fail-safe design, FDA compliant, Clean ergonomic design
Custom Machine Tests for Two Types of Leaks