The Kymanox® design, development, and commercialization group designed, procured components, and assembled a fixture used for an in process test which is capable of performing four simultaneous vacuum decay tests in order to pass/fail blood collection devices on the manufacturing line.

Challenge

Kymanox needed to design both the mechanical and electrical layouts, program the Zaxis vacuum decay units, program the Programmable Logic Controller (PLC),
and validate the test method.

Solution

Kymanox designed the mechanical layout including the device nests, system pneumatics, and operator touchpoints and safeguards. Kymanox designed the electrical layout including the electronics box and its components, PLC integration, and operator touchpoints and safeguards. Kymanox procured various mechanical, electrical, and pneumatic off-the-shelf components as well as custom machined components to program the Zaxis vacuum decay units with a custom recipe to detect a leak threshold for a particular device and program the PLC to manage four simultaneously operating Zaxis vacuum decay units and alert operators to pass/fail conditions. The test method was validated utilizing a crossed gauge R&R (repeatability and reproducibility) with statistical analysis performed using Minitab®.

Results

Kymanox designed a fully-functional 4-up fixture which measures vacuum decay rate of four blood collection devices. The fixture was installed on a production manufacturing line in a Good Manufacturing Practices (GMP) setting and was validated by gauge R&R. The fixture required only one operator and, assuming a typical 8 hour working day 5 days per work, it was capable of testing approximately 900,000 devices per year.