4-Up Leak Test Equipment

Neuma 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.

Approach

  • Design the mechanical layout, including the device nests, system pneumatics, and operator touchpoints and safeguards.
  • Design the electrical layout, including the electronics box and its components, PLC integration, and operator touchpoints and safeguards.
  • Procure various mechanical, electrical, and pneumatic off-the-shelf components as well as custom machined components
  • Program the Zaxis vacuum decay units with a custom recipe to detect a leak threshold for a particular device.
  • 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®.

Key Accomplishments

  • Fully functional 4-up fixture which measures vacuum decay rate of four blood collection devices. The fixture is installed on a production manufacturing line in a GMP setting and was validated by gauge R&R.  The fixture requires only one operator and, assuming a typical 8 hour working day 5 days per work, it is capable of testing approximately 900,000 devices per year.
  • 3D CAD for the mechanical layout
  • Pneumatics schematic
  • Altium files for the electrical layout
  • PLC integration
  • Final fixture assembly performed in house
  • Delivered validated and ready to be installed in a GMP environment.