Ultra-Sensitive Pressure and Flow Testing Machine

The Pressure and Flow Test machine was custom designed to test and inspect medical device performance under a controlled environment. The fully automated inspection process starts with a digital signature from the operator for critical phases of each inspection.

After the device under test ("DUT") barcode and traveler are scanned, the DUT enters the machine within a custom cartridge. The machine automatically performs recipe-driven tests that enable:

• Measuring pressure drop (Δp) in the range of 1-mm Hg with ±0.008-mm Hg accuracy at a fixed flow rate of 16 liters/minute.

• Measuring reverse flow at a constant pressure between 0 and 250-mm Hg.

• Calculating an effective orifice area with ±0.15-cm2 accuracy.

• Viewing real-time video of DUT part performance via on-board endoscope.

The system tracks all aspects of each test including operator, test media type and age, test parameters, and test results. Forward flow is controllable to ±1% of target flow rate. All data is stored in compliance with FDA 21 CFR Part 11. A custom operator interface dynamically displays process parameters during each test. A label is automatically printed after the current test has been completed. All fluidics are segregated within a polypropylene encasement and are designed for complete drainage with automated sanitizing. Fluid is pumped via a magnetically levitated coupled pump.