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Ultra-Sensitive Pressure and Flow Testing Machine

Custom automation system for medical device inspection.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.

Technical Specifications
Control System and User Interface:

Custom touch-sensitive user interface designed in WonderWare ArchestrA, running on a Windows platform with product & recipe support through SQL server.

Machine Safety:

Fully interlocked enclosure. No operator access while machine controls are enabled.

Environment:

Designed for class 1000 cleanroom environment.

Throughput:

Process dependent/varies with recipe in use.

Material Handling: Component under test is hand-loaded within a custom-made cartidge. Part I.D. and testing results are tracked throughout the process. Critical process functions are tracked via digital signature.

automated test and inspection system for medical devices