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WORLD LEADER IN TEST TECHNOLOGY

Medical Filter Leak Test System

Medical filters are water burst tested 15 bar limit up to 70 bar max test pressure.

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an image of medical filters to leak test
an image of InterTech's medical filter burst test stand

Test Specifications

  • Fixture is designed to accommodate various types of filter models
  • Burst pressure: 2 – 70 bar max
  • Ramp rate: 1 bar per second (programmable)
  • Burst accept limit: 15 bar depending on the filter model
  • Traceability: Scans 2D barcode and stores data to MED75y test instrument
  • Test sequencing includes:
    • Increase pressure to 10 bar in 1 bar per second increments
    • Maintain at 10 bar for 5 minutes
    • If no burst, increase the pressure to 15 bar in 1 bar/sec
    • Maintain at 15 bar for 5 minutes
    • If no burst, continue raise pressure and record the burst pressure

Features

  • 2D code scanning prior to testing enables seamless data tracking
  • Compact design minimizes floor space
  • Cost Effective: Using the MED75y burst test instrument control all machine
    functions simplifies wiring and eliminates expensive purchased components
    including a PLC.
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Our Applications Engineers are on-call to provide no-cost consultations

InterTech’s medical filter leak test system consistently lower medical device, and medical product testing costs by 25% or more. To achieve these cost reductions and maintain GMP standards, InterTech utilizes an encyclopedic knowledge base of test fixture design and a wide array of leak test technology methodologies for medical device manufacturers. Contact our applications engineers for help.

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Wetted Filter Membrane Elements are tested for diffusive flow to a 20 µL/min at 140 kPa 

The InterTech MED75y MicroScale mass flow leak detector measures diffusive flow in filter membranes as low as 1.2 micron in 23 seconds.  

The half-shell filter membranes are also leak tested for diffusive flow to a 10 µL/min at 100 kPa gauge applied upstream.

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Application

The diffusion testing of membrane filters that can only be bubble tested (not diffusion tested) by the current generation of integrity testers such as the Pall Flowstar 5. Testing in the lab or in the assembly area to meet R&D and audit testing requirements Target application: sterilization filter assemblies (generally in the range of 0.05 to 0.2 micron pore size)

Technology

Some diffusion testing basics that are used to determine application parameters

  • Diffusive Flow= k*Area*Differential Pressure
  • Diffusive Flow test pressure= 0.8 Bubble Point
  • IPA Diffusive Flow= 2-3 x Water Diffusive Flow approx.
  • IPA Bubble Point= 1/3 x Water Bubble Point approx.

IDC Test Process & Parameters

  • Pressure range: 3.0 psig - 60 psig standard - Other pressure ranges available if required
  • Instrument Flow range: 350 microliter/min Full Scale
  • Diffusion Flow Test Limit: 5-300 microliter/min

Note: in general filter area >200 cm3 will flow in excess of 300 microliters/min

have any questions?

Consult Our Experts

Please contact InterTech for further information or help with your test application. We are happy to answer any questions you may have. Give us a call at 847-679-3377 or fill out the form and we'll be in touch as soon as possible.

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