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Container Closure Integrity (CCI) Leak Testing

  • Proven InterTech Microscale Technology measures leaks down to the equivalent of a 0.5 micron defect diameter.
  • A careful review of application requirements including the Maximum Allowable Leakage Limit (MALL) will dictate the test method used.
  • Testing is consistent with ASTM requirements (F-3287-17, F-2338-09).
  • Proprietary technology is available for testing with minimal headspace volumes.
  • Pressure change, mass flow, and mass extraction under vacuum and positive pressures are available.
  • These technologies are non-destructive and deterministic allowing manufacturers to comply with GMP guidelines.
  • Applications include the Container Closure Integrity (CCI) testing of vials, assay kit assemblies, cups and combined products.
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Turnkey Solutions

Standard or custom designed test fixtures meet unique customer application requirements.

The InterTech TechPressTM is an off-the-shelf solution for product development and audit testing.

High speed inline test cells are delivered ready to integrate into the production line.

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  • MicroScale Leak Test Cell tests Medical Assay Base Assembly to < 0.02 sccm (20 microliters/minute) at 0.2 bar, at rate of 180 parts per hour.
  • Parts are leak tested to a 0.008 sccm (8 microliters/minute) at 700 mbar, at a rate of 150 parts per minute.
  • Parts are leak tested to 0.1 sccm (100 microliters /minute) limit at 8.5 psig, at a rate of 120 parts per hour.

Our Applications Engineers are on-call to provide no-cost consultations

InterTech’s turnkey test solutions 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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Test Features and Benefits

  • InterTech’s proprietary MicroScale leak test technology is reliable and offers speed and accuracy superior to competitive pressure testing methods.
  • MED75 Microscale Test Instruments are ready to use for both in the lab and on the production line.
  • Ethernet/IP capability of test instruments allows seamless integration of test data with all quality assurance systems.
  • Remote access creates significant savings in maintenance, product change-over times and reduces time to market
  • The implementation of InterTech’s deterministic test technology results in a robust product quality and traceability system.
  • 21 CFR Part 11 data requirement compatibility are built into InterTech test instruments and testing solutions.This protects manufacturers and end-users from negative product safety events.
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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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