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Leak Testing Equipment and Medical Device Leak Testing Systems

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8640 N. Eldridge Parkway,
Houston, TX 77041,
United States of America
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USON leak testing equipment is used around the world by manufacturers of all kinds of medical devices, medical equipment and medical supplies that have specifications for leak rates – catheters, drug-eluting stents, laparoscopic surgical instruments, medical check valves, ocular surgical kits, wound care supplies, sealed device packaging and more.

Leak testing of medical devices and medical device components

When quality and patient safety require reliable leak testing of medical device components, sub-assemblies and/or fully assembled medical devices, equipment and technology, leading medical device manufacturers look to USON and its deep bench of leak testing applications engineering expertise.

USON leak testing equipment has cradle-to-grave support, from validation to re-configuration for testing new device designs. Always ‘on-call’, USON has designed more medical device leak test solutions than any other company in the world.

A detailed no-cost evaluation of best-match leak testing equipment for your medical device requirements will typically be returned to you within 48 hours by USON’s leak testing applications engineers. Similarly, a detailed proposal for semi- or fully-automated leak test assemblies will typically be returned to you within two weeks, or sooner. At your request, and also at no charge, video conference consultations are also available to discuss your leak test challenges.

The Optima vT leak and flow tester offers advanced multi-sensor leak testing within a highly configurable and versatile package. Use Optima vT to leak test both today’s and tomorrow’s medical devices.
Sprint iQ leak testing equipment can perform 13 types of tests for devices such as catheters, tube sets and other medical products and is available with up to four channels.
Vector leak testing equipment provides unrivalled speeds for unsurpassed production rates, accuracy and repeatability. Easy-to-operate Vector runs Windows® and features a
modular design allowing you expand as needed.
The Qualitek mR for multi-range (mR) leak testing is best-match leak testing equipment for accurate leak testing for light- to medium-duty medical device applications.
Eliminate destructive testing of flexible packaging for medical devices with USON’s Qualipak package testers. Qualipak flexible package integrity testing systems deliver clear objective results. No operator interpretation is necessary.

Leak and flow tester for medical devices

The unique Optima vT multi-sensor design can leak test two parts with four chambers needing different leak test or other test specifications or simultaneously test one medical device with eight compartments that need to function differently. If you want to do sequential multiple leak or other tests on each part with a throughput of more than a million parts per year this is the world’s best-match leak detector.

Optima vT was designed to not only handle leak and flow testing of the medical device designs you have today; it can be easily re-configured for medical device designs of the future.

Features that make Optima vT so versatile include: a highly intuitive and large easy-to-read operating display built both for operators and engineers programming leak test and other test sequences; ability to do any combination of flow tests, pressure decay leak tests, differential pressure decay, vacuum leak tests, occlusion or burst and cracking pressure tests, force decay leak tests and more (combining for over a half billion possible permutations on test sequences); totally customizable pneumatic configurations; built-in automated calculators; and multiple options for data handing and data storage.

Leak detector for small-volume medical device production

Sprint IQ is the leak detector used and validated for FDA compliance by the greatest number of medical device manufacturers in the world. Sprint IQ is the ideal leak tester for small-volume medical device component leak testing at the fastest throughputs. It has up to 13 different leak test modes – pressure decay, mass flow, vacuum, occlusion / burst, etc. – with the capability to run up to four tests concurrently.

Leak tester for high-volume medical device production lines

The Vector leak tester has up to ten independent leak test channels (up to two sensors, i.e. 20 independent leak tests) making it the best-in-class leak detector for high-volume medical device production lines. Any medical device that requires multiple types tests performed asynchronously – up to 20 leak and flow test types in any combination – can harness Vector, the world’s leak testing equipment ‘powerhouse’. Windows®-based, extensive I/O programming, easy integration into automated assemblies and more – Vector is designed for leak testing any size part, or for medical devices in high volumes.

Leak testing equipment for medium-volume leak testing

Qualitek MR leak testing equipment features USON’s proprietary and most sensitive differential pressure decay sensor and a wide array of other leak tests to select from, up to 32 I/O step programming, easy integration into automated assemblies, ready-to-use pneumatics and electronics. This is the best match leak detector for medium volume (up to 4l) single channel leak testing.

Non-destructive leak testing

Flexible packaging of medical devices can be non-destructively tested under vacuum for leaks with real-time monitoring during production with Qualipak, unique leak testing equipment that totally eliminates human error or requirements for highly trained operators needed for other types of package leak testers.

Semi-automated and fully automated medical device leak testing

USON Innovative Systems (UIS) provides world-class turnkey solutions for semi-automated and fully automated medical device leak testing.

UIS delivers accelerated time-to-market with a validation-centered approach, industry-leading engineering talent with a concentration on solving leak testing challenges, efficient automated systems with high reliability USON leak testers, and elimination of risks inherent with less sophisticated systems or lower quality leak testing equipment.

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8640 N. Eldridge Parkway
Houston, TX 77041
United States of America

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Bury St Edmunds
Suffolk, IP33 3SP
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31471 Utica Rd
Fraser, MI 48026
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Room 1701 Suncome Liauw’s Plaza
No. 738 Shangcheng Road
Pudong, Shanghai 200120

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